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CompletedNCT03257176Updated Aug 22, 2017

Stepping Stones and Creating Futures Intervention Pilot

A Phase 2 interventional study of Stepping Stones and Creating Futures in Physical Violence, Sexual Violence and Livelihoods, sponsored by University of KwaZulu. Completed at 1 site in South Africa. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by University of KwaZulu · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
232
Allocation
Not applicable
Ages
18 Years to 30 Years
Sex
All
01

Study summary

This is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined Stepping Stones and Creating Futures intervention can reduce men's perpetration of IPV and women's experience of IPV, strengthen livelihoods and reduce gender inequality.

02

Conditions studied

  • Physical Violence
  • Sexual Violence
  • Livelihoods
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Over 18
  • Mentally competent
  • Able to communicate in English, Zulu, or Xhosa
  • Normally resident in the informal settlement

Exclusion criteria

Exclusion Criteria:

  • Over 30
  • Unable to do informed consent
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
232 participants (actual)

Study arms

  • Experimental
    Stepping Stones and Creating Futures

    Receive the 21 session intervention

    Behavioral: Stepping Stones and Creating Futures

Interventions

  • BehavioralStepping Stones and Creating Futures

    21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods.

05

What researchers measure

Primary outcomes

  1. Past three month physical IPV perpetration (men) and experience (women)

    Physical intimate partner violence is assessed using five items based on the WHO VAW scale, asking about perpetration (men) and experience (women) of these five behaviourally specific actions in the past three months. A positive response to any of the five items leads to a person being classified as perpetrating (men) and experiencing (women) physical IPV in the past three months.

    Time frame: 12 months post baseline

  2. Past three month sexual IPV perpetration (men) and experience (women)

    Sexual intimate partner violence is assessed using three items based on the WHO VAW scale for sexual IPV. Questions are asked for the past three month perpetration (men) and experience (women). A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past three months.

    Time frame: 12 months post baseline

  3. Earnings in past month

    A single item question asks "Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?" Responses are in Rands and a continuous scale.

    Time frame: 12 months post baseline

Secondary outcomes

  1. Work stress

    4 items ask about work stress because of a lack of work. Responses are on a likert scale.

    Time frame: 12 months post baseline

  2. Feelings about work shame

    4 items ask about shame because of type and lack of work. Responses are on a likert scale.

    Time frame: 12 months post baseline

  3. Gender attitudes

    Modified gender equitable men's scale assess participant's gender attitudes.

    Time frame: 12 months post baseline

  4. Controlling behaviours

    Controlling behaviours are assessed using a modified Sexual Relationship Power (SRP) scale. Men's control of female sexual partner's and women's experience of controlling behaviours from a male partner.

    Time frame: 12 months post baseline

  5. Condom use at last sex

    Single item asking about condom use at last sex

    Time frame: 12 months post baseline

  6. Hunger in the past month

    Single item assesses hunger in the past month

    Time frame: 12 months post baseline

06

Study locations

1 site
  • Gender and Health Research Unit, South African Medical Research Council
    Durban, KwaZulu-Natal 4001, South Africa
07

References and documents

Publications

  • Gibbs A, Willan S, Jama-Shai N, Washington L, Jewkes R. 'Eh! I felt I was sabotaged!': facilitators' understandings of success in a participatory HIV and IPV prevention intervention in urban South Africa. Health Educ Res. 2015 Dec;30(6):985-95. doi: 10.1093/her/cyv059. PubMed 26590246 ↗
  • Jewkes R, Gibbs A, Jama-Shai N, Willan S, Misselhorn A, Mushinga M, Washington L, Mbatha N, Skiweyiya Y. Stepping Stones and Creating Futures intervention: shortened interrupted time series evaluation of a behavioural and structural health promotion and violence prevention intervention for young people in informal settlements in Durban, South Africa. BMC Public Health. 2014 Dec 29;14:1325. doi: 10.1186/1471-2458-14-1325. PubMed 25544716 ↗
08

Registry details

Key details

Study ID
NCT03257176
Lead sponsor
University of KwaZulu
Collaborators
Medical Research Council, South Africa, Project Empower
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
May 2, 2012
Primary completion
Jul 30, 2013
Completion
Jul 30, 2013
Last update
Aug 22, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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