Gender-based ViolenceNCT05295342
The No Means No South Africa Evaluation Study
A study testing Active comparator: Life Orientation in people with Gender-based Violence and Sexual Violence, run by RTI International at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender-based Violence, Sexual Violence
- What is being tested?
- Active comparator: Life Orientation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,173 participants
- Where
- 1 siteSouth Africa
- Study dates
- 16 Feb 2022to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- ° 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal Mixed Method Evaluation of the No Means No Intervention for Violence Prevention in Gqeberha, South Africa
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.
Read the detailed 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:
- To test the effectiveness of the No Means No intervention in reducing girls' reported experiences of sexual violence (SV);
- To identify the mechanisms of action of No Means No on girls' reported experience of SV;
Secondary Objective:
- 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);
- 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;
- To examine change in boys' knowledge, attitudes, and behaviors related to violence perpetration as a result of participation in a prevention program.
- Conditions
- Gender-based Violence, Sexual Violence
- Being tested
- No Means No intervention Girls' Curriculum, No Means No intervention Boys' Curriculum, Active comparator: Life Orientation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Means No intervention Girls' CurriculumBehavioural
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' CurriculumBehavioural
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 OrientationBehavioural
The standard school-based Life Orientation curriculum
| Study group | Role | What they receive |
|---|---|---|
| Girls-only intervention arm | Experimental | Schools in this arm will receive only the girls intervention. Receives: 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. Receives: Behavioral: No Means No intervention Boys' Curriculum |
| Control | Active comparator | The control arm will receive the standard school-based Life Orientation curriculum. Receives: Behavioral: Active comparator: Life Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured at three months and one year from enrollment
Secondary outcomes (8)
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: Measured at baseline, six months and one year from enrollment
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: Measured at baseline, six months and one year from enrollment
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: Measured at baseline, six months and one year from enrollment
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: Measured at baseline, three months, six months, and one year from enrollment
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: Measured at baseline, three months, six months, and one year from enrollment
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: Measured at baseline, three months, six months, and one year from enrollment
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: Measured at baseline, three months, six months, and one year from enrollment
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: Measured at baseline, six months and one year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start16 Feb 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gender-based ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- No Means No Worldwide
- Responsible party
- Principal investigator, Miriam Hartmann, RTI International
- Investigators
- Miriam A Hartmann, MPH, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295342
- Sponsor's protocol ID
- 0217796
- Other IDs
- REC 2/17/03/21
- Status last verified
- Apr 2024
- First submitted
- 9 Dec 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40087623
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Mixed Method Evaluation of the No Means No Intervention for Violence Prevention in Gqeberha, South Africa
- ClinicalTrials.gov ID
- NCT05295342
- Acronym / sponsor ID
- 0217796
- Conditions
- Gender-based Violence, Sexual Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,173 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- No Means No Worldwide
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- To test the effectiveness of the No Means No intervention in reducing girls' reported experiences of sexual violence (SV);
- To identify the mechanisms of action of No Means No on girls' reported experience of SV;
Secondary Objective:
- 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);
- 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;
- To examine change in boys' knowledge, attitudes, and behaviors related to violence perpetration as a result of participation in a prevention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Girls-only intervention arm | Experimental | Behavioral: No Means No intervention Girls' CurriculumSchools in this arm will receive only the girls intervention. |
| Girls and Boys intervention arm | Experimental | Behavioral: No Means No intervention Boys' CurriculumSchools in this arm will receive both the girls and boys intervention. |
| Control | Active comparator | Behavioral: Active comparator: Life OrientationThe control arm will receive the standard school-based Life Orientation curriculum. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- ° 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Means No intervention Girls' CurriculumThe 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. | Behavioural | Girls-only intervention arm |
| No Means No intervention Boys' CurriculumThe 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. | Behavioural | Girls and Boys intervention arm |
| Active comparator: Life OrientationThe standard school-based Life Orientation curriculum | Behavioural | Control |
Primary outcome
Change in reported sexual violence exposure incidence, intervention vs. control
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
Change in intervention mechanisms of action
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.
8 secondary outcomes
Change in reported intimate partner violence exposure incidence
Time frame: Measured at baseline, six months and one year from enrollment
Change in reported community violence exposure incidence
Time frame: Measured at baseline, six months and one year from enrollment
Change in reported sexual violence exposure incidence
Time frame: Measured at baseline, six months and one year from enrollment
Change in knowledge of sexual violence and prevention strategies
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change in gender norms
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change in attitudes towards violence
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change in use of intervention behaviors
Time frame: Measured at baseline, three months, six months, and one year from enrollment
Change in sexual violence perpetration
Time frame: Measured at baseline, six months and one year from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 40087623Hartmann 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.
- Website of the non-profit organization No Means No Worldwide, whose intervention is being evaluated through this trial.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam A Hartmann, MPH principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator: Life Orientation in people with Gender-based Violence and Sexual Violence, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reported sexual violence exposure incidence, intervention vs. control (time frame: Measured at baseline, six months and one year from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.