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临床试验/NCT04790201
NCT04790201已完成不适用

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

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Percent of FB Sessions Attended (Intervention Feasibility)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible individuals will meet the following criteria:
  • Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic
  • Medical record indicates infection with HIV
  • Have been screened with the Depression Anxiety Stress Scale-21 (DASS-21) which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD. The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥
  • 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.

排除标准

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

结局指标

主要结局

Percent of FB Sessions Attended (Intervention Feasibility)

时间窗: 6 weeks

The percent of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks.

Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility)

时间窗: Baseline

This measure of feasibility will be measured as the ability to successfully enroll people living with HIV (PLWH) and opioid use disorder (OUD) with CMDs in the pilot intervention. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).

Number of Participants Satisfied With Friendship Bench (Intervention Acceptability)

时间窗: 6 weeks

The number of patients who were either very satisfied or somewhat satisfied with the FB among all participants who received the FB. Satisfaction will be measured using a single question with a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.

Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity)

时间窗: 6 weeks

The total number of FB sessions meeting or exceeding for at least 75% of the total number of fidelity checklist items assessed per session.

Study Retention (Study Feasibility)

时间窗: Through study completion, an average of 12 months

This measure of feasibility will be measured as the ability to retain PLWH and OUD with CMDs in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial), through study completion.

次要结局

  • Total CMD Symptoms Score for Participants(6 weeks after enrollment)
  • Change in CMD Symptoms(Baseline, 6 weeks after enrollment)
  • Mean Depressive Disorder Score Among Participants(6 weeks after enrollment)
  • Mean Anxiety Disorder Score Among Participants(6 weeks after enrollment)
  • Number of Participants Achieving HIV Viral Suppression(6 months after enrollment)
  • Absolute Reduction in Depressive Symptoms(6 weeks after enrollment)
  • Mean Stress Disorder Score Among Participants(6 weeks after enrollment)
  • Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period(Study baseline through 12 months of follow-up)
  • Absolute Reduction in Anxiety Symptoms(6 weeks after enrollment)
  • Absolute Reduction in Stress Symptoms(6 weeks after enrollment)
  • Mean Proportion of Days With MMT Adherence(Study baseline through 6 months of follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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