HIV/AIDSS-ITESTNCT07072481
Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing
A study testing Activities, Benefits and Capacity in people with HIV/AIDS and Sexually Transmitted Diseases, run by Washington University School of Medicine at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Sexually Transmitted Diseases
- What is being tested?
- Activities, Benefits and Capacity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,401 participants
- Where
- 1 siteNigeria
- Study dates
- 13 Oct 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Activities, Benefits, Capacity, Activities-S, Benefits-S
- Keywords
- HIV Prevention, HIV self-testing, Young people
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivitiesBehavioural
Activities include the implementation of the three main components of 4YBY that include;
- 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.
BenefitsBehavioural
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.
CapacityBehavioural
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.
Activities-SBehavioural
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.
Benefits-SBehavioural
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.
Capacity-SBehavioural
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.
PeopleBehavioural
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
Learning MeetingsBehavioural
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.
Adaptation MonitoringBehavioural
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.
Nurturing CoachesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Activities-S; Behavioral: Benefits-S; Behavioral: Capacity-S; Behavioral: People; Behavioral: Learning Meetings; Behavioral: Adaptation Monitoring; Behavioral: Nurturing Coaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured at baseline, 6 months, 12 months, 18 months, and 24 months
Secondary outcomes (5)
People: Youth, CHW and CBO characteristics
The investigators will use study-created measures to capture all youth, CHW and CBOs socio-demographic profiles. The investigators will assess program reach with youth participants and assess effectiveness outcomes among youth participants randomized to 4YBY-S versus 4YBY-E. Additionally, the investigators will use the coalitions, partnerships and networks domain of the Sustainment Measurement System Scale (SMSS) to assess support for continued operation of 4YBY, perceptions of engagement, among youth, communities and CBO's overtime. The investigators will also use the implementation climate scale, an 18-item questionnaire of implementation climate in an organization that supports evidence-based intervention adoption and use with very psychometric properties (18-items; α=0.894).
Measured: Measured at baseline, 6 months, 12 months, 18 months, and 24 months
Learning
The Dimension of the Learning Organization questionnaire, a psychometrically valid assessment of learning environment will be used to explore perceptions of the degree to which the atmosphere in the CBOs encouraged learning and provided opportunities for continuous learning, inquiry and dialogue, team learning, empowerment toward a collective vision, and a learning leadership with implementing and sustaining 4YBY across participating communities and CBOs. Additionally, the investigators will use the Measure of Innovation-Specific Implementation Intention (MISII) to measure individual CHWs and CBOs' intentions to implement and sustain 4YBY before and after learning. It consists of three items that each capture an aspect of intention: plans, desire, and scope, and the scale has good internal consistency (0.90).
Measured: Measured at baseline, 12 months, and 24 months
Adaptation
CHWs and CBOs will complete a checklist from the coding manual for FRAME-IS. The checklist will be used to capture whether they have made any adaptations to 4YBY based on patient/community characteristics, such as recruitment of at-risk youth populations or access to HIV prevention services. This outcome will also be reported as frequencies (i.e., the number of CBOs who reported making adaptations per recruit participant).
Measured: Measured at baseline, 12 months, and 24 months
Nurturing
The Implementation Citizenship Behavior Scale (ICBS) will be used to measure the extent to which CHW and CBO's exceed expectations with supporting 4YBY implementation overtime. It consists of six items divided equally across the two dimensions: (1) helping others and (2) keeping informed. Both subscales show good internal consistency in the original study (.93 and .91, respectively), as did the total scale (.93). Additionally, the Community Citizen Behavior Scale (CCB) will be adapted for use with at-risk youth participants to measure the positive behavior of AYA towards the community and CBOs with 4YBY implementation and sustainability. It includes 27 items and five five-dimensions namely, helping behavior, keeping interpersonal harmony, involving behavior, protecting behavior, and recommending behavior with Cronbach's α value that ranges from 0.841 to 0.918
Measured: Measured at baseline, 12 months, and 24 months
Semi-structured interviews
The investigators will interview a subset of youth, CHWs, and administrators of CBOs to contextualize and extend findings from the quantitative data collection. The investigators will sample from each community and CBO at baseline. At post-implementation and follow-up, a purposive sampling strategy will be utilized to ensure representation across communities and CBOs and to capture perspectives of youth, CHWs, and CBOs who experience different outcomes within each condition (e.g., 4YBY-S vs. 4YBY-E). The interviews will assess multilevel influences on 4YBY implementation and sustainability. The interview guide will be based on the tenets of the PEN-3 cultural model and the Consolidated Framework for Implementation Research.
Measured: Measured at baseline, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start13 Oct 2025
- Primary completion24 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Nigerian Institute of Medical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Juliet Iwelunmor, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072481
- Sponsor's protocol ID
- 202312092
- Other IDs
- UG1HD113156
- Acronym
- S-ITEST
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39547480Nathan 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.
