Syndemics and Loss from the HIV Care Continuum in India - Intervention

NCT03966586 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

BEHAVIORAL

Active outreach

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.

BEHAVIORAL

Appointments

Participants in the enhanced-care intervention will be given specific appointment times/dates.

BEHAVIORAL

Financial support

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.

BEHAVIORAL

Microenterprise

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.

BEHAVIORAL

Enhanced counseling

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.

BEHAVIORAL

Usual clinical care and counseling

Usual clinical care and counseling

Sponsors & Collaborators

  • YR Gaitonde Centre for AIDS Research and Education

    collaborator OTHER
  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-11-18
Completion
2023-12-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966586 on ClinicalTrials.gov