Actively Recruiting
Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing
Led by Washington University School of Medicine · Updated on 2025-10-29
1216
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
Nigerian Institute of Medical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Younger than 14 and older than 24
- Inability to comply with the study protocol
- Illness, cognitive impairment or threatening behavior with acute risk to self or others
- No informed consent
- No contact phone number
- Do not reside in any of the LGAs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nigerian Institute of Medical Research
Yaba, Lagos, Nigeria
Actively Recruiting
Research Team
J
Juliet Iwelunmor, PhD
CONTACT
O
Oliver C Ezechi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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