Resilient HIV Implementation Science With SGM Youths Using Evidence

NCT ID: NCT06350682

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-03-31

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.

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.

Conditions

Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

HealthMPowerment (HMP) Delayed Access

Delayed access for 12 months to the HMP app, individuals will have access but it will be restricted

Group Type: NO_INTERVENTION

No interventions assigned to this group

HealthMPowerment (HMP) Open Access

Full access to the HMP app

Group Type: EXPERIMENTAL

HealthMPowerment (HMP)

Intervention Type: BEHAVIORAL

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.

Interventions

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 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Man Charurat

Director, Division of Epidemiology and Prevention

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Manhattan Charurat, PhD

Role: CONTACT

mcharurat@ihv.umaryland.edu

410-706-1948

Ashley Shutt, MS, CCRP

Role: CONTACT

ashutt@ihv.umaryland.edu

410-706-1292

Other Identifiers

HP-00107323

Identifier Type: -

Identifier Source: org_study_id