Mpata Yathu Trial for Young Women in Zambia

Background

Young women, aged 15 to 24 years, in Zambia are vulnerable to gender-based violence (GBV)1 such as intimate partner violence (IPV), forced sex, other forms of sexual assault, and stalking. GBV increases risks for HIV acquisition by 50% in high HIV-burden countries like Zambia. The HIV prevalence among Zambian young women is three times higher than their male counterparts and positive HIV status among these women is significantly associated with experiencing IPV. GBV-exposed women are also at elevated risk for mental health disorders (depression, anxiety, PTSD, substance abuse). In a cohort study of 1,915 young women in Zambia, women who experienced sexual violence perpetrated by non-partners had increased odds of depression and anxiety. GBV and mental health disorders also undermine HIV prevention and treatment including antiretroviral therapy adherence, clinic attendance, and pre-exposure prophylaxis (PrEP) use. Young Zambians who have experienced physical violence, psychological abuse, or forced sex have higher odds of HIV viral load suppression failure. Although the integration of mental health treatments within HIV interventions can lead to improvements in HIV and mental health outcomes, there is insufficient evidence of this impact among young women with a history of GBV in low-resource settings like Zambia. Therefore, we propose to pilot test the integration of a locally adapted, lay-delivered evidence-based problem solving therapy intervention, known as Mpata Yathu, to improve mental health and HIV prevention and treatment outcomes among young women with a history of GBV in Zambia. This protocol outlines the evaluation of Mpata Yathu, which aims to:

1. Assess the effect of the intervention on common mental health disorder (CMD) symptoms, the primary outcome for which the study is statistically powered. 2. Evaluate the implementation outcomes of the Mpata Yathu intervention, specifically its feasibility, acceptability, and fidelity, as delivered by lay counselors to AGYW with a history of GBV experiences. 3. Explore potential effects of the Mpata Yathu intervention on additional mental health outcomes such as depression, anxiety, and PTSD; HIV prevention and treatment engagement outcomes based on participant HIV status; and gender-based violence (GBV)-related attitudes and experiences, as well as psychosocial variables including adverse childhood experiences and coping self-efficacy. 4. Whether changes in mental health symptoms mediate or moderate the intervention's effects on HIV-related outcomes.

Methods

Study Design We will conduct a two-arm randomized controlled trial (RCT) to evaluate the effectiveness and implementation of the adapted Friendship Bench intervention, Mpata Yathu, on HIV prevention and treatment, and depression outcomes among young women, living with or at risk for HIV, with a lifetime history of GBV and depression symptoms in Zambia. This study will have two arms: an intervention group and a waitlist control group. The intervention is designed to be delivered in six sessions, with one session per week. However, participants will be given up to three months to complete all sessions to accommodate common barriers such as caregiving responsibilities, stigma, mobility, and illness. Counseling sessions will be scheduled to accommodate participant availability, and lay counselors will track session completion. After screening and enrollment, eligible participants will be randomized in a 1:1 ratio to either group.

Intervention Group: Participants will receive up to six individual counseling sessions between baseline and 3-month follow-up (0-3 months).

Waitlist Control Group: Participants will receive usual care from 0-3 months, followed by the intervention (up to six counseling sessions) between 3 and 6 months

Due to the nature of the intervention, participants and lay counselors will not be blinded to study arm assignment. However, quantitative outcome assessors conducting follow-up assessments will be blinded to participants' group assignment to reduce potential bias in data collection. Unblinding will only occur in cases of adverse events or safety concerns where knowledge of intervention status is necessary for appropriate clinical management or referral.

Study Setting Our study will be conducted in two Roman Catholic churches in Lusaka, one located in the Matero catchment area and one located in Chawama. Our community partners, who are Native Zambians, recommended implementation of Friendship Bench within churches in the Matero and Chawama catchment areas of Lusaka since women are disproportionately affected by both poverty and GBV in these areas, aligning with literature linking economic vulnerability to sexual coercion. Roman Catholic churches were recommended by native Zambians as appropriate sites for implementation since they serve a wide population and offer the classroom space and organizational structure needed to host counseling sessions.

Screening and Enrollment We anticipate screening 300 young women over four months to enroll 90 eligible participants. We are planning for a conservative dropout rate of 30%. This estimate draws from comparable implementation research in sub-Saharan Africa, including a trial in rural Ethiopia, which used a similar assumption to test feasibility of participant retention and study procedures. This estimate allows us to account for structural barriers (e.g., mobility, stigma, early pregnancy, GBV recurrence, financial hardship, caregiving responsibilities) that commonly affect longitudinal follow-up among AGYW who have experienced GBV. Collecting actual retention data during the RCT will allow us to empirically estimate the true dropout rate and its variability, which will inform the design and sample size calculations of a future fully powered randomized controlled trial, and for refining strategies to improve participant retention.

