Clinical trial NCT05165810: Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: People who inject drugs (PWID)
Health services
Behavioral interventions
Antiretroviral Therapy
HIV
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: YR Gaitonde Centre for AIDS Research and Education
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a non-blinded, randomized, factorial trial with a secondary adaptive randomization, designed to assess the effectiveness of three interventions (relative to standard care) to increase viral suppression among HIV-positive PWID in India.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: People who inject drugs (PWID) are at high risk for HIV infection and experience worse antiretroviral therapy (ART) outcomes than other key populations, particularly in low and middle income countries (LMIC). India has the largest number of opioid users in the world, and new injection drug epidemics have emerged in the North and Central regions of the country.

In phase 1, the investigators will evaluate two structural interventions to improve treatment outcomes among HIV-positive PWID in India. First, same-day ART (initiating ART on the day of HIV diagnosis/confirmation rather than waiting until standard evaluations are completed in an HIV clinic), was found to increase viral suppression rates in African studies with generalized HIV epidemics, but has not been evaluated in PWID. The second intervention is community-based HIV care. At present, all publicly-financed HIV treatment is provided at designated government ART centers. In prior work, the investigators found that PWID-centric integrated care centers (ICCs) were effective at engaging the population and increasing HIV testing uptake and were rated favorably by clients in anonymous surveys. ICCs linked HIV-positive PWID to government clinics, but were not equipped to provide primary HIV care. However, ICCs can be scaled-up to provide HIV treatment on-site and the investigators hypothesize this will improve initiation and retention to ART among PWID. The investigators will use a randomized factorial design to determine the individual and joint effects of same-day ART initiation and community-based HIV care. The primary outcome of the phase-1 trial is viral suppression at 6 months, with longer term follow-up to 18 months.

In phase 2, the investigators will evaluate a psychosocial/navigation intervention (enhanced adherence support) among participants who experience treatment failure during the first trial phase, defined as non-suppressed HIV RNA at the 6-month visit. These participants will be randomly assigned (in a second randomization) to enhanced adherence support or routine adherence support. The primary outcome of phase-2 will be viral suppression 6 months following the second randomization (12 months from enrollment in phase-1).

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

Primary outcomes:
measure: Number of participants with viral load suppression at 6 months after phase 1 randomization
timeFrame: Measured at 6 months after phase 1 randomization
measure: Number of participants with viral load suppression at 12 months after phase 1 randomization
timeFrame: Measured at 6 months after the second randomization (12 months since phase 1 randomization)
Secondary outcomes:
measure: Number of participants with HIV viral suppression in each intervention at non-primary time points
timeFrame: Measured at 3, 12 and 18 months since phase 1 randomization
measure: Mortality rate among participants
timeFrame: Measured at 3, 6, 12 and 18 months since phase 1 randomization
measure: Number of participants who are linked or re-linked (if in care previously) to HIV care
timeFrame: Measured up to 18 months after phase 1 randomization
measure: Number of participants who initiate or re-initiate ART
timeFrame: Measured up to 18 months after phase 1 randomization
measure: Number of participants who remain in HIV care
timeFrame: Measured up to 18 months after phase 1 randomization
measure: Number of participants who adhere to their ART medication refills
timeFrame: Measured up to 18 months after phase 1 randomization
measure: Number of participants who report increased quality of life since baseline
timeFrame: Measured at 3, 6, 12 and 18 months since phase 1 randomization
measure: Number of participants who engage with or are retained on medication for opioid use disorder (MOUD)
timeFrame: Measured at 3, 6, 12 and 18 months since phase 1 randomization
measure: Number of participants who experience HIV-related stigma (anticipated, enacted, internalized)
timeFrame: Measured at 1, 3, 6, 12 and 18 months since phase 1 randomization
Other outcomes:
measure: Number of participants who develop antiretroviral drug resistance at follow-up compared with baseline
timeFrame: Measured at baseline, 3, 6, 12 and 18 months
measure: Cost effectiveness analysis of providing each intervention relative to health outcomes
timeFrame: Measured from data captured across duration of trial up to five years
Locations:
city: New Delhi
country: India
facility: POINTER study -YRGCARE
Study officials:
affiliation: Johns Hopkins University
name: Gregory M Lucas, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Shruthi H Mehta, PhD MPH
role: PRINCIPAL_INVESTIGATOR
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