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

Mass General Brigham

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Active outreach; Behavioral: Enhanced counseling; Behavioral: Usual clinical care and counseling; Behavioral: Appointments; Behavioral: Microenterprise; Behavioral: Financial support

Study type: Interventional

Funder types: Other

Identifiers

NCT03966586

2019P001573

Details and patient eligibility

About

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.

Full description

This pilot intervention represents the final Aim of the NIMH-sponsored study "Syndemics and Loss from the HIV Care Continuum in India." This trial will be conducted at the Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE), located in Chennai, the capital of Tamil Nadu state and one of the epicenters of the Indian HIV epidemic.

The investigators will recruit 50 adult (age >=18) PLHIV presenting to care at YRG CARE and ART-naïve. Participants will be recruited at their first visit to YRG CARE, at which the participant's HIV diagnosis is established or confirmed and the participant receives initial counseling and clinical care. At this recruitment stage, research assistants will conduct a pre-intervention questionnaire including measures of depressive symptoms, internalized stigma, self-efficacy, mental health, and physical health. The investigators will then randomize the patient to usual care vs. enhanced-care intervention (25 in each arm).

The enhanced-care intervention will be multi-faceted, reflecting the likelihood of multiple syndemic conditions as well as evidence from LMICs suggesting that programs combining multiple approaches are the most effective in improving retention in care.

The enhanced-care intervention will consist of the following components:

1. Active outreach, including bidirectional weekly SMS messaging / automated voice messaging (depending on literacy)
2. Appointments (specific appointment times/dates).
3. Financial support, including free clinic visits, labs, medications, and transportation incentives on a sliding scale based on distance to clinic
4. Microenterprise, including bag-making or food-making ventures for women
5. Enhanced counseling. Participants in the enhanced-care intervention will participate in an individual enhanced counseling program called Steps to Success, based upon a Life Steps and Problem Solving curriculum.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Previous ART exposure
• Not competent to provide informed consent or participate in the study

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Enhanced Care

Experimental group

Description:

Usual clinical care + intervention components

Treatment:

Behavioral: Microenterprise

Behavioral: Financial support

Behavioral: Appointments

Behavioral: Enhanced counseling

Behavioral: Active outreach

Usual Care

Active Comparator group

Description:

Usual clinical care and counseling

Treatment:

Behavioral: Usual clinical care and counseling