Operational manual for implementing HTC in clinical settings

Operational Manual for Implementing
Provider-Initiated HIV Testing and
Counselling in Clinical Settings
2010
MINISTRY OF PUBLIC HEALTH & SANITATION
MINISTRY OF MEDICAL SERVICES

Operational Manual for Implementing Provider-Initiated HIV Testing and Counselling in Clinical Settings
ii
© Kenya Ministry of Public Health and Sanitation, and Ministry of Medical
Services, 2010
National AIDS and STI Control Programme (NASCOP)
PO Box 19361
Nairobi 00200, Kenya
Tel: +254 20 2729549 or 2729502
Email: head@nascop.or.ke
Website: www.nascop.or.ke
Correct citation
[NASCOP] National AIDS and STI Control Programme. Ministry of Public Health
and Sanitation and Ministry of Medical Services Kenya. Operational Manual for
Implementing Provider-Initiated HIV Testing and Counselling in Clinical Settings
2010. Nairobi: NASCOP, 2010.
Editing : Dali Mwagore
Design concept: Conrad Mudibo
Layout : Support to Development Communication
Printing : Soloh Worldwide Inter-Enterprises Ltd.
P.O. Box 00100 - 1868 Nairobi - Kenya
Tel: +254-020-2247191, 317871,
Fax: +254-020-2220520
Email: info@soloworld.co.ke, soloworld@wananchi.com

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Contents
FOREWORD....................................................................................................vii
ACKNOWLEDGEMENTS..................................................................................ix
ABBREVIATIONS..............................................................................................xi
INTRODUCTION AND BACKGROUND
CHAPTER 1: INTRODUCTION.........................................................................1
1.1 General Principles in Implementing Provider-Initiated HTC.......................1
1.2 Target population for Provider-Initiated HTC.............................................2
1.3 Settings for HIV Testing and Counselling....................................................3
1.4 Conceptual Approaches to HIV Testing and Counselling............................3
1.5 Purpose of this Manual..............................................................................4
PRE-IMPLEMENTATION PHASE
CHAPTER 2: INITIATIING PROVIDER-INITIATED HTC ....................................5
2.1 Stakeholders’ Involvement.........................................................................5
2.2 Initiating the Process in the District...........................................................5
2.3 Initiating the Process in the Health Facility................................................6
CHAPTER 3: HEALTH SYSTEMS FOR SERVICE DELIVERY.................................7
3.1 Human Resource.......................................................................................7
3.2 Infrastructure.............................................................................................9
3.3 Supplies Chain Management.....................................................................9
CHAPTER 4: ADVOCACY AND COMMUNICATION......................................11
4.1 National and Regional Levels .................................................................11
4.2 Health Facility and Community Levels....................................................11
IMPLEMENTATION PHASE
CHAPTER 5: PROVIDER-INITIATED HTC SERVICE DELIVERY MODELS.........13
5.1 Outpatient Setting...................................................................................13
5.2 Inpatient Setting 14
CHAPTER 6: PROVIDER-INITIATED HTC PROTOCOL....................................17
6.1 Pre-test Information Giving......................................................................17
6.2 Testing.....................................................................................................17

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6.3 Post-test Counselling...............................................................................18
6.4 Confidentiality........................................................................................18
6.5 Disclosure...............................................................................................18
6.6 Testing and Counselling Children............................................................18
6.7 Couple Counselling and Testing...............................................................21
6.6 Retesting and Repeat Testing....................................................................22
CHAPTER 7: REFERRALS AND LINKAGES.......................................................25
7.1 Patient Referrals......................................................................................25
CHAPTER 8: QUALITY MANAGEMENT FOR PROVIDER-INITIATED HTC......27
8.1 Quality Testing........................................................................................28
8.2 Facility Quality Assurance Teams.............................................................32
8.3 Infection Prevention and Control in Provider-Initiated HTC Settings........32
CHAPTER 9: RECORDING AND REPORTING................................................35
9.1 Quality Data Management......................................................................35
9.2 Data Tools...............................................................................................35
9.3 Data Recording.......................................................................................36
9.4 Data Reporting........................................................................................36
9.5 Data Storage............................................................................................37
CHAPTER 10: MANAGEMENT AND COORDINATION..................................39
10.1 Role of Management Teams.....................................................................39
10.2 Role of HTC Coordinators in Clinical Settings.........................................39
APPENDICES
Appendix 1: Key Messages..............................................................................41
1.1: Reasons for HIV testing....................................................................41
1.2: Post-test counselling.........................................................................41
1.3: WHO re-testing guidelines...............................................................42
Appendix 2: HTC Protocols.............................................................................44
2.1: Determine®
assay..............................................................................44
2.2: SD Bioline®
assay.............................................................................45
2.3: Unigold®
assay.................................................................................47
Appendix 3: Protocol for Testing Children........................................................49

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3.1: Guidelines for HIV Diagnosis in Children Less than 18 months......49
3.2: Children (18 months to 18 years)......................................................50
3.3: Emancipated Minors.........................................................................51
Appendix 4: Example of a Checklist for Use by Facility Quality Assurance Teams.
......................................................................................................52
Appendix 5: Data Tools...................................................................................55
5.1: HTC Lab Register.............................................................................56
5.2: HTC Service Summary.....................................................................64
5.3: Data summry for MOH 711and MOH731.......................................67
REFERENCES...................................................................................................69

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Foreword
The Ministry of Public Health and Sanitation in collaboration with the
Ministry of Medical Services is delighted to release this Operational Manual
for Implementing Provider-Initiated HIV Testing and Counselling in Clinical
Settings. Through this publication, we aim to rapidly increase access to HIV
testing and counselling services in all health facilities by equipping healthcare
providers with skills to offer, test and counsel patients in HIV and refer them
as appropriate. This manual operationalizes the Guidelines for HIV Testing and
Counselling released in 2008.
As the main entry point to HIV prevention, care, support and treatment services,
HIV testing and counselling (HTC) is central to all HIV programmes nationwide.
HTC therefore should be provided as an ‘opt-out’ service in all service delivery
points in the health facility to ensure that there are no missed opportunities for
knowledge of status.
Provider-initiated HTC has been available in health facilities since 2004. Although
uptake has been increasing, this service has yet to attain ‘universal’ status and
more efforts are required to ensure that no patient leaves a health facility without
being offered the opportunity to be tested for HIV. Therefore, this manual will be a
guide for implementing partners on the facility entry processes that will minimize
delays and service delivery challenges. It will serve as a daily companion for
providers in all clinical settings and, together with job aids that will accompany
this manual, will increase provider capacity to plan, offer and test patients for
HIV.
We would like to emphasize, though, that provider-initiated HTC is not a new
programme. Rather, it is a concept that seeks to support healthcare providers at
the facility level to routinely offer HTC services. Additionally, provider-initiated
HTC encompasses all testing in the clinical setting including at antenatal
clinics and maternity (prevention of mother-to-child transmission - PMTCT),
and in inpatient and outpatient units (previously called diagnostic testing and
counselling). Therefore any provider with sufficient competencies in testing and
counselling, whether previously trained in PMTCT, voluntary counselling and
testing or diagnostic testing and counselling, should be able to provide provider-
initiated HTC and will not require further training unless such training will be for

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the purposes of refreshing skills and / or receiving updates.
Finally, we encourage healthcare providers including administrative and support
staff throughout Kenya to optimize the use of this manual.
Dr SK Sharif Dr Francis Kimani
Director of Public Health Sanitation Director of Medical Services

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Acknowledgements
NASCOP and the authors would like to acknowledge the following individuals
who contributed their time and expertise to the development of the
Operational manual for implementing provider-initiated HIV testing and counselling
in clinical settings. Their input, guidance and valuable feedback contributed
significantly in the development of this manual.
Dr Peter Cherutich NASCOP
Dr Anne Ng’ang’a NASCOP
James Chembeni NASCOP
Japheth Gituku NASCOP
Janet Ogega NASCOP
Yuko Takenaka NASCOP-SPEAK II
Catherine Gichimu NHRL
Hellen Komen NHRL
Dr Anne Wekesa PASCO- NAIROBI
Dr Dan Koros CDC
Emma Mwamburi USAID
Dr Paul Wekesa LVCT
Dr Lilian Otiso LVCT
Maureen Obbayi LVCT
Dr Muhsin Sheriff ICAP
Dr Frida Njogu ICAP
Isaac Munene ICAP
Beatrice Odero ICAP
Peter Maingi KNH
Christine Otieno KNH
Eliud Walutsachi KNH
Margaret Wandabwa MTRH / AMPATH
Dr Frank Mwangemi FHI
Thomas Ondimu FHI
Dr Allan Gohole JHPIEGO
Sila Kimanzi JHPIEGO
Francis Kathambana JHPIEGO
Wycklife Obwiri WRP

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Leonard Soo WRP
Dr David Bukusi KNH
JaneHarriet Namwebya FHI
I sincerely thank bilateral partners, NGOs, technical organizations and individuals
who participated in the many series of meetings and workshops to share useful
ideas in developing this document. Special and sincere acknowledgement goes
to the US Centers for Disease Control and Prevention (CDC) and Liverpool VCT,
Care and Treatment (LVCT) for the technical, financial and logistical support for
the entire process from conceptualization, peer review to final production.
In addition I would like to acknowledge the coordination and strong leadership
provided by Dr Peter Cherutich, Head of HIV Prevention at NASCOP, and his
team comprising Dr Anne Nganga (HTC manager), James Chembeni, Merina
Lekorere, Carol Ngare and Edward Musau, throughout the entire process, an
effort that ensured harmonious working environment.
Dr Nicholas Muraguri
Head, NASCOP

