Strategies to Improve the HIV Care Continuum Among Key Populations in India
3 other identifiers
interventional
2,314
1 country
1
Brief Summary
This clinical trial will compare the effectiveness of integrated care centers vs. integrated care centers plus HIV patient treatment incentives for achieving HIV treatment targets among people who inject drugs and men who have sex with men in India. The investigators will also assess cost-effectiveness and barriers and facilitators to implementation through targeted mixed-methods approaches. This study is a model for improving HIV treatment outcomes in key populations in low to middle-income countries.
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 Oct 2017
Longer than P75 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedStudy Start
First participant enrolled
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2020
CompletedResults Posted
Study results publicly available
December 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedDecember 15, 2025
December 1, 2025
2.4 years
November 18, 2016
November 1, 2022
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Surviving With Viral Suppression
Viral Suppression defined as HIV RNA \<150 copies/mL
12 months
Secondary Outcomes (8)
Proportion of Participants Surviving With Viral Suppression
6 months
Proportion of Participants Surviving With Viral Suppression
18 months
Proportion of Participants Surviving With Viral Suppression
24 months
Proportion of Participants With Viral Suppression at One or More Follow-up Visits
24 months
Antiretroviral Therapy (ART) Initiation
12 months
- +3 more secondary outcomes
Study Arms (2)
Integrated care centers
ACTIVE COMPARATORParticipants in the active comparator arm have access to integrated care centers (ICCs)
ICC + incentives
EXPERIMENTALParticipants in the experimental arm have access to the ICC intervention and the incentive intervention
Interventions
ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services
Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.
Eligibility Criteria
You may qualify if:
- Speaks Hindi, English, or local language
- HIV-positive
- Antiretroviral therapy (ART) naive or has used ART less than 12 months
- Registered client at the local integrated care center (ICC), which serves either people who inject drugs (PWID) or men who have sex with men (MSM).
You may not qualify if:
- Not competent to provide informed consent or participate in the study.
- Receives HIV care in the private sector
- Plans to migrate in next 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- YR Gaitonde Centre for AIDS Research and Educationcollaborator
- Elton John AIDS Foundationcollaborator
Study Sites (1)
YR Gaitonde Center for AIDS Research and Education
Chennai, Tamil Nadu, 600010, India
Related Publications (1)
Solomon SS, McFall AM, Srikrishnan AK, Verma V, Anand S, Khan RT, Kushwaha BS, Vasudevan C, Saravanan S, Paneerselvam N, Kumar MS, Das C, Celentano DD, Mehta SH, Lucas GM. Voucher incentives to improve viral suppression among HIV-positive people who inject drugs and men who have sex with men in India: a cluster randomised trial. Lancet HIV. 2024 May;11(5):e309-e320. doi: 10.1016/S2352-3018(24)00005-5. Epub 2024 Apr 4.
PMID: 38583461RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gregory M. Lucas
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Shruti H Mehta, PhD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Gregory M Lucas, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2016
First Posted
November 21, 2016
Study Start
October 30, 2017
Primary Completion
March 23, 2020
Study Completion
May 30, 2024
Last Updated
December 15, 2025
Results First Posted
December 22, 2022
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
The investigators will require prospective collaborators to submit concept sheets to the study PIs that include a brief summary of the proposed hypothesis, summary of research methods, specific data or specimens that are being requested, and plans for analysis. Reasonable requests that address relevant scientific questions will be welcomed and supported to the extent possible.