- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257176
Stepping Stones and Creating Futures Intervention Pilot
August 17, 2017 updated by: University of KwaZulu
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4001
- Gender and Health Research Unit, South African Medical Research Council
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18
- Mentally competent
- Able to communicate in English, Zulu, or Xhosa
- Normally resident in the informal settlement
Exclusion Criteria:
- Over 30
- Unable to do informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stepping Stones and Creating Futures
Receive the 21 session intervention
|
21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication.
11 Creating Futures sessions focused on livelihoods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Past three month physical IPV perpetration (men) and experience (women)
Time Frame: 12 months post baseline
|
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)
Time Frame: 12 months post baseline
|
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
Time Frame: 12 months post baseline
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work stress
Time Frame: 12 months post baseline
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4 items ask about work stress because of a lack of work.
Responses are on a likert scale.
|
12 months post baseline
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Feelings about work shame
Time Frame: 12 months post baseline
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4 items ask about shame because of type and lack of work.
Responses are on a likert scale.
|
12 months post baseline
|
Gender attitudes
Time Frame: 12 months post baseline
|
Modified gender equitable men's scale assess participant's gender attitudes.
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12 months post baseline
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Controlling behaviours
Time Frame: 12 months post baseline
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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.
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12 months post baseline
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Condom use at last sex
Time Frame: 12 months post baseline
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Single item asking about condom use at last sex
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12 months post baseline
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Hunger in the past month
Time Frame: 12 months post baseline
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Single item assesses hunger in the past month
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12 months post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2012
Primary Completion (Actual)
July 30, 2013
Study Completion (Actual)
July 30, 2013
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 17, 2017
First Posted (Actual)
August 22, 2017
Study Record Updates
Last Update Posted (Actual)
August 22, 2017
Last Update Submitted That Met QC Criteria
August 17, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- HSS/0789/011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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