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Abbreviations
AIDS Acquired Immunodeficiency Syndrome
ANC Ante-Natal Clinic
CITC Client-Initiated Testing and Counselling
CCC Comprehensive Care Clinic
CDC Centrers for Disease Control and Prevention
CHW Community Health Worker
DTC Diagnostic Testing and Counselling
DASCO District AIDS / STI Coordinator
DMLT District Medical Laboratory Technologist
DBS Dried Blood Spot
ELISA Enzyme Linked Immune Sorbent Assay
HIV Human Immunodeficiency Virus
HMIS Health Management Information System
HMT Health Management Team
HTC HIV Testing and Counselling
IDU Injecting Drug Users
MOH Ministry of Health
MSM Men who have Sex with Men
NASCOP National AIDS and STIs Control Programme
NHRL National HIV Reference Laboratory
OI Opportunitistic Infection
PITC Provider-Initiated Testing and Counselling
PEP Post-Exposure Prophylaxis
SDP Service Delivery Point
STI Sexually Transmitted Infection
TB Tuberculosis
VCT Voluntary Counselling and Testing

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INTRODUCTION
AND BACKGROUND

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Chapter 1: Introduction
Provider-initiated HIV testing and counselling refers to HIV testing and
counselling (HTC) that is recommended to persons attending healthcare
facilities as a standard component of medical care in countries with a generalized
HIV epidemic. The purpose of such testing and counselling is to enable specific
clinical decisions to be made or specific medical services to be offered or both
that would not be possible without knowledge of the person’s HIV status.
Provider-initiated HTC also aims to identify unrecognized or unsuspected HIV
infection in order to interrupt HIV transmission. As a service, provider-initiated HTC
is therefore recommended to all persons attending any healthcare facility, whether
manifesting HIV-related symptoms and signs or not.
1.1 General principles in the implementation of
provider-initiated HTC
The key policy documents that have informed this operational manual are:
• Kenya national HTC guidelines, 2008
• HIV and AIDS Prevention and Control Act, 2006
• Sexual Offences Act, 2006
• Children’s Act, 2001
• Medical Laboratory Act, 1999
• Medical Practitioners and Dentists Act
• Public Health Act (Cap 242)
The KenyaNationalHTCGuidelines (2008) emphasizes that in both provider-initiated
HTC and client-initiated HTC, the three Cs - informed consent, counselling and
confidentiality - must always be observed.
Provider-initiated HTC is neither mandatory nor compulsory; it utilizes the opt-out
approach where individuals must specifically decline the HIV test after receiving
pre-test information if they do not want the test to be performed. This approach
of informed consent is similar to that required for common clinical investigations
such as chest X-rays, blood tests and other non-invasive investigations.

2
HTC should be recommended by the healthcare worker as part of the normal
standard of care provided to a patient, regardless of whether the patient shows
signs and symptoms of underlying HIV infection or of the patient’s reason for
presenting at the health facility.
In most circumstances, the healthcare worker’s recommendation will lead to
the procedure being performed unless the patient declines. The HTC guidelines
further recommend that in generalized epidemics, such as in Kenya, where an
enabling environment is in place and adequate resources are available, healthcare
workers should recommend HTC to everyone attending health facilities. This
applies to medical and surgical services, public and private facilities, inpatient
and outpatient settings and mobile or outreach medical services.
In the context of health facilities, HIV testing should be treated in a manner similar
to other methods for laboratory diagnosis and should ideally be carried out as part
of routine medical care before the onset of HIV-related symptoms. For persons
who are ill, HTC can facilitate the identification of HIV-associated disease so that
they may more readily access comprehensive care and treatment services.
Failure to offer HIV testing and counselling is substandard care and is not
acceptable.
A crucial issue is that clients or patients must receive their test results, whatever
the system used. Appropriate post-test counselling should accompany disclosure
of results.
1.2 Target population for HTC within health facilities
In line with HTC guidelines, provider-initiated HTC must target all persons visiting
health facilities. These include:
• the general population - adults, youth including adolescents and
children, and infants with unknown HIV status
• special populations - couples, families of people receiving HIV and
AIDS care and treatment, people with disabilities, populations abusing
alcohol and other drugs, survivors of sexual violence
• additional populations vulnerable to HIV infection - prisoners, long-
distance truck drivers, taxi and bus drivers, commercial sex workers,
men who have sex with men, orphans and vulnerable children, families

3
and children living on the streets, children living in a group home,
children 7–12 years, adults older than 50 years, refugees, displaced
persons and migrants, persons separated from their spouses because of
employment, and staff working in uniformed services and their families.
1.3 Settings for HIV testing and counselling
HTC can be offered in two main settings.
Community-based settings
• Outreach HTC: non-static temporary HTC sites (mobile trucks, tents,
etc.)
• Stand-alone sites: not integrated in a health facility
• Home-based testing and counselling: services provided in a home
setting
• Workplace HTC: services provided in a work site.
Health facility settings
1 Integrated HTC services: for example, VCT centres within health facility
settings
2 Routine testing in health facilities: these include testing in the context of
provider-initiated HTC, diagnostic testing and counselling, prevention of
mother-to-child transmission and early infant diagnosis.
1.4 Conceptual approaches to HIV testing and
counselling
Provider-initiated HTC
Provider-initiated HTC refers to a scenario where the service provider, who may
be a healthcare worker or other cadre of HTC provider, offers an HIV test to a
client or patient regardless of their reason for attending the health facility.

4
It is important to note that provider-initiated HTC is significantly different
from diagnostic testing and counselling (DTC). Whereas in DTC the
provider targets patients where there is a high index of suspicion for HIV
diagnosis, provider-initiated HTC opens up HIV testing and counselling to
all patients in the health facility making it part of routine care in health
facilities in Kenya.
Client-initiated HTC
In client-initiated HTC, an individual, couple or group actively seeks HTC
services at a site where these services are provided and are accessible. Previously,
in Kenya, this took place primarily in the VCT context.
Within the greater context of HTC, the service may be initiated by clients in
settings other than VCT sites such as at health facilities or in mobile sites. Client-
initiated HTC requires that persons wishing to know their HIV status take it upon
themselves to request an HIV test.
Clients may seek HTC services to guide decision-making in their personal life,
plan for the future or the future of their family, understand the symptoms they may
be experiencing, or to support personal HIV prevention efforts.
1.5 Purpose of this manual
The purpose of this manual is to operationalize the Kenya National HTC Guidelines,
which gives an overview of all forms of HTC in the country.
The overall goal is to provide guidance on how provider-initiated HTC should
be offered in health facility settings in a standardized and nationally accepted
format, as approved by the Ministry of Health through the National AIDS and STI
Control Programme (NASCOP). It seeks to empower trained personnel working in
health facilities to set up, deliver and monitor HTC services according to national
standards.

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Chapter 2: Initiating Provider-initiated
HTC
Phis section describes the process of introducing routine HTC services in health
facilities at all levels and in all service delivery points within the facilities. All
stakeholders, managers and implementers need to be involved in this process to
ensure adherence to the national policy.
To successfully initiate provider-initiated HTC, it is critical to involve the various
stakeholders and district and health facilities.
Through this document, the Director of Medical Services and the Director
of Public Health and Sanitation direct all stakeholders to provide HTC
services to all persons, including children, attending health facilities.
2.1 Stakeholders’ involvement
Stakeholders include the Ministry of Health (health management teams at the
facility, district and province levels), healthcare workers, implementing partners
and donors, non-governmental organizations, community-based and faith-
based organizations and other service providers providing direct support or
complementary services. They should be involved at all stages of implementation.
During this process, the following shall be discussed:
• Ownership of HTC within the facility
• Roles, responsibilities and expectations of the various stakeholders
• HTC coordination mechanism
• Standardized provider-initiated HTC operating procedures, tools and
other systems
• Referral mechanisms and links
• Quality control, quality assurance and quality improvement strategies
Initiating the process in the district
The district health management team (DHMT) shall convene a meeting whose
objective will be to plan to set up of HTC services within health facilities in the

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district. A detailed implementation framework shall be developed, discussed and
adopted for all health facilities in the district. The DHMT shall identify one of its
members to serve as the district HTC coordinator for purposes of mainstreaming
HTC in all service delivery points within the facilities.
Initiating the process at the health facility
Setting up HTC services in a health facility will require the following steps:
• A meeting of the health management team shall be convened whose
objective will be to plan to set up HTC services within the health facility.
The officer in charge of the facility will be responsible for coordinating
HTC services in the entire facility. However, a specific team may
be appointed to coordinate HTC activities as may be applicable. In
addition, it is recommended that each unit within the health facility
identifies and appoints a team leader.
• A needs assessment shall be conducted to identify specific gaps
and needs of the health facility such as availability of space for HTC
provision, availability of equipment and commodities, human resource
capacity and training. The assessment will be done by the HTC
coordinator with the support of the hospital management team and
other relevant stakeholders.
• A detailed implementation framework shall be developed, discussed
and adopted for all departments in the health facility. It should include
the following details:
o Facility HTC targets
o Training and sensitization of healthcare workers
o Integration of HTC into existing health facility systems
o Procurement and supply of equipment and commodities
o Monitoring and evaluation—recording, reporting and feedback
mechanisms
o Referral mechanisms and links
o Quality control, quality assurance and quality improvement strategies.

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Chapter 3: Health Systems for Service
Delivery
3.1 Human resource
The role of the human resource is critical both for attaining optimal HTC coverage
and for providing quality HTC services within the facilities. Standardized and
coordinated training, mentorship and supervision are required to achieve these.
HTC providers shall be supported and exposed to the changing disease trends
and new testing technologies through pre-service and in-service training and
continuous professional development.
Who should provide HIV testing and counselling services in
health facilities?
Every healthcare worker is expected to offer HTC information to all persons
visiting health facilities. All healthcare workers offering testing and counselling
services must receive adequate training, continuous mentorship and supervision
to ensure they provide quality HTC, and must adhere to the required policies and
standards outlined in this manual. Healthcare workers include medical doctors,
clinical officers, nurses, lab technicians and technologists, pharmacists and
pharmaceutical technologists, physiotherapists, occupational therapists, dentists,
radiologists, nutritionists, public health officers, medical social workers.
Qualified lab technicians and technologists may also perform laboratory machine-
based HIV tests such as standard ELISA, PCR and p24 antigen testing.
Task shifting for provider-initiated HTC
Healthcare workers should provide HTC services in health facilities, but in some
health facilities the assistance of well-trained and certified lay counsellors may be
required. Lay counsellors refer to non-medical personnel who have undergone
training and certification in HTC. They are mainly used to provide HTC in health
facilities offering both outpatient and inpatient services, and are not involved with
provision of other health services. Lay counsellors include community health
workers who are trained and certified to provide HTC services.

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Training service providers in HTC service delivery
All HTC service providers in the facility must be trained using the national HTC
curriculum. There are different approaches to training based on the cadre of staff
in health facilities.
Healthcare workers: Training will involve
• sensitizing all healthcare workers including senior managers not involved
in day-to-day provision of HTC services
• a residential five -day HTC training
• cascaded on-the-job training, and mentorship
• orientation for staff already trained in other HTC approaches (VCT, DTC,
etc.)
HTC providers: The comprehensive national HTC training that is tailored to the
needs of non-medical personnel.
HTC supervisors: To ensure quality, internal or external HTC supervisors shall be
trained in laboratory and / or counsellor supervision training as defined in the
National Quality Management Guidance (2010).
All the training will be cascaded through classroom-based training and on-the-
job training and mentorship as shown in figure 1. (NB: This will be based on the
national training curriculum.)

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• Mentorship
• Practising skills
• Observed practise
• Certification
Certified practising
HCWs trained to
become facility
TOT/ mentors to train
other HCWs
Training of health care workers
(residential / on-the-job training)
District and facility TOTs (mentors)
Provincial TOTs
National / master trainers
Certified healthcare workers
Figure 1: Cascaded approach for training healthcare workers.
3.2 Infrastructure
HTC shall be provided through the existing service delivery structures within
health facilities and similar to those for providing general healthcare services.
These settings include but are not limited to consultation rooms, bedsides in
wards, general wards and procedure rooms. All HTC providers should always
aspire to put in place appropriate infrastructural measures to ensure client comfort
and confidentiality.
3.3 Supplies chain management
All commodities procured for HTC in Kenya shall be approved and registered for
use by the ministries of health. The minimum commodities required for HTC are:

10
• Test kits and their accessories
• Consumables - gloves, cotton wool and spirit.
• Data tools
• Waste disposal containers
• Quality assurance package - filter papers, zip lock bags, glycine bags,
humidity indicators, desiccants, drying racks.
Distribution of commodities will be coordinated from a central level, but the
district / county level will distribute to the sites. At facility level, test kits are kept
by the laboratory (where present) or by the officer in charge.
When commodities have been received, they are recorded in the laboratory
inventory book and distributed to the service delivery points based on their written
orders and subject to submission of consumption reports. The lab in charge or the
person responsible will compile a monthly consumption report and submit it to the
district medical lab technologist by the fifth day of every month in order to receive
kits supplies in subsequent months.
Note: Every service delivery point shall store test kits and consumables safely
and securely at appropriate temperatures, and maintain a record of kits received.
Daily use and orders should be made in the Daily Activity Register.
At the district, the district medical lab technologist (DMLT) is in charge of
compiling reports, and receiving and distributing test kits. The DMLT will receive
consumption reports and orders from all sites, compile and submit them to the
national Kenya Medical Supplies Agency (KEMSA) for further compilation and
delivery of orders.
Where possible, test kits will be supplied directly to the health facilities, but in other
cases the kits will be delivered to the DMLT who will ensure they are delivered to
every health facility that requires them.
NOTE: FAILURE TO SUBMIT MONTHLY REPORTS ON TEST KITS
CONSUMPTION WILL RESULT IN FAILURE TO GET KITS FOR THE DISTRICT
OR HEALTH FACILITY

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Chapter 4: Advocacy and
Communication
It is important to promote HTC to service providers within the facility and to the
public for the following reasons:
• improve patient management
• increase awareness and acceptance of HIV testing and counselling
(HTC) by the public and healthcare workers
• increase uptake of HTC services.
Advocacy strategies shall be employed at different levels.
4.1 National and regional levels
• There will be communication from the national level to health managers
in public and private facilities requiring them to provide HTC to all
clients visiting health facilities.
• All health managers will be sensitized on provider-initiated HTC
implementation, advocacy and communication.
• Facility-based HTC service provision will be included as part of the
performance contract indicators for all managers at national, regional,
county, district and facility levels.
• National mass media advocacy campaigns will be carried out to
sensitize the public that it is their RIGHT to receive HTC services at a
health facility. These sensitization campaigns will also target healthcare
workers.
4.2 Health facility and community levels
• HTC will be integrated in all communication within the facility, e.g.
during health talks / health education at different service delivery points.
• IEC (information education and communication) materials will be
available in strategic locations in the facility. Where possible, nationally
produced IEC materials shall be used and may be adapted to suit local
contexts. Billboards relaying key HTC messages shall also be positioned
at the entrances.
• Facility-based HTC service provision will be included as part of the

12
performance target indicators of all healthcare workers.
• HTC will be included in the service charter and be integrated in all
documents in the facility.
• Healthcare workers will be continuously sensitized on provider-
initiated HTC during facility-based continuous medical education,
professional association meetings, conferences and other meetings.
HTC messaging shall form part of the key messages in the community strategy. A
variety of community-based services and events including barazas and religious
gatherings, and community-based institutions such as schools and colleges shall
be used to promote HTC.
IMPLEMENTATION
PHASE

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Chapter 5: Facility-Based HTC Service
Delivery Models
HIV testing and counselling (HTC) is now required as part of the minimum
package of care for all persons visiting health facilities. It also has a wide reach
as it targets patients visiting the hospital, their friends and relatives, and helps
identify many HIV-positive individuals and link them to care and treatment early.
Persons testing HIV negative but at high risk of infection shall be linked to more
intensive counselling and prevention services.
Given the high number of people that will be tested and counselled, it is important
to employ models that will work for different settings within inpatient and
outpatient health facilities. Optimal use of resources including human resources
is key in these settings.
5.1 Outpatient setting
The outpatient department is diverse with various departments and services:
preventive, promotive, rehabilitative and curative. Routine HTC shall be integrated
in these service delivery points in the health facility. To achieve this effectively,
this manual describes the models to be applied in the various outpatient outlets.
Depending on the circumstances, innovative approaches can also be used to
achieve universal HTC coverage.
Models in outpatient settings
This manual describes various models depending on the facility workload and
resources.
• Healthcare worker-based model
o Healthcare workers initiate, conduct the test and provide counselling.
• Laboratory-based model
o Clinical staff offer the test, provide pre-test counselling and refer the
client to the laboratory for testing by lab staff. Clinical staff give the
results and provide post-test counselling.
o The laboratory initiates and offers HTC then refers the client to the
appropriate service delivery point.
• Task-shifting model

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o In this model, lay counsellors augment the healthcare worker’s
services.
o A healthcare worker initiates the service but the actual testing and
counselling are provided by another designated HTC provider.
o A designated HTC provider initiates and offers HTC, then refers the
client to the appropriate service delivery point for clinical services.
(This is especially in case of visitors, relatives or friends accompanying
patients).
These models can all function at the same time in a health facility to get maximum
benefits (fig. 2). Healthcare workers are responsible for providing HTC to all persons
visiting health facilities and should ensure that they offer optimum services in the facility
regardless of their circumstances.
Diagnosed patients
Diagnosed friends /
relatives
Sensitization / Education
Outpatient waiting bay
Outpatient clinics
Maternal and child health
Laboratory
Physiotherapy / OT
Dental clinic
HTC provider
(Initiates and offers test)
Comprehensive HIV clinic
Other referred services;:
- Professional counselling
- TB clinic
- Family planning
- STI clinic, etc.
Laboratory
(Test and refer back
to HCW)
Healthcare worker
(initiates and offers test
or initiates and refers
for test)
Results
Figure 2. Provider-initiated HTC outpatient setting
Optimizing HTC in the outpatient setting
All attempts must be made to ensure HTC is offered optimally within the facility.
Efficiency can be improved in various innovative ways such as:
• Group information: Group information can be provided through health

15
education where clients are informed about HTC. Key messages here
include:
o HIV test is to be offered as part of comprehensive health services and
consent is implied unless the client specifically declines to take the
test
o test available and free at that set-up
o the benefits of HTC and the need to receive test results
o where to access HTC services before seeing the healthcare worker
(where appropriate) to reduce waiting time
HIV test should be prescribed alongside other laboratory tests prescribed for the
patient to reduce missed opportunities and to avoid multiple bleeding.
Multiple tests should be run concurrently in facilities with appropriate technologies
to do so, e.g. the lab-based ELISA, to reduce waiting time (this may not apply to
rapid tests).
In all settings, clients testing HIV negative or positive should be referred for
further support such as detailed post-test counselling, supported disclosure
and psychosocial support where necessary. Clients can be referred to the lay
counsellors (within or outside the facility) and to comprehensive care centres for
these services. Clients can also be linked to post-test clubs and support groups for
continued psychosocial support.
This manual recommends that a cadre of qualified counsellors be provided in
health facilities to support the management of chronic illnesses including HIV, as
well as other psychological sequelae of health conditions.
5.2 Inpatient setting
The inpatient setting refers to all departments in a health facility where patients
are admitted. These include the general wards, observation wards and maternity.
HTC is part of the required admission procedure in all health facilities; the client
has to be provided with HTC unless he / she opts out.
The patient should be tested at the outpatient setting. However, if that is not the
case, the patient must be offered the test upon admission or while in the ward.

16
Upon admission:
• All patients should be tested for HIV and given their results as part of
the admission procedure.
• In case the patient is unconscious, very sick or confused, consent for
testing should be obtained from relatives, guardians or the medical
practitioner. Counselling should be provided to them and to the patient
upon recovery.
• Where possible, HTC should be extended to spouses, relatives and
friends of the inpatients.
• HIV test results must be appropriately documented in the patient’s file
and HTC laboratory register.
• HTC provided in the wards should be part of the daily ward reports
given to facility heads and heads of departments.
• Patients testing positive for HIV must be initiated on appropriate care
and treatment while in the ward, according to the national guidelines.
• Supported disclosure shall be provided as appropriate.
Prior to discharge, discussions must be held with the patient about referral and
links to prevention and continued care and support in HIV care clinics.
Healthcare workers are responsible for providing HTC services in the
ward as part of their duties.

17
Chapter 6: The HTC Protocol
The HTC protocol has three phases:
• pre-test information
• testing
• post-test counselling
6.1 Pre-test information
Information shall be provided to individuals, couples, and parents / guardians
accompanying children during group health talks. When recommending HIV
testing and counselling to a patient, the patient’s partner or family, the healthcare
worker shall at a minimum provide them with specific information on why HTC
is being recommended. (See appendix 1 for key messages.)
6.2 Testing
Unless the patient / client specifically declines, a rapid HIV test will be conducted
as outlined in the national approved testing algorithm (fig. 2). The testing point
will be in accordance with the implementation model stated above.
Testing and interpreting results
Note: According to the national algorithm, at the time of writing this manual,
serial testing strategy will continue to be used unless otherwise revised and
officially communicated from NASCOP.
All HTC programmes will use:
Determine®
the first test kit
SD Bioline®
the second test kit
Unigold®
the tiebreaker
For details on the testing procedure with each test kit, refer to the detailed
algorithms and job aids in appendix 2.

18
Testing with ELISA
Where available, lab-based ELISA tests for HIV should be performed for all
indeterminate results or when specifically requested.
6.3 Post-test counselling
All individuals, couples and parents or guardians accompanying children must
be counselled after the test results are given, regardless of the test result. (See
appendix 1.2 for Key post-test counselling messages).
6.4 Confidentiality
Confidentiality is an integral part of standard medical practice to which all
patients / clients have a right. However, test results will be shared with other
healthcare workers providing health services to the client (shared confidentiality).
Documentation of HIV in medical records shall adhere to the same standards of
confidentiality as for any other disease. Access to HTC records shall be available
only to healthcare workers who must ensure confidentiality of the test results as
they provide confidential referrals for appropriate care services. In case of couple
counselling and testing, consent for disclosure to the partner is given during
information giving.
6.5 Disclosure
Disclosure of results to any other party can be done only with explicit consent of
the client / patient or otherwise, as prescribed in the HIV Prevention and Control
Act, 2006. Disclosure to children will be done in a guided manner that will
support both the child and the caregiver as captured below under ‘Testing and
counselling children’.
6.6 Testing and counselling children
Children should be tested as an entry point to care and treatment irrespective of
age and ability to understand. For children who are not emancipated minors
(pregnant, married, themselves a parent, symptomatic, or engaged in HIV risk
behaviour) the parent or guardian must be involved in the process.

19
Pre-test education
and / or counselling
First HIV rapid test
DETERMINE Assay
Second HIV rapid test
BIOLINE Assay
Third HIV rapid test
UNIGOLD Assay
Negative test result
counsel for negative result
counsel for negative result
Positive test result
counsel for positive result
counsel for positive result
Figure 2. Rapid HIV testing algorithm: serial testing.
In cases where the parent of the child is absent, the guardian or caregiver can
consent to HTC for the child. Healthcare workers should generally pursue testing
if it is in the best interest of the child.
Pre-test information
Information in child counselling is usually given to the parent or guardian
accompanying the child (a child in Kenya is anyone under 18 years). However,
a parent or guardian of an emancipated minor does not need to be involved
unless the minor specifically requests to have the parent involved in the process.
Age of consent for HTC: All children should be tested with informed
consent of a parent or guardian unless they are emancipated minors.
Guidelines for HIV diagnosis in children
Children shall be tested according to the approved protocol explained below.
Children less than 18 months (algorithm appendix 3.1)
• Perform routine rapid HIV antibody tests for all infants and mothers

20
presenting with unknown HIV status at 6 weeks or at first contact
thereafter to determine HIV exposure status.
• Perform routine dried blood spot (DBS) for DNA PCR for all infants
known to be HIV-exposed at 6 weeks or thereafter.
• Perform routine antibody testing for all sick infants in outpatient and
paediatric wards to establish HIV exposure status.
• Perform DBS for all HIV-exposed sick infants under 18 months.
• All HIV-exposed infants should be started on cotrimoxazole from 6
weeks of age or on first contact thereafter and referred for appropriate
care and treatment if confirmed HIV positive.
HIV-negative infant at age 6 weeks but exposed or first contact
• Perform antibody testing at 9 months.
• If HIV negative at 9 months and still breastfeeding, continue
cotrimoxazole.
• If HIV positive, perform dried blood spot for PCR to confirm infection
status
• If not breastfeeding for at least 6 weeks and HIV antibody is negative,
stop cotrimoxazole.
• Perform confirmatory antibody testing at 18 months.
Older children (18 months to 18 years)
Testing is always done with the parent or guardian to provide consent. Steps
involved include:
• Give information and orientation to test to the parent or guardian.
• Test for HIV.
• Negative result post-test counselling of child and consenting parent /
guardian.
• Positive result post-test counselling of child and consenting parent /
guardian.
Detailed testing algorithm for children 18 months to 18 years is in appendix 3.2.
Emancipated minors
Emancipated minors are children less than 18 years who are pregnant, married,

21
themselves a parent, symptomatic, or engaged in HIV risk behaviour. The minors
can go through the HTC without parental consent. Steps involved include:
• information giving and orientation to test
• HIV testing
• negative result, give post-test counselling of the minor
• positive result, give post-test counselling of the minor.
A detailed testing algorithm for emancipated minors is in appendix 3.3.
Disclosure of test results
HIV test results for all children other than emancipated minors will be given to
the parents / guardians. Disclosure of the test results to children will be based on
capacity of the child to understand and accept the result as assessed by both the
provider and the parent / guardian.
Family testing approach
When a child tests positive for HIV, the possibility that other family members
are also HIV positive should be considered. As part of standard care, healthcare
workers must therefore offer HTC to parents and siblings of all HIV-positive
children.
6.7 Couple counselling and testing
Where possible it is desirable that couples (married or unmarried partners in sexual
unions) be provided with HTC jointly. This encourages disclosure and facilitates
exploration of risk-reducing strategies to prevent HIV infection, or supportive care
and treatment services. A couple counselling session involves joint counselling,
testing and reporting of results.
The focus of couple counselling will be:
• discussing HIV / STI risks
• addressing options for risk reduction
• discussing testing and meaning of results
• providing test and results
• developing risk reduction and support plan.

22
In case any partner tests HIV positive, the provider should facilitate discussions
on positive living, staying well, living longer, obtaining support and medical care
and follow-up (fig. 3).
Figure 3. Couple counselling testing protocol
6
Introduction and orientation to session
Assess risk (May separate couple if
need be at this point but bring them back
together for test preparation)
Explore options for risk reduction
Test preparation
Test result counselling
Negotiate risk-reduction plan
Support for risk-reduction plan
Test result counselling
Identify sources of support
PWP issues
Test
Negative test results Positive or discordant test
Note – the testing and
results should be done
jointly with both members
mutually consenting

23
6.8 Repeat testing and retesting
Repeat testing
Refers to situation where additional testing is performed for an individual
immediately following a first test during the same testing visit due to inconclusive
or discordant test results; the same assays are used and where possible the same
specimen.
Retesting
Refers to a situation where additional testing is performed for an individual after
a defined period for explicit reasons, such as a specific incident of possible HIV
exposure within the past three months (window period) or ongoing risk of HIV
exposure. Re-testing is always performed on a new specimen
For specific WHO guidelines on ‘Repeat testing and retesting’, see appendix 1.2.

24

25
Chapter 7: Referrals and Linkages
7.1 Patient referrals
In all settings, all clients (both HIV negative and positive) should be referred for
prevention, care and treatment as appropriate (fig. 4). Relevant referral tools
should be utilized appropriately at all times. All efforts should be made to ensure
that all persons testing HIV positive are enrolled into care and treatment services
immediately by either escorting them to the HIV clinic or initiating treatment in
the ward as per the national guidelines.
Mechanisms should be put in place to track referrals regularly and document the
outcome for public health concerns.
Family
planning
Nutritional
counselling
PMTCT
Support
groups, alcohol
and drug abuse
counselling
Community
services
VMMC
Home-based
care
Care for
children
Blood
donation
Treatment
for OIs and
prophylaxis
ART
TB
STI testing
Psychosocial
counselling/
gender
violence
HIV testing
and counselling
Figure 4. Comprehensive referral options for persons receiving provider-initiatied HTC.

26

27
Chapter 8: Quality Management For
HTC In Clinical Settings
Quality management is an ongoing effort to provide services that meet or exceed
clients’ expectations in an equitable and acceptable manner within the available
resources. The Kenya National Quality Management Guidance (2010) provides
guidance on the quality management systems that need to be put in place at every
HTC setting.
Quality management is an integral part of any health service organization as
it addresses issues of access, acceptability, equity, safety, effectiveness and
efficiency of service delivery. Quality management therefore contributes to better
health and also creates provider and public confidence in the services provided;
this is particularly important for HTC service provision.
Quality management has three core components: quality assurance, quality
control and quality improvement.
Quality assurance is a systematic and planned approach to monitoring, assessing
and improving the quality of services on a continuous basis.
Sustained quality improvement requires both a change in attitude and a sense of
ownership of the quality of services provided by all.
Quality control is a process employed to ensure a certain level of quality in a
product or service, for example, standardized inbuilt controls for rapid test kits.
8.1 Core principles of quality assurance
Four core principles of quality assurance will be applied when implementing
provider-initiated HTC.
• Focus on clients: Within this context ‘client’ refers to service providers
(HTC providers and managers) and the consumers (patients and
community) with a goal of meeting the needs and expectations of both.
• Focus on systems and processes: Understanding and following the
different steps and procedures that should be followed to deliver
services.

28
• Focus on measurement: Collecting and using data to assess service
delivery processes to identify gaps, to test solutions and to measure
performance.
• Focus on team work: Encourages a team approach to service provision,
problem solving and quality improvement.
8.2 Quality for HTC
Quality for HTC focuses on four components: testing, counselling, data and
logistics.
Quality testing
Quality testing refers to testing that produces results that are accurate, reliable,
reproducible and timely. It is important to have in place measures to control
quality in an HIV testing site because the consequences of either a false positive
or a false negative result are great. HIV testing in HTC must be conducted as
stipulated in the National guidelines on HTC. Protocols should be pinned up
clearly on walls of every service delivery point where HTC is provided.
Quality testing involves:
• proper identification of clients, e.g. children under 18 months
• availability of appropriate infrastructure
• use of recommended testing commodities
• testing by qualified staff
• adherence to nationally approved standard operating procedures
• proper recording and documenting of tests done
• monitoring of test kit performance
• regular laboratory support supervision
• participation in external quality assurance including proficiency testing
and DBS validation to ensure testing standards are maintained. At the
time of writing this manual, proficiency testing is recommended for
all sites and DBS only for new sites and any other site that has failed
proficiency testing.

29
NOTE: Any discrepancies noted in testing must be clearly
documented and reported to the DMLT for further reporting.
Suspect batches of test kits must be put aside for further
verification by National HIV Reference Laboratory (NHRL).
Proficiency testing is a quality control function used to compare concordance
between the NHRL and HTC delivery points. The NHRL prepares different
samples of pre-known HIV status every four months and sends them to the
regional laboratories and HTC sites for testing.
At the facilities analysis is done and the results sent back to the NHRL to compare
concordance. The proficiency testing analysis at the facility should be done by
an individual HTC provider and not as a group. Every HTC provider should
participate at least twice a year and pass.
The NHRL then gives feedback to the HTC facilities. In the case of discordant
results, the NHRL should visit the facilities in question for lab supervision quarterly.
To ensure quality of rapid tests, lab supervisors will conduct quarterly supervision
on testing. During this exercise, every HTC provider will be expected to carry out
a test under their supervision (observed proficiency testing). Specific indicators,
such as waiting time, use of sufficient amount of buffer, will be checked as a
measure of quality.
Dried blood spot (DBS) : DBS entails the application of a few drops of blood,
drawn by a lancet from the finger, heel or toe, to specially manufactured absorbent
filter paper. The blood is allowed to thoroughly saturate the paper and is air dried
for several hours. DBS should be collected for
• persons with discrepant test results
• every twentieth client in new sites and in those that have failed
proficiency testing.
These blood samples are collected on a filter paper and sent to the NHRL for
external validation. Feedback to the sites allows comparison for the concurrence
of results.
Each HTC SDP service delivery point should participate in DBS collection for at
least one month a year, i.e., based on a monthly rotation of 5% of sites.

30
The DBS samples should be packaged for transport and taken to the DMLT
who sends them to the NHRL via the courier services contracted by NASCOP.
The samples should be accompanied by a DBS submission form signed by the
facility in charge and the DMLT. Where this is not applicable, the samples can
be sent directly to the NHRL, and a report given to the DMLT who is the overall
coordinator of all HTC quality assurance and quality control activities in the
district. All service providers performing HIV testing must be conversant with
DBS collection (DMLT can provide additional training for those not competent).
Quality counselling
Quality counselling for HIV testing in medical settings involves providing and
clarifying information to clients about the HIV test to facilitate informed decision-
making regarding the test. It explores mechanisms of disclosure and partner or
child testing, addresses client’s health-related needs and access for the same
including appropriate referrals.
Provision of quality counselling requires that providers adhere to the following:
• adhere to counselling protocols (see appendix 1)
• undertake self-assessment
• seek continuous professional development e.g. through continuous
medical education and other capacity building forums
• access regular counsellor supervision / debriefing sessions.
Debriefing sessions will be conducted by trained HTC supervisors identified
among senior health providers who are respected by their peers.They will conduct
regular supervision of HTC providers during scheduled debriefing sessions to
ensure quality counselling.
Matters to be addressed in these sessions include:
• administrative and management issue, e.g. logistics, client flow systems
• staff motivation
• psychological issues such as HTC provider burn out, challenges
experienced
• client-based issues such as difficult clients with several challenges
• ethical issues such as client–provider relationship.

31
Debriefing sessions should be integrated into existing facility structures. The
sessions may be conducted during continuous medical education settings or on
demand. The meetings can be at departmental level for large facilities or at facility
level for health centres. Providers who feel the need for further debriefing will be
provided with the same on demand.
Quality logistics
Quality logistics should be integrated and strengthened within the existing
hospital / facility logistics and procurement processes. Quality logistics involves
proper procurement, storage, distribution and inventory control of the testing
commodities.
Proper procurement includes quantifying and forecasting, and ordering and
receiving testing commodities from district stores to facility stores. Proper
procurement guarantees that adequate HTC commodities like test kits,
consumables, data registers, etc., are acquired based on the current utilization
levels at the facilities and the required commodities to sustain future HIV testing
at the facility. This is guaranteed by maintaining proper records and inventory
controls every month. These records include daily activity registers and monthly
consumption data registers and requisitions.
Proper storage, especially of testing commodities, assures security by shielding
testing commodities from elements that affect their quality like temperatures,
theft, rodents, fires, pilferage, etc.
Proper distribution of HTC commodities ensures that movement of commodities
from one point to the next within a facility is done effectively and efficiently to
avoid wastage, damage, losses and stock outs.
Quality data management
Data generated and submitted for HTC should have the following elements: be
accurate, timely, complete, concise, legible. Internal and external data quality
assurance mechanisms must be implemented by the relevant supervising
authorities on a regular basis.
Quality data management entails having:
• appropriate tools for collecting and analysing data

32
• accurate recording and entry
• reporting and feedback mechanisms
• confidential and proper storage of client / patient records.
Refer to chapter 9 for more on data management, tools and storage.
8.2 Facility quality assurance teams
Each facility must establish a facility quality assurance team to ensure that
minimum standards for service delivery are maintained at all times and in all
departments. The teams should be multidisciplinary and should meet on a regular
basis to assess the services provided by the various departments. Ideally, the
regularity of these meetings is determined by the team but should be held at least
quarterly. The teams should visit the departments using checklists (see appendix
5) and previous supervision reports and give immediate feedback.
The facility quality assurance teams together with other service providers in
various departments within the facility should discuss possible ways of improving
performance in weak areas and assess performance at least quarterly.
The following elements constitute minimum standards for provider-initiated
HTC service delivery at any facility that can be assessed by the facility quality
assurance teams:
• IEC materials available at the reception / waiting bays
• test kits and buffers available and within expiry dates and properly
stored
• safety guidelines available and well displayed
• DBS regularly submitted to reference lab (last submission date)
• client records stored in confidence
• appropriate national data collection and reporting tools used
• health talks conducted daily
• staff duty rota in place—responsibilities allocation
• patient referral system functional

