Back to resultsFriendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Primary Purpose
Depression, Pre-Exposure Prophylaxis
Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Youth Friendship Bench SA
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: Female 18-25 years of age at screening Documentation of symptoms of a common mental disorder, as evidenced by a score greater than or equal to 7 on the Self Reporting Questionnaire 20-item (SRQ-20) Willingness to enroll and be randomized to either the Youth Friendship Bench SA or standard-of-care mental health services Written informed consent (obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study. Able to verbally communicate in one or more study languages to ensure participation in the counseling sessions (English, isiZulu) Taking PrEP at the Ward 21 clinic, as determined by clinic records. PrEP provision will be conducted by the clinic following National PrEP Guidelines and will not be part of study-specific procedures. Exclusion Criteria: Not on PrEP and/or not intending to use PrEP for the duration of the study Planning to relocate in the next three months Report of suicidal intent or self harm Active, unmanaged mental health disorders, including untreated or severe somatic symptoms and active psychiatric symptoms (e.g., hallucinations) Reactive or positive HIV test at enrollment (based on clinic records only; HIV testing will not be performed under this protocol)
Sites / Locations
- Wits Reproductive Health InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard-of-Care Mental Health Services
Youth Friendship Bench SA + Standard-of-Care
Arm Description
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 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.
Outcomes
Primary Outcome Measures
PrEP adherence at Week 12
proportion with PrEP adherence at Month 3, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay
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).
Secondary Outcome Measures
PrEP adherence at Week 4
proportion with PrEP adherence at Week 4, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay
Full Information
NCT ID
NCT05664490
First Posted
December 15, 2022
Last Updated
June 27, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), University of Witwatersrand, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT05664490
Brief Title
Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Official Title
Youth Friendship Bench SA: Optimization of the Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH), University of Witwatersrand, South Africa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Pre-Exposure Prophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard-of-Care Mental Health Services
Arm Type
No Intervention
Arm Description
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.
Arm Title
Youth Friendship Bench SA + Standard-of-Care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Youth Friendship Bench SA
Intervention Description
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.
Primary Outcome Measure Information:
Title
PrEP adherence at Week 12
Description
proportion with PrEP adherence at Month 3, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay
Time Frame
Week 12
Title
Change in Proportion of Participants with Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7
Description
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).
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
PrEP adherence at Week 4
Description
proportion with PrEP adherence at Week 4, defined as tenofovir (TFV) concentrations ≥1500 ng/mL in urine measured using a urine POC assay
Time Frame
Week 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female 18-25 years of age at screening
Documentation of symptoms of a common mental disorder, as evidenced by a score greater than or equal to 7 on the Self Reporting Questionnaire 20-item (SRQ-20)
Willingness to enroll and be randomized to either the Youth Friendship Bench SA or standard-of-care mental health services
Written informed consent (obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.
Able to verbally communicate in one or more study languages to ensure participation in the counseling sessions (English, isiZulu)
Taking PrEP at the Ward 21 clinic, as determined by clinic records. PrEP provision will be conducted by the clinic following National PrEP Guidelines and will not be part of study-specific procedures.
Exclusion Criteria:
Not on PrEP and/or not intending to use PrEP for the duration of the study
Planning to relocate in the next three months
Report of suicidal intent or self harm
Active, unmanaged mental health disorders, including untreated or severe somatic symptoms and active psychiatric symptoms (e.g., hallucinations)
Reactive or positive HIV test at enrollment (based on clinic records only; HIV testing will not be performed under this protocol)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Velloza, PhD, MPH
Phone
9173923561
Email
jennifer.velloza@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Velloza, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wits Reproductive Health Institute
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sinead Delany-Moretlwe, MBBCh, PhD
Phone
+27 82 377 6275
Email
sdelany@wrhi.ac.za
First Name & Middle Initial & Last Name & Degree
Nomhle Khoza, PhD
Phone
+27 76 512 5071
Email
NKhoza@wrhi.ac.za
First Name & Middle Initial & Last Name & Degree
Sinead Delany-Moretlwe, MBBCh, PhD
First Name & Middle Initial & Last Name & Degree
Nomhle Khoza, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data from the study will be available at the end of the project by contacting the Principal Investigator.
IPD Sharing Time Frame
End of study.
IPD Sharing Access Criteria
Reasonable request to the Principal Investigator.
Citations:
PubMed Identifier
34164929
Citation
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.
Results Reference
background
PubMed Identifier
30950883
Citation
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.
Results Reference
background
PubMed Identifier
28063075
Citation
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.
Results Reference
background
PubMed Identifier
28027368
Citation
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.
Results Reference
background
PubMed Identifier
30064418
Citation
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.
Results Reference
background
PubMed Identifier
34826035
Citation
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.
Results Reference
background
Learn more about this trial
Friendship Bench Mental Health Intervention for Adolescent Girls and Young Women in South African PrEP Delivery Settings
We'll reach out to this number within 24 hrs