Clinical trial NCT03966586: Syndemics and Loss from the HIV Care Continuum in India - Intervention
Official title: Syndemics and Loss from the HIV Care Continuum in India - Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: hiv
India
retention
continuum
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: YR Gaitonde Centre for AIDS Research and Education
First posted: 2019-05-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as assessed by semi-structured qualitative interviews
timeFrame: 12 months
measure: Acceptability among participants and providers as assessed by semi-structured qualitative interviews
timeFrame: 12 months
Secondary outcomes:
measure: Retention in care
timeFrame: 12 months
measure: Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
timeFrame: 3 months
measure: ART initiation success (accepted ART and continued ART for at least 6 months)
timeFrame: 6 months
measure: Depressive symptoms as measured by PHQ-9
timeFrame: 12 months
measure: Internalized stigma as measured by Internalized AIDS-Related Stigma Scale
timeFrame: 12 months
measure: Self-efficacy as measured by General Self-Efficacy Scale--shortened version
timeFrame: 12 months
measure: Social support as measured by Multidimensional Scale of Perceived Social Support
timeFrame: 12 months
measure: Food insecurity as measured by Household Food Insecurity Access Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: YRG CARE
state: Tamil Nadu
Study officials:
References: