HIV InfectionsVITALNCT04790201
Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam
A study testing Friendship Bench Delivered by Professional Counselor and Friendship Bench Delivered by Lay Counselor in people with HIV Infections and Behavioral Symptoms, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
Trial summary
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Behavioral Symptoms, Depression
- What is being tested?
- Friendship Bench Delivered by Professional Counselor and Friendship Bench Delivered by Lay Counselor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteVietnam
- Study dates
- 28 Feb 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Eligible individuals will meet the following criteria:
- Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic
- Medical record indicates infection with HIV
- Have been screened with the Depression Anxiety Stress Scale-21 (DASS-21) which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD. The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 10. Elevated depressive symptoms be present for ≥2 weeks and elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. The investigators will consider a positive screen for any of the three categories as indicating a CMD.
Who cannot join
- Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation of the Friendship Bench Counseling Intervention to Improve Mental Health and HIV Care Engagement Outcomes Among People Living With HIV Who Inject Drugs in Vietnam
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
Read the detailed description
Injection drug use is the primary driver of the HIV epidemic in Southeast Asia. In 2017, the HIV prevalence among people who inject drugs (PWID) in Southeast Asia was 15%. PWID, most of whom have OUD, who are living with HIV have low rates of retention in care, antiretroviral therapy (ART) initiation, and viral suppression. PWID also experience high rates of HIV-related and all-cause mortality. Common mental disorders (CMDs), including depressive, anxiety, and stress-related illnesses, occur in 40-50% of PLWH and OUD. Despite serious consequences of mental illness on health and HIV progression, mental illness remains under-diagnosed and under-treated in HIV populations, especially in low- and middle-income countries (LMICs), such as many countries in Southeast Asia.
To respond to the great need for mental health treatment in low- and middle-income countries, the global mental health field has focused on developing task-shifting and integration approaches that equip non-specialists to deliver evidence-based mental health interventions at scale. However, such task shifting interventions to address CMDs have received limited attention in Southeast Asia among OUD. Vietnam, with its high prevalence of PLWH and OUD, its integration of methadone maintenance therapy (MMT) with HIV care, and its priority for developing CMD care for this population, is an ideal setting to evaluate task-shifting mental health approaches to address CMDs and improve HIV care outcomes.
The Friendship Bench (FB) is a feasible and effective task-shifting mental health intervention designed for low-resource settings that is a strong candidate to address CMDs in this population. FB is a problem solving therapy-based intervention with demonstrated effectiveness in treating CMDs among primary care patients when delivered by lay counselors. Lay counselors may effectively deliver FB to PLWH with OUD, but CMD may prove more difficult to treat in patients with OUD and require professionally trained counselors to be effective.
The investigators' objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi. The investigators' specific aims are: 1) To adapt the Friendship Bench (FB) protocol to be optimized for PLWH and OUD in Vietnam; and 2) To evaluate the feasibility, fidelity, and acceptability of the adapted FB as well as preliminary indicators of its impact in improving CMDs and HIV care and drug use treatment outcomes. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among PLWH with OUD, a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
- Conditions
- HIV Infections, Behavioral Symptoms, Depression, Anxiety, Opioid-use Disorder, Virus Infection
- Being tested
- Friendship Bench Delivered by Professional Counselor, Friendship Bench Delivered by Lay Counselor, Enhanced Usual Care
- Medical subject headings
- HIV Infections, Behavioral Symptoms, Depression, Anxiety Disorders, Opioid-Related Disorders, Virus Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friendship Bench Delivered by Professional CounselorBehavioural
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
Friendship Bench Delivered by Lay CounselorBehavioural
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
Enhanced Usual CareBehavioural
Enhanced usual care (EUC) will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Information will be collected in follow-up interviews to characterize the care that patients receive. These activities will occur in all three arms, but they are the only activities in the EUC arm.
| Study group | Role | What they receive |
|---|---|---|
| Friendship Bench Delivered by Professional Counselor | Experimental | Participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1). Receives: Behavioral: Friendship Bench Delivered by Professional Counselor |
| Friendship Bench Delivered by Lay Counselor | Experimental | Participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a trained lay counselor. Individuals enrolled in this arm arm will receive 6 weekly counselling sessions per the adapted FB protocol (Aim 1). Receives: Behavioral: Friendship Bench Delivered by Lay Counselor |
| Enhanced Usual Care | Active comparator | Participants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Enhanced usual care will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility)
This measure of feasibility will be measured as the ability to successfully enroll people living with HIV (PLWH) and opioid use disorder (OUD) with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).
Measured: Baseline
Study Retention (Study Feasibility)
This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.
Measured: Through study completion, an average of 12 months
Percent of FB Sessions Attended (Intervention Feasibility)
The percent of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.
Measured: 6 weeks
Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)
The number of patients who were either very satisfied or somewhat satisfied with the FB among all participants who received the FB. Satisfaction will be measured using a single question with a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
Measured: 6 weeks
Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)
The total number of FB sessions meeting or exceeding for at least 75% of the total number of fidelity checklist items assessed per session.
Measured: 6 weeks
Secondary outcomes (11)
Number of Participants Achieving HIV Viral Suppression
HIV viral load will be measured from clinical records, or measured and ordered by the study if no viral load is collected in the appropriate window. Viral suppression is defined as <20 copies of HIV-1 RNA per milliliter.
Measured: 6 months after enrollment
Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period
The proportion of scheduled visits in the 12-month follow-up period that are attended vs. no-shows (the "kept visit proportion"), with no-show defined as no appointment kept in the 30 days following a scheduled appointment. HIV appointment data will be abstracted from clinic records at the end of the study period.
Measured: Study baseline through 12 months of follow-up
Total CMD Symptoms Score for Participants
CMD symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. The total scale is calculated by summing the subscales, range 0-126, for depression (threshold ≥14), anxiety (threshold ≥10), and stress (threshold ≥19); higher scores indicate higher severity of symptoms.
Measured: 6 weeks after enrollment
Change in CMD Symptoms
The change in CMD symptoms from baseline to 6 weeks in the DASS-21 total score is calculated as Baseline DASS-21 total score minus the Week 6 DASS-21 total score. CMD symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. The total scale is calculated by summing the subscales, range 0-126, for depression (threshold ≥14), anxiety (threshold ≥10), and stress (threshold ≥19); higher scores indicate higher severity of symptoms.
Measured: Baseline, 6 weeks after enrollment
Mean Depressive Disorder Score Among Participants
Depression symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder.
Measured: 6 weeks after enrollment
Absolute Reduction in Depressive Symptoms
The absolute reduction of depressive symptoms from baseline to 6 weeks will be evaluated via the DASS-21 depression subscale. Depression symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder.
Measured: 6 weeks after enrollment
Mean Anxiety Disorder Score Among Participants
Anxiety symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder.
Measured: 6 weeks after enrollment
Absolute Reduction in Anxiety Symptoms
The absolute reduction of anxiety symptoms from baseline to 6 weeks will be evaluated via the DASS-21 anxiety subscale. Anxiety symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder.
Measured: 6 weeks after enrollment
Mean Stress Disorder Score Among Participants
Stress symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder.
Measured: 6 weeks after enrollment
Absolute Reduction in Stress Symptoms
The absolute reduction of stress symptoms from baseline to 6 weeks will be evaluated via the DASS-21 stress scale. Stress symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder.
Measured: 6 weeks after enrollment
Mean Proportion of Days With MMT Adherence
Out of the first 183 days of study participation, the total number of days a participant attended their MMT visit appointment divided by 183 days.
Measured: Study baseline through 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start28 Feb 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm individually randomized trial
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University, The Friendship Bench Trust, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Bradley Gaynes, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790201
- Sponsor's protocol ID
- 20-1689
- Other IDs
- R34DA051933, IGHID 12028
- Acronym
- VITAL
- Status last verified
- May 2024
- First submitted
- 18 Feb 2021
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Publications
Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
PubMed 16004657Le MTH, Tran TD, Holton S, Nguyen HT, Wolfe R, Fisher J. Reliability, convergent validity and factor structure of the DASS-21 in a sample of Vietnamese adolescents. PLoS One. 2017 Jul 19;12(7):e0180557. doi: 10.1371/journal.pone.0180557. eCollection 2017.
PubMed 28723909Tran TD, Tran T, Fisher J. Validation of the depression anxiety stress scales (DASS) 21 as a screening instrument for depression and anxiety in a rural community-based cohort of northern Vietnamese women. BMC Psychiatry. 2013 Jan 12;13:24. doi: 10.1186/1471-244X-13-24.
PubMed 23311374Mathers BM, Degenhardt L, Phillips B, Wiessing L, Hickman M, Strathdee SA, Wodak A, Panda S, Tyndall M, Toufik A, Mattick RP; 2007 Reference Group to the UN on HIV and Injecting Drug Use. Global epidemiology of injecting drug use and HIV among people who inject drugs: a systematic review. Lancet. 2008 Nov 15;372(9651):1733-45. doi: 10.1016/S0140-6736(08)61311-2. Epub 2008 Sep 23.
PubMed 18817968Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23.
PubMed 29074409Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849.
PubMed 10860902Malta M, Strathdee SA, Magnanini MM, Bastos FI. Adherence to antiretroviral therapy for human immunodeficiency virus/acquired immune deficiency syndrome among drug users: a systematic review. Addiction. 2008 Aug;103(8):1242-57. doi: 10.1111/j.1360-0443.2008.02269.x.
PubMed 18855813Sherer R. Adherence and antiretroviral therapy in injection drug users. JAMA. 1998 Aug 12;280(6):567-8. doi: 10.1001/jama.280.6.567. No abstract available.
PubMed 9707152Jordan MR, Obeng-Aduasare Y, Sheehan H, Hong SY, Terrin N, Duong DV, Trung NV, Wanke C, Kinh NV, Tang AM. Correlates of non-adherence to antiretroviral therapy in a cohort of HIV-positive drug users receiving antiretroviral therapy in Hanoi, Vietnam. Int J STD AIDS. 2014 Aug;25(9):662-668. doi: 10.1177/0956462413516301. Epub 2013 Dec 18.
PubMed 24352130Mathers BM, Degenhardt L, Bucello C, Lemon J, Wiessing L, Hickman M. Mortality among people who inject drugs: a systematic review and meta-analysis. Bull World Health Organ. 2013 Feb 1;91(2):102-23. doi: 10.2471/BLT.12.108282.
PubMed 23554523Weber R, Huber M, Battegay M, Stahelin C, Castro Batanjer E, Calmy A, Bregenzer A, Bernasconi E, Schoeni-Affolter F, Ledergerber B; Swiss HIV Cohort Study. Influence of noninjecting and injecting drug use on mortality, retention in the cohort, and antiretroviral therapy, in participants in the Swiss HIV Cohort Study. HIV Med. 2015 Mar;16(3):137-51. doi: 10.1111/hiv.12184. Epub 2014 Aug 15.
PubMed 25124393Lappalainen L, Hayashi K, Dong H, Milloy MJ, Kerr T, Wood E. Ongoing impact of HIV infection on mortality among people who inject drugs despite free antiretroviral therapy. Addiction. 2015 Jan;110(1):111-9. doi: 10.1111/add.12736. Epub 2014 Oct 16.
PubMed 25203392Adams C, Zacharia S, Masters L, Coffey C, Catalan P. Mental health problems in people living with HIV: changes in the last two decades: the London experience 1990-2014. AIDS Care. 2016;28 Suppl 1(sup1):56-9. doi: 10.1080/09540121.2016.1146211. Epub 2016 Feb 17.
PubMed 26888472Gaynes BN, Pence BW, Eron JJ Jr, Miller WC. Prevalence and comorbidity of psychiatric diagnoses based on reference standard in an HIV+ patient population. Psychosom Med. 2008 May;70(4):505-11. doi: 10.1097/PSY.0b013e31816aa0cc. Epub 2008 Mar 31.
PubMed 18378865Bouhnik AD, Preau M, Vincent E, Carrieri MP, Gallais H, Lepeu G, Gastaut JA, Moatti JP, Spire B; MANIF 2000 Study Group. Depression and clinical progression in HIV-infected drug users treated with highly active antiretroviral therapy. Antivir Ther. 2005;10(1):53-61.
PubMed 15751763
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Friendship Bench Counseling Intervention to Improve Mental Health and HIV Care Engagement Outcomes Among People Living With HIV Who Inject Drugs in Vietnam
- ClinicalTrials.gov ID
- NCT04790201
- Acronym / sponsor ID
- VITAL / 20-1689
- Conditions
- HIV Infections, Behavioral Symptoms, Depression, Anxiety, Opioid-use Disorder, Virus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Hanoi Medical University, The Friendship Bench Trust, National Institute on Drug Abuse (NIDA)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
Detailed description
Injection drug use is the primary driver of the HIV epidemic in Southeast Asia. In 2017, the HIV prevalence among people who inject drugs (PWID) in Southeast Asia was 15%. PWID, most of whom have OUD, who are living with HIV have low rates of retention in care, antiretroviral therapy (ART) initiation, and viral suppression. PWID also experience high rates of HIV-related and all-cause mortality. Common mental disorders (CMDs), including depressive, anxiety, and stress-related illnesses, occur in 40-50% of PLWH and OUD. Despite serious consequences of mental illness on health and HIV progression, mental illness remains under-diagnosed and under-treated in HIV populations, especially in low- and middle-income countries (LMICs), such as many countries in Southeast Asia.
To respond to the great need for mental health treatment in low- and middle-income countries, the global mental health field has focused on developing task-shifting and integration approaches that equip non-specialists to deliver evidence-based mental health interventions at scale. However, such task shifting interventions to address CMDs have received limited attention in Southeast Asia among OUD. Vietnam, with its high prevalence of PLWH and OUD, its integration of methadone maintenance therapy (MMT) with HIV care, and its priority for developing CMD care for this population, is an ideal setting to evaluate task-shifting mental health approaches to address CMDs and improve HIV care outcomes.
The Friendship Bench (FB) is a feasible and effective task-shifting mental health intervention designed for low-resource settings that is a strong candidate to address CMDs in this population. FB is a problem solving therapy-based intervention with demonstrated effectiveness in treating CMDs among primary care patients when delivered by lay counselors. Lay counselors may effectively deliver FB to PLWH with OUD, but CMD may prove more difficult to treat in patients with OUD and require professionally trained counselors to be effective.
The investigators' objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi. The investigators' specific aims are: 1) To adapt the Friendship Bench (FB) protocol to be optimized for PLWH and OUD in Vietnam; and 2) To evaluate the feasibility, fidelity, and acceptability of the adapted FB as well as preliminary indicators of its impact in improving CMDs and HIV care and drug use treatment outcomes. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among PLWH with OUD, a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm individually randomized trial
| Arm | Type | Receives |
|---|---|---|
| Friendship Bench Delivered by Professional Counselor | Experimental | Behavioral: Friendship Bench Delivered by Professional CounselorParticipants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a professional counselor. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the adapted FB protocol (Aim 1). |
| Friendship Bench Delivered by Lay Counselor | Experimental | Behavioral: Friendship Bench Delivered by Lay CounselorParticipants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will initiate FB with a trained lay counselor. Individuals enrolled in this arm arm will receive 6 weekly counselling sessions per the adapted FB protocol (Aim 1). |
| Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareParticipants seeking HIV and/or MMT services at participating clinics in Hanoi, Vietnam will be enrolled in this study arm during study recruitment. Enhanced usual care will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic
- Medical record indicates infection with HIV
- Have been screened with the Depression Anxiety Stress Scale-21 (DASS-21) which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD. The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 10. Elevated depressive symptoms be present for ≥2 weeks and elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. The investigators will consider a positive screen for any of the three categories as indicating a CMD.
Key exclusion criteria (1 listed)
- Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.
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 |
|---|---|---|
| Friendship Bench Delivered by Professional CounselorParticipants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor. | Behavioural | Friendship Bench Delivered by Professional Counselor |
| Friendship Bench Delivered by Lay CounselorParticipants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. | Behavioural | Friendship Bench Delivered by Lay Counselor |
| Enhanced Usual CareEnhanced usual care (EUC) will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Information will be collected in follow-up interviews to characterize the care that patients receive. These activities will occur in all three arms, but they are the only activities in the EUC arm. | Behavioural | Enhanced Usual Care |
Primary outcome
Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility)
Time frame: Baseline
This measure of feasibility will be measured as the ability to successfully enroll people living with HIV (PLWH) and opioid use disorder (OUD) with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).
Study Retention (Study Feasibility)
Time frame: Through study completion, an average of 12 months
This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.
Percent of FB Sessions Attended (Intervention Feasibility)
Time frame: 6 weeks
The percent of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.
Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)
Time frame: 6 weeks
The number of patients who were either very satisfied or somewhat satisfied with the FB among all participants who received the FB. Satisfaction will be measured using a single question with a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)
Time frame: 6 weeks
The total number of FB sessions meeting or exceeding for at least 75% of the total number of fidelity checklist items assessed per session.
11 secondary outcomes
Number of Participants Achieving HIV Viral Suppression
Time frame: 6 months after enrollment
Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period
Time frame: Study baseline through 12 months of follow-up
Total CMD Symptoms Score for Participants
Time frame: 6 weeks after enrollment
Change in CMD Symptoms
Time frame: Baseline, 6 weeks after enrollment
Mean Depressive Disorder Score Among Participants
Time frame: 6 weeks after enrollment
Absolute Reduction in Depressive Symptoms
Time frame: 6 weeks after enrollment
Mean Anxiety Disorder Score Among Participants
Time frame: 6 weeks after enrollment
Absolute Reduction in Anxiety Symptoms
Time frame: 6 weeks after enrollment
Mean Stress Disorder Score Among Participants
Time frame: 6 weeks after enrollment
Absolute Reduction in Stress Symptoms
Time frame: 6 weeks after enrollment
Mean Proportion of Days With MMT Adherence
Time frame: Study baseline through 6 months of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16004657Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
- Background: PubMed 28723909Le MTH, Tran TD, Holton S, Nguyen HT, Wolfe R, Fisher J. Reliability, convergent validity and factor structure of the DASS-21 in a sample of Vietnamese adolescents. PLoS One. 2017 Jul 19;12(7):e0180557. doi: 10.1371/journal.pone.0180557. eCollection 2017.
