The No Means No South Africa Evaluation Study

Sexual Violence Clinical Trial

Official title:

A Longitudinal Mixed Method Evaluation of the No Means No Intervention for Violence Prevention in Gqeberha, South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05295342
• Other study ID #: 0217796
• Secondary ID: REC 2/17/03/21
• Status: Completed
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: October 24, 2023

Study information

• Verified date: April 2024
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. To test the effectiveness of the No Means No intervention in reducing girls' reported experiences of sexual violence (SV);

2. To identify the mechanisms of action of No Means No on girls' reported experience of SV;

Secondary Objective:

1. To determine the effectiveness of the No Means No intervention in reducing girls' reported experiences of other forms of violence (i.e. IPV, and CV);

2. To compare the effect of simultaneous implementation of a boys violence perpetration prevention program, versus the girls' program alone or no intervention, on girls' reported experiences of SV;

3. To examine change in boys' knowledge, attitudes, and behaviors related to violence perpetration as a result of participation in a prevention program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2173
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

Inclusion Criteria:

• Age 10-19

• Enrolled in a selected school or afterschool program in the Nelson Mandela Bay municipality

• Not planning to move, de-enroll, or graduate during the study period

• Willing to participate in the 6 session No Means No intervention

• Able and willing to provide written informed consent or assent and parental consent if under 18

• English, isiXhosa, or Afrikaans speaking

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

Related Conditions & MeSH terms

• Gender-based Violence
• Sexual Violence

Intervention

Behavioral:
• No Means No intervention Girls' Curriculum
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.
• No Means No intervention Boys' Curriculum
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.
• Active comparator: Life Orientation
The standard school-based Life Orientation curriculum

Locations

Country	Name	City	State
South Africa	No Means No South Africa	Port Elizabeth	Eastern Cape

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	No Means No Worldwide

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in reported sexual violence exposure incidence, intervention vs. control	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	Measured at baseline, six months and one year from enrollment
Primary	Change in intervention mechanisms of action	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.	Measured at three months and one year from enrollment
Secondary	Change in reported intimate partner violence exposure incidence	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	Measured at baseline, six months and one year from enrollment
Secondary	Change in reported community violence exposure incidence	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	Measured at baseline, six months and one year from enrollment
Secondary	Change in reported sexual violence exposure incidence	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	Measured at baseline, six months and one year from enrollment
Secondary	Change in knowledge of sexual violence and prevention strategies	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?").	Measured at baseline, three months, six months, and one year from enrollment
Secondary	Change in gender norms	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.	Measured at baseline, three months, six months, and one year from enrollment
Secondary	Change in attitudes towards violence	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.	Measured at baseline, three months, six months, and one year from enrollment
Secondary	Change in use of intervention behaviors	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?"	Measured at baseline, three months, six months, and one year from enrollment
Secondary	Change in sexual violence perpetration	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.	Measured at baseline, six months and one year from enrollment

External Links

•   Website of the non-profit organization No Means No Worldwide, whose intervention is being evaluated through this trial.