Trial Outcomes & Findings for Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings (NCT NCT05664490)

Results Overview

The proportion of participants with PrEP adherence at Month 3, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

Week 12

Results posted on

2025-04-11

Participant Flow

Participants were recruited based on referral from clinic personnel during clinic visits between April and October of 2023. The first participant was enrolled in April 2023 and the last participant was enrolled in October 2023.

222 participants were assessed for eligibility. 93 did not meet eligibility criteria and thus were excluded from randomization. 3 screened participants declined participation and 10 participants did not complete enrollment procedures. 116 participants were randomized. We enrolled 6 additional participants, over our target sample size of 110 participants, to replace 6 participants who terminated the study early (6 had terminated within 4 weeks, at the time of enrollment close).

Participant milestones

Participant milestones
Measure	Standard-of-Care Mental Health Services Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Overall Study STARTED	58	58
Overall Study Week 2	58	57
Overall Study Week 4	41	35
Overall Study Week 8	41	37
Overall Study Week 12	44	36
Overall Study COMPLETED	44	35
Overall Study NOT COMPLETED	14	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard-of-Care Mental Health Services Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	14	22

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard-of-Care Mental Health Services n=58 Participants Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=57 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.	Total n=115 Participants Total of all reporting groups
Age, Continuous	21 Years n=58 Participants	21 Years n=57 Participants	21 Years n=115 Participants
Sex: Female, Male Female	58 Participants n=58 Participants	57 Participants n=57 Participants	115 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=58 Participants	0 Participants n=57 Participants	0 Participants n=115 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
SRQ-20 Score	8 Score n=58 Participants	9 Score n=57 Participants	9 Score n=115 Participants
PHQ-9	8.5 Score n=58 Participants	8 Score n=57 Participants	8 Score n=115 Participants
GAD-7	6 Score n=58 Participants	7 Score n=57 Participants	6 Score n=115 Participants
Has experienced gender-based violence	41 Participants n=58 Participants	44 Participants n=57 Participants	85 Participants n=115 Participants

PRIMARY outcome

Timeframe: Week 12

Population: This data is from an intent-to-treat analysis that included all randomized participants that completed enrollment procedures (N = 115). We used multiple imputation using chained equations (MICE) to account for missingness due to missed visits and early terminations. Randomly imputed values were generated from 100 imputations and, to meet assumptions that data were conditionally missing at random, we included baseline variables associated with missingness in our imputation model.

The proportion of participants with PrEP adherence at Month 3, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services n=58 Participants Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=57 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
PrEP Adherence at Week 12	29 Participants	22 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: This data is from an intent-to-treat analysis that included all randomized participants that completed enrollment procedures (N = 115). We used multiple imputation using chained equations (MICE) to account for missingness due to missed visits and early terminations. Randomly imputed values were generated from 100 imputations and, to meet assumptions that data were conditionally missing at random, we included baseline variables associated with missingness in our imputation model.

The change in the proportion of participants with SRQ-20 scores \<7 will be reported. Mental health symptoms will be measured on the SRQ-20, with a score below 7 indicating no or mild symptoms of depression, anxiety, or stress. SRQ-20 scores are calculated as the sum of responses across 20 items asking about symptoms of common mental disorders (e.g. depression, anxiety). Each item has a yes or no response and 'yes' responses are coded as '1' and 'no' responses are coded as '0' (possible score range = 0-20, with higher scores indicating greater severity of common mental disorder symptoms).

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services n=58 Participants Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=57 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7	29 Participants	23 Participants

SECONDARY outcome

Timeframe: Week 4

Population: This data is from an intent-to-treat analysis that included all randomized participants that completed enrollment procedures (N = 115). We used multiple imputation using chained equations (MICE) to account for missingness due to missed visits and early terminations. Randomly imputed values were generated from 100 imputations and, to meet assumptions that data were conditionally missing at random, we included baseline variables associated with missingness in our imputation model.

The proportion of participants with PrEP adherence at Week 4, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services n=58 Participants Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=57 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
PrEP Adherence at Week 4	25 Participants	29 Participants

SECONDARY outcome

Timeframe: Week 4

Population: This data is from an intent-to-treat analysis that included all randomized participants that completed enrollment procedures (N = 115). We used multiple imputation using chained equations (MICE) to account for missingness due to missed visits and early terminations. Randomly imputed values were generated from 100 imputations and, to meet assumptions that data were conditionally missing at random, we included baseline variables associated with missingness in our imputation model.

