HIV InfectionsNCT03966586
Syndemics and Loss from the HIV Care Continuum in India - Intervention
A study testing Active outreach, Appointments and Financial support in people with HIV Infections, run by Brigham and Women's Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Active outreach, Appointments and Financial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jun 2019to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous ART exposure
- Not competent to provide informed consent or participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Active outreach, Appointments, Financial support, Microenterprise, Enhanced counseling
- Keywords
- hiv, India, retention, continuum
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active outreachBehavioural
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.
AppointmentsBehavioural
Participants in the enhanced-care intervention will be given specific appointment times/dates.
Financial supportBehavioural
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.
MicroenterpriseBehavioural
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 counselingBehavioural
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 counselingBehavioural
Usual clinical care and counseling
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Care | Experimental | Usual clinical care + intervention components Receives: Behavioral: Active outreach; Behavioral: Appointments; Behavioral: Financial support; Behavioral: Microenterprise; Behavioral: Enhanced counseling |
| Usual Care | Active comparator | Usual clinical care and counseling Receives: Behavioral: Usual clinical care and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
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
Measured: 12 months
Secondary outcomes (8)
Retention in care
No unexpected absences > 90 days
Measured: 12 months
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
Undetectable HIV-1 RNA, <50 copies / mL
Measured: 3 months
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)
Measured: 6 months
Depressive symptoms as measured by PHQ-9
Score of >10 indicates probable depression
Measured: 12 months
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.
Measured: 12 months
Self-efficacy as measured by General Self-Efficacy Scale--shortened version
Six item scale of self-efficacy
Measured: 12 months
Social support as measured by Multidimensional Scale of Perceived Social Support
12 item scale of social support
Measured: 12 months
Food insecurity as measured by Household Food Insecurity Access Scale
8 item scale of food insecurity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start20 Jun 2019
- Primary completion18 Nov 2021
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- YR Gaitonde Centre for AIDS Research and Education
- Responsible party
- Principal investigator, Brian Chan, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966586
- Sponsor's protocol ID
- 2019P001573
- Status last verified
- Jul 2022
- First submitted
- 24 May 2019
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndemics and Loss from the HIV Care Continuum in India - Intervention
- ClinicalTrials.gov ID
- NCT03966586
- Acronym / sponsor ID
- 2019P001573
- Conditions
- HIV Infections
- Keywords
- hiv, India, retention, continuum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- YR Gaitonde Centre for AIDS Research and Education
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Care | Experimental | Behavioral: Active outreach, Behavioral: Appointments, Behavioral: Financial support, Behavioral: Microenterprise, Behavioral: Enhanced counselingUsual clinical care + intervention components |
| Usual Care | Active comparator | Behavioral: Usual clinical care and counselingUsual clinical care and counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Previous ART exposure
- Not competent to provide informed consent or participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active outreachParticipants 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. | Behavioural | Enhanced Care |
| AppointmentsParticipants in the enhanced-care intervention will be given specific appointment times/dates. | Behavioural | Enhanced Care |
| Financial supportParticipants 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. | Behavioural | Enhanced Care |
| MicroenterpriseYRG 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. | Behavioural | Enhanced Care |
| Enhanced counselingParticipants 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. | Behavioural | Enhanced Care |
| Usual clinical care and counselingUsual clinical care and counseling | Behavioural | Usual Care |
Primary outcome
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
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
8 secondary outcomes
Retention in care
Time frame: 12 months
Viral suppression (Undetectable HIV-1 RNA, <50 copies / mL)
Time frame: 3 months
ART initiation success (accepted ART and continued ART for at least 6 months)
Time frame: 6 months
Depressive symptoms as measured by PHQ-9
Time frame: 12 months
Internalized stigma as measured by Internalized AIDS-Related Stigma Scale
Time frame: 12 months
Self-efficacy as measured by General Self-Efficacy Scale--shortened version
Time frame: 12 months
Social support as measured by Multidimensional Scale of Perceived Social Support
Time frame: 12 months
Food insecurity as measured by Household Food Insecurity Access Scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active outreach, Appointments and Financial support in people with HIV Infections, run by Brigham and Women's Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by semi-structured qualitative interviews (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.