Clinical trial NCT05427318: Peers Plus Mobile App for Treatment in HIV
Official title: Peers Plus Mobile App for Treatment in HIV (PATH)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV
Telemedicine
Substance use
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Viral suppression
timeFrame: 6 months
measure: Viral suppression
timeFrame: 12 months
Secondary outcomes:
measure: Retention in HIV care
timeFrame: 6 months
measure: Retention in HIV care
timeFrame: 12 months
measure: Gap in HIV medical visits
timeFrame: 6 months
measure: Gap in HIV medical visits
timeFrame: 12 months
measure: Antiretroviral therapy adherence
timeFrame: 3 months
measure: Antiretroviral therapy adherence
timeFrame: 6 months
measure: Antiretroviral therapy adherence
timeFrame: 9 months
measure: Antiretroviral therapy adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: San Ysidro
country: United States
facility: San Ysidro Health
state: California
Study officials:
References: