- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966586
Syndemics and Loss From the HIV Care Continuum in India - Intervention
Study Overview
Status
Conditions
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:
- Active outreach, including bidirectional weekly SMS messaging / automated voice messaging (depending on literacy)
- Appointments (specific appointment times/dates).
- Financial support, including free clinic visits, labs, medications, and transportation incentives on a sliding scale based on distance to clinic
- Microenterprise, including bag-making or food-making ventures for women
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Tamil Nadu
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Chennai, Tamil Nadu, India, 600010
- YRG Care
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Care
Usual clinical care + intervention components
|
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.
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Active Comparator: Usual Care
Usual clinical care and counseling
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Usual clinical care and counseling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as assessed by semi-structured qualitative interviews
Time Frame: 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
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12 months
|
Acceptability among participants and providers as assessed by semi-structured qualitative interviews
Time Frame: 12 months
|
Acceptability among patients and providers as measured by semi-structured qualitative interviews of participants and providers
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention in care
Time Frame: 12 months
|
No unexpected absences > 90 days
|
12 months
|
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
Time Frame: 3 months
|
Undetectable HIV-1 RNA, <50 copies / mL
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3 months
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ART initiation success (accepted ART and continued ART for at least 6 months)
Time Frame: 6 months
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Successful ART initiation (accepted ART and continued ART for at least 6 months)
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6 months
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Depressive symptoms as measured by PHQ-9
Time Frame: 12 months
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Score of >10 indicates probable depression
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12 months
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Internalized stigma as measured by Internalized AIDS-Related Stigma Scale
Time Frame: 12 months
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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.
|
12 months
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Self-efficacy as measured by General Self-Efficacy Scale--shortened version
Time Frame: 12 months
|
Six item scale of self-efficacy
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12 months
|
Social support as measured by Multidimensional Scale of Perceived Social Support
Time Frame: 12 months
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12 item scale of social support
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12 months
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Food insecurity as measured by Household Food Insecurity Access Scale
Time Frame: 12 months
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8 item scale of food insecurity
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P001573
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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