Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam (VITAL)

• ClinicalTrials.gov Identifier: NCT04790201
• Recruitment Status: Recruiting
• First Posted: March 10, 2021
• Last Update Posted: January 31, 2023
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Hanoi Medical University; The Friendship Bench Trust; National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections; Behavioral Symptoms; Depression; Anxiety; Opioid-use Disorder; Virus Infection; Immune System Diseases; Opioid Dependence	Behavioral: Friendship Bench Delivered by Professional Counselor; Behavioral: Friendship Bench Delivered by Lay Counselor; Behavioral: Enhanced Usual Care	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Three-arm individually randomized trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 28, 2022
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Friendship Bench Delivered by Professional Counselor; 25 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).	Behavioral: Friendship Bench Delivered by Professional Counselor; Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
Experimental: Friendship Bench Delivered by Lay Counselor; 25 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).	Behavioral: Friendship Bench Delivered by Lay Counselor; Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
Active Comparator: Enhanced Usual Care; 25 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.	Behavioral: Enhanced Usual Care; 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.

Outcome Measures

Primary Outcome Measures :

1. Recruitment Rate (Intervention Feasibility) [ Time Frame: Baseline ]
   This measure of feasibility will be measured as the ability to successfully enroll PLWH and 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).
2. Study Retention (Study Feasibility) [ Time Frame: Through study completion, an average of 90 days. ]
   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 retention rate (proportion of patients enrolled at baseline who are still enrolled in the trial, through study completion.
3. Proportion of FB sessions Attended (Intervention Feasibility) [ Time Frame: 6 weeks ]
   The proportion of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.
4. Proportion of Overall Satisfaction with the FB among Participants (Intervention Acceptability) [ Time Frame: Through study completion ]
   The proportion of patients who were either very satisfied or somewhat satisfied with the FB among all participants who received the FB. Satisfaction will be measured on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
5. Proportion of Intervention Checklist Items meeting Fidelity Threshold (Intervention Fidelity). [ Time Frame: 6 weeks ]
   Proportion of FB sessions meeting or exceeding for at least 75% of the total number of fidelity checklist items assessed per session.

Secondary Outcome Measures :

1. Proportion of Participants Achieving HIV Viral Suppression [ Time Frame: Study baseline through 6 months ]
   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.
2. Proportion of Participants with Consistent ART Use over 12 Months [ Time Frame: Assessed during entire study period (Study baseline through 12 months follow-up) ]
   Consistent ART use over 12 months as confirmed by clinical records.
3. Proportion of Scheduled HIV Visits Attended vs. Unattended in the 12-Month Follow-Up period. [ Time Frame: Study baseline and each study follow-up through 12 months of follow-up. ]
   The proportion of scheduled visits in the 12-month follow-up period that are attended vs. no-shows (the "kept visit proportion"). HIV appointment data will be abstracted from clinic records at the end of the study period.
4. Proportion of Participants indicating any CMD symptoms [ Time Frame: 3 months after enrollment ]
   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.
5. Proportion of Participants with a depressive disorder [ Time Frame: 3 months after enrollment ]
   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 ≥ 14 on the depression subscale indicate a depressive disorder
6. Proportion of participants with a 50 percent decrease in depressive symptom severity as measured using the DASS-21 depression sub-scale [ Time Frame: 3 months after enrollment ]
   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). Severity on the depression sub-scale is measured as follows: Normal 0-9, Mild: 10-12, Moderate: 13-20, Severe: 21-27, Extremely Severe: 28-42. The proportion of participants with a 50% decrease in depression symptom severity will be measured via a 50% decrease in the depressive sub-scale between study follow-up timepoints.
7. Proportion of participants no longer meeting depression threshold score [ Time Frame: 3 months after enrollment ]
   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 ≤ 9 indicate no longer meeting depression diagnostic criteria
8. Proportion of Participants with an anxiety disorder [ Time Frame: 3 months after enrollment ]
   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 ≥ 10 on the anxiety subscale indicate an anxiety disorder
9. Proportion of participants with a 50 percent decrease in anxiety symptom severity as measured using the DASS-21 anxiety sub-scale [ Time Frame: 3 months after enrollment ]
   The DASS-21 measures self-reported depression, anxiety, and stress using three sub-scales. Questionnaire items ask about experiencing various signs and symptoms over the last week and use a Likert scale with response choices and scoring as follows: 0 indicating "Does not apply to me at all (Never)", 1 indicating "Applied to me to some degree, or some of the time (Sometimes)", 2 indicating "Applied to me to a considerable degree, or a good part of time (Often)", and 3 indicating "Applied to me very much, or most of the time (Always)". A DASS-21 anxiety sub-scale score ≥10 indicates anxiety disorders. Severity on the anxiety sub-scale is measured as follows: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe: 15-19, Extremely Severe: 20-42. The proportion of participants with a 50% decrease in depressive symptom severity will be measured, as indicated by the proportion of participants with a 50% decrease in depression symptom severity between study follow-up points.
10. Proportion of participants no longer meeting anxiety threshold score [ Time Frame: 3 months after enrollment ]
    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 ≤6 indicate no longer meeting anxiety diagnostic criteria
11. Proportion of Participants with a stress disorder [ Time Frame: 3 months after enrollment ]
    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 ≥ 19 on the stress subscale indicate a stress disorder
12. Proportion of participants with a 50 decrease in stress symptom severity as measured using the DASS-21 stress sub-scale [ Time Frame: 3 months after enrollment ]
    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). Severity on the stress sub-scale is measured as follows: Normal 0-10, Mild: 11-18, Moderate: 19-26, Severe: 27-34, Extremely Severe: 35-42. The proportion of participants with a 50% decrease in anxiety symptom severity will be measured via a 50% decrease in the anxiety sub-scale between baseline and 3 month study visits.
13. Proportion of participants no longer meeting stress threshold score [ Time Frame: 3 months after enrollment ]
    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 ≤ 10 indicate no longer meeting depression diagnostic criteria
14. Proportion of Participants with Methadone Maintenance Engagement [ Time Frame: Study baseline and each study follow-up through 12 months of follow-up. ]
    The proportion of participants engaged in Methadone Maintenance Therapy.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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 DASS-21 which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD (Henry & Crawford 2005; Le et al. 2017; Tran et al. 2013). 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.

Exclusion Criteria:

• Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.

Contacts and Locations

Contacts

Contact: Ha Viet Tran, MD, MSc; 84-24-3211-5839; vietha@live.unc.edu

Contact: Thi Thuy Ha Nong; thuyha@unc.edu.vn

Locations

Vietnam

CDC Hanoi; Recruiting

Hanoi, Hanoi City, Vietnam

Contact: Ha Viet Tran, MD, MSc 84-24-3211-5839 vietha@live.unc.edu

Contact: Thuy Ha Nong 84-24-3211-5839 ext 206 thuyha@unc.edu.vn

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Hanoi Medical University

The Friendship Bench Trust

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Bradley Gaynes, MD, MPH; University of North Carolina, Chapel Hill

More Information

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.

Le 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.

Tran 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.

Mathers 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.

Degenhardt 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. Erratum In: Lancet Glob Health. 2017 Nov 15;:

Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849.

Malta 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.

Sherer 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.

Jordan 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.

Mathers 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.

Weber 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.

Lappalainen 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.

Adams 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.

Gaynes 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.

Bouhnik 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.

Jones DL, Waldrop-Valverde D, Gonzalez P, Mack A, Kumar AM, Ownby R, Weiss SM, Kumar M. Mental health in HIV seronegative and seropositive IDUs in South Florida. AIDS Care. 2010 Feb;22(2):152-8. doi: 10.1080/09540120903039851.

Springer SA, Chen S, Altice F. Depression and symptomatic response among HIV-infected drug users enrolled in a randomized controlled trial of directly administered antiretroviral therapy. AIDS Care. 2009 Aug;21(8):976-83. doi: 10.1080/09540120802657555.

WHO Secretariat. HIV/AIDS and mental health. World Health Institution; 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tran HV, Nong HTT, Tran TTT, Filipowicz TR, Landrum KR, Pence BW, Le GM, Nguyen MX, Chibanda D, Verhey R, Go VF, Ho HT, Gaynes BN. Adaptation of a Problem-solving Program (Friendship Bench) to Treat Common Mental Disorders Among People Living With HIV and AIDS and on Methadone Maintenance Treatment in Vietnam: Formative Study. JMIR Form Res. 2022 Jul 8;6(7):e37211. doi: 10.2196/37211.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT04790201
• Other Study ID Numbers: 20-1689; R34DA051933 ( U.S. NIH Grant/Contract ); IGHID 12028 ( Other Identifier: UNC-CH )
• First Posted: March 10, 2021
• Last Update Posted: January 31, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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).
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Communicable Diseases; Immune System Diseases; Opioid-Related Disorders; Behavioral Symptoms; Disease Attributes; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders