HivNCT04884867
A Psychosocial Tele-health Stigma Intervention for Youth Living With HIV in Vietnam
A study testing CBT-based supportive skills delivered by phone by lay coaches in people with Hiv and Stigma, Social, run by University of New England at 1 site in Vietnam.
Trial summary
The overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Hiv, Stigma, Social
- What is being tested?
- CBT-based supportive skills delivered by phone by lay coaches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteVietnam
- Study dates
- 14 Apr 2021to 15 May 2022
- 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 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- are between 18 and 24 years old
- are a patient at the OPC
- are expected to remain in care at the OPC for 3 months minimum(?)
- are currently on ART
- have primary responsibility for taking their own medications,
- self-report intrapersonal stigma via a brief screening questionnaire,
Show all 9Show fewer
- are able to complete a short phone call from the location where they intend to be when participating in coaching sessions,
- agree to follow all study procedures, AND
- provide informed consent.
Who cannot join
- are below the age of 18 years or above the age of 24,
- are not currently on ART,
- live outside the clinic catchment area,
- are identified as having severe mental health issues as identified through screening, OR
- are not willing to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Sống Vui, Live Happily": A Psychosocial Tele-health Intervention to Address Multi-level Stigma Among Youth Living With HIV in Vietnam
The overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing, and treatment adherence.
The project has the following Specific Aims:
Read more
- Adapt a psychosocial stigma-reduction intervention for YLHIV in Vietnam based on cognitive-behavioral therapy principles and delivered by telephone, using input from youth during intervention development.
- Assess the feasibility, acceptability and preliminary efficacy of this innovative approach to reduce stigma, and improve psychosocial wellbeing and ART adherence among YLHIV through a small pre-post study.
- Explore the multiple facets of stigma experienced by YLHIV in Vietnam and their relationships with ART adherence and psychosocial wellbeing via quantitative surveys and electronic adherence monitoring.
The study will assess the feasibility and acceptability of this approach among YLVIV in Vietnam, and generate preliminary evidence for the potential effect of the intervention on important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral load (VL).
Read the detailed description
For the pilot, the investigators will recruit YLHIV on ART who self-report intrapersonal stigma and implement a 12-week pre-post intervention study in which participants will receive the phone-based intervention developed in the first phase. YLHIV will use an electronic adherence monitoring device for their ART medications.
In the pre-post intervention study, each of 40 patients will be followed for a total of 16 weeks. All patient subjects will be given an eCAP wireless pill container (WPC) that will be used to measure their adherence throughout the 16-week period. Study participation will involve two phases, with the following activities:
- Adherence monitoring, pre-intervention period (Weeks 1-2). Once enrolled, the investigators will provide each subject with a WPC and instruction on correct use. The investigators will select one medication for each WPC. While subjects continue to receive care as usual, the investigators will collect their adherence data using the WPC.
II. Intervention period (Weeks 3-12). The intervention will be implemented for about 10 weeks; adherence data will be collected via WPCs through Week 16. They will remain blinded to the adherence information generated by the devices, as will their care providers.
- Conditions
- Hiv, Stigma, Social
- Being tested
- CBT-based supportive skills delivered by phone by lay coaches
- Keywords
- HIV, Stigma, Vulnerable groups, Vietnam
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-based supportive skills delivered by phone by lay coachesBehavioural
8-10 weekly coaching sessions delivered by telephone
| Study group | Role | What they receive |
|---|---|---|
| Supportive life skills coaching | Experimental | CBT-based supportive like skills delivered by phone by lay coaches Receives: Behavioral: CBT-based supportive skills delivered by phone by lay coaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapersonal (self) Stigma
modified 21-item self stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)
Measured: change between Week 1-Week 12
Interpersonal Stigma
modified 21-item enacted stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)
Measured: change between Week 1 and Week 12
Depression
7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)
Measured: change between Week 1 and Week 12
Anxiety
7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)
Measured: change between Week 1 and Week 12
Adherence
%≥95% on-time adherence
Measured: Week 12 (endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start14 Apr 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Social Development Studies (ISDS), Fogarty International Center of the National Institute of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Mary DeSilva, University of New England
- Investigators
- Mary DeSilva, ScD, MS, Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884867
- Sponsor's protocol ID
- R21TW011085-01
- Status last verified
- May 2022
- First submitted
- 7 May 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Sống Vui, Live Happily": A Psychosocial Tele-health Intervention to Address Multi-level Stigma Among Youth Living With HIV in Vietnam
- ClinicalTrials.gov ID
- NCT04884867
- Acronym / sponsor ID
- R21TW011085-01
- Conditions
- Hiv, Stigma, Social
- Keywords
- HIV, Stigma, Vulnerable groups, Vietnam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Collaborators
- Institute for Social Development Studies (ISDS), Fogarty International Center of the National Institute of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 13 May 2021 (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 overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing, and treatment adherence.
