Peers Plus Mobile App for Treatment in HIV

NCT ID: NCT05427318

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2025-07-25

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).

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PATH Active Intervention Arm

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.

Group Type: ACTIVE_COMPARATOR

PATH

Intervention Type: BEHAVIORAL

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)

Usual Care

Participants assigned to this group are in the control arm and will receive standard of care following the Ryan White model of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: BEHAVIORAL

Other Intervention Names

Camino

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

San Ysidro Health

San Ysidro, California, United States

Countries

United States

References

Pitpitan EV, Horvath KJ, Aldous J, Stockman JK, Patterson TL, Liang M, Barrozo C, Moore V, Penninga K, Smith LR. Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV. Trials. 2024 Mar 22;25(1):212. doi: 10.1186/s13063-024-08042-8.

Reference Type: DERIVED

PMID: 38520030 (View on PubMed)

Other Identifiers

R01DA053167

Identifier Type: NIH

Identifier Source: org_study_id

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