NCT07072481

Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,216 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 24 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

Utilizing a participatory approach, an open call for submissions was published to engage young people in partnerships with certified community-based organizations in Nigeria. This initiative encouraged them to share their ideas, experiences, and perspectives on how community-based organizations can sustain or enhance HIV self-testing (HIVST) and youth-friendly preventive services for at-risk adolescents and young adults. During the open call, 123 submissions were received from 178 young adults and adolescents aged 14-24, offering a variety of capacity-building and adaptable ideas, such as peer health education and community engagement activities. In the designathon phase, where youth refined their ideas, 10 teams comprising 40 participants were involved, with 24 teams focusing on mobile health outreach, 8 adapting health messaging to sports, and 8 creating safe spaces for marginalized communities. Five teams (n=20) were invited to a 4-week hybrid innovative Bootcamp to further refine their sustainment strategy, which involved training the trainers (1 team), tailoring services (1 team), creating safe spaces (1 team), modifying vans (1 team), and adapting health messaging for sporting events (1 team). All teams were awarded prizes. Strategies from all teams were combined to form the enhanced sustainability strategy for this clinical trial. In this hybrid type 2 implementation-effectiveness trial, cluster randomization will occur in a parallel group approach, with phased enrollment to standard 4YBY for all study arms, followed by an enhanced condition for CBOs randomized to the intervention condition. This study protocol will involve undertaking a prospective three-year assessment of the sustained intervention focused on the sustainment of the 4YBY core elements and uptake of HIV prevention services (HIV testing/ retesting, STI testing/treatment, PrEP adherence), sustained capacity to implement the 4YBY program, youth engagement, and reach Step 1: Participant enrollment and baseline data collection. This will involve recruiting youth to participate in the randomized controlled trial. Participant recruitment strategies will include social media, online, event- and venue-based, participant referral, and community and school-based referrals. Participant enrollment will be completed by the study team. Step 2: Intervention implementation. Following participant recruitment and enrollment in the study. All 40 sites will receive standard 4YBY implementation (4YBY-S), with 20 sites with matched CBOs randomized to receive standard with enhanced sustainability strategy (4YBY-E). 4YBY-S includes the continuation of standard 4YBY activities, benefits, and capacities at all participating CBOs. The Enhanced Sustainability Strategy package includes developing formal commitments and sustainability blueprint (herein referred to as PLAN) for 4YBY at randomized CBOs that includes all goals and strategies, timeframes, and milestones as well as; 1) people (i.e. identify and prepare champions known as sustainability teams); 2) learning (create a bi-weekly collaborative to improve learning, sustainability, and network weaving that promote information sharing, collaborative problem solving and shared vision/goal with sustaining 4YBY); 3) adaptation monitoring (promote and monitor adaptation to meet local needs); and 4) access to nurturing coaches (provide supportive climate and technical assistance with sustainability as well as audit and feedback) Step 3: The investigators will conduct follow-up surveys across all 4YBY communities and CBOs and among AYA in the cohort at baseline and every six months for 24 months. Participants will use their mobile phone numbers to access the survey in person or online. Reminders will be sent via text message. The completion of the surveys will be tracked in an online database. Follow-up surveys will also be conducted to assess intervention sustainment every six months for 24 months. Additionally, every implementation encounter (i.e., initial or ongoing training, implementation of the 4YBY program, and use of sustainment strategies by the trained CHWs) will be documented in an electronic implementation dashboard maintained by the NIMR study team that will include encounter length time, time spent on 4YBY program implementation, and a checklist of implementation and sustainment strategies used.

Conditions

• HIV/AIDS
• Sexually Transmitted Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Activities	Activities include the implementation of the three main components of 4YBY that include; 1\) provision of HIV self-testing bundles and navigation to youth-friendly clinical sites for sexually transmitted infection screening to recruited youth participants; 2) use of trained community health workers to implement the HIV self-testing bundles and STI screening services to recruited youth participants; and 3) peer-to-peer support and supervision on what works or does not work with implementing 4YBY services among recruited youth participants.
BEHAVIORAL	Benefits	The benefits are conceptualized at the individual, community and CBO levels. At the individual level, at-risk youth gain access to HIV prevention services and educational materials. Community outreach will tailor educational materials to local needs, enhancing the overall impact. CBOs will form academic-community partnerships, receive training, and access resources to sustain 4YBY. A quarterly learning collaborative will also promote effective implementation.
BEHAVIORAL	Capacity	Following a baseline assessment, CBOs will receive initial training on 4YBY through live videoconferences, with options for self-study for those unable to attend. Training will cover research evidence, implementation procedures, and necessary tools. Refresher training will occur every six months, ensuring ongoing support. Young people will engage in educational meetings to improve program uptake, assess quality, and enhance long-term retention.
BEHAVIORAL	Activities-S	Activities include the implementation of the three main components of 4YBY that include; 1) provision of HIV self-testing bundles and navigation to youth-friendly clinical sites for sexually transmitted infection screening to recruit youth participants; 2) use of trained community health workers to implement the HIV self-testing bundles and STI screening services to recruited youth participants; and 3) peer-to-peer support and supervision on what works or does not work with implementing 4YBY services among recruited youth participants.
BEHAVIORAL	Benefits-S	The benefits are conceptualized at the individual, community, and CBO levels. At the individual level, at-risk youth gain access to HIV prevention services and educational materials. Community outreach will tailor educational materials to local needs, enhancing the overall impact. CBOs will form academic-community partnerships, receive training, and access resources to sustain 4YBY. A quarterly learning collaborative will also promote effective implementation.
BEHAVIORAL	Capacity-S	Following a baseline assessment, CBOs will receive initial training on 4YBY through live videoconference, with options for self-study for those unable to attend. Training will cover research evidence, implementation procedures, and necessary tools. Refresher training will occur every six months, ensuring ongoing support. Young people will engage in educational meetings to improve program uptake, assess quality, and enhance long-term retention.
BEHAVIORAL	People	Sustainability teams will be established in CBOs to lead the implementation of their sustainability blueprint for 4YBY. These teams will train staff, monitor goals, and provide feedback on performance and progress over time
BEHAVIORAL	Learning Meetings	CBOs will participate in bi-weekly collaborative meetings to enhance their sustainability efforts, share lessons learned, and support one another. These meetings will focus on creating a supportive learning environment and reinforcing leadership that promotes continuous learning.
BEHAVIORAL	Adaptation Monitoring	CBOs will adapt best practices for their sustainability plans using the FRAME-IS framework to ensure that strategies meet local needs while documenting the modifications and maintained elements over time.
BEHAVIORAL	Nurturing Coaches	Trained coaches will provide individualized support to CBOs, holding weekly office hours to assist with their sustainability plans, monitor progress, and address site-specific barriers to change.

Timeline

• Start date: 2025-10-13
• Primary completion: 2027-12-24
• Completion: 2028-08-31
• First posted: 2025-07-18
• Last updated: 2025-10-29

Locations

1 site across 1 country: Nigeria