Resilient HIV Implementation Science With SGM Youths Using Evidence
RISE
1 other identifier
interventional
1,500
2 countries
3
Brief Summary
The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Mar 2026
Typical duration for not_applicable hiv
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2024
CompletedFirst Posted
Study publicly available on registry
April 5, 2024
CompletedStudy Start
First participant enrolled
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
May 19, 2026
May 1, 2026
3.3 years
February 20, 2024
May 14, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
PrEP initiation for HIV seronegative seropositive
For those HIV seronegative, initiation of pre-exposure prophylaxis (PrEP) (Oral PrEP dispensed by pharmacy or Long-acting injectable defined as receiving first dose)
24 months
Viral load suppression for HIV
HIV seropositive viral load suppression at 12 months of taking ART (defined as HIV viral load of less than 1,000 copies/mL)
24 months
RE-AIM
Implementation Effectiveness on reach (characteristics of participants enrolled), Adoption (HMP physician and client interaction), Implementation (barriers and facilitators), Maintenance (HMP immediate access group at 21-24 months) and cost effectiveness of the HMP (incremental costs effectiveness ration and net monetary benefit)
24 months
Secondary Outcomes (4)
HIV testing cascade
12-24 months
PrEP continuum
12-24 months
HIV care and treatment continuum
12-24 months
Implementation effectiveness
24 months
Study Arms (2)
HealthMPowerment (HMP) Delayed Access
NO INTERVENTIONDelayed access for 12 months to the HMP app, individuals will have access but it will be restricted
HealthMPowerment (HMP) Open Access
EXPERIMENTALFull access to the HMP app
Interventions
Participants will be provided access to the status neutral platform (HMP)mobile app for 12 months exposure period or a delayed access period. The HMP is developed specific to RISE and will be adapted based off feedback from each local site via stakeholders/YABs. The HMP will encompass a range of features including a robust content management system and back end administrative dashboard, multi media resources and information center, social support features such as connections to peers and providers, interactive activities and self assessments, and flexible medication and health trackers. In addition the app will support HIV/STI test kit ordering and results portal and a gamified reward system. With real time analytics to monitor user engagement and response with the DHI we can adapt the delivery of tailored content to fit emergent HIV prevention and care challenges.
Eligibility Criteria
You may qualify if:
- Male sex at birth
- Age 15-24 years
- Own an Android or iOS smartphone
- Had receptive or insertive sex with another man in the past 12 months
- Receiving care or prevention services at the CBSP-associated with the CRPS at the time of study.
You may not qualify if:
- Less than 15 years old
- Greater than 24 years old
- Inability or cognitively impaired to provide consent
- Does not own an Android or iOS smartphone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Maryland, Baltimorelead
- Florida State Universitycollaborator
Study Sites (3)
Icarh/Ihvn
Abuja, Nigeria, Nigeria
Centre for Population Health Initiative
Lagos, Nigeria, Nigeria
CIHEB Zambia Limited
Lusaka, Zambia, Zambia
Related Publications (2)
Brasileiro J, Muessig KE, Lascko T, Sam-Agudu NA, Rochelle A, Mansfield ME, Ehoche A, Adebajo S, Hightow-Weidman LB, Charurat ME, Shoyemi E, Claassen CW, Trapence G, Kimani J, Aghedo OG, Ayorinde O, Sambambi K, Ndalumbira G, Gichuki R, Lavoie MC. Adapting the HealthMpowerment (HMP) mobile application for youth living with or at risk of HIV in Africa using the ADAPT-ITT model. Implement Sci Commun. 2026 Apr 13. doi: 10.1186/s43058-026-00913-2. Online ahead of print.
PMID: 41968361DERIVEDAdebajo S, Lascko T, Lavoie MC, Ehoche A, Mutumba C, Aernan NS, Nganga N, Njoroge B, Chinseu PD, Gichuki R, Ayorinde O, Aghedo OG, Sambambi K, Ndalumbira G, Ngulube MC, Chama J, Shoyemi E, Trapence G, Kimani J, Claassen CW, Sam-Agudu NA, Hightow-Weidman L, Charurat M; RISE Study. Implementing youth advisory boards with sexual minority adolescents and young men: sharing experiences, challenges and opportunities from East, South, and West Africa. Trials. 2026 Mar 11;27(1):307. doi: 10.1186/s13063-026-09596-5.
PMID: 41808215DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2024
First Posted
April 5, 2024
Study Start
March 4, 2026
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share