Evaluation of Multiple Interventions to Improve HIV Treatment Outcomes Among People Who Inject Drugs in India
POINTER
2 other identifiers
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Mar 2023
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2021
CompletedFirst Posted
Study publicly available on registry
December 21, 2021
CompletedStudy Start
First participant enrolled
March 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 27, 2026
March 1, 2026
2.8 years
December 8, 2021
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Measured at 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
Secondary Outcomes (6)
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).
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).
Measured at 12 months following phase-2 randomization (corresponding to 18 months after phase-1 randomization)
All-cause mortality rate
Measured up to 21 months
Percentage of participants who link to ART at a clinic by 3- or 6-months following randomization
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
Measured at 6 months following phase-1 randomization and 6 months following phase-2 randomization (corresponding to 12 months after phase-1 randomization)
- +1 more secondary outcomes
Other Outcomes (6)
Quality of life (QOL) score
Measured at 3, 6, 12, and 18 months after phase-1 randomization
Percentage of participants who use of medication for opioid use disorder (MOUD)
Measured at 3, 6, 12, and 18 months after phase-1 randomization
Drug Use Stigma scale
Measured at 3, 6, 12, and 18 months after phase-1 randomization
- +3 more other outcomes
Study Arms (8)
Arm 1: standard ART initiation + government-based HIV care + routine adherence support
ACTIVE COMPARATORParticipants randomized to Arm 1 will i) initiate ART on a standard timeline \[usual care\], ii) receive ongoing care in a government HIV clinic \[usual care\], and iii) receive routine adherence support should they experience treatment failure at 6 months \[usual care\].
Arm 2: same-day ART + government-based HIV care + routine adherence support
EXPERIMENTALParticipants randomized to Arm 2 will i) initiate ART on the day of enrollment \[experimental\], ii) receive ongoing care in a government HIV clinic \[usual care\], and iii) receive routine adherence support should they experience treatment failure at 6 months \[usual care\].
Arm 3: standard ART initiation + community-based HIV care + routine adherence support
EXPERIMENTALParticipants randomized to Arm 3 will i) initiate ART on a standard timeline \[usual care\], ii) receive ongoing care in a PWID-focused community-based site \[experimental\], and iii) receive routine adherence support should they experience treatment failure at 6 months \[usual care\].
Arm 4: standard ART initiation + government-based HIV care + enhanced adherence support
EXPERIMENTALParticipants randomized to Arm 4 will i) initiate ART on a standard timeline \[usual care\], ii) receive ongoing care in a government HIV clinic \[usual care\], and iii) receive enhanced adherence support should they experience treatment failure at 6 months \[experimental\].
Arm 5: same-day ART initiation + community-based-based HIV care + routine adherence support
EXPERIMENTALParticipants randomized to Arm 5 will i) initiate ART on the day of enrollment \[experimental\], ii) receive ongoing care in a PWID-focused community-based site \[experimental\], and iii) receive routine adherence support should they experience treatment failure at 6 months \[usual care\].
Arm 6: same-day ART initiation + government-based-based HIV care + enhanced adherence support
EXPERIMENTALParticipants randomized to Arm 6 will i) initiate ART on the day of enrollment \[experimental\], ii) receive ongoing care in a government HIV clinic \[usual care\], and iii) receive enhanced adherence support should they experience treatment failure at 6 months \[experimental\].
Arm 7: standard ART initiation + community-based-based HIV care + enhanced adherence support
EXPERIMENTALParticipants randomized to Arm 7 will i) initiate ART on a standard timeline \[usual care\], ii) receive ongoing care in a PWID-focused community-based site \[experimental\], and iii) receive enhanced adherence support should they experience treatment failure at 6 months \[experimental\].
Arm 8: same-day ART initiation + community-based-based HIV care + enhanced adherence support
EXPERIMENTALParticipants randomized to Arm 8 will i) initiate ART on the day of enrollment \[experimental\], ii) receive ongoing care in a PWID-focused community-based site \[experimental\], and iii) receive enhanced adherence support should they experience treatment failure at 6 months \[experimental\].
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Participants who experience treatment failure at 6 months (HIV RNA\>1000c/mL)
- Participants who do not experience treatment failure at 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
POINTER study -YRGCARE
New Delhi, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory M Lucas, PhD MD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Shruthi H Mehta, PhD MPH
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2021
First Posted
December 21, 2021
Study Start
March 9, 2023
Primary Completion
December 17, 2025
Study Completion
May 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03