NCT03257176

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 7, 2017

Last Update Submit

August 17, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 months post baseline

  • 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.

    12 months post baseline

  • 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.

    12 months post baseline

Secondary Outcomes (6)

  • Work stress

    12 months post baseline

  • Feelings about work shame

    12 months post baseline

  • Gender attitudes

    12 months post baseline

  • Controlling behaviours

    12 months post baseline

  • Condom use at last sex

    12 months post baseline

  • +1 more secondary outcomes

Study Arms (1)

Stepping Stones and Creating Futures

EXPERIMENTAL

Receive the 21 session intervention

Behavioral: Stepping Stones and Creating Futures

Interventions

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

Stepping Stones and Creating Futures

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Over 30
  • Unable to do informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gender and Health Research Unit, South African Medical Research Council

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (2)

  • 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.

    PMID: 26590246BACKGROUND
  • 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.

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 22, 2017

Study Start

May 2, 2012

Primary Completion

July 30, 2013

Study Completion

July 30, 2013

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations