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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA051933 | U.S. NIH Grant/Contract | View source | |
| IGHID 12028 | Other Identifier | UNC-CH |
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| Name | Class |
|---|---|
| Hanoi Medical University | OTHER |
| The Friendship Bench Trust | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Friendship Bench Delivered by Professional Counselor | Behavioral | Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after enrollment |
| Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period |
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Inclusion Criteria:
Eligible individuals will meet the following criteria:
Exclusion Criteria:
• Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Gaynes, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CDC Hanoi | Hanoi | Hanoi City | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16004657 | Background | 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. | |
| 28723909 | Background | 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. |
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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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9 to 36 months following publication
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.
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Two of the randomized participants (1 in Friendship Bench delivered by Professional Counselor arm and 1 in Usual Care arm) were found to be ineligible for the study shortly after enrollment and were excluded from all analyses.
Study recruitment began in February 2022. Recruitment occurred in Methadone Maintenance Treatment (MMT) clinics located in Hanoi, Vietnam.
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| ID | Title | Description |
|---|---|---|
| FG000 | Friendship Bench Delivered by Professional Counselor | 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). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2023 |
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Three-arm individually randomized trial
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| Friendship Bench Delivered by Lay Counselor | Behavioral | Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
|
| Enhanced Usual Care | Behavioral | 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. |
|
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 |
| 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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Study baseline through 6 months of follow-up |
| 23311374 | Background | 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. |
| 18817968 | Background | 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. |
| 29074409 | Background | 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. |
| 10860902 | Background | Chesney MA. Factors affecting adherence to antiretroviral therapy. Clin Infect Dis. 2000 Jun;30 Suppl 2:S171-6. doi: 10.1086/313849. |
| 18855813 | Background | 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. |
| 9707152 | Background | 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. |
| 24352130 | Background | 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. |
| 23554523 | Background | 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. |
| 25124393 | Background | 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. |
| 25203392 | Background | 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. |
| 26888472 | Background | 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. |
| 18378865 | Background | 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. |
| 15751763 | Background | 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. |
| 19662550 | Background | 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. |
| 20024753 | Background | 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. |
| Background | WHO Secretariat. HIV/AIDS and mental health. World Health Institution; 2008. |
| 41649734 | Derived | Nong HTT, Nguyen HN, Tran HV, Cao ATV, Tran TTT, Filipowicz TR, Landrum KR, Giang LM, Verhey R, Pence BW, Gaynes BN. Providers' Experiences in Implementation of Friendship Bench: A Problem-Solving Therapy-Based Mental Health Intervention Adapted for People on Methadone Maintenance Treatment Who Live with HIV in Vietnam. AIDS Behav. 2026 Feb 6. doi: 10.1007/s10461-026-05054-0. Online ahead of print. |
| 39894853 | Derived | Gaynes BN, Tran HV, Nong HTT, Filipowicz TR, Landrum KR, Tran TTT, Nguyen VQ, Verhey R, Nguyen HN, Giang LM, Pence BW. An Adapted Friendship Bench Counseling Intervention (FB) to Improve Mental Health and HIV Care Engagement Outcomes Among People Living with HIV (PWH) Who Inject Drugs in Hanoi, Vietnam: Results from the VITAL Pilot Randomized Controlled Trial. AIDS Behav. 2025 Jun;29(6):1761-1774. doi: 10.1007/s10461-025-04645-7. Epub 2025 Feb 2. |
| 36517849 | Derived | Tran HV, Filipowicz TR, Landrum KR, Nong HTT, Tran TTT, Pence BW, Go VF, Le GM, Nguyen MX, Verhey R, Chibanda D, Ho HT, Gaynes BN. Stigma experienced by people living with HIV who are on methadone maintenance treatment and have symptoms of common mental disorders in Hanoi, Vietnam: a qualitative study. AIDS Res Ther. 2022 Dec 14;19(1):63. doi: 10.1186/s12981-022-00491-y. |
| 35802402 | Derived | 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. |
| FG001 | Friendship Bench Delivered by Lay Counselor | 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| FG002 | Enhanced Usual Care | 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 common mental disorder (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. 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. |
| COMPLETED |
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| NOT COMPLETED |
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Two of the randomized participants (1-Friendship Bench Delivered by Professional Counselor and 1-Enhanced Usual Care) were found to be ineligible for the study shortly after enrollment and were excluded from all analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Friendship Bench Delivered by Professional Counselor | 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). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor. |
| BG001 | Friendship Bench Delivered by Lay Counselor | 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| BG002 | Enhanced Usual Care | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis population includes the total number of people approached for study eligibility and screening. Two of the randomized participants (1-Friendship Bench Delivered by Professional Counselor and 1-Enhanced Usual Care) were found to be ineligible for the study shortly after enrollment and were excluded from all analyses. | Posted | Count of Participants | Participants | Baseline |
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| 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. | The analysis population includes the total number of eligible study participants (n=75) enrolled. Two of the randomized participants (1-Friendship Bench Delivered by Professional Counselor and 1-Enhanced Usual Care) were found to be ineligible for the study shortly after enrollment and were excluded from all analyses. | Posted | Count of Participants | Participants | Through study completion, an average of 12 months |
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| Primary | 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. | The analysis population includes the total number of planned intervention sessions across the two arms (FB delivered by professional counselor and FB delivered by lay counselor). Each arm had 25 participants with 6 planned, weekly sessions per participant for a total of (25*6)150 sessions per arm. The enhanced usual care arm (n=25) did not receive an intervention and are not included in the analysis population. | Posted | Number | percent of FB Sessions Attended | 6 weeks | Intervention Sessions | Intervention Sessions |
