Depression, Pre-Exposure Prophylaxis
Conditions
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.
Interventions
BEHAVIORALYouth Friendship Bench SA
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.
Sponsors
University of California, San Francisco
National Institute of Mental Health (NIMH)
University of Witwatersrand, South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence at Week 12 | 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 |
| Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | Baseline and Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| PrEP Adherence at Week 4 | 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 |
| Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | Week 4 | 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). |
| Acceptability of Youth Friendship Bench SA | 12 Weeks | 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. |
| Feasibility of Youth Friendship Bench SA | 12 Weeks | 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. |
| Appropriateness of Youth Friendship Bench SA | 12 Weeks | 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. |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORJennifer Velloza, PhD, MPH
University of California, San Francisco
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| 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. | 57 |
| Total | 115 |
Baseline characteristics
| Characteristic | Youth Friendship Bench SA + Standard-of-Care | Total | Standard-of-Care Mental Health Services |
|---|---|---|---|
| Age, Continuous | 21 Years | 21 Years | 21 Years |
| GAD-7 | 7 Score | 6 Score | 6 Score |
| Has experienced gender-based violence | 44 Participants | 85 Participants | 41 Participants |
| PHQ-9 | 8 Score | 8 Score | 8.5 Score |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 57 Participants | 115 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| SRQ-20 Score | 9 Score | 9 Score | 8 Score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 57 |
| other Total, other adverse events | 0 / 58 | 0 / 57 |
| serious Total, serious adverse events | 1 / 58 | 1 / 57 |
Outcome results
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard-of-Care Mental Health Services | Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 29 Participants |
| Youth Friendship Bench SA + Standard-of-Care | Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 23 Participants |
p-value: 0.9995% CI: [0.71, 1.42]Poisson regression
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard-of-Care Mental Health Services | PrEP Adherence at Week 12 | 29 Participants |
| Youth Friendship Bench SA + Standard-of-Care | PrEP Adherence at Week 12 | 22 Participants |
p-value: 0.4495% CI: [0.64, 1.22]Poisson regression
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.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Youth Friendship Bench SA + Standard-of-Care | Acceptability of Youth Friendship Bench SA | 3.5 score on a scale |
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.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Youth Friendship Bench SA + Standard-of-Care | Appropriateness of Youth Friendship Bench SA | 3.25 score on a scale |
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).
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard-of-Care Mental Health Services | Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 20 Participants |
| Youth Friendship Bench SA + Standard-of-Care | Change in Proportion of Participants With Self Reporting Questionnaire 20-Item (SRQ-20) Scores Below 7 | 15 Participants |
p-value: 0.3795% CI: [0.5, 1.29]Poisson regression
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.
Time frame: 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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Youth Friendship Bench SA + Standard-of-Care | Feasibility of Youth Friendship Bench SA | 3.75 score on a scale |
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard-of-Care Mental Health Services | PrEP Adherence at Week 4 | 25 Participants |
| Youth Friendship Bench SA + Standard-of-Care | PrEP Adherence at Week 4 | 29 Participants |
p-value: 0.0395% CI: [1.03, 1.89]Poisson regression