- Background: PubMed 23311374Tran TD, Tran T, Fisher J. Validation of the depression anxiety stress scales (DASS) 21 as a screening instrument for depression and anxiety in a rural community-based cohort of northern Vietnamese women. BMC Psychiatry. 2013 Jan 12;13:24. doi: 10.1186/1471-244X-13-24.
- Background: PubMed 18817968Mathers BM, Degenhardt L, Phillips B, Wiessing L, Hickman M, Strathdee SA, Wodak A, Panda S, Tyndall M, Toufik A, Mattick RP; 2007 Reference Group to the UN on HIV and Injecting Drug Use. Global epidemiology of injecting drug use and HIV among people who inject drugs: a systematic review. Lancet. 2008 Nov 15;372(9651):1733-45. doi: 10.1016/S0140-6736(08)61311-2. Epub 2008 Sep 23.
- Background: PubMed 29074409Degenhardt L, Peacock A, Colledge S, Leung J, Grebely J, Vickerman P, Stone J, Cunningham EB, Trickey A, Dumchev K, Lynskey M, Griffiths P, Mattick RP, Hickman M, Larney S. Global prevalence of injecting drug use and sociodemographic characteristics and prevalence of HIV, HBV, and HCV in people who inject drugs: a multistage systematic review. Lancet Glob Health. 2017 Dec;5(12):e1192-e1207. doi: 10.1016/S2214-109X(17)30375-3. Epub 2017 Oct 23.
- Background: PubMed 10860902Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849.
- Background: PubMed 18855813Malta M, Strathdee SA, Magnanini MM, Bastos FI. Adherence to antiretroviral therapy for human immunodeficiency virus/acquired immune deficiency syndrome among drug users: a systematic review. Addiction. 2008 Aug;103(8):1242-57. doi: 10.1111/j.1360-0443.2008.02269.x.
- Background: PubMed 9707152Sherer R. Adherence and antiretroviral therapy in injection drug users. JAMA. 1998 Aug 12;280(6):567-8. doi: 10.1001/jama.280.6.567. No abstract available.
- Background: PubMed 24352130Jordan MR, Obeng-Aduasare Y, Sheehan H, Hong SY, Terrin N, Duong DV, Trung NV, Wanke C, Kinh NV, Tang AM. Correlates of non-adherence to antiretroviral therapy in a cohort of HIV-positive drug users receiving antiretroviral therapy in Hanoi, Vietnam. Int J STD AIDS. 2014 Aug;25(9):662-668. doi: 10.1177/0956462413516301. Epub 2013 Dec 18.
- Background: PubMed 23554523Mathers BM, Degenhardt L, Bucello C, Lemon J, Wiessing L, Hickman M. Mortality among people who inject drugs: a systematic review and meta-analysis. Bull World Health Organ. 2013 Feb 1;91(2):102-23. doi: 10.2471/BLT.12.108282.
- Background: PubMed 25124393Weber R, Huber M, Battegay M, Stahelin C, Castro Batanjer E, Calmy A, Bregenzer A, Bernasconi E, Schoeni-Affolter F, Ledergerber B; Swiss HIV Cohort Study. Influence of noninjecting and injecting drug use on mortality, retention in the cohort, and antiretroviral therapy, in participants in the Swiss HIV Cohort Study. HIV Med. 2015 Mar;16(3):137-51. doi: 10.1111/hiv.12184. Epub 2014 Aug 15.
- Background: PubMed 25203392Lappalainen L, Hayashi K, Dong H, Milloy MJ, Kerr T, Wood E. Ongoing impact of HIV infection on mortality among people who inject drugs despite free antiretroviral therapy. Addiction. 2015 Jan;110(1):111-9. doi: 10.1111/add.12736. Epub 2014 Oct 16.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
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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.
Bradley Gaynes, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Friendship Bench Delivered by Professional Counselor and Friendship Bench Delivered by Lay Counselor in people with HIV Infections and Behavioral Symptoms, run by University of North Carolina, Chapel Hill 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 4 inclusion and 1 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 13 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility) (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT04790201, which also lists 22 linked publications.
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 13 Aug 2024.