The project has the following Specific Aims:
- Adapt a psychosocial stigma-reduction intervention for YLHIV in Vietnam based on cognitive-behavioral therapy principles and delivered by telephone, using input from youth during intervention development.
- Assess the feasibility, acceptability and preliminary efficacy of this innovative approach to reduce stigma, and improve psychosocial wellbeing and ART adherence among YLHIV through a small pre-post study.
- Explore the multiple facets of stigma experienced by YLHIV in Vietnam and their relationships with ART adherence and psychosocial wellbeing via quantitative surveys and electronic adherence monitoring.
The study will assess the feasibility and acceptability of this approach among YLVIV in Vietnam, and generate preliminary evidence for the potential effect of the intervention on important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral load (VL).
Detailed description
For the pilot, the investigators will recruit YLHIV on ART who self-report intrapersonal stigma and implement a 12-week pre-post intervention study in which participants will receive the phone-based intervention developed in the first phase. YLHIV will use an electronic adherence monitoring device for their ART medications.
In the pre-post intervention study, each of 40 patients will be followed for a total of 16 weeks. All patient subjects will be given an eCAP wireless pill container (WPC) that will be used to measure their adherence throughout the 16-week period. Study participation will involve two phases, with the following activities:
- Adherence monitoring, pre-intervention period (Weeks 1-2). Once enrolled, the investigators will provide each subject with a WPC and instruction on correct use. The investigators will select one medication for each WPC. While subjects continue to receive care as usual, the investigators will collect their adherence data using the WPC.
II. Intervention period (Weeks 3-12). The intervention will be implemented for about 10 weeks; adherence data will be collected via WPCs through Week 16. They will remain blinded to the adherence information generated by the devices, as will their care providers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive life skills coaching | Experimental | Behavioral: CBT-based supportive skills delivered by phone by lay coachesCBT-based supportive like skills delivered by phone by lay coaches |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- are between 18 and 24 years old
- are a patient at the OPC
- are expected to remain in care at the OPC for 3 months minimum(?)
- are currently on ART
- have primary responsibility for taking their own medications,
Key exclusion criteria (5 listed)
- are below the age of 18 years or above the age of 24,
- are not currently on ART,
- live outside the clinic catchment area,
- are identified as having severe mental health issues as identified through screening, OR
- are not willing to provide informed consent.
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 |
|---|---|---|
| CBT-based supportive skills delivered by phone by lay coaches8-10 weekly coaching sessions delivered by telephone | Behavioural | Supportive life skills coaching |
Primary outcome
Intrapersonal (self) Stigma
Time frame: change between Week 1-Week 12
modified 21-item self stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)
Interpersonal Stigma
Time frame: change between Week 1 and Week 12
modified 21-item enacted stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome)
Depression
Time frame: change between Week 1 and Week 12
7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)
Anxiety
Time frame: change between Week 1 and Week 12
7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome)
Adherence
Time frame: Week 12 (endline)
%≥95% on-time adherence
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 31 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Mary DeSilva, ScD, MS principal investigator
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-based supportive skills delivered by phone by lay coaches in people with Hiv and Stigma, Social, run by University of New England at 1 site in Vietnam.
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 9 inclusion and 5 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 31 May 2022. 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 Vietnam. 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?
Intrapersonal (self) Stigma (time frame: change between Week 1-Week 12). The study lists 5 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 31 May 2022.