The change in the proportion of participants with SRQ-20 scores \<7 will be reported. Mental health symptoms will be measured on the SRQ-20, with a score below 7 indicating no or mild symptoms of depression, anxiety, or stress. SRQ-20 scores are calculated as the sum of responses across 20 items asking about symptoms of common mental disorders (e.g. depression, anxiety). Each item has a yes or no response and 'yes' responses are coded as '1' and 'no' responses are coded as '0' (possible score range = 0-20, with higher scores indicating greater severity of common mental disorder symptoms).

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services n=58 Participants Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=57 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7	20 Participants	15 Participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: The acceptability of the Youth Friendship Bench SA intervention was only asked among Youth Friendship Bench SA + Standard of Care participants who attended the week 12 visit (n = 35).

Acceptability of the Youth Friendship Bench SA intervention as measured by the 4-item Acceptability of Intervention Measure (AIM). The AIM used in this study consists of 4 questions with scales values that range from 1 to 4. Higher scores indicate greater acceptability.

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=35 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Acceptability of Youth Friendship Bench SA	—	3.5 score on a scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 12 Weeks

Population: The feasibility of the Youth Friendship Bench SA intervention was only asked among Youth Friendship Bench SA + Standard of Care participants who attended the week 12 visit (n = 35).

Feasibility of the Youth Friendship Bench SA intervention as measured by the 4-item Feasibility of Intervention Measure (FIM). The FIM used in this study consists of 4 questions with scales values that range from 1 to 4. Higher scores indicate greater acceptability.

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=35 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Feasibility of Youth Friendship Bench SA	—	3.75 score on a scale Interval 3.25 to 4.0

SECONDARY outcome

Timeframe: 12 Weeks

Population: The appropriateness of the Youth Friendship Bench SA intervention was only asked among Youth Friendship Bench SA + Standard of Care participants who attended the week 12 visit (n = 35).

Appropriateness of the Youth Friendship Bench SA intervention as measured by the 4-item Intervention Appropriateness Measure (IAM). The IAM used in this study consists of 4 questions with scales values that range from 1 to 4. Higher scores indicate greater acceptability.

Outcome measures

Outcome measures
Measure	Standard-of-Care Mental Health Services Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=35 Participants Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Appropriateness of Youth Friendship Bench SA	—	3.25 score on a scale Interval 3.0 to 4.0

Adverse Events

Standard-of-Care Mental Health Services

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Youth Friendship Bench SA + Standard-of-Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard-of-Care Mental Health Services n=58 participants at risk Participants randomized to this group will receive standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will return for visits at Weeks 4 and 12.	Youth Friendship Bench SA + Standard-of-Care n=57 participants at risk Participants randomized to this group will receive the Youth Friendship Bench SA intervention in addition to standard-of-care mental health services as specified in the South African Department of Health Adult Primary Care Guidelines. Participants randomized to this group will receive counseling at Enrollment, Weeks 2, 4, 8, and 12.
Injury, poisoning and procedural complications Poison Ingestion	0.00% 0/58 • 12 weeks Adverse Events were non-systematically reported via a REDCap case report form (CRF) for each participant. The CRF did not have to be completed for each participant, and was only completed is an adverse event was reported or discovered.	1.8% 1/57 • Number of events 1 • 12 weeks Adverse Events were non-systematically reported via a REDCap case report form (CRF) for each participant. The CRF did not have to be completed for each participant, and was only completed is an adverse event was reported or discovered.
Psychiatric disorders Suicidal Attempt	1.7% 1/58 • Number of events 1 • 12 weeks Adverse Events were non-systematically reported via a REDCap case report form (CRF) for each participant. The CRF did not have to be completed for each participant, and was only completed is an adverse event was reported or discovered.	0.00% 0/57 • 12 weeks Adverse Events were non-systematically reported via a REDCap case report form (CRF) for each participant. The CRF did not have to be completed for each participant, and was only completed is an adverse event was reported or discovered.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Velloza

University of California, San Francisco

Phone: 9173923561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place