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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00MH123369-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Witwatersrand, South Africa | OTHER |
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Adolescent girls and young women (AGYW) at risk of HIV in sub-Saharan Africa, frequently (20-50%) have symptoms of common mental disorders, including depression, anxiety, and stress. These symptoms are associated with suboptimal adherence to HIV pre-exposure prophylaxis (PrEP), a highly effective HIV prevention approach. In this project, the team seeks to address poor mental health and consequent impacts on PrEP adherence and among AGYW at risk of HIV by testing an evidence-based mental health intervention (the Youth Friendship Bench SA) adapted for PrEP delivery programs.
This is a randomized hybrid implementation-effectiveness trial which will be conducted in a real-world healthcare setting. Eligible women who accept open-label daily oral PrEP (n=110) will be enrolled and randomized to either the Youth Friendship Bench SA intervention (plus standard-of-care mental health services as needed) or standard-of-care mental health services alone. Randomization will be conducted in a 1:1 ratio with randomly-sized blocks of ≤10.
HIV-uninfected women ages 18-25 in Johannesburg, South Africa, who have symptoms of common mental disorders as evidenced by a score greater than or equal to 7 on the SRQ-20 will be eligible to enroll.
The investigators hypothesize that the Youth Friendship Bench SA will significantly improve PrEP adherence and reduce symptoms of common mental disorders among AGYW at Month 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-of-Care Mental Health Services | No Intervention | 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. | |
| Youth Friendship Bench SA + Standard-of-Care | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Youth Friendship Bench SA | Behavioral | The intervention includes: 5 individual counseling sessions; one optional in-person or WhatsApp-based group counseling session; optional remote counseling sessions; and optional one-way SMS messages to provide reminders about upcoming visits. During the initial session, participants will meet with the trained counselor to discuss mental health challenges, identify problems in their life that affect their mental health and PrEP use, generate alternative solutions, make decisions about the alternatives, and collaboratively decide on a plan to implement the solutions. During follow-up counseling sessions, participants will discuss progress in implementing solutions to address the problems they identified in prior sessions with the lay counselor. They will also discuss any other mental health challenges and problems in their life that affect their mental health and PrEP use which they would like to address. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence at Week 12 | 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 | Week 12 |
| Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 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). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Adherence at Week 4 | 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 | Week 4 |
| Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Velloza, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wits Reproductive Health Institute | Johannesburg | Gauteng | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34164929 | Background | Velloza J, Hosek S, Donnell D, Anderson PL, Chirenje M, Mgodi N, Bekker LG, Delany-Moretlwe S, Celum C; HPTN 082 study group. Assessing longitudinal patterns of depressive symptoms and the influence of symptom trajectories on HIV pre-exposure prophylaxis adherence among adolescent girls in the HPTN 082 randomized controlled trial. J Int AIDS Soc. 2021 Jun;24 Suppl 2(Suppl 2):e25731. doi: 10.1002/jia2.25731. | |
| 30950883 | Background | Remien RH, Stirratt MJ, Nguyen N, Robbins RN, Pala AN, Mellins CA. Mental health and HIV/AIDS: the need for an integrated response. AIDS. 2019 Jul 15;33(9):1411-1420. doi: 10.1097/QAD.0000000000002227. |
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Data from the study will be available at the end of the project by contacting the Principal Investigator.
End of study.
Reasonable request to the Principal Investigator.