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| Primary | 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. | The analysis population includes all participants who received the intervention [FB delivered by professional counselor (n=25) and FB delivered by lay counselor(n=25)] for a total of 50 analyzed participants. Participants who received enhanced usual care (n=25) are not included in the analysis population as they did not receive the intervention. | Posted | Count of Participants | Participants | 6 weeks |
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| 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. | The analysis population includes the total number of intervention sessions across the two arms (FB delivered by professional counselor and FB delivered by lay counselor) assessed for fidelity. Each FB counselor had >=3 randomly-chosen sessions reviewed for fidelity. The FB delivered by professional counselors had n=92 sessions and the FB delivered by lay counselors has n=95 sessions. The enhanced usual care arm did not receive an intervention and are not included in the analysis population. | Posted | Number | Number of sessions meeting fidelity | 6 weeks | Intervention Sessions | Intervention Sessions |
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| 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. Viral suppression is defined as <20 copies of HIV-1 RNA per milliliter. | The analysis population includes all study participants (across all 3 arms) who attended the 6-month follow-up visit and provided a sample for viral load testing. Note not all participants were able to provide a blood sample for viral load testing. The professional counselor FB arm had n=25 participants, the lay counselor FB arm had n= 24 participants, and the enhanced usual care arm had (n=23) participants. | Posted | Count of Participants | Participants | 6 months after enrollment |
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| 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. | This analysis population includes the total number of scheduled HIV visits. The n = 25 participants in the Friendship Bench (FB) delivered by professional counselor arm contributed n= 201 HIV visits. The n = 25 participants in the FB delivered by lay counselor arm contributed n = 170 HIV appointments. The n=25 participants in the enhanced usual care arm contributed n = 179 HIV visits. The number of visits represents the total possible number of visits (regardless of attendance) in each arm. | Posted | Number | proportion of scheduled visits attended | Study baseline through 12 months of follow-up | scheduled HIV visits | scheduled HIV visits |
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| 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. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| Secondary | 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. | The analysis population includes all study participants (across all 3 arms) who completed the 6 week followup visit. The professional counselor FB arm had n=25 participants, the lay counselor FB arm had n= 25 participants, and the enhanced usual care arm had n=24 participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks after enrollment |
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| 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 on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| 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. 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. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| 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 on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| 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. 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. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| 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 on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| 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. 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. | The analysis population includes all study participants (across all 3 arms) who attended the 6-week follow-up visit. The two intervention arms (FB by professional and lay counselors) each had n=25 participants complete the 6-week follow-up visit. The enhanced usual care arm had n=24 participants complete the 6-week follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after enrollment |
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| Secondary | 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. | The analysis population includes the number of participant MMT visits for all participants who had complete MMT adherence data from baseline to 6 months (183 days in total). All participants (n=25) in each intervention arm had complete data for a total of 4575 (25*183) visits, while n=23 participants in the usual care arm had complete data for a total of 4209 (23*183) visits. Note: data was collected at the participant level. | Posted | Mean | Standard Deviation | proportion of days | Study baseline through 6 months of follow-up | MMT visits | MMT visits |
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Adverse events were collected from the time of signing informed consent through completion of the follow up period, a total of 1 year.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Friendship Bench Delivered by Professional Counselor | 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). Friendship Bench Delivered by Professional Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor. | 0 | 26 | 1 | 26 | 2 | 26 |
| EG001 | Friendship Bench Delivered by Lay Counselor | 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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. | 1 | 25 | 0 | 25 | 1 | 25 |
| EG002 | Enhanced Usual Care | 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. 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. | 0 | 26 | 0 | 26 | 0 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Hepatobiliary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Thoughts / Ideations | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Gaynes, MD, MPH | University of North Carolina at Chapel Hill | (919) 445-0214 | bradley_gaynes@med.unc.edu |
| Apr 10, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2022 | Aug 17, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D001526 | Behavioral Symptoms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009293 | Opioid-Related Disorders |
| D014777 | Virus Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
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| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
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).
Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| OG001 |
| Friendship Bench Delivered by Lay Counselor |
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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 common mental disorder (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. 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. |
|
|
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| OG001 |
| Friendship Bench Delivered by Lay Counselor |
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| Friendship Bench Delivered by Lay Counselor |
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
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).
Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| Friendship Bench Delivered by Lay Counselor |
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
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).
Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
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). Friendship Bench Delivered by Lay Counselor: Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor. |
| OG002 | Enhanced Usual Care | 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. 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. |
|
|
| OG002 | Enhanced Usual Care | 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. 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. |
|
|