Anxiety, Behavioral Symptoms, Depression, HIV Infections, Immune System Diseases, Opioid Dependence, Opioid-use Disorder, Virus Infection
Conditions
Brief summary
This project will adapt and pilot a feasible and effective problem-solving therapy designed for low-resource settings to address common mental disorders like depression and anxiety - the Friendship Bench- in a Vietnamese population of individuals living with HIV who also have opiate use disorder. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among people living with HIV (PLWH) with Opioid Use Disorder (OUD), a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the investigation team's adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
Detailed description
Injection drug use is the primary driver of the HIV epidemic in Southeast Asia. In 2017, the HIV prevalence among people who inject drugs (PWID) in Southeast Asia was 15%. PWID, most of whom have OUD, who are living with HIV have low rates of retention in care, antiretroviral therapy (ART) initiation, and viral suppression. PWID also experience high rates of HIV-related and all-cause mortality. Common mental disorders (CMDs), including depressive, anxiety, and stress-related illnesses, occur in 40-50% of PLWH and OUD. Despite serious consequences of mental illness on health and HIV progression, mental illness remains under-diagnosed and under-treated in HIV populations, especially in low- and middle-income countries (LMICs), such as many countries in Southeast Asia. To respond to the great need for mental health treatment in low- and middle-income countries, the global mental health field has focused on developing task-shifting and integration approaches that equip non-specialists to deliver evidence-based mental health interventions at scale. However, such task shifting interventions to address CMDs have received limited attention in Southeast Asia among OUD. Vietnam, with its high prevalence of PLWH and OUD, its integration of methadone maintenance therapy (MMT) with HIV care, and its priority for developing CMD care for this population, is an ideal setting to evaluate task-shifting mental health approaches to address CMDs and improve HIV care outcomes. The Friendship Bench (FB) is a feasible and effective task-shifting mental health intervention designed for low-resource settings that is a strong candidate to address CMDs in this population. FB is a problem solving therapy-based intervention with demonstrated effectiveness in treating CMDs among primary care patients when delivered by lay counselors. Lay counselors may effectively deliver FB to PLWH with OUD, but CMD may prove more difficult to treat in patients with OUD and require professionally trained counselors to be effective. The investigators' objective is to complete a pilot randomized trial of 75 patients from 4 MMT clinics in Hanoi. The investigators' specific aims are: 1) To adapt the Friendship Bench (FB) protocol to be optimized for PLWH and OUD in Vietnam; and 2) To evaluate the feasibility, fidelity, and acceptability of the adapted FB as well as preliminary indicators of its impact in improving CMDs and HIV care and drug use treatment outcomes. The Friendship Bench approach has the potential to make an important contribution to address CMDs and reduce barriers to HIV treatment success among PLWH with OUD, a critical population driving the HIV epidemic in Vietnam and many Southeast Asian countries. This proposal will generate critical evidence for designing a fully powered clinical trial to test the adapted FB protocol in improving HIV, mental health, and drug use treatment outcomes for this vulnerable population.
Interventions
BEHAVIORALFriendship Bench Delivered by Professional Counselor
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
BEHAVIORALFriendship Bench Delivered by Lay Counselor
Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
BEHAVIORALEnhanced 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.
