No Means No South Africa
Port Elizabeth, Eastern Cape, South Africa
NCT Number: NCT05295342
This school-based study will evaluate a behavioral intervention-the No Means No (NMN) intervention-to reduce violence among enrolled girls, ages 10-19, through a cluster-randomized control trial and a nested qualitative study.
Looking for future studies?
Notify Me10 year–19 year
All sexes
Interventional
Not applicable
Port Elizabeth, Eastern Cape, South Africa
This protocol describes a mixed method evaluation study of a behavioral intervention-the No Means No (NMN) intervention-to reduce violence among enrolled girls, ages 10-19.
The No Means No intervention is an 8-12-hour behavioral intervention designed to teach Empowerment Self-Defense (ESD) to girls. A parallel intervention with boys focuses on violence perpetration by addressing issues of consent and bystander intervention. The intervention also includes a network of referrals.
The intervention will be evaluated through a cluster-randomized, controlled trial and a nested qualitative study. Implementation sites such as schools and afterschool programs (hereafter collectively referred to as schools) will be randomized to receive the girls' intervention only, the girls' and boys' interventions in parallel, or the control condition (standard of care). Control arm schools will receive the intervention as is following the study period if proven safe and effective. The study will enroll a subset of intervention participants (ages 10-19 years inclusive) at each intervention school, and an equal number of girls and boys at each control school. Experience and perpetration of sexual violence (SV), other forms of intimate partner violence (IPV), and community violence (CV) will be compared across the study arms over time, as well as engagement with referral services. At any timepoint when violence is disclosed, participants will receive first-line support and referrals for care. Participants will be followed longitudinally for 12 months.
Population: Approximately 2250 girls and 1000 boys, aged 10 to 19 years of age (inclusive) who are enrolled in 15 schools. Boys will be enrolled from the schools randomized to receive the boys' intervention and the control schools only.
Study Site(s): NMNW Implementation Site, Gqeberha, South Africa
Approach: This project will evaluate the impact of the No Means No intervention on SV prevention when paired with GBV referral services through a cluster randomized controlled study among girls and boys, with a nested qualitative component.
Study Duration: Accrual will require approximately 6 weeks. Participants in all study arms will participate in scheduled visits for enrollment (baseline), and 3, 6, and 12 months of follow-up. A subset of participants will be recruited for qualitative interviews (serial in depth interviews) to be conducted at or around 3 and 12 months post-intervention.
Primary Objectives:
Secondary Objective:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
° Has any significant medical condition or other condition that, in the opinion of the Principal Investigator (PI)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
The No Means No (NMN) Girls' Curriculum is a violence prevention program designed for adolescent girls and young women 10-20 years old. This curriculum has been designed specifically for safer implementation during the COVID-19 pandemic. NMN Girls' programming is deeply rooted in Empowerment Self-Defense, which is a uniquely holistic, survivor-centered, feminist approach to self-protection skills. Youth educators called "Instructors" deliver the curriculum to young people in schools. This 8-hour intervention is comprised of classes that teach young people mental, verbal and physical self-defense skills that can be used to prevent sexual assault and other forms of gender-based violence.
The No Means No (NMN) Boys' Curriculum is a violence prevention curriculum that has been designed specifically for implementation during the COVID-19 pandemic. Designed for adolescent boys and young men age 10-20. Like the girls program it is delivered by youth educators called "Instructors" in schools. This 8-hour intervention is comprised of classes that teach young people gender equitable attitudes, skills to defend equality and how to avoid violence as a power paradigm.
The standard school-based Life Orientation curriculum
Time frame: Measured at baseline, six months and one year from enrollment
Change in female participants self-report of sexual violence experience measured using adapted questions from the Manhood 2.0 study, assessed in the combined intervention arms vs. the control arm
Time frame: Measured at three months and one year from enrollment
Qualitative assessment of changes in theorized mechanisms of action, e.g. ways in which the intervention impacts sexual violence, explored over time using open-ended questions.
Time frame: Measured at baseline, six months and one year from enrollment
Change in female participants self-report of intimate partner violence experience, assessed using WHO Violence Against Women instrument (VAWI) questions in the combined intervention arms vs. the control arm
Time frame: Measured at baseline, six months and one year from enrollment
Change in female participants self-report of community violence experience, assessed using questions from the Global Early Adolescent Study (GEAS) in the girls only intervention arm vs. the girls and boys intervention arm
Time frame: Measured at baseline, six months and one year from enrollment
Change in female participants self-report of sexual violence experience measured using adapted questions from the Manhood 2.0 study, assessed in the girls-only intervention arm vs. the girls' and boys' intervention arm
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change in self-reported knowledge of sexual violence and associated prevention strategies among male participants in the intervention vs. control arm, using questions adapted from prior evaluations (e.g. "What is consent?" and "What are the tools you can use for intervention?").
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change among male participants in gender norms according to a 20-item gender scale questions, used in the Manhood 2.0 study, in the intervention vs. control arm. Scores can range from 20 to 40 with high scores representing greater support for gender equity.
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change among male participants in attitudes towards violence according to a 4-item rape myths scale previously used in South Africa in the intervention vs. control arm. Scores can range from 4 to 12 with high scores representing lower acceptability of rape.
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change in self-reported application of specific behaviors taught in the intervention related to violence prevention among male participants in the intervention vs. control arm, using questions from prior evaluations of the intervention, e.g. "Have you successfully intervened in any situations where someone was verbally harassing a girl or woman to stop the harassment?"
Time frame: Measured at baseline, six months and one year from enrollment
Change in male participants who report perpetrating sexual violence in the intervention vs. control arm, measured using adapted questions from the Manhood 2.0 study.
RTI International
Other
A Longitudinal Mixed Method Evaluation of the No Means No Intervention for Violence Prevention in Gqeberha, South Africa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06144216
Gender-Based Violence, Outreach Intervention
Vancouver, British Columbia, Canada
View Trial DetailsNCT06854770
Access to Health Care, Access to Social Services
Vancouver, British Columbia, Canada
View Trial DetailsNCT05839457
Gender-Based Violence
Lusaka, Zambia
View Trial DetailsNCT05981417
Anxiety Disorders, Behavior
Pontevedra, Spain
View Trial Details