Finalized SOPs For HIVST With Signatures

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STANDARD OPERATING

PROCEDURES FOR THE DELIVERY


OF HIV SELF TESTING IN NIGERIA

Federal Ministry of Health

NOVEMBER, 2021

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Table of Contents
Foreword............................................................................................................................................................. 3
Acknowledgments .............................................................................................................................................. 4
List of Contributors ............................................................................................................................................ 5
Executive Summary ............................................................................................................................................ 7
Acronyms ........................................................................................................................................................... 8
Definition of Terms ............................................................................................................................................ 9
Chapter 1: Introduction ..................................................................................................................................... 10
1.1 Background ................................................................................................................................................. 10
1.2 Overview of HIV Self-Testing ................................................................................................................... 10
1.3 Purpose of the HIVST SOP ........................................................................................................................ 11
1.4 SOP Objectives ........................................................................................................................................... 11
1.5 Target Audience ......................................................................................................................................... 11
1.6 HIV Self-Testing Promotion and Communication ..................................................................................... 11
Chapter 2: HIVST Delivery Approaches .......................................................................................................... 12
2.1 HIVST Approaches .................................................................................................................................... 13
2.2 HIVST Service Delivery Channels ............................................................................................................. 13
2.3. Stakeholders to be engaged for HIVST Kits Distribution ......................................................................... 14
Chapter 3: HIV Self-Test Delivery ................................................................................................................... 15
3.1 Methods for HIVST Delivery ..................................................................................................................... 15
3.2 Quality Assurance for HIVST .......................................................................Error! Bookmark not defined.
3.3 HIVST Flow Charts for Users .................................................................................................................... 16
3.4 Post HIVST Information ............................................................................................................................. 17
Chapter 4: Community Engagement and Demand Creation ............................................................................. 18
4.1 Community Stakeholders ............................................................................................................................ 18
4.2 Channels of Community Engagement ........................................................................................................ 19
4.3 Methods for Community Engagement ............................................................Error! Bookmark not defined.
4.4 Demand Creation for HIVST ...................................................................................................................... 20
Chapter 5: Referral and Linkage ....................................................................................................................... 21
5.1 Method for HIVST Referrals ...................................................................................................................... 21
5.2 Linkage approaches for HIVST .................................................................................................................. 21
5.3 Index Testing .............................................................................................................................................. 21
Chapter 6: Commodity Management ................................................................................................................ 23
6.1 HIVST Kit Selection................................................................................................................................... 23
6.2 Inventory Management ............................................................................................................................... 23
Chapter 7: Monitoring and Evaluation ............................................................................................................. 24
7.1 Indicators for M&E in HIVST .................................................................................................................... 24
7.2 Reporting tools and systems ....................................................................................................................... 24
Chapter 8: Human Resources and Training ..........................................................Error! Bookmark not defined.
8.1 Human Resources and Training ......................................................................Error! Bookmark not defined.
References ........................................................................................................................................................ 25

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Foreword

HIV Self- Testing (HIVST) is an additional approach to HIV Testing strategy with potential to extend testing
beyond present limitations of the HIV testing by addressing barriers to testing. It is estimated that only 90% of
the 1.9million people living with HIV know their status (NAIIS 2018). It is expected that HIV self-testing will play
a key role in closing the testing gaps and accelerating progress towards attainment of the first 95%of the 95-
95-95 targets by 2030.

The Federal Ministry of Health has made tremendous progress in ensuring the smooth implementation of HIV
Self-Testing and, going forward, intends that the opportunity HIV self-testing presents is fully utilized to
increase access to HIV testing. HIV testing service is the entry point to HIV prevention, treatment and care. HIV
self –testing will help to bridge the gap of access, especially amongst key populations who remain
disproportionately affected by HIV, partners of PLHIV and other vulnerable groups who are at risk of HIV
infection.
The National Standard Operating Procedures for HIV self-testing was developed to ensure that all service
providers have the requisite access to use in the diverse settings, for various target populations, and above all,
for linkages to treatment services where needed.
This document provides explicit directives for implementers and distributors of HIV self-test kits, to ensure
uniformity and quality of service. It is an important tool and it is hoped its use will contribute significantly to
the delivery of high-quality HIV self-testing services.

I therefore endorse its use for the provision of HIV self-testing services in Nigeria.

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Acknowledgments

On behalf of the Federal Ministry of Health, I wish to acknowledge the contributions of all stakeholders
who participated in the development of the Standard Operating Procedures for the delivery of HIV Self-
Testing (HIVST)

We acknowledge the technical contributions of the National Task Team on HTS, the National Agency
for the Control of AIDS (NACA), National Primary Health Care Development Agency (NPHCDA),
National Agency for Food and Drug Administration and Control (NAFDAC), Nasarawa and Akwa
Ibom State Ministries of Health, the Pharmaceutical Society of Nigeria Foundation (PSNF), and Civil
Society organizations.

We are particularly grateful to the Unitaid/Jhpiego-STAR Project and Faith-based Action for Scaling
up Testing and Treatment for the Epidemic Response, Catholic Relief Services (FASTER-CRS), for
providing financial and technical support for the development of the document.

Our sincere appreciation also goes to the other development and Implementing partners for their
technical support: World Health Organization (WHO), Joint United Nations Programme AIDS
(UNAIDS), US Center for Disease Control and Prevention (CDC), US Agency for International
Development (USAID), US Department of Defence (DOD), Family Health International (FHI360)
/Achieving Health Nigeria Initiative (AHNI), Institute for Human Virology, Nigeria (IHVN), AIDS
Healthcare Foundation (AHF), Heartland Alliance Nigeria Limited by Guarantee, Centre for Integrated
Health Programs (CIHP), APIN Public Health Initiatives, Center for Clinical Care and Clinical
Research–Nigeria (CCCRN), Society for Family Health (SFH), Clinton Health Access Initiative
(CHAI), DKT International (DKT), Oraquick Nigeria, and John Snow Incorporated (JSI).

Finally, I commend the staff of the National AIDS and STI Control Program (NASCP) for their efforts
in the development of this document.

Dr. M. O. Okoh
Director/Head of Department
Department of Public Health

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List of Contributors
Federal Ministry of Health
Dr Akudo Ikpeazu FMoH/NASCP
Dr Adesigbin Clement O. FMoH /NASCP
Mrs Ima John–Dada FMoH /NASCP
Mrs Grace Bassey FMoH/NASCP
Mrs Tina John-Okoro FMoH /NASCP
Mrs Olufunke Fagbemiro FMoH/NASCP
Mrs Caroline Osahon FMoH/NASCP
Mrs Folorunsho Roseline FMoH/NASCP
Ms Bridget Onyebuchi FMoH/NASCP
Mr Ogbeke Geoffrey I. FMoH /NASCP
Mrs Hauwa Maigari FMoH/NASCP
Mr Usman Mohammed FMoH/NASCP
Mrs Adisa- Olutayo Patricia Adetola FMoH /NASCP
Ms Aiki Sabina Denis FMoH /NASCP
Mrs Bosah Edwina FMoH/NASCP
Mr Samson Omoighe FMoH/NASCP
Mrs Sim Blessing Amadu FMoH/NASCP

State Ministry of Health


Dr Attah Peter Ombugadu SMOH Nasarawa
Mrs Elizabeth Ekanem SMOH Akwa Ibom
National Primary Health Care Development Agency
Dr Elemuwa Chris NPHCDA
National Agency for Food and Drug Administration and
Control
Dr Fatimah Jajere NAFDAC
National Agency for the Control of AIDS
Dr Okorie Gideon NACA
Dr Yewande Olaifa NACA
Dr Babayemi Olakunde NACA
National Task Team on HTS
Dr Ali Onoja African Health Project
Mr Gerald E Teleh Y. E. Lautanto
Dr Yetunde Akani UPTH
Mrs Itodo Eleojo Grace FMC Lokoja
Dr Chika Ndiokwelu UNICAL
Regulatory Bodies
Pharm. Elelu Munir PSN Foundation
Mr Olafusi O. Samuel PSN Foundation
Civil Society
Dr Walter Ugwuocha CISHAN
Dr Bright Oniovokiukor CISHAN
Donors & Implementing Partners
Dr Funke Ilesanmi WHO
Dr Richards Amenya UNAIDS
Dr Jerry Gwamna CDC
Dr Chidozie Meribe CDC

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Mrs Pamela Gado USAID
Mrs Angela Agweye USAID
Dr Yusuf Ahmed USDOD
Dr Oniyire Adetiloye Jhpiego
Dr Jaiyeola Layi Jhpiego
Mrs Zainab Adeyanju Jhpiego
Mr Adebanjo Adetosoye Moses Jhpiego
Mr Obinna Nwogu Jhpiego
Ms Chidinma Umebido Jhpiego
Mr Femi Quaitey Jhpiego
Dr Emeka Anoje CRS
Dr Chizoba Mbanefo CRS
Dr Oke Olufemi CRS
Dr Umar Nasir CRS
Mr Ikechukwu Okoroezi CRS
Mr Ani Chiwetalu CRS
Mr Anthony Idu CIHP
Dr David Akpan CCCRN
Dr Chioma Helga Claw-Maduka Heartland Alliance LTD GTE
Mr Osilade Adewole Heartland Alliance LTD GTE
Mr Valor Atte-basi Ede Heartland Alliance LTD GTE
Ms. Nwafor Precious Heartland Alliance LTG GTE
Mr Micheal Akanji Heartland Alliance LTG GTE
Mr Agboola Oguntonade Heartland Alliance LTG GTE
Mr Akhigbe Mark Heartland Alliance LTG GTE
Mr Adeleye Toafeek AHF
Mr Godspower Omoregie SFH
Mr Obed Nnamdi SFH
Ms Kucheli Wudiri SFH
Mr Dennis Aizobu SFH
Dr Ugochi Ezenwelu FHI360/GF Project
Mr Azihaiwe-Justin Austin AHNI/FHI 360
Dr Felicia Mariga AHNI/FHI 360
Ms Chika Okafor AHNI/FHI 360
Ms Oluwakemi Sowale, CHAI
Mr Chidozie Nwafor CHAI
Mr Silas Gurumdi IHVN
Mrs Olubunmi Amoo APIN
Mr Harry Omoakhia Mozuk/Oralsure
Mr Nkasiobim Nebo, DKT
Mr Tolashe Olatinwo JSI
Mr Abubakar Mohammed JSI
Mr Emmanuel Nwala JSI

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Executive Summary

Increased access and uptake of HIV testing services is the first critical step of the HIV treatment
cascade. HIV testing remains the biggest challenge to meeting the 95-95-95 targets. To reach those
people living with HIV who do not yet know their status, innovative approaches to HIV testing are
needed.

The Federal Ministry of Health is coordinating the implementation of HIV Self testing as an additional
approach to HIV testing services, this will enable us reach populations that are currently underserved
by existing HIV testing service modalities.

The Standard Operating Procedures for HIVST is a guide to inform HIVST providers at all levels on
HIVST delivery. Its primary purpose of this SOP is to standardize the processes and procedures in
Public and Private HIVST delivery outlets in Nigeria to incorporate high-quality HIV self-testing
services to clients accessing health services nationwide.

The document describes the steps that service providers will follow to provide the needed support for
HIVST users. The SOP also addresses logistics, monitoring & evaluation and coordination mechanisms
for HIV self-testing delivery.

This SOP will be used in conjunction with the National Guidelines for HIV Testing Services. It is user
friendly and will ensure that all persons who provide HIVST operate within acceptable standards.

Dr. Akudo Ikpeazu


Director/ National Coordinator
National AIDS & STIs Control Programme (NASCP)
Department of Public Health

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Acronyms

AIDS: - Acquired Immune Deficiency Virus


ANC: - Antenatal Care
ART: - Antiretroviral Therapy
ARVs: - Antiretroviral Drugs
CBDA: - Community Based Distributing Agent
CHIPS: - Community Health Influencer Promoter Services
CiSHAN: - Civil Society for HIV/AIDS in Nigeria
COVID-19: - Corona Virus Disease
DICs: - Drop in Centers
EMTCT: - Elimination of mother-to-child HIV transmission
FBOs: - Faith-based Organization
FMOH - Federal Ministry of Health
GBV: - Gender-Based Violence
HIVST - HIV Self-Testing
HIVOFT: - HIV Oral Fluid Test
HIV: - Human Immunodeficiency Virus
HCW: - Health Care Worker
HTS: - HIV Testing Services
IEC: - Information, Education and Communication
IPC: - Interpersonal communication
IPV: - Intimate Partner Violence
KPs: - Key Populations
M&E: - Monitoring and Evaluation
MSM: - Men who have Sex with Men
NACA: - National Agency for the Control of AIDS
NAIIS: - National AIDS Indicator and Prevalence Survey
NASCP - National HIV AIDS STI control Program
NSP: - National Strategic Plan for HIV, TB
NPHCDA: - National Primary Health Care Development Agency
NPHRL: - National Public Health Reference Laboratory
OPD: - Out Patient Department
OSS: - One Stop Shops
OVC: - Orphans and Vulnerable Children
PITC: - Provider Initiated Testing and Counselling
PMTCT: - Prevention of Mother-to-Child HIV Transmission
PPMV: - Patent Proprietary Medicine Vendors
PrEP: - Pre-Exposure Prophylaxis
PLHIV: - People living with HIV and AIDS
SOP: - Standard Operating Procedures
STIs: - Sexually Transmitted Infections
TBA - Traditional Birth Attendants
TB: - Tuberculosis
UNAIDS: - Joint United Nations Program on HIV/AIDS
WHO: - World Health Organization

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Definition of Terms

HIV Self-Testing (HIVST): This is a process whereby an individual collects his or her specimen,
performs a test and interprets the results, often in a private setting either alone or with someone he or
she trusts. HIVST can either be assisted or unassisted.

Assisted HIV self-testing: Refers to when an individual who is performing a self-test for HIV receives
an demonstration (in-person or video clip) from a trained provider or peer before and/or during HIVST.
This assistance is provided in addition to the manufacturer supplied instructions and other materials
found inside HIVST kits.

Unassisted HIV self-testing: Refers to an individual obtaining a kit for HIVST and performing the
HIV test following the instructions on the insert on their own without assistance.

