Peers Plus Mobile App for Treatment in HIV

Human Immunodeficiency Virus Clinical Trial

— PATH  

Official title:

Peers Plus Mobile App for Treatment in HIV (PATH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427318
• Other study ID #: R01DA053167
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: San Diego State University
• Contact: Eileen Pitpitan, PhD
• Phone: 7147595766
• Email: epitpitan[@]sdsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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)

Locations

Country	Name	City	State
United States	San Ysidro Health	San Ysidro	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	Having an undetectable HIV viral load; <200 copies/mL	6 months
Primary	Viral suppression	Having an undetectable HIV viral load; <200 copies/mL	12 months
Secondary	Retention in HIV care	Health Resources and Services Administration definition: = 2 HIV medical visits at least 90 days apart	6 months
Secondary	Retention in HIV care	Health Resources and Services Administration definition: = 2 HIV medical visits at least 90 days apart	12 months
Secondary	Gap in HIV medical visits	Health Resources and Services Administration definition: no HIV medical visits in last 6 months	6 months
Secondary	Gap in HIV medical visits	Health Resources and Services Administration definition: no HIV medical visits in last 6 months	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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