Peers Plus Mobile App for Treatment in HIV

Not Applicable

Active, not recruiting

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: PATH

• Registration Number: NCT05427318
• Lead Sponsor: San Diego State University

Brief 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).

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Primary Completion: 2024-06-14
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30
• Study Completion: 2025-06-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

• ≥18 years old

• Can read and speak English or Spanish

• Self-reported diagnosis of HIV by a physician or healthcare provider

• Currently prescribed HIV medication

• Having access to an internet browser on a home computer, tablet, or smart phone

• Does not plan to move out of the San Diego area in the next 12 months

• Meets one or more of the following medical chart verified or self-reported criteria

  • One or more detectable viral load test result (>200 copies m/L) in the past 12-months while on antiretroviral therapy for at least 3 months
  • Having missed 1 or more scheduled HIV care appointments in the last 12 months
  • Last HIV care visit was more than 6 months ago
  • Self-reporting less than 90% antiretroviral therapy adherence in the last 4 weeks using the Wilson-3 scale
  • Report stimulant or opioid use (non-prescription) in the past 6 months

Exclusion Criteria

• <18 years old
• Currently enrolled in any program, intervention, or research study designed to improve antiretroviral therapy adherence or engagement in HIV care (e.g., LinkPositively)
• Members of one of the community advisory boards providing advisement on the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PATH Active Intervention Arm	PATH	Participants assigned to this group will receive care as usual if they are assigned to this group. In addition, participants in this arm will receive HIV care support from a trained peer navigator and have access to a mHealth web application designed to support their health and HIV care.

Primary Outcome Measures

Name	Time	Method
Viral suppression	12 months	Having an undetectable HIV viral load; \<200 copies/mL

Secondary Outcome Measures

Name	Time	Method
Antiretroviral therapy adherence	12 months	Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Retention in HIV care	12 months	Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Gap in HIV medical visits	12 months	Health Resources and Services Administration definition: no HIV medical visits in last 6 months

Trial Locations

Locations (1)

San Ysidro Health; 🇺🇸 San Ysidro, California, United States