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

NCT07072481 | Recruiting DMC

• 2 other identifiers: 202312092UG1HD113156
• Study Type: interventional
• Target: 1,216
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HIV Prevention; HIV self-testing; Young people

Outcome Measures

Primary Outcomes (3)

• Percent sustainment of core 4YBY elements overtime (Sustained activities)

  Sustainment of the activities will be assessed using the sustainment outcome of the Sustainment Measurement System Scale (SMSS). This includes 4-items that assess the continued operation of 4YBY including delivering it services to intended populations overtime. All youth participants as well as CHWs and CBOs will complete this assessment

  Measured at baseline, 6 months, 12 months, 18 months, and 24 months

• Percent sustainment of core 4YBY elements overtime (Sustained benefits)

  The investigators will use the Sustainment Measurement System Scale (SMSS) domains focused on responsiveness to community needs and values to assess 4YBY responsiveness to youth and community needs over time. At-risk youth recruited to participate as well as CHWs and CBOs will complete 7-items measuring whether the 4YBY intervention, as implemented and sustained, currently meets their needs, is consistent with the norms and values of the CBOs, fits with the values of CBOs, communities and young people, with a shared perception of project importance by all participants.

  Measured at baseline, 6 months, 12 months, 18 months, and 24 months

• Percent sustainment of core 4YBY elements overtime (Sustained capacity)

  The infrastructure and capacity to support the sustainment domain of the Sustainment Measurement System Scale (SMSS) will be used to assess available resources for 4YBY implementation and sustainment over time. All youth, CHWs, and CBOs will complete surveys that assess whether 4YBY is fully integrated into the operations of their communities and CBOs, as well as plans for implementing and sustaining 4YBY.

  Measured at baseline, 6 months, 12 months, 18 months, and 24 months

Secondary Outcomes (5)

• People: Youth, CHW and CBO characteristics

  Measured at baseline, 6 months, 12 months, 18 months, and 24 months

• Learning

  Measured at baseline, 12 months, and 24 months

• Adaptation

  Measured at baseline, 12 months, and 24 months

• Nurturing

  Measured at baseline, 12 months, and 24 months

• Semi-structured interviews

  Measured at baseline, 12 months and 24 months

Study Arms (2)

Standard arm (4YBY-S)

ACTIVE COMPARATOR

All Community-Based Organizations (CBOs) will implement 4YBY activities, focusing on three main components: providing HIV self-testing bundles and navigation to youth-friendly clinical sites, utilizing trained community health workers for service delivery, and facilitating peer-to-peer support among youth participants. CBOs will complete an organizational readiness survey to evaluate their capacity for implementing 4YBY.

Behavioral: Activities; Behavioral: Benefits; Behavioral: Capacity

Enhanced Arm (4YBY-E)

EXPERIMENTAL

Cluster randomization will occur using a parallel group approach at the community level. Communities and their corresponding CBOs will be randomized 1:1 to two clusters in 40 community sites and CBOs. The 4YBY-E package will include the 4YBY-S (CBO will implement 4YBY activities, focusing on three main components: providing HIV self-testing bundles and navigation to youth-friendly clinical sites, utilizing trained community health workers for service delivery, and facilitating peer-to-peer support among youth participants) with enhanced (4YBY-E) interventions using the PLAN (People, Learning, Adaption, and Nurture) approach for sustainability and will be measured at 24 months for sustained activities, benefits, and capacity over time using both qualitative and quantitative data. NOTE: In this arm, the investigators will have 4YBY-S + 4YBY-E

Behavioral: Activities-S; Behavioral: Benefits-S; Behavioral: Capacity-S; Behavioral: People; Behavioral: Learning Meetings; Behavioral: Adaptation Monitoring; Behavioral: Nurturing Coaches

Interventions

Activities BEHAVIORAL

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.

Standard arm (4YBY-S)

Benefits BEHAVIORAL

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.

Standard arm (4YBY-S)

Capacity BEHAVIORAL

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.

Standard arm (4YBY-S)

Activities-S BEHAVIORAL

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.

Enhanced Arm (4YBY-E)

Benefits-S BEHAVIORAL

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.

Enhanced Arm (4YBY-E)

Capacity-S BEHAVIORAL

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.

Enhanced Arm (4YBY-E)

People BEHAVIORAL

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

Enhanced Arm (4YBY-E)

Learning Meetings BEHAVIORAL

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.

Enhanced Arm (4YBY-E)

Adaptation Monitoring BEHAVIORAL

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.

Enhanced Arm (4YBY-E)

Nurturing Coaches BEHAVIORAL

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.

Enhanced Arm (4YBY-E)

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Nigerian Institute of Medical Research: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

RECRUITING

Related Publications (4)

• Iwelunmor J, Adeoti E, Gbaja-Biamila T, Nwaozuru U, Obiezu-Umeh C, Musa AZ, Xian H, Tang W, Oladele D, Airhihenbuwa CO, Rosenberg N, Conserve DF, Yates F, Ojo T, Ezechi O, Tucker JD. Factors associated with HIV self-testing and PrEP use among Nigerian youth: Baseline outcomes of a pragmatic, stepped-wedge, cluster-randomized controlled trial. Contemp Clin Trials. 2025 Jan;148:107733. doi: 10.1016/j.cct.2024.107733. Epub 2024 Nov 14.

  PMID: 39547480 BACKGROUND

• Nathan N, Shelton RC, Laur CV, Hailemariam M, Hall A. Editorial: Sustaining the implementation of evidence-based interventions in clinical and community settings. Front Health Serv. 2023 Mar 24;3:1176023. doi: 10.3389/frhs.2023.1176023. eCollection 2023. No abstract available.

  PMID: 37033900 BACKGROUND

• Tucker JD, Iwelunmor J, Abrams E, Donenberg G, Wilson EC, Blachman-Demner D, Laimon L, Taiwo BO, Kuhns LM, John-Stewart GC, Kohler P, Subramanian S, Ayieko J, Gbaja-Biamila T, Oladele D, Obiezu-Umeh C, Chima KP, Jalil EM, Falcao J, Ezechi OC, Kapogiannis BG. Accelerating adolescent HIV research in low-income and middle-income countries: evidence from a research consortium. AIDS. 2021 Dec 1;35(15):2503-2511. doi: 10.1097/QAD.0000000000003049.

  PMID: 34870930 BACKGROUND

• Iwelunmor J, Tucker JD, Ezechi O, Nwaozuru U, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Musa AZ, Airhihenbuwa CO. Sustaining HIV Research in Resource-Limited Settings Using PLAN (People, Learning, Adapting, Nurturing): Evidence from the 4 Youth by Youth Project in Nigeria. Curr HIV/AIDS Rep. 2023 Apr;20(2):111-120. doi: 10.1007/s11904-023-00652-2. Epub 2023 Mar 29.

  PMID: 36988831 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Juliet Iwelunmor, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliet Iwelunmor, PhD

CONTACT

2405280123; ijuliet@wustl.edu

Oliver C Ezechi, MD

CONTACT

oezechi@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 18, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): December 24, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)