RS-ARTNCT06541028
Reducing Stigma in People Who Inject Drugs (PWID) With HIV Using a Rapid Start Antiretroviral Therapy Intervention (ART)
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Record History
All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗
Notable Eligibility criteria expanded, about 19 words Show 6 more changesShow less
- Enrollment increased: 135 → 180 participants
- Primary completion moved earlier from May 2028 to Dec 2027
- Study completion moved earlier from May 2028 to Mar 2028
- Trial arms changed: 2 → 1
- Secondary endpoints: details revised at 1 of 1 entry
- Study description expanded, about 21 words
- Notable Trial status: Not Yet Recruiting to Recruiting
- Primary and study completion dates: Aug 2026 to May 2028
- Study sites: 4 to 3
- Start date changed from estimate of Nov 2025 to Nov 4, 2025
- Notable Start date: Aug 2025 to Nov 2025v5
- Notable Start date: Feb 2025 to Aug 2025v4
- Notable Start date: Dec 2024 to Feb 2025v3
- Notable Start date: Aug 2024 to Dec 2024v2
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Secondary (1)
Arms and interventions
Adults newly enrolling into or restarting HIV care, including people who inject drugs and men who have sex with men, at primary healthcare clinics in the general population and at prison receive the RS-ART strategy from their prescribing physician. Patients complete surveys on stigma, health behaviors and related constructs at baseline and at months 1, 3, 6, 9 and 12; their prescribing clinicians complete matched surveys at the same time points. Viral load results obtained as part of standard of care are collected through medical record review.
Behavioral: Rapid-Start ART (RS-ART)
Sites
3 sites in 1 country