CompletedNot Applicable

Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India

India800 participantsStarted 2023-03-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-1 randomization

Timeframe: Measured at 6 months following phase-1 randomization

Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 months after phase-2 randomization

Timeframe: Measured at 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)

Trial details

NCT IDNCT05165810

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-16

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