Sponsors
Hanoi Medical University
The Friendship Bench Trust
National Institute on Drug Abuse (NIDA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three-arm individually randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility) | 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). |
| Study Retention (Study Feasibility) | 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. |
| Percent of FB Sessions Attended (Intervention Feasibility) | 6 weeks | The percent of FB sessions attended by participants out of total FB sessions offered, during the target intervention duration of 6 weeks. |
| Number of Participants Satisfied With Friendship Bench (Intervention Acceptability) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Reduction in Depressive Symptoms | 6 weeks after enrollment | 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. |
| Mean Anxiety Disorder Score Among Participants | 6 weeks after enrollment | Anxiety symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the anxiety subscale range from 0-42, with ≥ 10 on the anxiety subscale indicating an anxiety disorder. |
| Absolute Reduction in Anxiety Symptoms | 6 weeks after enrollment | 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. |
| Number of Participants Achieving HIV Viral Suppression | 6 months after enrollment | 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. |
| Absolute Reduction in Stress Symptoms | 6 weeks after enrollment | 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. |
| Mean Proportion of Days With MMT Adherence | Study baseline through 6 months of follow-up | 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. |
| Mean Stress Disorder Score Among Participants | 6 weeks after enrollment | Stress symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the stress subscale range from 0-42, with ≥ 19 on the stress subscale indicating a stress disorder. |
| Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period | Study baseline through 12 months of follow-up | The proportion of scheduled visits in the 12-month follow-up period that are attended vs. no-shows (the kept visit proportion), 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. |
| Total CMD Symptoms Score for Participants | 6 weeks after enrollment | CMD symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. The total scale is calculated by summing the subscales, range 0-126, for depression (threshold ≥14), anxiety (threshold ≥10), and stress (threshold ≥19); higher scores indicate higher severity of symptoms. |
| Change in CMD Symptoms | Baseline, 6 weeks after enrollment | 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. |
| Mean Depressive Disorder Score Among Participants | 6 weeks after enrollment | Depression symptoms will be evaluated via the 21-item Depression, Anxiety, and Stress Scale (DASS-21), which consists of three subscales. Responses are ranked from 0 (Does not apply to me at all) to 3 (Applied to me very much or most of the time). All subscales are multiplied by 2. Scores on the depression subscale range from 0-42, with ≥ 14 on the depression subscale indicating a depressive disorder. |
Countries
Vietnam
Participant flow
Recruitment details
Study recruitment began in February 2022. Recruitment occurred in Methadone Maintenance Treatment (MMT) clinics located in Hanoi, Vietnam.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| 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. | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Friendship Bench Delivered by Professional Counselor | Friendship Bench Delivered by Lay Counselor | Enhanced Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 44.1 years STANDARD_DEVIATION 5 | 44.9 years STANDARD_DEVIATION 7.2 | 44.9 years STANDARD_DEVIATION 5.2 | 44.6 years STANDARD_DEVIATION 5.8 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Vietnam | 25 Participants | 25 Participants | 25 Participants | 75 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 24 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 1 / 25 | 0 / 26 |
| other Total, other adverse events | 2 / 26 | 1 / 25 | 0 / 26 |
| serious Total, serious adverse events | 1 / 26 | 0 / 25 | 0 / 26 |
Outcome results
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Population | Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity) | 66 Number of sessions meeting fidelity |
| Friendship Bench Delivered by Lay Counselor | Number of Counseling Sessions Meeting Fidelity Threshold (Intervention Fidelity) | 42 Number of sessions meeting fidelity |
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Population | Number of Participants Satisfied With Friendship Bench (Intervention Acceptability) | 25 Participants |
| Friendship Bench Delivered by Lay Counselor | Number of Participants Satisfied With Friendship Bench (Intervention Acceptability) | 25 Participants |
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.
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Population | Percent of FB Sessions Attended (Intervention Feasibility) | 100 percent of FB Sessions Attended |
| Friendship Bench Delivered by Lay Counselor | Percent of FB Sessions Attended (Intervention Feasibility) | 100 percent of FB Sessions Attended |
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.
Time frame: Through study completion, an average of 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Population | Study Retention (Study Feasibility) | 25 Participants |
| Friendship Bench Delivered by Lay Counselor | Study Retention (Study Feasibility) | 25 Participants |
| Enhanced Usual Care | Study Retention (Study Feasibility) | 23 Participants |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Population | Total Number of Participants Who Were Eligible and Enrolled (Intervention Feasibility) | 75 Participants |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Absolute Reduction in Anxiety Symptoms | -6.4 score on a scale | Standard Deviation 6.7 |
| Friendship Bench Delivered by Lay Counselor | Absolute Reduction in Anxiety Symptoms | -5.9 score on a scale | Standard Deviation 10.6 |
| Enhanced Usual Care | Absolute Reduction in Anxiety Symptoms | -3.9 score on a scale | Standard Deviation 9.4 |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Absolute Reduction in Depressive Symptoms | -8.2 score on a scale | Standard Deviation 10.6 |
| Friendship Bench Delivered by Lay Counselor | Absolute Reduction in Depressive Symptoms | -7.8 score on a scale | Standard Deviation 10.5 |
| Enhanced Usual Care | Absolute Reduction in Depressive Symptoms | -5.4 score on a scale | Standard Deviation 10.7 |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Absolute Reduction in Stress Symptoms | -9.5 score on a scale | Standard Deviation 11.1 |
| Friendship Bench Delivered by Lay Counselor | Absolute Reduction in Stress Symptoms | -9.8 score on a scale | Standard Deviation 11.9 |
| Enhanced Usual Care | Absolute Reduction in Stress Symptoms | -4.1 score on a scale | Standard Deviation 10.2 |
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.
