NCT07072481Active, not recruiting
Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing (S-ITEST), locally known as 4 Youth by Youth (4YBY) in Nigeria, builds on the investigator's previous efforts, which are detailed in ClinicalTrial ID#: NCT04070287, NCT03874663, and NCT04710784. Many adolescents and young adults (AYA, 14-24 years old) in Nigeria have a substantial HIV risk but do not receive adequate HIV prevention services. While pre-exposure prophylaxis (PrEP), HIV self-testing, sexually transmitted infection (STI) testing, and linkage to AYA-friendly clinical services are essential, they have not been widely implemented or sustained in Nigeria. In this study, the investigators aim to 1) use participatory approaches (i.e., crowdsourcing, designathons, and participatory learning communities (PLC)) to develop sustainability strategies that sustain 4YBY in participating community sites served by recruited community-based organizations; 2) test the effects of the standard 4YBY implementation versus standard with enhanced sustainability strategy on site-level adoption and sustainability of the 4YBY intervention across 24 months in participating community sites (n=40) and community-based organizations (n=20); and 3) characterize and estimate the impact and cost-effectiveness of sustaining 4YBY over time. Guided by youth participatory action research (YPAR), the PEN-3 cultural model, Proctor's Implementation Outcomes Framework, and the Consolidated Framework for Implementation Research (CFIR), this study intends to support community-based organizations in implementing and sustaining the 4YBY intervention to increase the uptake of HIV prevention services while optimizing resource allocation to achieve sustainability in collaboration between the Washington University School of Medicine, the University of North Carolina at Chapel Hill, Georgia State University, George Washington University, Monash University, Wake Forest University School of Medicine, and the Nigerian Institute of Medical Research (NIMR).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1401 (actual)
- First submitted
- 17 Jun 2025
- Start date
- 13 Oct 2025
- Primary completion date
- 24 Dec 2027
- Lead sponsor
- Washington University School of Medicine
- Diseases
- HIV
- NCT number
- NCT07072481
What you commit to
- Study type: Interventional
- Participants enrolled: 1401
- From 13 Oct 2025 to the primary completion date, 24 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Illness, cognitive impairment or threatening behavior with acute risk to self or others
Age
- Younger than 14 and older than 24
Other
- Inability to comply with the study protocol
- No informed consent
- No contact phone number
- Do not reside in any of the LGAs
Who the study is looking for
- Age 14-24
- Condomless anal or vaginal sex in the past six months Meet PrEP-eligibility criteria according to Nigerian guidelines (sex worker, MSM, person who uses drugs, partner with HIV, or sexually exposed youth, or engagement in transactional sex)
- No history of prior PrEP use
- HIV negative based on fourth-generation test
- Current resident of the recruitment city with plans to stay in city for the next 12-24 months
- Able to complete a written survey in English (the national language of Nigeria) or Pidgin English
- All participants must agree to an informed consent and provide their cell mobile number for follow-up and retention
Age in the registry: 14 years to 24 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nigerian Institute of Medical Research Coordinator of this site? Confirm its status | Yaba | Nigeria | Unknown status |
Related publications
- Sustaining the 4 youth by youth HIV prevention intervention in Nigeria: a cluster randomized controlled trial protocol.Implement Sci · 2026 · PMID 42251355
This page is information, not medical advice. Discuss any trial with your doctor.