Syndemics and Loss from the HIV Care Continuum in India - Intervention
- Conditions
- HIV Infections
- Interventions
- Behavioral: Usual clinical care and counselingBehavioral: Active outreachBehavioral: AppointmentsBehavioral: Financial supportBehavioral: MicroenterpriseBehavioral: Enhanced counseling
- Registration Number
- NCT03966586
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Previous ART exposure
- Not competent to provide informed consent or participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Care Appointments Usual clinical care + intervention components Enhanced Care Financial support Usual clinical care + intervention components Usual Care Usual clinical care and counseling Usual clinical care and counseling Enhanced Care Active outreach Usual clinical care + intervention components Enhanced Care Microenterprise Usual clinical care + intervention components Enhanced Care Enhanced counseling Usual clinical care + intervention components
- Primary Outcome Measures
Name Time Method Acceptability among participants and providers as assessed by semi-structured qualitative interviews 12 months Acceptability among patients and providers as measured by semi-structured qualitative interviews of participants and providers
Feasibility as assessed by semi-structured qualitative interviews 12 months 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
- Secondary Outcome Measures
Name Time Method Retention in care 12 months No unexpected absences \> 90 days
Depressive symptoms as measured by PHQ-9 12 months Score of \>10 indicates probable depression
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL) 3 months Undetectable HIV-1 RNA, \<50 copies / mL
ART initiation success (accepted ART and continued ART for at least 6 months) 6 months Successful ART initiation (accepted ART and continued ART for at least 6 months)
Food insecurity as measured by Household Food Insecurity Access Scale 12 months 8 item scale of food insecurity
Internalized stigma as measured by Internalized AIDS-Related Stigma Scale 12 months Includes six items related to concerns about disclosure as well as items related to feelings of shame and/or self-hatred. Responses are elicited on a binary scale (yes/no) and scores represent the sum of endorsed items.
Self-efficacy as measured by General Self-Efficacy Scale--shortened version 12 months Six item scale of self-efficacy
Social support as measured by Multidimensional Scale of Perceived Social Support 12 months 12 item scale of social support
Trial Locations
- Locations (1)
YRG CARE
🇮🇳Chennai, Tamil Nadu, India