Peers Plus Mobile App for Treatment in HIV (PATH)

Peers Plus Mobile App for Treatment in HIV (PATH)

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).

Study Overview

• Status: Recruiting
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: PATH

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 Type: Interventional
• Enrollment (Estimated): 375
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eileen Pitpitan, PhD; Phone Number: 7147595766; Email: epitpitan@sdsu.edu
• Study Contact Backup: Name: Megan Liang, MPP; Email: mkliang@sdsu.edu

Study Locations

• United States
  • California
    • San Ysidro, California, United States, 91910
      • Recruiting
      • San Ysidro Health
      • Contact: Jeannette Aldous, MD; Email: jlaldous@syhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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); Other Names: Camino
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in HIV care	Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart	6 months
Retention in HIV care	Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart	12 months
Gap in HIV medical visits	Health Resources and Services Administration definition: no HIV medical visits in last 6 months	6 months
Gap in HIV medical visits	Health Resources and Services Administration definition: no HIV medical visits in last 6 months	12 months
Antiretroviral therapy adherence	Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)	3 months
Antiretroviral therapy adherence	Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)	6 months
Antiretroviral therapy adherence	Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)	9 months
Antiretroviral therapy adherence	Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)	12 months

Collaborators and Investigators

• Sponsor: San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Telemedicine; HIV; Substance use
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R01DA053167 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No