33
8.3 Infection prevention and control
Waste management
Waste management involves the proper management of generated waste. It should
be practised in the entire facility and not just within HTC settings. Contaminated
and non-contaminated solid waste and sharps should be disposed of in separate
special waste bags bearing a ‘biohazard’ label. The bags should be properly
sealed and incinerated. Contaminated liquid waste should be poured into the
drainage followed with plenty of water.
All facilities that provide HTC services but do not have incinerators should identify
a nearby facility or institution that can offer the service, request the service and
agree on the terms of incinerating.
Infection prevention
Standard operating procedures (SOPs) for providing provider-initiated HTC
should be available in all service delivery points in a health facility and should be
strictly adhered to. They should be clearly displayed on walls so that all service
providers can easily access them. SOPs should also give clear guidelines on
infection prevention and waste management.
Infection prevention entails:
• wearing protective clothing and gloves before performing tests. Lab
coats must be worn at all times in the facility and removed when taking
meals or leaving the facility.
• washing hands before beginning any procedure and in between
patients.
• proper handling and disposing of waste, especially biohazardous
material
• cleaning biohazardous waste, e.g. in case of blood spills
• making vaccines and treatment available in case of occupational
exposure. This includes post-exposure prophylaxis and hepatitis B
vaccine.

34
Post-exposure prophylaxis (PEP)
In case a HTC provider is accidentally pricked during testing, the site should be
washed with water and soap and the bleeding arrested by holding with a piece
of cotton wool, but without applying pressure. The provider should then take an
immediate dose of PEP from pharmacy staff or designated health service provider
before seeing a clinician immediately or within 72 hours for risk assessment and
management.
In case of high-risk exposure, antiretrovirals for PEP are initiated for a few days
to allow the provider time to undergo an HIV test. If the test result is negative,
the provider should complete the whole 28-day course of PEP. PEP adherence
counselling is important and must be provided. Possible side effects of PEP should
be explained.
If the provider tests HIV positive, the attending clinician should stop the PEP
immediately and refer the HTC provider to comprehensive care clinic for care
and follow up. PEP must be administered according to the national antiretrovirals
guidelines.
Hepatitis B
Hepatitis B is a viral infection transmitted through contact with contaminated
blood or body fluids from an infected person. It is recommended that all healthcare
workers be vaccinated against hepatitis B. Healthcare workers who have never
been vaccinated and those who have not been vaccinated in five years should be
referred to the lab for screening.
For those who test negative, the first dose of the hepatitis B vaccine should be
administered, followed by subsequent doses 3 and 9 months after the initial dose.
Upon testing positive for Hepatitis B, the provider should consult a clinician for
management and follow up.

35
Chapter 9: Recording and Reporting
The national health management information system (HMIS) provides a monitoring
and evaluation framework for HTC programs in Kenya. The specific data tools to
be used are attached in appendix 4.
9.1 Quality data management
To ensure quality, accurate measures of performance are needed. Service providers
shall maintain registers and generate required accurate and current reports. The
relevant records officers shall be expected to:
• collect, summarize, submit and store the reports appropriately
• ensure the data and reporting tools are available at the service delivery
points.
HTC coordinators in collaboration with relevant health records and information
officers shall ensure that:
• the data and reporting tools are used appropriately at the service
delivery points
• they conduct regular internal data quality audits
• the data and reporting tools are available at the service delivery points
• they analyse and give appropriate feedback on data generated.
Management teams should receive, review reports and give appropriate feedback
on a regular basis (see appendix 4.1 for the HTC quality assurance monitoring
tool) The teams should also analyse and use the data as a monitoring and quality
improvement tool. Regular audits will be undertaken to ensure the accuracy of
data and data collection systems by relevant supervising authorities.
9.2 Data tools
1 The HTC Lab Register (appendix 5.1) is a department-based document
where all persons who are offered the HIV test by healthcare workers are
entered. This includes patients seeking healthcare at the health facility, their
family members as well as their partners. Each service provider point should
have one HTC register to ensure all the work done is captured.

36
2 The HTC service summary (appendix 5.2). Each service delivery point
will summarize its data in the summary tool on a monthly basis. This
information will be summarised appropriately at all levels.
3 MoH 711 form (appendix 5.3)- the facility summarises HTC data from
all departments and records in HTC section of MoH 711 form. This is
the tool used by health facilities to report HTC and other services to the
national level.
4 A national referral tool should be made available at all SDPs to facilitate
referral of HIV-positive and -negative clients for other services within or
outside the health facility.
5 Clinical notes. Test results and date of test should be clearly documented
on every patient’s clinical notes to facilitate decision-making.
Where desired and specifically requested by the client, written results should be
provided to the client.
9.3 Data recording
Where services have been offered in the wards, the healthcare worker should fill
out the form after providing HTC and before either the patient leaves the room
or the healthcare worker leaves the room (fig. 5). Data recording is guided by a
data collection guide / dictionaries (appendices 5.1a; 5.2a; 5.3a). The service
providers should ensure all the information required is captured in the tools as
specified and confidentiality is maintained at all times.
9.4 Data reporting
Monthly HTC service summary (appendix 5.2) is the monthly summary report
prepared by the HTC service providers at each department. The officer in-charge
of each department should ensure that this report reaches the hospital records
office before the fifth day of the following month. For example, the report for
the month of January should reach the hospital records office before the fifth of
February to be submitted to the district records office by the fifth. A duplicate
copy of the report should be left at the HTC point.
The MoH 711 (appendix 5.3) is the monthly summary report for HTC (and other
services) at the health facility. The report is compiled by the health records officer

37
after receiving the departmental HTC summaries. The health records officer
prepares the report by keying in the various departmental reports onto one report
form. The report generated should be shared with the HTC service providers, the
hospital management teams and the national programme through the established
systems: district health records and information officer / DASCO to district
health records and information officer PHRIO / PASCO to health management
information system / NASCOP).
Timely submission of reports is important so that national and provincial databases
are accurate and current.
9.5 Data storage
All data tools should be kept and stored safely to ensure confidentiality is
maintained at all times while enabling service providers to access the information.
Patients / clients should not have access to the tools which have patient details.
Figure 5 shows the data flow for routine HMIS data in Kenya.
Figure 5. Data flow for routine HMIS data in Kenya.
Health facility: dispensary,
health centre, hospitals
Summary report (MOH711A) from
source documents: registers and tools
(paper based)
Aggregate facility reports into
aggregated district report, MOH
711B, which is then uploaded into
the FTP (file transfer protocol) system
Aggregate district reports into
provincial and national summary
reports
National HMIS
District level
NASCOP, NACC, other national bodies

38

39
Chapter 10: Management and
Coordination
A strong management and coordination team is key to the success of programmes.
Effective and efficient management of HTC requires that members of the national
office (NASCOP), the provincial, district and facility health management teams
and departmental heads in the health facility ensure establishment, ownership
and coordination of the programme. A coordinator for HTC in clinical settings at
national to facility level should be identified by the teams. The management team
and the HTC coordinator have specific roles to play.
10.1 Role of management teams
These principles apply to facility management teams at national, provincial,
district levels. Their role is to:
• be champions of HTC
• provide guidance and leadership to all staff on provider-initiated HTC
• identify an HTC coordinator, preferably an officer who commands the
respect of all staff and understands the concept of provider-initiated
HTC
• ensure that HTC is included as a performance contract indicator for all
healthcare workers.
• set HTC performance targets for all staff
• provide supportive environment for provider-initiated HTC service
provision
• provide supportive supervision and mentorship to the staff
• ensure quality is maintained at all times
• routinely review performance and give appropriate feedback
• conduct training needs assessment and recommend staff for training.
10.2 Role of HTC Coordinators in clinical settings
• Coordinate day-to-day HTC activities in the facility / district to ensure
targets are met.
• Ensure availability of HTC commodities when and where required—test
kits, gloves, swabs, etc.

40
• Data management: ensure data tools are available and used at all
service delivery points, collecting reports, summarizing and forwarding
them to the relevant offices
• Supervision: provide monitoring and support supervision
• Training: provide or recommend staff for training (on-the-job training or
residential), mentorship and updates to all staff providing HTC
• Ensure quality is maintained at all times including quality control for
testing at all service delivery points
Note: The coordinator must be well informed and practising HTC to be able to
provide leadership, mentorship and supervision.
APPENDICES

41
Appendix 1: Key Messages
1.1 Reasons for HIV testing
Individuals and couples
• Possibility of illness caused by HIV immunosuppression
• Discordance (30% to 50% of couples where one partner is positive are
discordant)
• Prevention of mother-to-child transmission
• Knowledge of one’s HIV status
• Management of HIV disease
• Disclosure
• Reduction of stigma
Children
• Possibility of illness caused by HIV immunosuppression
• Prevention of mother-to-child transmission
• Management of HIV disease
• Disclosure
• Reduction of stigma
• Discussion of HIV testing with parents and family
1.2 Post-test counselling
Counselling for those who test HIV negative shall include:
• An explanation of the test result, including information about the
window period and a recommendation to re-test in case of a recent
exposure
• Basic advice on prevention of HIV transmission
• Provision of male and female condoms and guidance on their use where
feasible
• Where need be, referral to more extensive post-test counselling or
additional prevention support, e.g. harm reduction interventions
including clean needles and syringes for injecting drug users
• Encourage and offer referral for testing and counselling of partners and
children.

42
Counselling for those who test HIV positive shall include:
• Simple and clear information on the test result
• Helping the client cope with emotions arising from the test result
• Discussing any immediate concerns and identifying any available and
acceptable social supportive network
• Describing follow-up services that are available in the health facility and
in the community such PMTCT, care and support services
• Getting basic information on prevention of transmission of HIV
• Providing male and female condoms and guidance on their use where
feasible
• Basic information on preventive health measures such as good nutrition,
use of cotrimoxazole and, in malaria areas, insecticide-treated bed nets
• Discussing possible disclosure of the result
• Encouraging and offering referral for testing and counselling of partners
and children
• Arranging a specific date and time for follow-up visits or referrals for
treatment, care, counselling, support and other services as appropriate
(e.g. TB screening and treatment, prophylaxis for opportunistic
infections, STI treatment, family planning and antenatal clinic).
1.3 WHO re-testing guidelines (www.who.int / hiv)
Why do we need re-testing guidelines?
• Limit unwarranted testing
• Limit waste of resources
• Foster early detection of HIV infection
• Enhance early referrals
The objective of the new guidelines is to:
• Explain why it is not advisable to recommend re-testing for HIV for all
populations and in all settings
• Clarify the specific populations and settings in which persons who
previously tested HIV negative can benefit from re-testing
• Provide timeframe for retesting
• Illustrate messages for the different scenarios

43
Recommendations for re-testing:
1 Based on population and settings
2 Based on risk
3 Based on indeterminate result - Re-test after two weeks
Based on population and settings: Generalized epidemic (Kenya has a generalized
epidemic)
1 Pregnant - Re-test in third trimester or in labour
2 Symptomatic patients (STI and TB) - Re-test after four weeks and in
every new episode of STI
Based on risk:
1 HIV-negative persons with on-going risk behaviours - Retest annually
o IDUs, MSMs, sex workers
o Persons with HIV-positive partner
o Persons with partners of unknown HIV status
2 HIV-negative persons who have had a specific incident of known HIV
exposure within the past three months - Re-test after four weeks
3 HIV negative persons who have had a specific incident of possible HIV
exposure within the past 72 hours - Re-test after 4 weeks and 12 weeks
Summary of situations requiring re-testing
Re-testing is recommended for HIV-negative persons who:
• have an indeterminate HIV test result
• are pregnant women who have tested negative in the first or second
trimester
• have an STI
• are outpatient with clinical findings suggestive of HIV
• have an ongoing risk of acquiring HIV
• have specific incident of exposure in the past three months
• have possible HIV exposure in the past 72 hours

44
Appendix 2: HTC Protocols
2.1 Determine® assay
Preparation
• Have all the requirements in place (swabs, lancets, chase buffer,
disposable specimen capillaries)
• Remove the test device from the foil pouch; place it on a flat surface.
• Label test device with client code.
• Identify and disinfect the finger with alcohol swab.
• Puncture / prick by lancet

45
2.2 SD Bioline® assay
Preparation
• Have all the requirements in place (swabs, lancets, assay diluents,
disposable specimen droppers)
• Remove the test device from the foil pouch; place it on a flat surface
• Label test device with client code
• Identify and disinfect the finger with alcohol swab
• Puncture / prick by lancet.
Then
• Collect blood up to the black line (10 µl) of the disposable dropper.
• Put one drop (whole blood – 20 µl) to the sample well of the test device
labelled ‘S’.
• Add four drops of assay diluents.
• Read test results within 5–10 minutes.
Interpreting test results
Negative result
The presence of only one coloured band in the (control band C) in the result
window indicates negative result for HIV.
HIV-1/2
C 2 1
C T
S
Positive results
• The presence of two coloured bands (‘1’ and ‘C’) in the result window
indicates a positive result for HIV-1.
• The presence of two coloured bands (‘2’ and ‘C’) in the result window
indicates a positive result for HIV-2.
• The presence of three coloured bands (‘1’, ‘2’ and ‘C’) in the result
window indicates a positive result for HIV-1 and HIV-2.

46
HIV-1/2
C 2 1
C T
S Invalid 1
HIV-1/2
C 2 1
C T
S Invalid 2
HIV-1/2
C 2
C T
S Invalid 4
C T
HIV-1/2
C 2
C T
S Invalid 3
Positive for HIV-2
HIV -1/2
C 2
1
C T
S
HIV -1/2
C 2
1
C T
S
Positive for both
HIV-1 and HIV-2
HIV -1/2
C 2 1
C T
S
Positive for HIV-1
Invalid results
If the control ‘C’ band is not visible in the result window after performing the
test, the result is considered invalid.
HIV-1/2
C 2 1
C T
S Invalid 1
HIV-1/2
C 2 1
C T
S Invalid 2
HIV-1/2
C 2
C T
S Invalid 4
C T
HIV-1/2
C 2
C T
S Invalid 3
Positive for HIV-2
HIV -1/2
C 2
1
C T
S
HIV -1/2
C 2
1
C T
S
Positive for both
HIV-1 and HIV-2
HIV -1/2
C 2 1
C T
S
Positive for HIV-1

47
Please note:
Interpret results within 10 minutes. Interpretation delayed beyond 10 minutes
may not be true and may give false positives or negatives.
Summary
• Negative will have only one line on the ‘C’ (control)
• Negative and positive MUST have a line on the ‘C’ (control)
• Only Positive can show 3 lines
• Invalid will have no line on the Control (C) or may have no line
anywhere
• If you forget everything else, please DO NOT forget these details!
2.3 Unigold® assay
Test principle
• HIV-1 HIV-2 antigens
• Lateral flow
Test components
• Test devices
• Wash reagent
• Instructions manual
• Disposable pipettes
Preparation
• specimen, pipettes).
• Remove the test device from the foil pouch; place it on a flat surface.
• Label test device with client code.
• Identify and disinfect the finger with alcohol swab.
• Puncture / prick by lancet.
And as you already know…
• False positive results are a personal disaster for the client
• False negative results are a public health hazard.

48
Add 2 drops of sample (whole blood,serum,plasma)
Add 2 drops of Wash Reagent
Allow to develop (10 min)
Interpret results
POSITIVENEGATIVE INVALID INVALID

49
Appendix 3: Protocol for Testing
Children
3.1 Guidelines for HIV diagnosis in children younger than
18 months
Conduct maternal or infant HIV antibody test for all children
of unknown HIV status to establish HIV exposure status
HIV-exposed child 18 months of age
DNA PCR positive
Infant is infected
Start on ART
Continue Cotrimoxazole
Child likely uninfected but
continue with follow up
HIV antibody negative
Review and repeat antibody
test at 18 months
In BF babies, repeat antibody
test 6 weeks after cessation
of BF
If HIV antibody positive, treat as
per national guidelines
If HIV antibody negative, stop
Cotrimoxazole but continue with
routine under 5s follow up
HIV antibody positive
DNA PCR positiveDNA PCR negative
Start on ART
Continue Cotrimoxazole
Review and repeat
antibody test at 18 months
In BF babies, repeat
antibody test 6 weeks
after cessation of BF
Conduct diagnostic antibody HIV test at 9 months irrespective of wellness of child
or before 9 months if child develops signs or symptoms suggestive of HIV
DNA PCR negative
Never breastfed
Establishing HIV exposure of children
Exposure status should be determined for
all infants of unknown status at the 6-week
visit or first contact,using maternal
medical information,maternal or infant
Ab testing.
ART recommendations for HIV-positive children
All children confirmed HIV-positive through DNA PCR at 6 weeks
or aged 18 months at first contact should be initiated on ART
immediately regardless of CD4 count or percentage,and regardless
of their WHO clinical staging.A CD4% baseline test should be
taken for monitoring purposes.
Children aged 18 months confirmed HIV positive,should be
initiatated on ART based on CD4 and/or WHO clinical staging.
Ever breastfed or breast-
feeding infant remains at
risk of HIV infection until
complete cessation of
breastfeeding (BF)
Conduct virologic diagnostic test (DBS for DNA PCR) at 6 weeks of age or at ﬁrst contact after 6 weeks
Start Cotrimoxazole at 6 weeks

50
3.2 Children (18 months to 18 years)
Session Key steps
1. Information giving
and orientation to test for
parent / guardian
o Introduce the session
Reasons for testing
Benefits of testing
Explain HIV testing process
o Obtain consent to test
o Discuss and agree involvement of parent /
guardian in session
o Discuss understanding of test results
2. HIV testing o Draw blood of child
o Review understanding of test result with
parent / guardian
3. Negative result post-
test counselling of child
and consenting parent /
guardian
Negative result
o Provide test result
o Discuss understanding of results
o Review risk-reduction plan
o Identify support for risk-reduction plan
o Discuss referral to other treatment services
4. Positive result post-
test counselling of child
and consenting parent /
guardian
Positive result
o Discuss understanding of results
o Discuss referrals to care and treatment
options
o Discuss transmission reduction
o Discuss persons with disability, positive
health dignity and prevention
o Discuss coping, mutual support and
disclosure

