Acceptability and Performance of HIV Self-Testing in a Youth Population in Nigeria
Condition: HIV Prevention
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the acceptability and performance of a directly
      assisted oral HIV self-testing (HIVST) program in a youth population aged 14-24 in Nigeria.
      The study is oral HIV self-testing (HIVST) program in a youth population aged 14-24 in
      Nigeria. The study is focused on assessing young people's ability to correctly perform the
      test.
    

Detailed description: 
      Nigerian youth aged 14-24 make up a significant proportion of Sub-Saharan African youth newly
      diagnosed with HIV. However, they do not access essential HIV prevention services, like
      routine HIV testing, pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI)
      testing.This is partly explained by barriers that are individual (fear, and low perceived
      risk), social (insufficient social support) and structural (poor access to testing) factors.
      Additionally, the most affected groups of young people have remained largely unreached by
      traditional HIV testing services.

      HIV self-testing (HIVST) can mitigate some of these barriers by decentralizing HIV
      testing,decreasing stigma, and linking HIV-negative individuals with preventive services.
      HIVST is a process in which a person collects his or her own specimen (oral fluid or blood)
      using a simple rapid HIV test and then performs the test and interprets the result, often in
      a private setting, either alone or with someone he or she trusts. HIVST offers an alternative
      to facility-based HIV testing services, particularly for youth populations who may fear to
      get tested for HIV due to stigma and discrimination. Recognizing the expanding evidence
      supporting the effectiveness of HIVST, particularly the OraQuick HIV self-testing kits (see
      Tun et al, 2018; Nagendo et al., 2017; Kurth et al., 2016; Choko et al., 2016; and WHO
      pre-qualification report under the Publications Tab), the World Health Organization released
      HIVST guidelines in 2016.

      This study is in part with a parent study called ITEST (Innovative Tools to Expand HIV
      Self-Testing) aimed at developing and implementing innovative youth-friendly HIV self-testing
      services through open challenges and apprenticeships that provides youth opportunities to
      learn about social problems (like HIV) that affect their lives and then propose actions to
      address these problems, informed by the youth participatory action research framework (YPAR).

      Recent study conducted in Nigeria, already demonstrate the feasibility and acceptability of
      HIVST among 257 men sleeping with men (MSMs) in Nigeria (see paper by Tun, 2018). In that
      study, 97% reported using the HIVST kits. Almost all participants reported that the HIVST kit
      instructions were easy or somewhat easy to understand (99.6%) and perform the test
      (98.0%).The most common reasons they liked the test were ease of use (87.3%),
      confidentiality/privacy (82.1%), convenience (74.1%) and absence of needle pricks (64.9%).

      However given the need for youth friendly HIV testing services that are accessible,
      acceptable, appropriate and effective to address the specialized needs of young people and
      the public health implications of unknown HIV status, especially among young people, the
      purpose of this study is to evaluate the acceptability and performance of directly assisted
      oral HIVST in a youth population in Nigeria.

      Given that oral HIV self-testing is a new testing approach in Nigeria, there is a strong need
      for more research to be done to provide evidence of its acceptability in the general
      population. Currently, there has been one completed study that assessed the feasibility and
      acceptability of HIVST; however, this was conducted among a sub-population group (Men who
      have sex with Men) [Tun et. al., 2018]. Thus, this study seeks to examine in a general
      population of adolescents and young people, the acceptability and performance of oral HIV
      self-testing and the factors that influence acceptability.

      Study Procedures:

        1. Study participants will be recruited from a health facility in Nigeria as well as from
           local college campuses and other youth-friendly community settings in Nigeria. At the
           health facilities, study flyers with mobile phone contact numbers will be used to
           recruit participants along with provider word of mouth. At the schools and college
           campuses, and community settings, research assistants will introduce the study and
           participants between the ages of 14-24 will be invited to participate in the study. All
           participants recruited at the health facility, schools, college campuses, and community
           settings will be given written informed consent.

        2. Following informed consent, study staff will administer a pre-HIV testing questionnaire
           to collect basic demographic information and assess HIV test history, sexual behavior
           history, HIV self-testing knowledge, importance, confidence, and concerns with
           performing the test. Respondents will be given a tablet computer-assisted survey
           instrument (CASI) due to the sensitive nature of some of questions by NIMR research
           assistant and are able to enter their responses themselves. This is thought to increase
           the validity of responses, as respondents are more likely to give truthful answers.

        3. Next, instructions on how to perform the oral HIVST using OraQuick Rapid HIV 1⁄2
           Antibody, (OraSure Technologies), a rapid oral fluid test kit approved by FDA to detect
           HIV antibodies, will be given in person to each participant by the research assistant.
           The research assistant will show a short professionally developed video to introduce the
           concept of HIVST. The use of the video will allow us to standardize information provided
           to participants and limit discrepancies in the content and quality of the information
           provided. Pictorial information on how to perform the test will also be provided to
           participants. Instructions on how to perform the test will be repeated if asked by
           participants.

        4. Next, participants perform the oral HIVST in the privacy of a separate room or mobile
           tent-set up. After completion of the test, participants take a photograph of their test
           results. The photographs of the test result will be taken using a study issued tablet.
           To login to the tablet, each participant will be provided with a unique login number
           which corresponds to the ID on their pre and post test. By using the photo verification
           component, we seek to examine whether they can correctly perform the test on their own
           and interpret the result, as intended. The trained research assistant will record the
           results as captured in the photo.

        5. Next the trained research assistant from our partner organization, the Nigerian
           Institute of Medical Research (NIMR), will perform a confirmatory finger prick HIV test
           according to the national standards using the Determine and Uni-Gold in parallel as per
           the Nigerian HIV testing country guidelines. In a case where a participant test positive
           for HIV using the the HIVST kit, confirmatory testing will be available to the
           participant at the same location immediately.

        6. Finally, study participants will complete a post-test questionnaire to capture perceived
           acceptability of HIVST and whether they had any problems performing oral HIVST.
           Respondents will complete survey on a tablet computer-assisted survey instrument (CASI)
           due to the sensitive nature of some of questions by NIMR research assistant and are able
           to enter their responses themselves.

      We will adhere to the WHO five key components-the "5 Cs"-that must be respected and adhered
      to by all HIV Testing services. These components are: Consent Confidentiality Counselling
      Correct test results Connection/linkage to prevention, care and treatment.

      The five Cs, and the key principles they entail include the following:

        1. People being tested for HIV must give informed consent to be tested. They must be
           informed of the process for HTC, the services that will be available depending on the
           results, and their right to refuse testing. Mandatory or compulsory (coerced) testing is
           never appropriate, regardless of where that coercion comes from: health-care providers,
           partners, family members, employers, or others.

        2. Testing services must be confidential, meaning that the content of discussions between
           the person tested and the health-care worker, testing provider, or counselor, as well as
           the test results, will not be disclosed to anyone else without the consent of the person
           tested.

        3. Testing services must be accompanied by appropriate and high-quality pre-test
           information or pre-test counselling, and post-test counselling. Given that the
           confirmatory testing will be administered immediately at the testing site, our partners
           NIMR, a PEPFAR supported site will provide pre- and post-test counseling following
           regulations in Nigeria. NIMR is a PEPFAR Support HIV Care Services in Lagos, Nigeria
           providing care since 2003 for over 24,000 individuals living with HIV in Lagos, Nigeria.

        4. Provision of correct test results. Testing must be performed and quality assurance
           measures followed according to internationally-recognized testing strategies, norms, and
           standards based on the type of epidemic. Results must be communicated to the person
           tested unless that person refuses the results.

        5. Connections to HIV prevention, treatment and care and support services should be
           supported through concrete and well-resourced patient referral, support, and/or tracking
           systems.
    

Intervention name(s): Directly assisted oral HIV self-testing (HIVST)
Intervention type(s): Device
Intervention description(s): To determine the ability of participants with unknown HIV status to correctly perform oral HIVST;
To compare the results of the oral HIVST with confirmatory rapid finger prick HIV test.
To explore participants attitudes and preferences towards oral HIVST.
To explore the feasibility, acceptability and appropriateness of using a mobile photo verification app to verify HIV self-testing results.
Other intervention name(s): OraQuick ADVANCE Rapid HIV 1/2 Antibody Test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals aged 14-24 years old and residing in Lagos, Nigeria. Individuals who do not
        know their HIV status because they have never tested or their last HIV test was negative.
      
Keywords: HIV; HIV self-testing; young people; Nigeria