San Ysidro Health
San Ysidro, California, 91910, United States
NCT Number: NCT05427318
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Ysidro, California, 91910, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months
Having an undetectable HIV viral load; <200 copies/mL
Time frame: 12 months
Having an undetectable HIV viral load; <200 copies/mL
Time frame: 6 months
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Time frame: 12 months
Health Resources and Services Administration definition: ≥ 2 HIV medical visits at least 90 days apart
Time frame: 6 months
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Time frame: 12 months
Health Resources and Services Administration definition: no HIV medical visits in last 6 months
Time frame: 3 months
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
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
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
Continuous measure of antiretroviral therapy adherence using the Wilson's three-item Adherence Self-Report Scale scale (0-100; 100=perfect adherence)
San Diego State University
Other
Peers Plus Mobile App for Treatment in HIV (PATH)
Acronym: PATH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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