N/A
Completed N=77
Friendship Bench Adaptation to Improve Mental Health & HIV Care Engagement Outcomes Among PLWH and PWID in Vietnam
Source: ClinicalTrials.gov NCT04790201 ↗Enrolled (actual)
77
Serious AEs
1.3%
Results posted
Aug 2024
Primary outcomePrimary: Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility) — 75 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility) |
75 | — |
| PRIMARY Study Retention (Study Feasibility) |
25; 25; 23 | — |
| PRIMARY Percent of FB Sessions Attended (Intervention Feasibility) |
100; 100 | — |
| PRIMARY Number of Participants Satisfied With Friendship Bench (Intervention Acceptability) |
25; 25 | — |
| PRIMARY Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity) |
66; 42 | — |
| SECONDARY Number of Participants Achieving HIV Viral Suppression |
19; 21; 21 | — |
| SECONDARY Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period |
0.95; 0.94; 0.92 | — |
| SECONDARY Total CMD Symptoms Score for Participants |
27.28; 23.9; 32.3 | — |
| SECONDARY Change in CMD Symptoms |
-24.2; -23.5; -13.4 | — |
| SECONDARY Mean Depressive Disorder Score Among Participants |
8.2; 6.2; 9.0 | — |
| SECONDARY Absolute Reduction in Depressive Symptoms |
-8.2; -7.8; -5.4 | — |
| SECONDARY Mean Anxiety Disorder Score Among Participants |
8.2; 8.3; 11.0 | — |
| SECONDARY Absolute Reduction in Anxiety Symptoms |
-6.4; -5.9; -3.9 | — |
| SECONDARY Mean Stress Disorder Score Among Participants |
10.9; 9.4; 12.3 | — |
| SECONDARY Absolute Reduction in Stress Symptoms |
-9.5; -9.8; -4.1 | — |
| SECONDARY Mean Proportion of Days With MMT Adherence |
0.99; 0.99; 0.96 | — |
Eligibility Criteria
Inclusion Criteria
Eligible individuals will meet the following criteria:
- Adult patients (18 years and older) being treated at the Methadone Maintenance Treatment (MMT) clinic
- Medical record indicates infection with HIV
- Have been screened with the Depression Anxiety Stress Scale-21 (DASS-21) which has been translated, standardized and validated in the Vietnamese population with a positive result indicating a CMD. The investigators will consider as eligible all patients with a depression subscale score ≥ 7, an anxiety subscale score ≥ 6, and/or a stress subscale score ≥ 10. Elevated depressive symptoms be present for ≥2 weeks and elevated anxiety or post-traumatic stress-related symptoms be present for ≥1 month. The investigators will consider a positive screen for any of the three categories as indicating a CMD.
Exclusion Criteria
- Those with evidence of psychosis or bipolar disorder per the Mini International Neuropsychiatric Interview (MINI) will be excluded.
Data sourced from ClinicalTrials.gov (NCT04790201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.