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One Youth Friendship Bench SA + Standard-of-Care participant was randomized but did not complete enrollment surveys and thus is excluded from Baseline Characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PrEP Adherence at Week 12 | 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 | 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. | Posted | Count of Participants | Participants | Week 12 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Poison Ingestion | Injury, poisoning and procedural complications | Non-systematic Assessment | One Youth Friendship Bench SA + Standard-of-Care participant accidentally ingested rat poison. She was hospitalized. Her counseling sessions showed progress and reduced SRQ-20 scores over time. |
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This study was a pilot study with a small sample size and retention challenges. Retention was lower in the Youth Friendship Bench arm than Standard of Care Mental Health Services arm. We did not collect biomarker data on longer-term PrEP adherence given the short duration of follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Velloza | University of California, San Francisco | 9173923561 | Jennifer.Velloza@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 27, 2022 | Mar 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2024 | Mar 10, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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). |
| Week 4 |
| Acceptability of Youth Friendship Bench SA | 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. | 12 Weeks |
| Feasibility of Youth Friendship Bench SA | 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. | 12 Weeks |
| Appropriateness of Youth Friendship Bench SA | 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. | 12 Weeks |
| 28063075 | Background | Abas M, Nyamayaro P, Bere T, Saruchera E, Mothobi N, Simms V, Mangezi W, Macpherson K, Croome N, Magidson J, Makadzange A, Safren S, Chibanda D, O'Cleirigh C. Feasibility and Acceptability of a Task-Shifted Intervention to Enhance Adherence to HIV Medication and Improve Depression in People Living with HIV in Zimbabwe, a Low Income Country in Sub-Saharan Africa. AIDS Behav. 2018 Jan;22(1):86-101. doi: 10.1007/s10461-016-1659-4. |
| 28027368 | Background | Chibanda D, Weiss HA, Verhey R, Simms V, Munjoma R, Rusakaniko S, Chingono A, Munetsi E, Bere T, Manda E, Abas M, Araya R. Effect of a Primary Care-Based Psychological Intervention on Symptoms of Common Mental Disorders in Zimbabwe: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2618-2626. doi: 10.1001/jama.2016.19102. |
| 30064418 | Background | Udedi M, Stockton MA, Kulisewa K, Hosseinipour MC, Gaynes BN, Mphonda SM, Mwagomba BM, Mazenga AC, Pence BW. Integrating depression management into HIV primary care in central Malawi: the implementation of a pilot capacity building program. BMC Health Serv Res. 2018 Jul 31;18(1):593. doi: 10.1186/s12913-018-3388-z. |
| 34826035 | Background | Brooks MJ, Phetogo BK, Schwennesen H, Phoi O, Tshume O, Matshaba M, Lowenthal E. Building a Community Based Mental Health Program for Adolescents in Botswana: Stakeholder Feedback. Community Ment Health J. 2022 Aug;58(6):1068-1075. doi: 10.1007/s10597-021-00915-5. Epub 2021 Nov 26. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| SRQ-20 Score | The SRQ-20 is a validated measure to detect non-specific psychological distress with possible values between 0 and 20. A higher score indicates more depressive symptoms. | Median | Inter-Quartile Range | Score |
|
| PHQ-9 | The PHQ-9 is a validated scale to measure depressive symptoms. It has a possible range of 0-27. Higher scores indicate more depressive symptoms. | Median | Inter-Quartile Range | Score |
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| GAD-7 | The GAD-7 is a validated scale to measure anxiety symptoms. It has a possible range of 0-21. A higher score indicates more anxiety symptoms. | Median | Inter-Quartile Range | Score |
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| Has experienced gender-based violence | Gender-based violence questions based on the World Health Organization's screening tool. | Count of Participants | Participants |
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| OG001 | 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. |
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| Primary | Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 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). | 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. | Posted | Count of Participants | Participants | Baseline and Week 12 |
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|
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| Secondary | PrEP Adherence at Week 4 | 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 | 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. | Posted | Count of Participants | Participants | Week 4 |
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| Secondary | Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 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). | 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. | Posted | Count of Participants | Participants | Week 4 |
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| Secondary | Acceptability of Youth Friendship Bench SA | 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 12 Weeks |
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| Secondary | Feasibility of Youth Friendship Bench SA | 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 12 Weeks |
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| Secondary | Appropriateness of Youth Friendship Bench SA | 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. | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 12 Weeks |
|
|
|
| 0 |
| 58 |
| 1 |
| 58 |
| 0 |
| 58 |
| EG001 | 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. | 0 | 57 | 1 | 57 | 0 | 57 |
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| Suicidal Attempt | Psychiatric disorders | Non-systematic Assessment | One Standard of Care Mental Health Services participant deliberately self-harmed and was treated with hospital management and medications. |
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