Syndemics and Loss from the HIV Care Continuum in India - Intervention
1 other identifier
interventional
50
1 country
1
Brief Summary
The investigators will assess the feasibility and acceptability of a pilot intervention to keep people living with HIV (PLHIV) in southern India in care and virologically suppressed. The lack of understanding of the causes of loss from the HIV care continuum in India stifles the armamentarium of effective interventions to keep Indian PLHIV in care. The results of this research will demonstrate the feasibility and acceptability of a pilot intervention targeting the multiple mechanisms by which PLHIV become lost to care. By targeting these mechanisms, this intervention will be designed to be scalable in a setting where access to mental health specialists is limited.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Jun 2019
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 12, 2025
July 1, 2022
2.4 years
May 24, 2019
February 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility as assessed by semi-structured qualitative interviews
Minimal negative impact on clinical work flow and ability to deliver all intervention components, particularly all sessions of enhanced counseling, as measured by semi-structured qualitative interviews of providers
12 months
Acceptability among participants and providers as assessed by semi-structured qualitative interviews
Acceptability among patients and providers as measured by semi-structured qualitative interviews of participants and providers
12 months
Secondary Outcomes (8)
Retention in care
12 months
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
3 months
ART initiation success (accepted ART and continued ART for at least 6 months)
6 months
Depressive symptoms as measured by PHQ-9
12 months
Internalized stigma as measured by Internalized AIDS-Related Stigma Scale
12 months
- +3 more secondary outcomes
Study Arms (2)
Enhanced Care
EXPERIMENTALUsual clinical care + intervention components
Usual Care
ACTIVE COMPARATORUsual clinical care and counseling
Interventions
Participants will get bidirectional weekly SMS messaging / automated voice messaging (depending on literacy), with messages to be programmed by the participant in the enhanced counseling sessions.
Participants in the enhanced-care intervention will be given specific appointment times/dates.
Participants in the enhanced-care intervention will receive free clinic visits, labs, and medications. They will also receive transportation incentives on a sliding scale based on distance to clinic, to range between 200-700 INR to be given each clinic/study visit. All participants, in both the usual care and enhanced care arms, will be offered VL testing free of charge, although this will not be known to the participants prior to the visit.
YRG CARE is affiliated with two microenterprise programs in bag-making and food-vending which can be leveraged as part of an intervention, particularly for women. There is an established training and mentoring program for individuals who wish to join the bag-making or food-making ventures. Participants who opt for this will be linked to the bag-making and food-vending programs, with all up-front costs (e.g. vending kiosk, training, serving materials, etc.) covered.
Participants in the enhanced-care intervention will participant in an individual enhanced counseling program called Steps to Success, based upon a Life Steps and Problem Solving curriculum. Steps to Success will consist of five one-on-one sessions of approximately 1 to 1.5 hours each. The first session will take place at the time of the participant's second clinical visit to YRG CARE, which will be between 1-3 weeks after the participant is recruited.
Eligibility Criteria
You may qualify if:
- Adult PLHIV presenting to care at YRG CARE who are ART-naïve and who plan to follow-up at YRG CARE
- Speaks Tamil, Telugu, or English
You may not qualify if:
- Previous ART exposure
- Not competent to provide informed consent or participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
YRG CARE
Chennai, Tamil Nadu, 600010, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Physician
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 29, 2019
Study Start
June 20, 2019
Primary Completion
November 18, 2021
Study Completion
December 1, 2023
Last Updated
February 12, 2025
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share