Clinical trial NCT06350682: Resilient HIV Implementation Science With SGM Youths Using Evidence
Official title: Resilient HIV Implementation Science With SGM Youths Using Evidence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Florida State University
First posted: 2024-04-05
Enrollment: 1500
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: PrEP initiation for HIV seronegative seropositive
timeFrame: 24 months
measure: Viral load suppression for HIV
timeFrame: 24 months
measure: RE-AIM
timeFrame: 24 months
Secondary outcomes:
measure: HIV testing cascade
timeFrame: 12-24 months
measure: PrEP continuum
timeFrame: 12-24 months
measure: HIV care and treatment continuum
timeFrame: 12-24 months
measure: Implementation effectiveness
timeFrame: 24 months
Other outcomes:
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