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

Plain-language summary

This study evaluated whether interventions such as same-day start of antiretroviral therapy, community-based HIV care and enhanced adherence support improve treatment outcomes among people who inject drugs and live with HIV in India. It enrolled people aged 18 and older who reported injection drug use in the past 24 months and were HIV positive. This study has no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Johns Hopkins University

Intervention

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], Routine adherence support [usual care]

Start date

3/9/2023

Estimated completion

3/30/2026

Countries

India

Related genes

Locations

• New Delhi, India

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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