Resilient HIV Implementation Science With SGM Youths Using Evidence (RISE)

May 14, 2026 updated by: Man Charurat, University of Maryland, Baltimore
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Nigeria
      • Abuja, Nigeria, Nigeria
        • Icarh/Ihvn
      • Lagos, Nigeria, Nigeria
        • Centre for Population Health Initiative
  • Zambia
    • Zambia
      • Lusaka, Zambia, Zambia
        • CIHEB Zambia Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: HealthMPowerment (HMP) Delayed Access
Delayed access for 12 months to the HMP app, individuals will have access but it will be restricted
Experimental: HealthMPowerment (HMP) Open Access
Full access to the HMP app
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP initiation for HIV seronegative seropositive
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV testing cascade
Time Frame: 12-24 months
HIV self testing
12-24 months
PrEP continuum
Time Frame: 12-24 months
PrEP education (restart/re-initiation)
12-24 months
Implementation effectiveness
Time Frame: 24 months
Study retention (participants who remained active at 24 months)
24 months
HIV care and treatment continuum
Time Frame: 12-24 months
For those HIV seropositive, antiretroviral treatment (ART) initiation and retention at 12 months
12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00107323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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