Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT07132905
Eligibility Criteria:
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 following sections of the WHO Multi-country Study on Women's Health and Domestic Violence Against Women instrument:
* Section 7 (Physical Violence by Intimate Partner): Reports of being slapped, pushed, hit with a fist, kicked, dragged, choked, or threatened/attacked with a weapon by a husband or partner.
* Section 8 (Sexual Violence by Intimate Partner): Reports of being physically forced to have sex, having sex out of fear, or being forced to engage in degrading sexual acts by a husband or partner.
* Section 9 (Emotional Abuse by Intimate Partner): Reports of being insulted, belittled, intimidated, or threatened by a partner.
* Section 10 (Physical Violence by Non-Partner): Lifetime experiences of being beaten or physically mistreated by someone other than a partner since age 15.
* Section 11 (Sexual Violence by Non-Partner): Forced sex or sexual acts since age 15 by a non-partner, and childhood sexual abuse before age 15.
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,25 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).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
24 Years
Study:
NCT07132905
Study Brief:
Protocol Section:
NCT07132905