Reactive results: This means the test indicates that HIV antibodies may be present in the oral fluid or
blood sample. Anyone whose result is reactive to a self-test must be linked for further HIV testing
services by a trained provider following the national HIV testing algorithm.

Non-reactive results: It means the test indicates that HIV antibodies were not found in the oral fluid
or blood sample. Anyone whose result is non-reactive to a self-test does not need further testing but
should be supported to repeat the test if they have had a recent potential HIV exposure or are at on-
going HIV risk.

Confirmatory test: Refers to the test carried out by a trained health care provider to ascertain the result
of a reactive HIVST following the National testing algorithm.

Mature Minor: A person who is not legally an adult but who, because he or she is married, is the
mother or father of a child, or otherwise no longer dependent on the parents. S/he may not require
parental permission for medical or surgical care.

HIVST distributor: someone who is trained to issue HIV self-test kits to individuals for free, or who
sells HIVST kits to consumers from a storefront, pharmacy, or patent medical vendor and online
distributors.

HIVST vendor: an outlet that sells HIV self-test kits to consumers (i.e. storefront, pharmacy, or patent
medical vendor

Provider: In the context of HIVST, a provider is a trained health care worker or lay provider that offers
HIVST services either in the community or health care facility.

HIV testing services (HTS): Indicates the full range of services that a client is offered together with
HIV testing. This includes counselling (pre-and post-testing); linkage to appropriate HIV prevention,
care and treatment services and other clinical support services. Coordination with laboratory services
to support quality assurance and delivery of correct results is necessary.

Primary distribution: This is when a provider distributes an HIVST kit to a person who intends to use
the kit by themselves. Sufficient information, education and access to follow-up services is provided.

Secondary distribution: This is when a provider distributes an HIVST kit to a person who intends to
give the kit to his or her sexual partner(s), peers, or family members. This approach expands the reach
of HIVST, giving access to hard-to-reach populations.

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Section 1: Introduction

1.1 Background
In Nigeria, approximately 1.9 million people are living with HIV accounting for a prevalence of 1.4%. The
prevalence of HIV varies from one geopolitical zone to another in Nigeria, the South-South zone has the
highest prevalence of 3.1% while the North-West Zone has the lowest prevalence of 0.6% (NAIIS Report,
2018).

HIV Case finding among the populace constitute the first critical step in the achievement of the UNAIDS
95:95:95 goals. In Nigeria, only 90% of people living with HIV know their status (NASCP Report 2020).
Nigeria continued to report a significant number of new HIV infections annually with about 130 000 new
infections reported in 2018 (UNAIDS 2018). HIV case finding among populations is challenging and this
has worsened with the advent of COVID-19 outbreak. Low HIV testing coverage among men, young
people, and other vulnerable populations such as key population remains a major challenge facing the HIV
response in Nigeria.

To address the gap in HIV case finding, innovative strategies must be deployed to rapidly increase uptake
of HIV testing services. One approach that shows promising outcome is the HIV self-testing launched by
WHO in 2016. Evidence has shown that HIVST can increase the uptake of HIV testing in Nigeria and will
contribute significantly to achieving the first 95 of the UNAIDS 95:95:95 treatment targets by 2030. Hence,
the Nigerian Government has rolled out HIV Self Testing (HIVST) as an innovative strategy to HIV case
identification. The HIVST procedure also applies to the National HIV Prevention programme as an entry
point to HIV prevention services and those who want to access Pre-exposure prevention (PrEP) services.

This HIVST Standard Operating Procedures was developed in line with the 2021 National HIV testing
Services Guidelines in Nigeria. (NASCP, 2021). The coordination of HIVST in Nigeria is aligned with the
roles and responsibilities outlined in the National Guidelines on HTS. Other key actors such as regulatory
bodies, professional organizations, test kit manufacturers and private sector distributors and vendors will
also be involved, particularly related to coordination in the private sector.

1.2 Overview of HIV Self-Testing


HIV self-testing is defined by WHO as a process whereby an individual collects his or her specimen,
performs a test, and interprets the results, often in a private setting either alone or with someone he or she
trusts. HIVST can either be assisted or unassisted. It is important to know that HIV self-testing is a screening
test and should not be used to provide a definitive HIV diagnosis. A reactive HIVST result should, therefore,
be confirmed using the validated national testing algorithm by an HTS -trained service provider. Therefore,
linkage to HIV testing services through a facility or community HTS provider or peer is critical following
a reactive HIVST result.

1.2.1 Benefits of HIV Self-Testing

✓ The HIVST is discreet, confidential and can be done in private and users interpret results on their own.
Increased access to HIV testing services and knowledge of HIV status
✓ To perform the HIV self-test, a health care provider is not needed.
✓ The test can be performed at the user convenient time, alone or with a trusted partner.
✓ HIVST is safe, accurate and the result is available immediately.

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✓ The test kit contains everything needed to complete the HIV self-test
✓ Available to key populations and hard-to-reach clients and can be bought over the counter
✓ Reduction in stigmatization and discrimination.
✓ Ease of use with minimal bio-hazard waste generation.
✓ Promotes index testing services – expands testing to partners of PLHIV and social networks of KP

1.2.2 Potential for Harm


Potential harm in HIVST include Gender based violence (GBV) especially intimate partner violence (IPV),
suicidal tendencies and vendetta. The potential for harm can be minimized if HIV self-testing is provided
within a context-specific approach which is right-based, ethical, safe, and acceptable. In view of this,
providers should be trained to provide counselling and screening for gender -based violence and create a
confidential and safe environment for HIV-positive result disclosure to sexual and drug-using partners. An
information line (6222) is in place for testing support and referral to additional support structures if GBV
and other psychosocial issues occur.

1.3 Purpose of the HIVST SOP


The purpose of this standard operating procedure (SOP) is to describe the steps and principles required to
provide HIV Self-testing to target populations including general population, key population, adolescents
and young persons, and persons living with disability, and to provide the guideline within which HIVST
can be implemented safely, ethically, effectively, and accurately. It is also intended to provide access to
HIV testing services and scale up services among underserved and most at risk populations who may require
HIV testing services often times based on their risk perception.

1.3.1 Scope
The scope of this SOP covers the use of HIVST in Nigeria by implementers in the facility, community and
private sector. It also looks at the structures, processes and procedures involved in providing and reporting
HIVST services in the country.

1.4 SOP Objectives


The general objective of this SOP is to provide the step by step approach in which HIVST can be
implemented safely, ethically, effectively and accurately.

The specific objectives of this SOP are to:

i. Describe delivery approaches and packages for HIVST


ii. Describe commodity management systems required for HIVST
iii. Outline quality assurance strategies in HIVST
iv. Describe the monitoring and evaluation activities for HIVST
v. Outline the coordination mechanisms for HIVST.

1.5 Target Audience


The HIVST SOP is intended for use by:
▪ Ministries, Departments & Agencies (MDAs) at all levels involved in the National HIV Response.
▪ Implementers of HTS, including international, national, and non-governmental organizations,
private licensed medical institutions, civil society, and community-based organizations such as
CiSHAN, CHIPS, community Pharmacists, PPMVs
▪ Service providers and program officers involved in HIV prevention, care and treatment services

1.6 HIV Self-Testing Promotion and Communication


To create awareness and increase utilization of HIVST, advocacy and communication strategies should aim
to inform lay providers, various sub-population and health care providers on the availability and the correct

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use of HIVST kits. The service providers should leverage on existing workplace wellness programs to
promote HIVST. This will include use of HIV self-testing champions, adherence counsellors to promote
HIVST using health talks, brochures, flyers, billboards, print and electronic media, social media and other
virtual platforms. This could be useful in reaching those who are hesitant to access existing HTS services
in the workplace due to stigma and discrimination as well as reaching men and other key populations.

HIVST should be preceded by key information. Additionally, HIVST should be guided by the five core
principles of HTS, known as the 5Cs, i.e. Consent, Confidentiality, Counselling, Correct test results, and
Connection to prevention, treatment, care, and support services. (Refer to National HTS guidelines)

NOTE: Mandatory or coerced testing is unethical and illegal, and should be prevented regardless of where
it comes from (service providers, partners, family members, employers, or others).

HIVST for children 2-11 years must be Caregiver or provider assisted with Care-giver consent.

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Section 2: HIVST Delivery Approaches

2.1 HIVST Approaches


There are two approaches to HIVST:

a. Assisted Approach
Refers to when individuals using HIVST kits receive a demonstration from a provider or peer before
or during HIVST, with instructions on how to perform a self-test and how to interpret result. This
assistance is provided in addition to the manufacturer-supplied instructions for use and other materials
found inside HIVST kits.
Note: Providers are not encouraged to perform an HIVST for a client.

b. Unassisted Approach
Refers to when individuals use HIVST kits without help from a provider or peer, but only using
manufacturer-provided instructions. As with all HIVST, unassisted users may be provided with links
or contact details to access additional support, such as telephone helplines or instructional videos
(WHO, 2016).

2.2 HIVST Delivery Channels

HIVST Delivery
Channels

Facility-based Community-based Private Sector

VCT, Mobile HTS,


Secondary distribution Community Distributors, Private Clinics, Pharmacy,
ART clinics, ANC One Stop Shops (OSS), Vending Machines,
(Index testing and Workplaces, OVC programs, Internet, PPMVs,
partners of PBFW) DICs, FBOs, TBA Networks, Workplaces
KP Social Networks

Figure 1 HIV Self-testing Service Delivery Channels

2.3 HIVST Distribution Approaches


Primary distribution is when a provider distributes HIVST kits to persons who intend to use the kit
themselves. The benefit of primary distribution is that the provider has an opportunity to provide sufficient

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information and education to the intended HIVST user, and can also provide information about accessing
follow-up services.

Secondary distribution is when a provider distributes HIVST kits to persons who intend to give the
kits to their sexual or needle sharing partner(s), peers, or family members. One benefit of secondary
distribution is that it expands the reach of HIVST, giving access to hard-to-reach populations. When
a provider is distributing HIVST kit to someone who intends to give it to his or her sexual
partner(s), peers, or family members, they should ensure the person adequately understands how to
use the kit and interpret the results, and how to explain this information to others. Printed or online
information, education, and communication (IEC) materials can be helpful to ensure the secondary
user performs the test correctly.

2.4. Stakeholders to be engaged for HIVST Kits Distribution


• Organizations, Religious/Opinion leaders, to mobilize and educate their congregations on HIVST
acceptability, availability, benefits, and adherence to the National HTS Guideline.
• Private sector should be engaged to ensure implementation of the total market approach as well as
social marketing to ensure equitable access to the HIVST kits and coordination of HIV self-testing
in the country.
• Civil society networks will serve as a platform to engage with key groups, mobilize members of
their community, dispel myths/misconceptions about HIVST, provide distribution strategies
suitable for network members and serve as monitoring mechanism in adherence to the National
HTS Guideline.

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Section 3: HIV Self-Test Delivery

HIV self-test kits approved for use in Nigeria should include clear and tested instruction for use in English,
Pidgin English, and other national languages, as appropriate. Instructions for use should contain both
written instructions and pictorials to help users understand how to perform and interpret HIVST results. It
is recommended that all HIVST kits distributed must be accompanied with IEC materials.

All distribution points should display illustrations or instructions on HIVST procedures, in case a person
requires further explanation or testing support. In addition, it is recommended that all outlets should have a
designated private space especially for assisted HIVST.

Benefits of the IEC Materials


• To empower HIV self-test users with precise and accurate information on HIVST
• To address the HIV self-test users fears and concerns regarding the use of HIV self-test Kit
• To outline the step-by-step procedure of conducting HIVST

HIVST Distributors/ Service providers


1. Community Distributors
2. Community Pharmacists
3. Patent Proprietary Medicine Vendors (PPMV)
4. Nurses/Midwives.
5. Laboratorians
6. CHEWs
7. CHIPs

Materials
1. HIVST Kit
2. IEC Materials
3. Good lightening source
4. Timer
5. Data collection tools (HIVST Response and Referral Card, HIVST Register, HTS Monthly
summary forms). etc.

3.1 Methods for HIVST Delivery


The HIVST Distributors should discuss the following with the users.
• Benefits and potential risks of HIVST
• Voluntary nature of HIVST
• Confidentiality of HIVST results
• Handling and storage of the HIVST kit before using it
• Conducting an HIVST, including a demonstration, if possible
• Discuss risk reduction plan, disclosure, partner notification and testing
• Interpreting the HIVST results, including the meaning of reactive and non-reactive results
• Persons with reactive HIVST result must access confirmatory testing in a health facility
• Providers may seek consent from the HIVST user for follow up and feedback
• Availability and importance of treatment for persons who are confirmed to be HIV positive,
including benefits for individual health and prevention to partners

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• Non-reactive HIVST results can be interpreted as an HIV-negative result; clients should be referred
to appropriate prevention services and repeat the test based on risk exposure
• Safe disposal of used HIVST kits
• Location and contact information for re-testing, prevention, care and treatment services
To support adherence to the provisions in this SOP, information would be provided in demand creation
materials and other mass media platforms.

3.2 Quality issues to address


• Ensure that the HIVST kit is approved by regulatory bodies.
• Ensure the HIVST kit is sealed
• Check for expiry date before use
• Ensure proper storage according to manufacturer’s instructions
• Adhere strictly to the manufacturer’s instruction when conducting the test
• HIVST distributors should ensure users understand the processes outlined to guarantee quality of
the HIVST result.

3.2.1 Waste Management


• Ensure that the waste generated during HIVST is properly disposed according to manufacturer’s
instructions in the leaflet.
• Discourage littering of HIVST materials in the community
• Inappropriate disposal can pose health hazard to the community.

3.3 HIVST Flow Charts for Users


The flow chart shows actions that HIVST users should take after performing their HIV Self-test.
Perform HIVST using approved
self-test kits and interpret results

Reactive Non-Reactive

Present for confirmatory testing by


Refer/link to appropriate HIV
a trained HTS provider as per the
prevention services
national HIV testing algorithm

Link to appropriate treatment and Client should repeat the test within
prevention services, as indicated 4-12 weeks after exposure

A reactive HIVST result always requires confirmatory testing by a


trained HTS provider according to the national HIV testing algorithm

Figure: 2 HIVST Flow Charts

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3.4 Post HIVST Information

For individuals who return after HIV self-testing, the service provider should discuss/ensure the
following:

• Challenges using the test


• Linkage to prevention services
• Linkage to confirmatory testing
• Instances of harm/misuse

Figure 3 How to perform an HIV self-test

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Settings 4: Community Engagement and Demand Creation
Providing advocacy and education about HIVST for community members, including networks of PLHIV,
KPs, and other affected populations is critical to increasing uptake of HIVST and minimizing the risks of
misuse. Community leaders can also provide strategic communication, sensitization and advocacy for
HIVST, and should be oriented to the goals of HIVST and appropriate use of HIVST kits.

Objectives
• To provide a step by step guide on community engagement for HIVST
• To outline the approaches for demand creation for HIVST
• To foster acceptability and ownership of HIV Self-testing

Human Resources
• HIVST Service Providers
• Other HIVST Stakeholders

Materials

• Advocacy tool kit


• IEC materials
• HIVST Kit
• Data collection tools

4.1 Community Stakeholders


It is important to hold consultative meetings and advocacy to local leadership to get permission to enter the
community:
Traditional chiefs

Village heads

Religious leaders

Ward councillor

Gate keepers

Key Influencers

law enforcement agents

Figure 4

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4.2 Channels of Community Engagement
o Community sensitization could be achieved using neighborhood committees and community-
based volunteers
o Community based organizations
o Town Criers/ Announcers
o Faith based organizations
o Community radios and drama performances
o Community meetings
o Focused group discussions
o Public Address System (PA System)
o Mass and Social Media

4.3.1 Steps for Community Engagement

HIVST service providers should:

Conduct a mapping of the community

Identify stakeholders

Conduct advocacy

Provide HIVST services

Figure 5

4.3.2 Household Entry Procedure: HIVST Session Approach


Service Providers must be aware of the traditional way of life and the need to respect people’s right to
privacy when conducting any community or door to door outreach health program.

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Figure 6 Household entry tips

4.4 Demand Creation for HIVST


Approaches for demand creation in HIVST include use of Mass media, IEC materials, social media,
religious leaders, community champions, various networks, etc.

4.4.1 Role of Social Media in HIVST


Social media can be used to provide strategic information, sensitization, education, and advocacy about
HIVST for community members, including networks of PLHIV, KPs and other affected populations.
Social media platforms such as Whatsapp, Facebook, twitter etc. will serve as avenue for sensitization,
advocacy, dissemination of information for specific population and age group.

HIVST service providers can use social media for:


• Demand Creation
• Platform for linkage to care
• Clients Support
• Online Purchase- Can be used to improve access to HIVST kits
• Feedback from clients – for quality improvement
• To build connections (networks) among clients and stakeholders.

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Section 5: Referral and Linkage

This session outlines the importance of referral and linkage in HIVST

Linkage - An act of connecting clients with relevant services for review and management.
Referral - The process by which immediate client’s needs for comprehensive care and supportive services
are assessed and clients are linked to gain access to other services

Objective:
To ensure that reactive and non-reactive clients receive comprehensive care through appropriate linkages

Human resources
HIVST Service Providers

Materials
1. Referral tools (Referral forms, Referral Register)
2. Referral directory
3. Stationery

5.1 Method for HIVST Referrals


During referrals:
• The HIVST provider should provide appropriate referral and linkage in line with National HTS
Operational guidelines.
• Individuals whose self-test results are reactive must seek confirmation from a qualified HTS
provider as soon as possible.
• Individuals whose self-test results are non-reactive should be linked to health facility or OSS for
risk reduction services.
• Information and enquiries on referral and risk reduction services can be obtained from NCCH help
line 6222 or visit any health facility or OSS

5.2 Linkage approaches for HIVST


Linkage and follow up approaches could be through;

▪ HIVST service providers


▪ Health care providers
▪ peer support officers
▪ adherence officers
▪ outreach workers
▪ Calls and SMS
▪ Social Media (Facebook, WhatsApp, Twitter etc.)

5.3 Index Testing

Index testing refers to the provision of HTS services to family members, sexual partner(s) or injecting drug
use partners of people living with HIV.

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• Clients should be informed about the potential health benefits of disclosing their HIV status to
sexual partners and needle sharing partners prior to receiving their self-testing kits.

In providing index testing services, providers should assess for possible social harm such as IPV
and GBV.

Appropriate guidance and referral should be provided.

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Section 6: Commodity Management

Commodity Management entails proper coordination and management of commodities to ensure the six
rights in supply chain, i.e. the right commodities in the right quantities, in the right condition delivered to
the right place at the right time and for the right cost.

The basic knowledge of logistics processes is important to ensure availability of HIVST kits at all time
and at all levels.

Objective:

•To provide HIVST Providers with basic processes in logistics including documentation
involved in receiving and usage of HIVST.
Human Resources
• HIVST Providers
• HIVST Vendors
Materials
• Filing cabinets and locks to ensure safety of records
• Computer and accessories
• Internet connection and/network connectivity
• Daily Usage Record for HIVST Kits
• The Inventory Control Card (ICC)
• The Bin Card
• Combined Reporting and Requisition Form
• Record for Transferring/Returning Commodities.

6.1 HIVST Kit Selection


The HIVST kits to be used in country should be guided by approved selection criteria, e.g NAFDAC
number
Refer to Operational Guidelines for HIVST in Nigeria for further details.

6.2 Inventory Management


The management of the HIVST kits will be aligned to the existing inventory management system. This will
include
• Receipt of HIVST kits.
• Storage according to the manufacturer’s instructions or in adherence to the recommended storage
guidelines.
• Proper record keeping shall be ensured by use of the existing tools (stock cards)
• Commodity management reporting systems

NB: During epidemic outbreaks, all trainings should be done in line with the epidemic response
guidelines e.g. COVID 19. In the event of insecurity issues and epidemic mitigation strategies such
as total lockdown seen with the COVID 19 pandemic, programmes could explore virtual platforms
for capacity building.

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Section 7: Monitoring and Evaluation

This session outlines the monitoring and evaluation (M&E) requirements to inform uptake and utilization
of HIVST. The reporting tools for HIVST are integrated into the existing HTS reporting system.

Objective
To maintain quality assurance system by improving the current and future management of inputs, outputs,
outcomes and impact
Human Resources
• HIVST providers
• Monitoring and evaluation officers
Space and equipment
• Filing cabinets and locks to ensure safety of records
• Tables and chairs
• Computer and accessories
• Internet connection and/network connectivity

7.1 Indicators for M&E in HIVST


• National and institutional specific standard tools should be utilized by the HIVST service providers
and programmers to collect and report data.
• Reports should be sent, to the relevant levels as specified in the national HIVST operational
guideline and as per specific programs requirements. (refer to the National HTS guideline for the
indicators)

7.2 Reporting tools and systems


The HIVST tools include:
• HIVST Response and Referral card
• HIVST Register
• HTS Monthly Summary form

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References
1. UNAIDS. The Gap Report. Geneva, Switzerland: UNAIDS, 2014.
2. UNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. UNAIDS, 2014.
3. Orasure Techonologies I. Ora Quick ADVANCE® Rapid HIV-1/2 Antibody Test Package Insert.
Bethlehem, PA.Accessed 14 September 2011 http://www.orasure.com/products-infectious/products-
infectious-Ora Quick.asp.
4. Dong M, Regina R, Hlongwane S, Ghebremichael M, Wilson D, Dong K. Can laypersons in high-
prevalence South Africa perform an HIV self-test accurately? 20th International AIDS conference;
Melbourne, Australia: IAS; 2014.
5. Napierala-Mavedzenge S, Sibanda E, Mavengere Y, Hatzold K, Mugurungi O, Ncube G, et al.
Supervised HIV self-testing to inform implementation and scale up of self-testing in Zimbabwe. In:
IAS, editor. The 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2015)
July 2015; Vancouver, Canada. Vancouver, Canada: IAS; 2015.
6. van Rooyen H, Tulloch O, Mukoma W, Makusha T, Chepuka L, Knight LC, et al. What are the
constraints and opportunities for HIVST scale-up in Africa? Evidence from Kenya, Malawi and
South Africa. J Int AIDS Soc. 2015;18(1):19445. Epub 2015/03/24.
8. World Health Organisation. Consolidated guidelines on HIV testing services 2015. Geneva,
Switzerland: WHO, 2015 July 2015. Report No.
9. WHO. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key
populations. Geneva, Switzerland: World Health Organization; 2014.
10. Mavengere Y, Sibanda, E., Hatzold, K., Mugurungi, O., Cowan, FM., Napierala Mavedzenge, S. Can
‘Late-Read’ of Self-Test Devices Be Used as a Quality Assurance Measure? Results of a Pilot HIV
Self-Test Project in Zimbabwe. XXI International AIDS Conference; Durban, South Africa2016.
11. Leventhal H, Singer R, Jones S. Effects of Fear and Specificity of Recommendation Upon Attitudes
and Behavior. Journal of personality and social psychology. 1965;2:20-9. Epub 1965/07/01.
12. Guidelines: South African HIV Self-Testing Policy and Guidance Considerations, 31st May 2017
13. Recommendations for the South African HIV Self-Testing Guidelines, 31st May 2017
14. HIV Self- Testing Operational Guidelines for the Delivery of HIV Self-Testing in Nigeria, December
2018

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