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Peers Plus Mobile App for Treatment in HIV (PATH)

Primary Purpose

Human Immunodeficiency Virus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PATH
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Human Immunodeficiency Virus focused on measuring HIV, Telemedicine, Substance use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • San Ysidro HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

PATH Active Intervention Arm

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Retention in HIV care
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Retention in HIV care
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Gap in HIV medical visits
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Gap in HIV medical visits
Health Resources and Services Administration definition: no HIV medical visits in last 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)
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)
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)
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)

Full Information

First Posted
June 15, 2022
Last Updated
June 16, 2022
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT05427318
Brief Title
Peers Plus Mobile App for Treatment in HIV
Acronym
PATH
Official Title
Peers Plus Mobile App for Treatment in HIV (PATH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, Telemedicine, Substance use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PATH Active Intervention Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants assigned to this group are in the control arm and will receive standard of care following the Ryan White model of care.
Intervention Type
Behavioral
Intervention Name(s)
PATH
Other Intervention Name(s)
Camino
Intervention Description
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)
Primary Outcome Measure Information:
Title
Viral suppression
Description
Having an undetectable HIV viral load; <200 copies/mL
Time Frame
6 months
Title
Viral suppression
Description
Having an undetectable HIV viral load; <200 copies/mL
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Retention in HIV care
Description
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Time Frame
6 months
Title
Retention in HIV care
Description
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Time Frame
12 months
Title
Gap in HIV medical visits
Description
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Time Frame
6 months
Title
Gap in HIV medical visits
Description
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Time Frame
12 months
Title
Antiretroviral therapy adherence
Description
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Time Frame
3 months
Title
Antiretroviral therapy adherence
Description
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Time Frame
6 months
Title
Antiretroviral therapy adherence
Description
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Time Frame
9 months
Title
Antiretroviral therapy adherence
Description
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Pitpitan, PhD
Phone
7147595766
Email
epitpitan@sdsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Liang, MPP
Email
mkliang@sdsu.edu
Facility Information:
Facility Name
San Ysidro Health
City
San Ysidro
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannette Aldous, MD
Email
jlaldous@syhealth.org

12. IPD Sharing Statement

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Peers Plus Mobile App for Treatment in HIV

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