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

Depression Clinical Trial

— VITAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790201
• Other study ID #: 20-1689
• Secondary ID: R34DA051933IGHID
• Status: Completed
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: September 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Behavioral Symptoms
• Communicable Diseases
• Depression
• HIV Infections
• Immune System Diseases
• Infections
• Opioid Dependence
• Opioid-Related Disorders
• Opioid-use Disorder
• Virus Infection

Intervention

Behavioral:
• Friendship Bench Delivered by Professional Counselor
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
• Friendship Bench Delivered by Lay Counselor
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
• 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.

Locations

Country	Name	City	State
Vietnam	CDC Hanoi	Hanoi	Hanoi City

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Hanoi Medical University, National Institute on Drug Abuse (NIDA), The Friendship Bench Trust

Country where clinical trial is conducted

Vietnam, 

References & Publications (18)

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. — View Citation

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. — View Citation

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

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;: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate (Intervention Feasibility)	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).	Baseline
Primary	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.	Through study completion, an average of 12 months
Primary	Number of FB sessions Attended (Intervention Feasibility)	The number of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.	6 weeks
Primary	Overall Satisfaction with the FB among Participants (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 on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.	6 weeks
Primary	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.	6 weeks
Secondary	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.	6 months after enrollment
Secondary	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.	Study baseline through 12 months of follow-up.
Secondary	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.	6 weeks after enrollment
Secondary	Absolute reduction in CMD symptoms	The absolute reduction in CMD symptoms from baseline to 6 weeks in the DASS-21 total score.	6 weeks after enrollment
Secondary	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 = 14 on the depression subscale indicate a depressive disorder.	6 weeks after enrollment
Secondary	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.	6 weeks after enrollment
Secondary	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 = 10 on the anxiety subscale indicate an anxiety disorder	6 weeks after enrollment
Secondary	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.	6 weeks after enrollment
Secondary	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 = 19 on the stress subscale indicate a stress disorder.	6 weeks after enrollment
Secondary	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.	6 weeks after enrollment
Secondary	Proportion of days with MMT adherence:	Out of the first 365 days of study participation, the total number of days a participant took their MMT dose divided by 365 days.	Study baseline through 12 months of follow-up.