Peers Plus Mobile App for Treatment in HIV

NCT05427318 | Completed

• 1 other identifier: R01DA053167
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

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).

Conditions

Human Immunodeficiency Virus

Keywords

HIV; Telemedicine; Substance use

Outcome Measures

Primary Outcomes (2)

• Viral suppression

  Having an undetectable HIV viral load; \<200 copies/mL

  6 months

• Viral suppression

  Having an undetectable HIV viral load; \<200 copies/mL

  12 months

Secondary Outcomes (8)

• Retention in HIV care

  6 months

• Retention in HIV care

  12 months

• Gap in HIV medical visits

  6 months

• Gap in HIV medical visits

  12 months

• Antiretroviral therapy adherence

  3 months

Study Arms (2)

PATH Active Intervention Arm

ACTIVE COMPARATOR

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.

Behavioral: PATH

Usual Care

NO INTERVENTION

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

Interventions

PATH 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)

Also known as: Camino

PATH Active Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

San Ysidro Health

San Ysidro, California, 91910, United States

Location

Related Publications (1)

• 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.

  PMID: 38520030 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 22, 2022
• Study Start: November 1, 2021
• Primary Completion: June 14, 2025
• Study Completion: July 25, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)