PubMed 37033900Tucker 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.
PubMed 34870930Iwelunmor 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.
PubMed 36988831Iwelunmor J, Arinze C, Okwuzu J, Akinsolu FT, Gbaja-Biamila T, Ojo T, Olusanya O, Abodunrin OR, Nwaozuru U, Musa AZ, Bradon A, Koledowo AA, Xian H, Rosenberg N, Nkengasong S, Day S, Tang W, Conserve DF, Airhihenbuwa CO, Brownson R, Zhang L, Blessing LA, Ong JJ, Tucker JD, Ezechi OC. Sustaining the 4 youth by youth HIV prevention intervention in Nigeria: a cluster randomized controlled trial protocol. Implement Sci. 2026 Jun 6. doi: 10.1186/s13012-026-01507-1. Online ahead of print.
PubMed 42251355
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing
- ClinicalTrials.gov ID
- NCT07072481
- Acronym / sponsor ID
- S-ITEST / 202312092
- Conditions
- HIV/AIDS, Sexually Transmitted Diseases
- Keywords
- HIV Prevention, HIV self-testing, Young people
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,401 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Nigerian Institute of Medical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of North Carolina, Chapel Hill
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 24 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard arm (4YBY-S) | Active comparator | Behavioral: Activities, Behavioral: Benefits, Behavioral: CapacityAll 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. |
| Enhanced Arm (4YBY-E) | Experimental | Behavioral: Activities-S, Behavioral: Benefits-S, Behavioral: Capacity-S, Behavioral: People, Behavioral: Learning Meetings, Behavioral: Adaptation Monitoring, Behavioral: Nurturing CoachesCluster 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 |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActivitiesActivities 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. | Behavioural | Standard arm (4YBY-S) |
| BenefitsThe 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. | Behavioural | Standard arm (4YBY-S) |
| CapacityFollowing 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. | Behavioural | Standard arm (4YBY-S) |
| Activities-SActivities 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. | Behavioural | Enhanced Arm (4YBY-E) |
| Benefits-SThe 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. | Behavioural | Enhanced Arm (4YBY-E) |
| Capacity-SFollowing 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. | Behavioural | Enhanced Arm (4YBY-E) |
| PeopleSustainability 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 | Behavioural | Enhanced Arm (4YBY-E) |
| Learning MeetingsCBOs 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. | Behavioural | Enhanced Arm (4YBY-E) |
| Adaptation MonitoringCBOs 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. | Behavioural | Enhanced Arm (4YBY-E) |
| Nurturing CoachesTrained 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. | Behavioural | Enhanced Arm (4YBY-E) |
Primary outcome
Percent sustainment of core 4YBY elements overtime (Sustained activities)
Time frame: Measured at baseline, 6 months, 12 months, 18 months, and 24 months
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
Percent sustainment of core 4YBY elements overtime (Sustained benefits)
Time frame: Measured at baseline, 6 months, 12 months, 18 months, and 24 months
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.
Percent sustainment of core 4YBY elements overtime (Sustained capacity)
Time frame: Measured at baseline, 6 months, 12 months, 18 months, and 24 months
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.
5 secondary outcomes
People: Youth, CHW and CBO characteristics
Time frame: Measured at baseline, 6 months, 12 months, 18 months, and 24 months
Learning
Time frame: Measured at baseline, 12 months, and 24 months
Adaptation
Time frame: Measured at baseline, 12 months, and 24 months
Nurturing
Time frame: Measured at baseline, 12 months, and 24 months
Semi-structured interviews
Time frame: Measured at baseline, 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 39547480Iwelunmor 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.
- Background: PubMed 37033900Nathan 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.
- Background: PubMed 34870930Tucker 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.
- Background: PubMed 36988831Iwelunmor 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.
- Derived from this study: PubMed 42251355Iwelunmor J, Arinze C, Okwuzu J, Akinsolu FT, Gbaja-Biamila T, Ojo T, Olusanya O, Abodunrin OR, Nwaozuru U, Musa AZ, Bradon A, Koledowo AA, Xian H, Rosenberg N, Nkengasong S, Day S, Tang W, Conserve DF, Airhihenbuwa CO, Brownson R, Zhang L, Blessing LA, Ong JJ, Tucker JD, Ezechi OC. Sustaining the 4 youth by youth HIV prevention intervention in Nigeria: a cluster randomized controlled trial protocol. Implement Sci. 2026 Jun 6. doi: 10.1186/s13012-026-01507-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliet Iwelunmor, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activities, Benefits and Capacity in people with HIV/AIDS and Sexually Transmitted Diseases, run by Washington University School of Medicine at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent sustainment of core 4YBY elements overtime (Sustained activities) (time frame: Measured at baseline, 6 months, 12 months, 18 months, and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07072481, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.