Clinical trial NCT04607564: Pilot Study of the Ntombi Vimbela Sexual Violence Intervention Among Female Tertiary Students in South Africa
Official title: Formative Research and Development of a Sexual Violence Prevention Intervention for South African Higher Education Institutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Violence
Lead sponsor: Medical Research Council, South Africa
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: Facilitator recruitment and training: The intervention piloting will be conducted in eight selected campuses. In each campus, three facilitators will be recruited through a process involving advertisements, applications, screening and interview. This makes a total of nine facilitators. The criteria for facilitators will be full time female students, between the ages of 25 and 30 years of age, enrolled at the institution for at least one year. Facilitators will be trained by the lead researchers to recruit participants and run intervention with groups of participants. The facilitator training will be conducted by the lead researchers over a duration of seven days. The training will cover the intervention content, participatory delivery protocol, group facilitation techniques, dynamics of co-facilitation and problem-solving techniques.

Project marketing and participant recruitment: First posters about the study will be put up in lecture rooms, residences and central meeting points at selected campuses. Posters will have information which will include the study aims, participation criteria and contact details of the project managers. Facilitators will also approach students, share the study information and invite them to participate. The Student Support managers will also assist in publicising the project as they conduct their normal duties. In each institution, 20 students will be recruited to participate in the intervention. To be eligible to participate, a student has to be female, aged 18-30 years and a full-time student at the college. At the final stage of recruitment, participants will receive the written project information leaflet and will be required to give written consent prior to participation. Participants will also be required to provide their contact details which will be used to communicate project activities.

Participant assessments and feedback: Prior to participating in the programme, participants will be required to complete a short baseline questionnaire that includes measures of their background data, gender attitudes, perceptions of sexual violence, violence exposures, knowledge or use of campus support services or other forms of support (informal and formal). The same tool used at baseline will be used at 1 year post-implementation of workshops to assess any changes in knowledge, attitudes and behaviour. In compliance to the COVID-19 regulations the researchers will contact participants and invite them to participate remotely. A survey link will be sent to them which they will use to complete the questionnaire. For the qualitative follow up component, researchers will systemically sample half of the participants at each site and invite them to participate in telephonic in-depth interviews. On agreed days and times, researchers will conduct the telephonic interview using a structured guide. All interviews will be audio-recorded, transcribed verbatim and translated into English in preparation for analysis. The assessments are solely for the purpose of assessing the acceptability and feasibility of the intervention and impact evaluation.

Facilitator support, debriefing and feedback: During the implementation of the programme, facilitators will be expected to fill attendance records, collect filled participant evaluation forms and compile session reports. Attendance record will allow us to ascertain whether workshop attendance gets sustained throughout the four sessions. Facilitators will use session reports to document challenges encountered and how those were resolved; which exercises worked well and which did not; what do they think could be done to make the exercises work better. Each facilitator will be expected to attend a weekly two-hour face to face debriefing and planning meeting chaired by the lead researchers. The debriefing sessions will be used to engage with the participant evaluations and as a means of getting facilitator feedback relating to intervention delivery. Facilitators will also be expected to request the inputs of the project manager when dealing with any challenges in implementation. In closing the implementation, in-depth one-on-one interviews will be conducted with facilitators on their experiences of delivering the intervention, reflecting on similar issues as are observed for participants. A focus group discussion will also be conducted with all facilitators to allow them to discuss in detail amongst themselves the challenges, successes and suggest improvements to the intervention.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in personal gender beliefs from baseline
timeFrame: 1 year
measure: Change in sexual self efficacy from baseline
timeFrame: 1 year
measure: Past year incidence of non-partner rape
timeFrame: 1 year
measure: Past year incidence of partner sexual violence
timeFrame: 1 year
measure: Self defence self efficacy
timeFrame: 1 year
Secondary outcomes:
measure: Change in mental health from baseline
timeFrame: 1 year
measure: Change in self esteem from baseline
timeFrame: 1 year
measure: Change in rape myth acceptance from baseline
timeFrame: 1 year
measure: Change in emotional help seeking behaviours from baseline
timeFrame: 1 year
Other outcomes:
Locations:
city: Alice
country: South Africa
facility: University of Fort Hare
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: South West Gauteng TVET College
state: Gauteng
city: Pinetown
country: South Africa
facility: Elangeni TVET College
state: KwaZulu Natal
city: Mankweng
country: South Africa
facility: University of Limpopo
state: Limpopo
city: King William's Town
country: South Africa
facility: Lovedale TVET College
city: Nelspruit
country: South Africa
facility: Ehlanzeni TVET College
Study officials:
affiliation: Medical Research Council, South Africa
name: Mercilene Machisa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Council, South Africa
name: Rachel Jewkes, MBBS
role: STUDY_DIRECTOR
References: