Innovative Tools to Expand HIV Self-Testing
Condition: HIV/AIDS; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The I-TEST study builds upon two participatory approaches, open challenge contests and
      entrepreneurship training. The study utilizes open challenge contest to generate youth-driven
      interventions on strategies to promote HIV self-testing and other testing for other sexually
      transmitted infections (STIs) among young people in Nigeria. Open challenge contests involves
      leveraging on the knowledge and strengths of the crowd (in this case young people) to
      generate solutions to an issue. Following completion of one of the open challenge contest,
      was the Designathon contest where young people in Nigeria collaborated to develop new
      services and products for promoting self-testing for HIV and other sexually transmitted
      diseases, guided by human-centered, design thinking framework. After which, six teams from
      the Designathon were selected to move onto an Innovation bootcamp. The Innovation bootcamp
      was a 4-week long accelerated training program for young people to delve into the world of
      entrepreneurial and innovation management skills, while applying basic research principles.
      At the end of the course, 5 finalist teams were selected to pilot test their innovation plan
      in the community for a duration of 6 months, beginning July 2019.

      This study is focused on evaluating the effectiveness of these five youth participatory
      interventions on HIV testing and other key prevention among at risk youth (14-24 years old in
      Nigeria).This research study will involve undertaking a prospective one-year assessment of
      these five pilot interventions.
    

Detailed description: 
      Step 1: Participant enrollment. This will involve recruiting youth to participate in the
      pilot study. Participant recruitment strategies will include: social media, online, event-
      and venue based, participant referral, and walk-ins at study clinics. Participant enrollment
      will be completed by study team.

      Step 2: Intervention implementation. Following participant recruitment and enrollment in the
      study. Study participants will be assigned to one of the 5 youth participatory interventions
      focused on expanding the uptake of HIV self-testing and key HIV prevention services. The
      pilot intervention implementation would occur for 6 months. Nigerian Institute of Medical
      Research (NMIR) will provide local training on HIV prevention to the five participatory
      interventions following their existing guidelines.The participatory interventions will be
      conducted in the locations of the five teams who emerged as winners from the innovation
      boot-camp. These participatory interventions will only provide HIV self-testing kits and
      instructions of how to perform the test to participants. They will also provide referral
      coupons to youth friendly centers for sexually transmitted infections (STI) screening and
      treatment and pre-exposure prophylaxis (PrEP) awareness and initiation for at-risk youth. The
      referral coupons are intended to provide study participants information on trained youth
      friendly centers that are involved with the research. The referral coupons give the study
      participants access to other sexually transmitted infections (STI) screening and treatment
      and pre-exposure prophylaxis (PrEP) awareness and initiation at these health facilities. The
      intervention only provide participants with the HIV self-testing kits and then refer them to
      youth-friendly health facilities for other testing services. The intervention does not
      involve monitoring HIV self-testing procedure, the investigators will only be asking for
      self-reported HIV testing and other sexually transmitted diseases testing.

      Step 3: Baseline data collection. After allocation of participants into the intervention,
      study team will collect baseline data on HIV testing history, sexual behavior history, youth
      participation experience, and other related outcomes will be collected (survey questionnaire
      attached) from recruited participants. Participants mobile phone numbers will also be
      collected as tracking information for follow-up and retention in a coupon format. The mobile
      phone numbers would be used to contact study participants through text messages and phone
      calls. These contacts would serve as reminders for participants to participate in follow-up
      data collection. The mobile phone service charge would be covered by the research. No other
      personal identifiers will be collected and no biological specimens will be collected at
      baseline. The investigators will obtain informed consent before proceeding with any data
      collection.

      Step 4:Health facilities training. For the purposes of this research study, the Nigerian
      Institute of Medical Research team would provide training to youth-friendly health centers
      currently working with the Nigerian Institute of Medical Research based on the World Health
      Organization guidebook for youth-friendly health services (handbook is attached).The training
      would be to ensure that these health facilities are trained to provide youth friendly
      services to participants who be referred to receive STI screening, STI treatment and PrEP
      awareness and initiation. Following the training, the NIMR research team would in charge of
      collecting data to record record participants HIV self-testing uptake as well as uptake of
      STI screening, STI treatment and PrEP awareness and initiation.

      Step 5: Follow up surveys at 3 and 6 months: At 3 and 6 months post intervention
      implementation, study team will collect similar baseline data from study participants. The
      follow-up survey will assess HIV testing, sexual behavior history, youth participation
      experience and other related outcomes will be collected (survey questionnaire attached) from
      recruited participants.
    

Intervention name(s): SMART Pack; Luv Box; Bili Vibes; BeterDoc; IUNGO
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.; The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.; The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.; The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.; The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
Other intervention name(s): The OraQuick®ADVANCERapid HIV-1/2 Antibody Test; The OraQuick®ADVANCERapid HIV-1/2 Antibody Test; The OraQuick®ADVANCERapid HIV-1/2 Antibody Test; The OraQuick®ADVANCERapid HIV-1/2 Antibody Test; The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Intervention MeSH terms: Antibodies; Immunoglobulins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention Pilot
This study protocol will involve undertaking a prospective one-year assessment of five youth participatory interventions. These interventions are focused on promoting HIV self-testing and referrals to health facilities for other sexually transmitted infections test.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; HIV self-testing; young people; Nigeria