NCT04607564

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

Completed NA Last updated 21 March 2023

What this trial tests

NA trial testing Ntombi Vimbela! intervention in Sexual Violence in 117 participants. Completed in 31 May 2021.

Timeline

23 August 2019

Primary endpoint
31 May 2021

31 May 2021

Quick facts

Lead sponsor	Medical Research Council, South Africa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	117
Start date	23 August 2019
Primary completion	31 May 2021
Estimated completion	31 May 2021
Sites	6 locations across South Africa

Drugs / interventions tested

• Ntombi Vimbela! intervention

Conditions studied

• Sexual Violence — all drugs for Sexual Violence →

Sponsor

Medical Research Council, South Africa

Who can join

Adults 18 to 30, female only, with Sexual Violence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Machisa MT, Mahlangu P, Chirwa E, Nunze N, et al · · 2023 · cited 3× · PMID 37370055 · DOI 10.1186/s12889-023-16149-x