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

University of Maryland Baltimore (UMB)

Status: Not yet enrolling

Conditions: Hiv

Treatments: Behavioral: HealthMPowerment (HMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06350682

HP-00107323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: Male

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

HealthMPowerment (HMP) Delayed Access

No Intervention group

Description:

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

HealthMPowerment (HMP) Open Access

Experimental group

Description:

Full access to the HMP app

Treatment:

Behavioral: HealthMPowerment (HMP)