The No Means No South Africa Evaluation Study

NCT05295342 | Completed

• 2 other identifiers: 0217796REC 2/17/03/21
• Study Type: interventional
• Target: 2,173
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gender-based Violence; Sexual Violence

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Change in reported intimate partner violence exposure incidence

  Measured at baseline, six months and one year from enrollment

• Change in reported community violence exposure incidence

  Measured at baseline, six months and one year from enrollment

• Change in reported sexual violence exposure incidence

  Measured at baseline, six months and one year from enrollment

• Change in knowledge of sexual violence and prevention strategies

  Measured at baseline, three months, six months, and one year from enrollment

• Change in gender norms

  Measured at baseline, three months, six months, and one year from enrollment

Study Arms (3)

Girls-only intervention arm

EXPERIMENTAL

Schools in this arm will receive only the girls intervention.

Behavioral: No Means No intervention Girls' Curriculum

Girls and Boys intervention arm

EXPERIMENTAL

Schools in this arm will receive both the girls and boys intervention.

Behavioral: No Means No intervention Boys' Curriculum

Control

ACTIVE COMPARATOR

The control arm will receive the standard school-based Life Orientation curriculum.

Behavioral: Active comparator: Life Orientation

Interventions

No Means No intervention Girls' Curriculum BEHAVIORAL

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.

Girls-only intervention arm

No Means No intervention Boys' Curriculum BEHAVIORAL

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.

Girls and Boys intervention arm

Active comparator: Life Orientation BEHAVIORAL

The standard school-based Life Orientation curriculum

Control

Eligibility Criteria

• Age: 10 Years - 19 Years
• Gender Eligibility Details: Male and female participants will enroll based on self-representation of their gender identity
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• ° 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

Sponsors & Collaborators

• RTI International: lead
• No Means No Worldwide: collaborator

Study Sites (1)

No Means No South Africa

Port Elizabeth, Eastern Cape, South Africa

Location

Related Publications (1)

• Hartmann M, Mutangabende S, Nash S, Browne EN, Hatcher A, Kagesten AE, Roberts ST. Effectiveness of an empowerment-based self-defense program among South African girls: results from a cluster-randomized control trial in schools. BMC Womens Health. 2025 Mar 14;25(1):119. doi: 10.1186/s12905-025-03647-w.

  PMID: 40087623 DERIVED

Related Links

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

Study Officials

• Miriam A Hartmann, MPH

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: March 25, 2022
• Study Start: February 16, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)