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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
800
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).
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.
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.
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
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.
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
POINTER study -YRGCARE
New Delhi, India
Percentage of participants with viral load suppression (HIV RNA <1000 c/mL) at 6 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
Time frame: 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
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
Time frame: Measured at 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
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).
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
Time frame: Measured at 3, 12, and 18 months after phase-1 randomization
Percentage of participants randomized in phase-2 with viral suppression (HIV RNA <1000 c/mL) at non-primary time point (18 months).
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
Time frame: Measured at 12 months following phase-2 randomization (corresponding to 18 months after phase-1 randomization)
All-cause mortality rate
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.
Time frame: Measured up to 21 months
Percentage of participants who link to ART at a clinic by 3- or 6-months following 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.
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)
Percentage of participants adherent to ART measured by self-report
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.
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)
Percentage of participants adherent to ART measured by medication possession ratio (MPR)
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).
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)
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