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

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).

Conditions

• HIV/AIDS
• Sexually Transmitted Diseases

Interventions

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.

Sponsors & Collaborators

• Nigerian Institute of Medical Research

  collaborator OTHER_GOV

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Juliet Iwelunmor, PhD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-13

Primary Completion

2027-12-24

Completion

2028-08-31

Countries

• Nigeria

Study Locations