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

Primary Purpose

HIV Infections

Status
Active
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Active outreach
Appointments
Financial support
Microenterprise
Enhanced counseling
Usual clinical care and counseling
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring hiv, India, retention, continuum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • YRG CARE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced Care

Usual Care

Arm Description

Usual clinical care + intervention components

Usual clinical care and counseling

Outcomes

Primary Outcome Measures

Feasibility as assessed by semi-structured qualitative interviews
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
Acceptability among participants and providers as assessed by semi-structured qualitative interviews
Acceptability among patients and providers as measured by semi-structured qualitative interviews of participants and providers

Secondary Outcome Measures

Retention in care
No unexpected absences > 90 days
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
Undetectable HIV-1 RNA, <50 copies / mL
ART initiation success (accepted ART and continued ART for at least 6 months)
Successful ART initiation (accepted ART and continued ART for at least 6 months)
Depressive symptoms as measured by PHQ-9
Score of >10 indicates probable depression
Internalized stigma as measured by Internalized AIDS-Related Stigma Scale
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
Six item scale of self-efficacy
Social support as measured by Multidimensional Scale of Perceived Social Support
12 item scale of social support
Food insecurity as measured by Household Food Insecurity Access Scale
8 item scale of food insecurity

Full Information

First Posted
May 24, 2019
Last Updated
July 18, 2022
Sponsor
Brigham and Women's Hospital
Collaborators
YR Gaitonde Centre for AIDS Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT03966586
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
YR Gaitonde Centre for AIDS Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
hiv, India, retention, continuum

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Care
Arm Type
Experimental
Arm Description
Usual clinical care + intervention components
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual clinical care and counseling
Intervention Type
Behavioral
Intervention Name(s)
Active outreach
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Appointments
Intervention Description
Participants in the enhanced-care intervention will be given specific appointment times/dates.
Intervention Type
Behavioral
Intervention Name(s)
Financial support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Microenterprise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual clinical care and counseling
Intervention Description
Usual clinical care and counseling
Primary Outcome Measure Information:
Title
Feasibility as assessed by semi-structured qualitative interviews
Description
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
Time Frame
12 months
Title
Acceptability among participants and providers as assessed by semi-structured qualitative interviews
Description
Acceptability among patients and providers as measured by semi-structured qualitative interviews of participants and providers
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Retention in care
Description
No unexpected absences > 90 days
Time Frame
12 months
Title
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
Description
Undetectable HIV-1 RNA, <50 copies / mL
Time Frame
3 months
Title
ART initiation success (accepted ART and continued ART for at least 6 months)
Description
Successful ART initiation (accepted ART and continued ART for at least 6 months)
Time Frame
6 months
Title
Depressive symptoms as measured by PHQ-9
Description
Score of >10 indicates probable depression
Time Frame
12 months
Title
Internalized stigma as measured by Internalized AIDS-Related Stigma Scale
Description
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.
Time Frame
12 months
Title
Self-efficacy as measured by General Self-Efficacy Scale--shortened version
Description
Six item scale of self-efficacy
Time Frame
12 months
Title
Social support as measured by Multidimensional Scale of Perceived Social Support
Description
12 item scale of social support
Time Frame
12 months
Title
Food insecurity as measured by Household Food Insecurity Access Scale
Description
8 item scale of food insecurity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
YRG CARE
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600010
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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

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