Resilient HIV Implementation Science With SGM Youths Using Evidence

Not Applicable

Not yet recruiting

• Conditions: Hiv
• Interventions: Behavioral: HealthMPowerment (HMP)

• Registration Number: NCT06350682
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Study Start: 2025-05
• Primary Completion: 2027-09
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 1500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HealthMPowerment (HMP) Open Access	HealthMPowerment (HMP)	Full access to the HMP app

Primary Outcome Measures

Name	Time	Method
RE-AIM	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)
PrEP initiation for HIV seronegative seropositive	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)
Viral load suppression for HIV	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)

Secondary Outcome Measures

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