Clinical Trial

Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

Recruiting
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Record status
This record was last updated September 3, 2024 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
The study will test two behavioral intervention components to identify the combination of the two components that best supports people who inject drugs to achieve and sustain HIV viral load suppression. The study design is a 2-to-the-2 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 2 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence and 2) behavioral activation therapy for depression (BAT). Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 4 conditions. Each condition represents a possible combination of the 2 components above. All participants will receive patient navigation for care engagement.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-05-11; most recent amendment 2024-08-28.
Status change: Active, Not Recruiting → Recruiting 2024-08-28
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-05-10
Trial Details
NCT Number NCT05377463
Lead Sponsor University of Texas, El Paso
Collaborators: University of California, San Francisco, Centro de Integracion Juvenil, El Centro Ambulatorio para la Prevención y Atención en SIDA e Infecciones de Transmisión Sexual
Conditions HIV Viremia
Enrollment 220 participants
Start Date 2023-05-10
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2024-09-03