NCT05427318

Peers Plus Mobile App for Treatment in HIV

Peers Plus Mobile App for Treatment in HIV (PATH)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: San Diego State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH).

Detailed description

PATH is a community-academic collaboration with a federally qualified health center serving patients in South San Diego under the Ryan White model of care. The scientific premise of this RCT is that combining two interventions developed by this team (peer navigation + mHealth) into a single mHealth peer navigation intervention (PATH) will eliminate the need for in-person support from peer navigators, promote high impact on HIV care continuum outcomes, as well as extend broader reach to underserved communities. The RCT will test the efficacy of PATH with 375 HBPLH (among whom \>33% will report stimulant and/or opioid use in the past 6 months). Aim 1. Improve the primary outcomes - sustained viral suppression (i.e., suppressed viral load at both 6- and 12-month follow-up), and secondary outcomes (e.g., retention in care) compared to usual care. Sub-aim 1: Explore subgroup differences in efficacy based on factors like race/ethnicity and substance use. Aim 2. Examine the theory-informed mediators (e.g., self-efficacy to engage in HIV care, HIV stigma) through which PATH has the greatest impact on sustained viral suppression among HBPLH. Aim 3. Explore whether PATH significantly affects substance-related outcomes (e.g., frequency of substance use, engagement in substance abuse treatment) when compared to usual care among those using substances (i.e., stimulants and/or opioids).

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
BEHAVIORAL	PATH	The intervention integrates two theoretically-grounded interventions - one with a strong peer navigator component and the other with a scalable mHealth component - into the intervention called Peers plus mobile App for Treatment in HIV (PATH)

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-06-14
• Completion: 2025-07-25
• First posted: 2022-06-22
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States