Time frame: Baseline, 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Change in CMD Symptoms | -24.2 score on a scale | Standard Deviation 25.8 |
| Friendship Bench Delivered by Lay Counselor | Change in CMD Symptoms | -23.5 score on a scale | Standard Deviation 30.2 |
| Enhanced Usual Care | Change in CMD Symptoms | -13.4 score on a scale | Standard Deviation 25.4 |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Mean Anxiety Disorder Score Among Participants | 8.2 score on a scale | Standard Deviation 8.3 |
| Friendship Bench Delivered by Lay Counselor | Mean Anxiety Disorder Score Among Participants | 8.3 score on a scale | Standard Deviation 8.7 |
| Enhanced Usual Care | Mean Anxiety Disorder Score Among Participants | 11.0 score on a scale | Standard Deviation 7.9 |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Mean Depressive Disorder Score Among Participants | 8.2 score on a scale | Standard Deviation 12.3 |
| Friendship Bench Delivered by Lay Counselor | Mean Depressive Disorder Score Among Participants | 6.2 score on a scale | Standard Deviation 7.4 |
| Enhanced Usual Care | Mean Depressive Disorder Score Among Participants | 9.0 score on a scale | Standard Deviation 9.1 |
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.
Time frame: Study baseline through 6 months of follow-up
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Mean Proportion of Days With MMT Adherence | 0.99 proportion of days | Standard Deviation 0.03 |
| Friendship Bench Delivered by Lay Counselor | Mean Proportion of Days With MMT Adherence | 0.99 proportion of days | Standard Deviation 0.01 |
| Enhanced Usual Care | Mean Proportion of Days With MMT Adherence | 0.96 proportion of days | Standard Deviation 0.14 |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Mean Stress Disorder Score Among Participants | 10.9 score on a scale | Standard Deviation 9.8 |
| Friendship Bench Delivered by Lay Counselor | Mean Stress Disorder Score Among Participants | 9.4 score on a scale | Standard Deviation 8.2 |
| Enhanced Usual Care | Mean Stress Disorder Score Among Participants | 12.3 score on a scale | Standard Deviation 7.8 |
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.
Time frame: 6 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Population | Number of Participants Achieving HIV Viral Suppression | 19 Participants |
| Friendship Bench Delivered by Lay Counselor | Number of Participants Achieving HIV Viral Suppression | 21 Participants |
| Enhanced Usual Care | Number of Participants Achieving HIV Viral Suppression | 21 Participants |
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.
Time frame: Study baseline through 12 months of follow-up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Population | Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period | 0.95 proportion of scheduled visits attended |
| Friendship Bench Delivered by Lay Counselor | Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period | 0.94 proportion of scheduled visits attended |
| Enhanced Usual Care | Proportion of Scheduled HIV Visits That Were Attended in the 12-Month Follow-Up Period | 0.92 proportion of scheduled visits attended |
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.
Time frame: 6 weeks after enrollment
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Population | Total CMD Symptoms Score for Participants | 27.28 score on a scale | Standard Deviation 26.4 |
| Friendship Bench Delivered by Lay Counselor | Total CMD Symptoms Score for Participants | 23.9 score on a scale | Standard Deviation 21.4 |
| Enhanced Usual Care | Total CMD Symptoms Score for Participants | 32.3 score on a scale | Standard Deviation 22.7 |