Participants will be considered lost to follow-up for a specific assessment (at 3 or 6 months after the baseline assessment) if they cannot be reached despite at least three documented re-contact attempts using various methods (e.g., phone calls, church-based outreach, or home visits, based on participant consent and preference) during the assessment window, defined as ±1 month from the target follow-up date. Re-contact efforts will begin approximately two weeks prior to each window and continue throughout. No outreach will occur after the close of each window. Participants who miss the 3-month follow-up assessment may still be contacted and retained for the 6-month follow-up. Participants who voluntarily withdraw from the study will not be considered lost to follow-up.

Randomization We will use permuted block randomization, stratified by HIV status, to ensure balance across study arms. The randomization sequence will be computer-generated using REDCap's randomization module. REDCap will conceal allocation until after baseline data entry is complete, ensuring that research staff cannot foresee or manipulate assignments. The study biostatistician will generate the allocation sequence and upload it into REDCap. The research assistants will enroll participants, and REDCap will automatically assign the participant to their group after enrollment and baseline data completion. Participants will be randomized 1:1 to the intervention group (offering intervention sessions from 0-3 months) or the waitlist control group (offering intervention sessions from 3-6 months), with up to six sessions delivered over three months among both arms.

Inclusion Criteria

To be eligible for enrollment in the RCT, participants must meet the following criteria:

1. aged 15 to 24 years; 2. Speak Nyanja, Bemba, and/or English fluently; 3. Reside in the Matero or Chawama constituency area during the time of recruitment; 4. Report lifetime exposure to GBV, as assessed by the WHO Multi-country Study on Women's Health and Domestic Violence Against Women instrument. 5. Exhibit moderate depressive symptoms indicated by a score of 10-14 on the 9-item Patient Health Questionnaire (PHQ-9), or common mental disorder (CMD) symptoms (e.g., depression, anxiety) as indicated by a score of 9 or higher on the 14-item Shona Symptom Questionnaire (SSQ-14); and 6. Be living with HIV or demonstrate HIV risk behaviors, as defined by validated items from the World AIDS Foundation survey, including unprotected sex, multiple sexual partners, coerced sex, or transactional sex.

Exclusion Criteria

Women will be excluded if they:

1. Require emergency treatment for any crisis (mental, physical, emotional) at the time of screening 2. Report severe symptoms of depression (score \> 14 on PHQ-9) or no to mild depression symptoms (PHQ-9 score \<10), and/or severe anxiety symptoms using the Generalized Anxiety Disorder 7-item scale or GAD-7 (score \>14 on GAD-7) 3. Have intellectual or cognitive disabilities that limit their ability to complete the screening tools, interact with a lay counselor and/or provide informed consent; and/or 4. Are considered in immediate danger (e.g., reoccurring physical violence) during time of the study. 5. Are currently receiving formal mental health counseling or psychotherapy (to avoid duplication of care and potential confounding effects).

Study Procedures for RCT Participants Recruitment, screening, and consenting will take place at both intervention and non-intervention sites across Lusaka, including churches, government health facilities, schools, and community-based organizations; the intervention will be delivered at two Catholic churches-one in Matero and the other in Chawama. These locations were identified in consultation with native Zambians who are familiar with these church settings to ensure accessibility and safety for potential participants. Private rooms within the selected locations will be used to ensure confidentiality during screening and consenting. In some cases where private rooms are unavailable, screening and consenting will take place outdoors in quiet, secluded areas to maintain privacy.

Participants will be informed whether they are eligible for the study immediately after completing the screening. Eligible individuals will be considered enrolled in the study immediately after consenting. If unavailable to screen, consent, and/or enroll during the time of recruitment, potential participants will be asked to schedule a time to complete the screening, enrolling, and/or consenting in person.

Consenting will be conducted by the local study team, including pastors, students, teachers, and youth peer navigators, who have completed training in research ethics and informed consent procedures. While some lay counselors delivering the intervention may also assist with consenting, they will not administer baseline or follow-up questionnaires to avoid potential bias in participant responses. All study personnel, including the lay counselors, will be certified in human subjects protection prior to study launch and follow safety protocols for women who may still be experiencing GBV and/or have specific mental health needs outside of the scope of our study (e.g., severe depression, suicidal ideation or attempt, psychosis).

Study Outcomes All outcomes will be assessed at both 3-month and 6-month follow-up timepoints. The 3-month follow-up will serve as the primary endpoint for between-group comparisons (intervention vs. waitlist control). At the 6-month follow-up, only within-group changes will be assessed, as both groups will have received the intervention by this time. The waitlist control group will begin intervention delivery after completing the 3-month assessment, with no contamination expected due to the ±1 month window applied to the time in which follow-up assessments must be completed. All instruments will be translated into from English to Nyanja and Bemba using a forward-backward translation process to ensure linguistic and cultural equivalence.

Mental He

• Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, 3-month, and 6-month follow-up]
• Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale [Срок оценки: Baseline, 3-month, and 6-month follow-up]
• Change in PTSD symptoms as measured by the Child PTSD Symptom Scale (CPSS) [Срок оценки: Baseline, 3-month, and 6-month follow-up]