An interventional study of Standard of Care (SOC) and Adapted Friendship Bench (AFB) in Depression, Anxiety and Adolescent Behavior, sponsored by University of North Carolina, Chapel Hill. Completed at 5 sites in Malawi. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
This pilot study will individually randomize 105 adolescents living with HIV 1:1:1 to standard of care, adapted intervention, or enhanced intervention. The intervention is called the Friendship Bench Intervention is a counseling intervention for depression and engagement in HIV care.
Sub-Saharan Africa is home to the largest population of adolescents living with HIV (ALWH). Engaging ALWH in HIV care is challenging and reflected in lower rates of viral suppression and higher rates of loss to follow-up as compared to adults in the region. Depression has been identified as a significant barrier to initiating and remaining in HIV care. Indeed, this is the case for ALWH in Malawi where estimates of viral suppression range from 40%-78% and estimates of depression range from 18-26%. Resource-appropriate interventions that improve depression and address engagement in HIV care for ALWH are urgently needed.
The Friendship Bench (FB) is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings but has not been adapted to be youth-friendly or enhanced with peer support to facilitate engagement in HIV care among ALWH. FB is based on problem-solving therapy, which offers an ideal framework for youth-friendly adaption and integration of retention peer support into a proven depression treatment model.
The long-term goal of the study team is to adapt, test, and scale up resource-appropriate interventions to reduce depression and improve engagement in HIV care amongst ALWH. The specific aims are: 1) to conduct formative research for youth-friendly adaptation and peer support enhancement of FB; 2) to adapt the evidence-based FB protocol to meet the developmental and contextual needs of ALWH and enhance this adapted FB protocol with peer support to facilitate HIV care engagement among ALWH; and 3) to determine the feasibility, fidelity, and acceptability of the Adapted and Enhanced FB protocols to improve depression and engagement in HIV care among ALWH. For the latter, a 3-arm individually randomized pilot study will be conducted to compare the adapted FB and the enhanced FB to standard care. The proposed aims pave the way for a R01 application to test the adapted and enhanced Friendship Bench interventions in a cluster randomized controlled trial and represent an important step forward towards improving depression among ALWH.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's enrollment of 106 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
35 adolescents living with HIV seeking HIV care at participating clinics in Lilongwe, Malawi 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 will included a mental health evaluation provided by a rained study nurse; brief supportive counseling; information, education, and support on depression; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic or to the tertiary care hospital.
Behavioral: Standard of Care (SOC)
35 adolescents living with HIV seeking HIV care at participating clinics in Lilongwe, Malawi will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will receive 6 weekly counseling sessions per the AFB protocol.
Behavioral: Adapted Friendship Bench (AFB)
35 adolescents living with HIV seeking HIV care at participating clinics in Lilongwe, Malawi will be enrolled in this study arm during study recruitment. Individuals enrolled in this arm will receive 6 weekly counseling sessions and peer support per the EFB protocol.
Behavioral: Enhanced Friendship Bench (EFB)
Participants randomized to this arm will received enhanced standard of care.
Participants randomized to this arm will receive the Adapted Friendship Bench protocol delivered by a trained counselor.
Participants randomized to this arm will receive the Enhanced Friendship Bench protocol delivered by a trained counselor and a peer supporter.
Number of Participants Enrolled of the Participants Approached (Intervention Feasibility)
This measure is the ability to successfully enroll adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the number of participants enrolled of the participants approached.
Time frame: Baseline
Number of Participants Retained in the Study (Intervention Feasibility)
This measure of feasibility will be measured as the ability to retain adolescents living with HIV (ALWH) 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: 12 months
Number of Participants Who Received Full Intervention (Intervention Feasibility)
The number of participants who attended all 6 planned Friendship Bench counseling sessions.
Time frame: 12 Months
Number of Sessions Meeting Fidelity Threshold (Intervention Fidelity)
Fidelity to content for sessions will be assessed by a member of the research team using a checklist of intervention characteristics. Scoring either 'meeting expectations' or 'exceeding' expectations' on at least 80% of applicable checklist items during each session will be considered fidelity to the intervention protocol.
Time frame: 12 Months
Overall Satisfaction Among Participants (Intervention Acceptability)
Intervention acceptability was measured as the number of participants who would either probably or definitely recommend the Friendship Bench to other adolescents living with HIV with depression. Responses were measured on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
Time frame: 6 Months
Change in Depression Symptoms From Baseline
Change in depression symptoms from baseline will be evaluated using Beck's Depression Inventory (BDI-II). The Beck Depression Inventory (BDI-II) is a 21-item patient self-report measure of the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is zero and the maximum total score is 63. A total score of 0-13 is considered nondepressed, 14-19 represents mild depression, 20-28 represents moderate depression, and 29-63 represents severe depression. Lower scores represent better outcomes. Scores reported are change in symptoms relative to baseline.
Time frame: Baseline,12 months
Number of Adolescents Living With HIV Who Attended at Least One Appointment Per Quarter
Number of adolescents living with HIV who attended at least one appointment per quarter.
Time frame: 12 months
Number of Participants Achieving HIV Viral Suppression
Number of participants achieving HIV viral suppression at 12 months (HIV RNA no detect + \<839 copies/mL)
Time frame: 12 months
Recruitment began on July 06 2024. Recruitment took place at government health facilities located in urban Lilongwe, Malawi with ART clinics on their grounds that conduct monthly Teen Clubs.
| Milestone | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Started | 35 | 35 | 36 |
| Completed | 34 | 34 | 34 |
| Not completed | 1 | 1 | 2 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 |
This measure is the ability to successfully enroll adolescents living with HIV (ALWH) in the pilot trial. Feasibility will be evaluated by measuring the number of participants enrolled of the participants approached.
| Participants | Study Population |
|---|---|
| Number of Participants Enrolled of the Participants Approached (Intervention Feasibility) | 106 |
This measure of feasibility will be measured as the ability to retain adolescents living with HIV (ALWH) 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.
| Participants | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Number of Participants Retained in the Study (Intervention Feasibility) | 34 | 34 | 34 |
The number of participants who attended all 6 planned Friendship Bench counseling sessions.
| Participants | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Number of Participants Who Received Full Intervention (Intervention Feasibility) | 34 | 33 | — |
Fidelity to content for sessions will be assessed by a member of the research team using a checklist of intervention characteristics. Scoring either 'meeting expectations' or 'exceeding' expectations' on at least 80% of applicable checklist items during each session will be considered fidelity to the intervention protocol.
| Number of sessions meeting fidelity | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Number of Sessions Meeting Fidelity Threshold (Intervention Fidelity) | 65 | 69 | — |
Intervention acceptability was measured as the number of participants who would either probably or definitely recommend the Friendship Bench to other adolescents living with HIV with depression. Responses were measured on a 4-point Likert scale-- 1 indicates high satisfaction and 4 indicates high dissatisfaction.
| Participants | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Overall Satisfaction Among Participants (Intervention Acceptability) | 33 | 32 | — |
Change in depression symptoms from baseline will be evaluated using Beck's Depression Inventory (BDI-II). The Beck Depression Inventory (BDI-II) is a 21-item patient self-report measure of the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The minimum total score is zero and the maximum total score is 63. A total score of 0-13 is considered nondepressed, 14-19 represents mild depression, 20-28 represents moderate depression, and 29-63 represents severe depression. Lower scores represent better outcomes. Scores reported are change in symptoms relative to baseline.
| Score on a scale | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Change in Depression Symptoms From Baseline | -16.5 ± 9.0 | -13.6 ± 11.5 | -14.0 ± 12.0 |
Number of adolescents living with HIV who attended at least one appointment per quarter.
| Participants | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Number of Adolescents Living With HIV Who Attended at Least One Appointment Per Quarter | 33 | 32 | 31 |
Number of participants achieving HIV viral suppression at 12 months (HIV RNA no detect + \<839 copies/mL)
| Participants | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Number of Participants Achieving HIV Viral Suppression | 24 | 25 | 26 |
Collected over Adverse events were collected from the time of enrollment and signing informed consent through completion of the follow up period, a total of 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adapted Friendship Bench (AFB) | 0/35 (0%) | 0/35 (0%) | 12/35 (34.3%) |
| Enhanced Friendship Bench (EFB) | 1/35 (2.9%) | 0/35 (0%) | 11/35 (31.4%) |
| Standard of Care (SOC) | 0/36 (0%) | 0/36 (0%) | 7/36 (19.4%) |
| Event | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) |
|---|---|---|---|
| Suicidal IdeationPsychiatric disorders | 12/35 | 11/35 | 7/36 |
Participant Flow reports 106 enrolled participants. One participant assigned to the Standard of Care arm inadvertently received counseling sessions and was excluded from the analysis population due to protocol violation. Baseline Characteristics are reported for the analysis population (N=105); therefore, the Overall Number of Baseline Participants differs from the Participant Flow enrollment count by one participant.
| Age, Customized(Participants) | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) | Total |
|---|---|---|---|---|
| Age — 13-14 years | 2 | 2 | 10 | 14 |
| Age — 15-16 years | 15 | 10 | 7 | 32 |
| Age — 17-18 years | 18 | 23 | 18 | 59 |
| Sex: Female, Male(Participants) | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) | Total |
|---|---|---|---|---|
| Female | 24 | 16 | 16 | 56 |
| Male | 11 | 19 | 19 | 49 |
| Race and Ethnicity Not Collected(Participants) | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Orphanhood(Participants) | Adapted Friendship Bench (AFB) | Enhanced Friendship Bench (EFB) | Standard of Care (SOC) | Total |
|---|---|---|---|---|
| Count of participants | 16 | 18 | 16 | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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).
Time frame: beginning 9 and continuing for 36 months after publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Ran from Jul 2024 to primary completion in Oct 2025, 15 months.
Results were first posted in Sep 2026, 11 months after primary completion.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 15 months is below that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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