NCT04710784

A Pragmatic Trial to Expand Youth-friendly HIV Self-testing

The 4 Youth by Youth Project: a Pragmatic Stepped-wedge Cluster Randomized Controlled Trial to Expand Youth-friendly HIV Self-testing Services in Nigeria

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 24 Years
• Healthy volunteers: Accepted

Summary

The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).

Detailed description

Following the completion of the open contests and apprenticeship training, four youth teams (with four distinct interventions) were selected to undergo a one-year pilot assessment in the community. Preliminary findings from the feasibility study suggest that the youth-developed interventions have the potential to impact HIV testing as well as uptake of sexually transmitted infections (STI) testing among young people in Nigeria. As a result, the investigators identified key components from the four interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, youth-developed intervention on HIV testing and other HIV prevention outcomes (i.e. condom use, PrEP referral, STI testing). Using a stepped-wedge cluster randomized controlled trial design, the I-TEST intervention package will be implemented sequentially across 32 local government areas (LGA) whereby each LGA will be exposed to a pre-intervention (control), intervention (implementing the intervention), and post-intervention condition, according to a randomized schedule. Young people between the ages of 14-24 years will be recruited from the selected 32 local government areas through in-person events, social media platforms, and online advertisements, clinics, and community centers that cater to young people. We included two additional LGAs in November 2021 to account for civil unrest activities that are taking place across two other study sites. Due to the civil unrest, the implementation of the intervention has been affected hence the addition of the two new sites. Upon enrollment, the study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes from the study participants. Two trained youth alongside one trained supervisor will implement the I-TEST intervention at the LGAs.

Conditions

• HIV/AIDS
• Sexually Transmitted Infections

Interventions

Type	Name	Description
BEHAVIORAL	Sexual health information	We will provide participants with sexual health information, that is basic, accurate, and directly contributes to health-promoting decisions and behavior, once a week at the beginning of the study.
BEHAVIORAL	I-TEST branded HIVST package	The I-TEST branded HIVST package will include HIV self-testing (HIVST) kits, referral coupons, condoms, female or male hygiene products, and instructions on how to use the I-TEST photo verification App or USSD (Unstructured Supplementary Service Data) system to verify the HIVST results. Study participants will be referred to a youth-friendly health clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment and PrEP referral.
OTHER	Follow-up testing and clinic assessments	Information to encourage routine retesting for HIV every 6 months and linkage to the youth-friendly clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment, and PrEP referral. Additionally, follow-up surveys will be administered to assess HIV testing, sexual behavior history, youth participation experience, and other related outcomes will be collected from enrolled participants.

Timeline

• Start date: 2021-05-10
• Primary completion: 2023-08-31
• Completion: 2023-12-01
• First posted: 2021-01-15
• Last updated: 2024-11-12

Locations

1 site across 1 country: Nigeria