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

CompletedNA

Sponsor: Johns Hopkins University

Conditions: HIV Infections

Interventions: Same-day ART initiation [experimental], Standard ART initiation [usual care], Community-based HIV care [experimental], Government-based HIV care [usual care], Enhanced adherence support [experimental]

Countries: India

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

New Delhi, India