Clinical trial NCT05783336: Stepping Stones and Creating Futures Plus Pilot
Official title: An Inter-disciplinary Approach to Understanding and Intervening on Contextual Factors That Shape HIV-risk for Young Women and Men in South Africa: Phase 2 - the Feasibility, Acceptability and Potential Effect Size of a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Poverty
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
name: University College, London
First posted: 2023-03-24
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomised controlled clinical trial is to test the Stepping Stones and Creating Futures Plus (SSCF+) intervention, in young (18-25 years) people living in urban informal settlements in Durban and rural communities in KwaZulu-Natal, South Africa. The main questions it aims to answer are:

* Is the intervention acceptable and feasible
* What is the potential effect size on key outcomes of intimate partner violence

Participants will be randomised (1:1) to compare SSCF+ and a control arm to see if there are differences between the two on intimate partner violence.

Detailed description: Intimate partner violence is very common in South Africa, particularly urban informal settlements. We have co-developed an intervention, called Stepping Stones and Creating Futures Plus (SSCF+), which will be evaluated in women and men aged 18-25 years living in KwaZulu-Natal, South Africa.

This is a pilot randomised controlled trial and as such there is focus on understanding whether the intervention is acceptable (to participants), feasible to deliver, and the potential effect sizes we may see in a full trial.

Eligibility criteria: Inclusion Criteria:

* Normally resident in the community where recruiting
* Aged 18-30 years old
* Not in formal employment, or full-time education
* Able to communicate in the main languages of the study (English, isiXhosa or isiZulu)
* Able to provide informed consent

Exclusion Criteria:

* Only in the community temporarily
* Unable to provide informed consent
* Under 18 years of age, or over 31 years old at point of recruitment
* Unable to communicate in main study languages

Primary outcomes:
measure: Physical Intimate Partner Violence
timeFrame: 6 months
measure: Sexual Intimate Partner Violence
timeFrame: 6 months
measure: Severe Intimate partner violence
timeFrame: 6 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 6 months
measure: Post-traumatic-stress symptoms
timeFrame: 6 months
measure: Emotional Dysregulation
timeFrame: 6 months
measure: Earnings
timeFrame: 6 months
measure: Savings
timeFrame: 6 months
measure: Hunger
timeFrame: 6 months
measure: Livelihood Activities
timeFrame: 6 months
measure: Work stress
timeFrame: 6 months
measure: Work shame
timeFrame: 6 months
measure: Capabilities
timeFrame: 6 months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: South African Medical Research Council
Study officials:
affiliation: Medical Research Council, South Africa
name: Rachel Jewkes
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Exeter
name: Andrew Gibbs
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Jenevieve Mannell
role: PRINCIPAL_INVESTIGATOR
References: