Resilient HIV Implementation Science With SGM Youths Using Evidence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HealthMPowerment (HMP).
- Who it may be relevant to
- Registry conditions: Hiv. Basic parameters: 15 years — 24 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria, Zambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
RISE is a randomized control trial where participants are randomized (1:1) to either healthMPower (HMP) exposure for a 12 month period or delayed access to the HMP within 8 strata based on the serostatus group. HIV seropositive and HIV seronegative at risk, age group 15 to 17 or 18 to 24 years of age and country either Nigeria, Kenya, Malawi, or Zambia. Within the strata of serostatus, age, and country, participants will be randomly assigned to the next treatment allocation from a randomly permuted block sequencing using block size of four.
750 Participants will be randomly assigned to the HMP exposure while the other 750 participants will have delayed access to HMP. The HMP is a culturally adapted status neutral mobile app that works to address HIV prevention to care continuum (PHCC) for SGM youth at each of the CBSPs.
Participants who are delayed access for 12 months will be granted "Open access" for 12 months thereafter, when compared to participants who were provided access for 12 months then provided 12 months of access called "continued access" without other external support. Therefore, participants will either be provided access for 12 or 24 months depending on the randomization.
Primary outcome, clinical effectiveness endpoint for HIV seronegative at risk young will be the uptake of PrEP and for HIV seropositive viral load suppression. Secondary outcome, PHCC pathway characterized for HIV seronegative at risk youth such as PrEP education and continuation and for HIV seropositive HIV testing, linkage, and ART initiation.
Interventions
- Behavioral HealthMPowerment (HMP)
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 provide
Primary outcome measures
- PrEP initiation for HIV seronegative seropositive [Time frame: 24 months]
- Viral load suppression for HIV [Time frame: 24 months]
- RE-AIM [Time frame: 24 months]
Secondary outcome measures (4)
- HIV testing cascade [Time frame: 12-24 months]
- PrEP continuum [Time frame: 12-24 months]
- HIV care and treatment continuum [Time frame: 12-24 months]
- Implementation effectiveness [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Nigeria · 2 centers
- Icarh/Ihvn — Abuja
- Centre for Population Health Initiative — Lagos
Zambia · 1 center
- CIHEB Zambia Limited — Lusaka
Publications
- 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. PMID 41968361
- Adebajo 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 PMID 41808215
Identifiers
NCT: NCT06350682 · HP-00107323