51
3.3 Emancipated minors
Session Key Steps
1. Information giving and
orientation to the test for
children
o Introduce the child pre-test session
Reasons for HIV testing
Benefits of HIV testing
Explain HIV testing process
o Consent individual to test
2. HIV testing Draw blood of child
Review understanding of test result
3. Negative result post-test
counselling of child
Negative result
o Provide prevention messages
o Discuss disclosure to parent / guardian
o Discuss prevention options
o Refer to other available prevention
services
4. Positive result post-test
counselling of child
Positive result
o Discuss disclosure to parent / guardian
o Discuss prevention with positive results
o Refer to available care and treatment
services site

52
Appendix 4: Example of a Checklist
for Use by Facility Quality Assurance
Teams
HTC Quality Assurance Monitoring Tool
Name of site / facility……………………….. Province ………………
District……………………
Name of supervisor / QA officer 1.
2.
Date
Quality aspects being assessed Yes No Remarks
A General
Working time clearly displayed?
General cleanliness of facility / section
maintained?
IEC materials available at the reception?
B Critical aspects
Trained provider-initiated HTC providers
Confidential storage of client records in
place?
Provider-initiated HTC counselling
protocols available and followed
Testing protocols available and followed?
Test kits available and within expiry
dates?
Test kits properly stored?
Recommended testing algorithm and
SOPs used?
Other non-pharmaceutical commodities
available (e.g. gloves, cotton, gauze, jik)

53
Protective clothing available and used
during testing?
Safety guidelines available and well
displayed?
Correct waste disposal procedures
followed?
Laboratory log / register book properly
maintained daily?
QC / DBS collected for every 20th
client?
DBS correctly packaged and stored
before submission to NHRL?
DBS regularly submitted to reference lab
(last submission date)
Feedback from reference lab received
regularly (last date received)
DBS results entered in the laboratory log
book.
All HTC providers participated in
proficiency testing?
Results for proficiency testing submitted
to NHRL within seven days?
Feedback for proficiency testing received
from NHRL?
Appropriate national data collection and
reporting tools used?
Client data registers checked daily for
correct entries?
Data / reports submitted as per the given
deadline?
C Service delivery structures
Named provider-initiated HTC
coordinator?
Health talks conducted daily?
QA data (including client satisfaction
surveys) collected and analysed regularly
for quality improvement?
Regular team meetings held to address
service delivery including QA?

54
Staff duty rota in place: responsibilities
allocation?
Condoms (male and female) available
and distributed when needed?
National provider-initiated HTC
operational guidelines available and
adhered to?
Proper stock register maintained?
Patient referral system functional?
D Status of previous action points
Action points Person(s)
responsible
Done /
Not done
E Current action points Person(s)
responsible
Timelines
Overall remarks and recommendations
Supervisors:

Signature……………………….. Date…………………………
Signature………………………. Date………………………...
Facility in-charge:

Signature…………………. Date…………………..……

55
Appendix 5: Data Tools
5.1 HTC Lab Register
The HTC register is a department-based document where all persons who are
offered the HIV test by healthcare workers are entered. This includes patients
seeking healthcare at the health facility, their family members as well as their
partners.
Who completes: All providers offereing HTC services at all service delivery points
in a facility.
Location: A HTC register should be availed in every department where healthcare
is offered at the outpatient and inpatient departments.
REPUBLIC OF KENYA
MINISTRY OF HEALTH
HIV TESTING AND COUNSELING (HTC)
LAB REGISTER
MOH362
Specific Service Delivery Point (SDP) :
:emaNytilicaF
Master Facility List (MFL) Code:
:emaNtcirtsiD
:emaNecnivorP
:emaNytnuoC
:etaDdnE:etaDtratS
Ver. MARCH 2011

56
How to fill the cover page of this register
The following information should be captured on the cover page.
Variables Instruction
Service Delivery Point Enter where HIV testing service is provided, e.g.
OPD Room 1, Pediatric ward, STI Clinic, VCT
Center Room 2 etc.
Facility Name Enter facility name
Master Facility List Code Enter the facility code as derived from the Master
Facility List (MFL). It should be 5 digits, e.g. 13023
(Kenyatta National Hospital)
District Name Enter district name
Province Enter province name
County Enter county name
Start Date
Enter date when you start usign this register: dd/
mm/yy
End Date Enter date when the register fills up: dd/mm/yy
How to use this register
This register is designed for service providers to record their daily HIV testing
and counseling (HTC) services using rapid HIV test kits. The register captures
information on HTC related variables. The information will be used to monitor
and evaluate the HTC Program at all levels including self and facility evaluation.
This register can be used in two ways depending on what works well for each
facility.
• per service delivery point e.g. particular counseling room
• per service provider (individual HTC provider)
NB: Information in this register should be confidential since actual client/patient
names appear in this book.

57
How to record HTC services into this register
Variable Instructions Note
Serial Number a Enter serial number e.g. 1, 2, 3. Start
fresh serialization at the beginning of
every year (Annual Serialization).
This is not
pervious VCT
Code Number.
Date b Enter date when client/patient is
offered/ seeks HTC service: dd/mm/yy
Client/Patient
Name
c Write all clients’ name (minimum 3
names)
Age d Enter actual age in number of years.
Sex e Enter M for male or F for female.
Strategy f Enter one of the following strategies
which you are using as explained
below:
HP: Regular HTC services for patients in
the health facility (PITC)
NP: HTC services for non-patients e.g.
family members, relatives, and friends
etc in PITC setting.
VI: Static HTC services in integrated
VCT sites.
VS: Static HTC services in stand alone
VCT sites.
HB: Home-based HTC services e.g.
door to door.
MO: Mobile and all other outreach
HTC services e.g. in market places,
schools, churches as well as
workplaces.
O: Others (specify)
Tested before? g Enter an applicable abbreviation.
Y: Client has been tested before.
N: Client has never tested before.

58
If yes, the result h Enter an applicable abbreviation if
the client has ever taken a test, as per
column “Tested before?”
N: Negative
P: Positive
DN: Client did not receive the test
results though previously tested. (Note
the reason why test results was not
given/received in remarks column)
NA: Not applicable (if client has never
tested before)
When last
tested
i Enter number of months ago e.g. 2
months ago, 24 months ago.
Marital Status j Enter an applicable abbreviation.
S: Single
MM: Married Monogamy
MP: Married Polygamy
D: Divorce/ Separated
W: Widow// Widower
Regardless of
age, indicate
marital status.
Legal status of
marriage is not
required; capture
what the client
tells you.
MARPs
(Most At Risk
Populations)
k Enter as applicable as described
below.
NA: Not applicable=not MARPs
F: Fisherperson
T: Truck driver
S: Sex worker
M: Men who have sex with men
(MSM)
P: Prisoner
I: IDUs (injecting drug users)
Please note
that the above
mentioned
categories are
the MARPs so far
articulated in the
Kenya National
AIDS Strategic
Plan (KNASP)
2008/09-
2013/14.
Disability l Enter an applicable abbreviation.
NA: Not applicable=not disabled
D: Deaf
B: Blind
M: Mental
P: Physically challenged
O: Other (specify)
If client/patient
has multiple
disabilities,
please indicate
all e.g. B/D (blind
and deaf)

59
Consent m Enter appropriately as either.
Y: Client has given consent to take a
HIV test today.
N: Client declines to take a HIV test
today.
The client can
confirm consent
verbally. It
is as per the
HTC Policy
Guidelines.
Client tested as n Enter appropriately as;
I: Individual
C: Couple includes polygamous
Couple means
either two or
more partners
who report they
want to be tested
as a couple.
Please bracket those who have agreed
to test as couple.
Couple could
be already
in a sexual
relationship or
planning to do
so.

60
HIV Test-1 o Kit Name: Write the name of the first
HIV rapid test kit which you have
used.
Lot No: Write lot number of the test
kit. If the lot number changes in the
middle of the page, skip one row and
write new lot number within one row.
Expiry Date: Write expiry date of the
test kit.
Test Result: Write either of the
following initial;
N: Negative (non-reactive)
P: Positive (Reactive)
I: Invalid
In case of invalid results, the same
test should be done again. The repeat
test results should be captured in the
following row.
The national
algorithm for HIV
testing is serial.
First test should
be Determine;
second test
should be SD
Bioline; tie
breaker should
be Uni-gold as
per circular dated
23-Sep-09 by
MOH.
HIV Test-2 p Kit Name: Write the name of the
second HIV rapid test kit which you
have used.
Lot No: Write lot number of the test
kit. If the lot number changes in the
middle of the page, skip one row and
write new lot number within one row.
Expiry Date: Write expiry date of the
test kit.
Test Result: Write either of the
following initial;
N: Negative (non-reactive)
P: Positive (Reactive)
I: Invalid
In case of invalid results, the same
test should be done again. The repeat
test results should be captured in the
following row.

Operational manual for implementing HTC in clinical settings

Operational manual for implementing HTC in clinical settings

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