NCT05165810Completed
Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India
Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India: a Randomized Factorial Trial With a Randomized Adaptive Component for Those Experiencing Early Treatment Failure
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
The goal of this study is to improve HIV care outcomes for people who inject drugs (PWID) in India. The study will implement a two-phase trial to evaluate whether HIV treatment outcomes (HIV viral suppression) in HIV infected PWID can be improved with three different interventions: i) by offering a faster treatment start time (same-day antiretroviral therapy \[ART\] initiation vs. standard), ii) by provided community-based HIV care in PWID-focused centers (vs. centralized government-based HIV care) and, iii) providing an enhanced adherence support to participants who experience treatment failure at six months (vs. routine adherence support). The investigators hypothesize that faster access to ART and HIV treatment in PWID-focused community sites will lead to higher levels of initiation and retention to ART compared with standard care; and use of enhanced navigation and psychosocial support to patients who experience treatment failure at six months will lead to improved viral suppression compared with routine adherence support.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 800 (actual)
- First submitted
- 8 Dec 2021
- Start date
- 9 Mar 2023
- Primary completion date
- 16 Dec 2025
- Lead sponsor
- Johns Hopkins University
- Diseases
- HIV
- NCT number
- NCT05165810
What you commit to
- Study type: Interventional
- Participants enrolled: 800
- From 9 Mar 2023 to the primary completion date, 16 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- PHASE 1 Inclusion Criteria:
- 18 years of age or older
- Reports injection drug use in prior 24 months
- Documented HIV positive
- Antiretroviral therapy naïve
- HIV RNA 1,000 c/mL or higher
- If previously linked to HIV care, able and willing to provide govt. ART book for documentation of care received.
- PHASE 1 Exclusion Criteria:
- Pregnant (if female)
- Does not speak English, Hindi, or local language
- Plans to migrate in next 12 months
- Not competent to participate in the study or provide written informed consent.
- PHASE 2 Inclusion Criteria:
- Participants who experience treatment failure at 6 months (HIV RNA\>1000c/mL)
- PHASE 2 Exclusion Criteria:
- Participants who do not experience treatment failure at 6 months
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| POINTER study -YRGCARE Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.