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Completed

NCT Number: NCT05165810

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

POINTER study -YRGCARE

New Delhi, India

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Same-day ART initiation [experimental]

Behavioral

Participants assigned to same-day ART initiation will be offered standard, first-line ART on the day of trial enrollment. Participants, will be provided with focused counseling and instructions on where to follow-up for ongoing HIV care (either community-based HIV care or government-based HIV care, depending on randomization).

Standard ART initiation [usual care]

Behavioral

Participants randomized to standard ART initiation will not initiate ART on the day of trial enrollment, but only after linking to their assigned source of HIV care (either community-based HIV care or government-based HIV care, depending on randomization). In standard ART initiation, patients typically, complete an intake visit at the HIV clinic, with baseline laboratory testing, and return to the clinic approximately 2 weeks later to begin ART.

Community-based HIV care [experimental]

Other

Participants randomized to community-based HIV care will be referred to PWID-focused integrated care centers (ICCs) for ongoing HIV clinical management - a prototype of decentralized HIV care in India. ICCs will provide free HIV care that will adhere closely to Indian HIV treatment guidelines and, when relevant, to local HIV treatment standards.

Government-based HIV care [usual care]

Other

Participants randomized to government-based HIV care will be referred to government-based HIV clinics for ongoing HIV clinical management. Government-based clinics provide free HIV care that adheres closely to Indian HIV treatment guidelines

Enhanced adherence support [experimental]

Behavioral

Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to enhanced adherence support will receive an intensive, tailored adherence intervention lasting a maximum of 6 months, with two components: 1) tracking and outreach, and 2) psychosocial support and navigation. These will aim to equip PWID with skills to independently manage their ART using motivational interviewing and strengths-based case management.

Routine adherence support [usual care]

Behavioral

Participants who i) experience virologic failure after 6 months in the study and ii) are randomized to routine adherence support will receive a guideline-based, HIV clinic-based adherence counselling intervention lasting a maximum of 6 months

Primary outcomes

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

    Time frame: Measured at 6 months following phase-1 randomization

    HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL

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

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

    HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL

Secondary outcomes

  1. Percentage of participants randomized in phase-1 with viral suppression (HIV RNA <1000 c/mL) at non-primary time points (i.e., 3, 12, and 18 months).

    Time frame: Measured at 3, 12, and 18 months after phase-1 randomization

    HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL

  2. Percentage of participants randomized in phase-2 with viral suppression (HIV RNA <1000 c/mL) at non-primary time point (18 months).

    Time frame: Measured at 12 months following phase-2 randomization (corresponding to 18 months after phase-1 randomization)

    HIV RNA levels in blood measured with GeneXpert 2 module, Xpert HIV-1 Viral Load XC Cartridge (Cepheid AB, Sweden). Lower limit of quantification 40 copies/mL

  3. All-cause mortality rate

    Time frame: Measured up to 21 months

    Research staff and outreach workers collected reports on participant deaths. Verified deaths required one of the following: i) hospital records or death certificate, ii) confirmation of death from a family member, or iii) confirmation of death from an eyewitness (usually another PWID). Rate will be presented as events per unit observation time.

  4. Percentage of participants who link to ART at a clinic by 3- or 6-months following randomization

    Time frame: Measured at 3 months and 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)

    Linkage to ART will be defined as collecting one or more ART prescriptions from a clinic by 3 months and 6 months, captured by medical record abstraction or, in the absence of medical record data, participant self-report of ART collection from a clinic.

  5. Percentage of participants adherent to ART measured by self-report

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

    Participants will be classified as adherent if they report taking ART in the prior 30 days and report adherence of 80% or higher using a visual analog scale (range: 0% to 100%), with higher numbers indicating higher adherence.

  6. Percentage of participants adherent to ART measured by medication possession ratio (MPR)

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

    ART fill data will be abstracted from medical records. In phase 1, participants will be classified as adherent if they have at least one ART refill by 3 months (91 days) and have an MPR of 80% or higher in the period between the first ART fill in the clinic and 6 months (182 days).

    In phase 2, participants will be classified as adherent if they have at least one ART refill by 3 months (91 days) following the second randomization (or prior to the second randomization) and have an MPR of 80% or higher in the period between the first ART refill (or the second randomization if the first ART refill was prior to the second randomization) and 6 months (182 days following the second randomization).

Other outcomes

  1. Quality of life (QOL) score

    Time frame: Measured at 3, 6, 12, and 18 months after phase-1 randomization

    QOL will be measured with a modified EuroQol EQ-5D-3L questionnaire with a visual analogue scale. Higher scores on both the EQ-5D-3L (range 0 to 1) and visual analog scale (range 0 to 100) indicate better QOL.

  2. Percentage of participants who use of medication for opioid use disorder (MOUD)

    Time frame: Measured at 3, 6, 12, and 18 months after phase-1 randomization

    Use of MOUD is captured by self-reported in the research visit questionnaire. Participants are asked whether they received MOUD in the prior 6 months and, if they did so, they are asked about frequency of MOUD visits.

  3. Drug Use Stigma scale

    Time frame: Measured at 3, 6, 12, and 18 months after phase-1 randomization

    Investigators will measure both HIV-related and drug use-related stigma as separate constructs using a survey. Each construct is evaluated by three sub-scales: 1) anticipated healthcare stigma, 2) enacted healthcare stigma, and 3) internalized stigma. All stigma subscales will be queried using Likert scales that range from 0 to 3, with higher scores indicating more stigma. For anticipated and enacted stigma, participants will be classified as experiencing stigma if the Likert scale is >0 for any one item (i.e., analyzed as a dichotomous outcome). For the internalized stigma subscale, scores will be converted to a continuous mean outcome from 0 to 3.0, with higher scores indicating worse stigma.

  4. Percentage of participants with at least moderate depression symptoms as assessed by Patient Health Questionnaire 9

    Time frame: Measured at 3, 6, 12, and 18 months after phase-1 randomization

    Depression will be measured with the PHQ-9 questionnaire. The scoring range is 0 to 27, with higher values indicating more depression symptoms. Participants will be categorized as having at least moderate depression symptoms if the score is ≥ 10.

  5. HIV treatment self-efficacy

    Time frame: Measured at 3, 6, 12, and 18 months after phase-1 randomization

    HIV treatment self-efficacy will be measured with a modified HIV Treatment Adherence Self-Efficacy Scale. Items will be averaged to calculate a self-efficacy score, ranging from 0 to 100, with higher scores indicating better self-efficacy.

  6. Percentage of participants who acquire drug resistance mutations (DRMs) at 12 months

    Time frame: Measured at baseline and 12 months after phase-1 randomization

    New antiretroviral drug resistance will be defined as the detection of one or more reverse transcriptase or integrase gene DRMs at follow-up that was not present at baseline, among participants with HIV RNA ≥1000 c/mL at follow-up visit. DRMs will be interpreted using the online Stanford HIV Database

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • YR Gaitonde Centre for AIDS Research and Education

Registry information

Official study 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

Acronym: POINTER

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 21, 2021
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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