Peers Plus Mobile App for Treatment in HIV (PATH)

San Diego State University

Status: Active, not recruiting

Conditions: Human Immunodeficiency Virus

Treatments: Behavioral: PATH

Study type: Interventional

Funder types: Other

Identifiers

NCT05427318

R01DA053167

Details and patient eligibility

About

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).

Full 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).

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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309 participants in 2 patient groups

PATH Active Intervention Arm

Active Comparator group

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.

Treatment:

Behavioral: PATH

Usual Care

No Intervention group

Description:

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