Pilot Study of the Ntombi Vimbela Sexual Violence Intervention Among Female Tertiary Students in South Africa

NCT04607564 | Completed

• 1 other identifier: EC002/2/2018
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 6

Brief Summary

The pilot study aims to test the acceptability of content, feasibility of delivery methods and preliminary assessment of outcomes from the implementation of the Ntombi Vimbela intervention with volunteer groups of female first year students at eight South African higher education campuses. Data to inform the different objectives will be collected from participants at different time points. A baseline questionnaire was administered at the beginning of the Ntombi Vimbela workshops. Qualitative data to provide evidence about the workshop content and relevance was collected using participant end of workshop evaluation forms and end of intervention delivery focus group discussions.Feasibility data was collected through research team observations, facilitator debriefings and end of intervention delivery workshop One year post-implementation data which provides evidence of preliminary impact has commenced which includes a survey and in-depth interviews with participants.

Conditions

Sexual Violence

Outcome Measures

Primary Outcomes (5)

• Change in personal gender beliefs from baseline

  Assessed by a summative score from 8 items of the Gender Equitable Men Scale Score . Scale items include "I think that a woman should obey her husband. I think that a man should have the final say in all family matters I think that men should share the work around the house with women such as doing dishes, cleaning and cooking. I think that if someone insults a man he should be prepared to physically fight to defend his honour.I think that if a wife does something wrong her husband has the right to punish her. I think that there are times when a woman deserves to be beaten.I think that it is possible for a woman to be raped by her husband. I think that people should be treated the same whether they are male or female" Possible responses are in likert scale : 1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree

  1 year

• Change in sexual self efficacy from baseline

  Assessed by a summative score from 12 items of the Sexual Efficacy Scale. Scale items include "Would you be able to use a condom every time you have sex?Would you be able to buy your own condoms or contraception? Would you be able to refuse to have sex without condom? Would you be able to talk to your partner about his previous sexual activities? Would you be able to talk about using contraception with your partner? Would you be able to talk about using condoms with your partner? Would you be able to tell your partner how he should treat you sexually and the kind of sex you like? Would be able to refuse sex with your partner? Would be able to refuse sex with someone whom you want to date again ? Would be able to refuse sex with someone whom you want to fall in love with you? Would you be able to refuse to do something sexual if you didn't want it? Would you be able to meet your own sexual needs through masturbation" Possible responses are 1=No ; 2=Probably not; 3= Probably; 4=Yes

  1 year

• Past year incidence of non-partner rape

  Assessed using a modified version of the World Health Organisation's Domestic Violence Questionnaire. Items include "How many times were you forced by someone who was not your boyfriend/husband to have oral sex? How many times were you forced by someone who was not your boyfriend/husband to have penetrative sex? How many times were you forced to have sex with a man when you didn't want to but you were too drunk or drugged to stop it? How many times were you forced to have sex with more than one man at the same time?" Possible responses 1=Never, 2=Once, 3=More than one time Has this happened in the past 12 months? Possible response Yes/No

  1 year

• Past year incidence of partner sexual violence

  Assessed using a modified version of the World Health Organisation's Domestic Violence Questionnaire . Items include "Has a current or previous husband or boyfriend ever forced you to do something sexual that you found degrading or humiliating? Did this happen many times, a few times, once or did it not happen? Have you ever had sex with a boyfriend/husband when you didn't want to because he physically forced or threatened or pressured you? Possible responses 1=Never, 2=Once, 3=More than one time Has this happened in the past 12 months? Possible responses Yes/No

  1 year

• Self defence self efficacy

  Assessed by a summative score of 8 adapted items of Self defence Self efficacy scales. Example of items include "If I sense anything about a man that makes me uncomfortable, I'm able to avoid being alone with him.If my date refused to stop after I told him to, I wouldn't know what I could do to make him stop. I know a number of basic hand strike self defense moves e.g straight punch, knife hand, hammer fist that I would be able to use if anyone tried to rape me. I know a number of basic kicking self defense moves e.g front or back kicks that I would be able to use if anyone tried to rape me. I know a number of basic elbow self defense moves that I would be able to use if anyone tried to rape me. I know a number of basic wrist release self defense moves that I would be able to use if anyone tried to rape me. Possible responses 1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree

  1 year

Secondary Outcomes (4)

• Change in mental health from baseline

  1 year

• Change in self esteem from baseline

  1 year

• Change in rape myth acceptance from baseline

  1 year

• Change in emotional help seeking behaviours from baseline

  1 year

Study Arms (1)

No comparison pilot group

EXPERIMENTAL

Attendance at ten Ntombi Vimbela workshops running for a total 35 hours over six weeks.

Other: Ntombi Vimbela! intervention

Interventions

Ntombi Vimbela! intervention OTHER

Ntombi Vimbela! constitutes a series of ten workshops running for a total 35 hours. The intervention is designed to raise awareness about sexual rights, violence against women and girls and its drivers; sensitise about gender inequality and build more gender equitable beliefs; sensitise about sexual assault; equip participants with skills to assess and act in situations where there is a high risk of sexual assault; build resilience and skills to withstand social and material pressures in college or university ; enable utilisation of health, psycho-social services and access to justice for survivors; enhance communication skills and building healthy sexual relationships; promote mental health and coping and build empathy towards survivors.

No comparison pilot group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female students,
• Ages 18-30 years
• First year students

You may not qualify if:

• Female students Ages 31+
• Post graduate students
• Students enrolled for at institution for more than 1 year

Sponsors & Collaborators

• Medical Research Council, South Africa: lead

Study Sites (6)

University of Fort Hare

Alice, Eastern Cape, South Africa

Location

South West Gauteng TVET College

Johannesburg, Gauteng, South Africa

Location

Elangeni TVET College

Pinetown, KwaZulu-Natal, South Africa

Location

University of Limpopo

Mankweng, Limpopo, South Africa

Location

Ehlanzeni TVET College

Mbombela, South Africa

Location

Lovedale TVET College

Qonce, South Africa

Location

Related Publications (1)

• Machisa MT, Mahlangu P, Chirwa E, Nunze N, Sikweyiya Y, Dartnall E, Pillay M, Jewkes R. Ntombi Vimbela! Sexual violence risk reduction intervention: pre and one-year post assessments from a single arm pilot feasibility study among female students in South Africa. BMC Public Health. 2023 Jun 27;23(1):1242. doi: 10.1186/s12889-023-16149-x.

  PMID: 37370055 DERIVED

Study Officials

• Mercilene Machisa, PhD

  Medical Research Council, South Africa

  PRINCIPAL INVESTIGATOR

• Rachel Jewkes, MBBS

  Medical Research Council, South Africa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Scientist

Model Details: This is a pilot and feasibility study where sites are conveniently selected and the recruitment of participants is by invitation and non-randomised. All participants will receive the Ntombi Vimbela intervention.

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 29, 2020
• Study Start: August 23, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (6)