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Completed

NCT Number: NCT03966586

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

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.

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YRG CARE

Chennai, Tamil Nadu, 600010, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active outreach

Behavioral

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

Behavioral

Participants in the enhanced-care intervention will be given specific appointment times/dates.

Financial Support

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

Usual clinical care and counseling

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Retention in care

    Time frame: 12 months

    No unexpected absences > 90 days

  2. Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)

    Time frame: 3 months

    Undetectable HIV-1 RNA, <50 copies / mL

  3. ART initiation success (accepted ART and continued ART for at least 6 months)

    Time frame: 6 months

    Successful ART initiation (accepted ART and continued ART for at least 6 months)

  4. Depressive symptoms as measured by PHQ-9

    Time frame: 12 months

    Score of >10 indicates probable depression

  5. Internalized stigma as measured by Internalized AIDS-Related Stigma Scale

    Time frame: 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.

  6. Self-efficacy as measured by General Self-Efficacy Scale--shortened version

    Time frame: 12 months

    Six item scale of self-efficacy

  7. Social support as measured by Multidimensional Scale of Perceived Social Support

    Time frame: 12 months

    12 item scale of social support

  8. Food insecurity as measured by Household Food Insecurity Access Scale

    Time frame: 12 months

    8 item scale of food insecurity

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • YR Gaitonde Centre for AIDS Research and Education

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
May 29, 2019
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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