Clinical trial NCT05295342: The No Means No South Africa Evaluation Study
Official title: A Longitudinal Mixed Method Evaluation of the No Means No Intervention for Violence Prevention in Gqeberha, South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender-based Violence
Sexual Violence
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: No Means No Worldwide
First posted: 2022-03-25
Enrollment: 2173
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in reported sexual violence exposure incidence, intervention vs. control
timeFrame: Measured at baseline, six months and one year from enrollment
measure: Change in intervention mechanisms of action
timeFrame: Measured at three months and one year from enrollment
Secondary outcomes:
measure: Change in reported intimate partner violence exposure incidence
timeFrame: Measured at baseline, six months and one year from enrollment
measure: Change in reported community violence exposure incidence
timeFrame: Measured at baseline, six months and one year from enrollment
measure: Change in reported sexual violence exposure incidence
timeFrame: Measured at baseline, six months and one year from enrollment
measure: Change in knowledge of sexual violence and prevention strategies
timeFrame: Measured at baseline, three months, six months, and one year from enrollment
measure: Change in gender norms
timeFrame: Measured at baseline, three months, six months, and one year from enrollment
measure: Change in attitudes towards violence
timeFrame: Measured at baseline, three months, six months, and one year from enrollment
measure: Change in use of intervention behaviors
timeFrame: Measured at baseline, three months, six months, and one year from enrollment
measure: Change in sexual violence perpetration
timeFrame: Measured at baseline, six months and one year from enrollment
Other outcomes:
Locations:
city: Port Elizabeth
country: South Africa
facility: No Means No South Africa
state: Eastern Cape
Study officials:
affiliation: RTI International
name: Miriam A Hartmann, MPH
role: PRINCIPAL_INVESTIGATOR
References: