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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03966586
• Other study ID #: 2019P001573
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: July 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Active outreach
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.
• Appointments
Participants in the enhanced-care intervention will be given specific appointment times/dates.
• Financial support
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.
• Microenterprise
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.
• Enhanced counseling
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.
• Usual clinical care and counseling
Usual clinical care and counseling

Locations

Country	Name	City	State
India	YRG CARE	Chennai	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	YR Gaitonde Centre for AIDS Research and Education

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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	12 months
Secondary	Retention in care	No unexpected absences > 90 days	12 months
Secondary	Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)	Undetectable HIV-1 RNA, <50 copies / mL	3 months
Secondary	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)	6 months
Secondary	Depressive symptoms as measured by PHQ-9	Score of >10 indicates probable depression	12 months
Secondary	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.	12 months
Secondary	Self-efficacy as measured by General Self-Efficacy Scale--shortened version	Six item scale of self-efficacy	12 months
Secondary	Social support as measured by Multidimensional Scale of Perceived Social Support	12 item scale of social support	12 months
Secondary	Food insecurity as measured by Household Food Insecurity Access Scale	8 item scale of food insecurity	12 months