Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,401
- 试验地点
- 1
- 主要终点
- Percent sustainment of core 4YBY elements overtime (Sustained activities)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Enhanced Arm (4YBY-E)
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
干预措施: Activities-S (Behavioral)
Enhanced Arm (4YBY-E)
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
干预措施: Benefits-S (Behavioral)
Enhanced Arm (4YBY-E)
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
干预措施: Capacity-S (Behavioral)
Enhanced Arm (4YBY-E)
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
干预措施: People (Behavioral)
Enhanced Arm (4YBY-E)
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
干预措施: Adaptation Monitoring (Behavioral)
Standard arm (4YBY-S)
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.
干预措施: Activities (Behavioral)
Standard arm (4YBY-S)
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.
干预措施: Capacity (Behavioral)
Enhanced Arm (4YBY-E)
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
干预措施: Learning Meetings (Behavioral)
Enhanced Arm (4YBY-E)
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
干预措施: Nurturing Coaches (Behavioral)
Standard arm (4YBY-S)
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.
干预措施: Benefits (Behavioral)
结局指标
主要结局
Percent sustainment of core 4YBY elements overtime (Sustained activities)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)