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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03257176
Other study ID # HSS/0789/011
Secondary ID
Status Completed
Phase Phase 2
First received August 7, 2017
Last updated August 17, 2017
Start date May 2, 2012
Est. completion date July 30, 2013

Study information

Verified date August 2017
Source University of KwaZulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date July 30, 2013
Est. primary completion date July 30, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stepping 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.

Locations

Country Name City State
South Africa Gender and Health Research Unit, South African Medical Research Council Durban KwaZulu-Natal

Sponsors (3)

Lead Sponsor Collaborator
University of KwaZulu Medical Research Council, South Africa, Project Empower

Country where clinical trial is conducted

South Africa, 

References & 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. — View Citation

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 v — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Work stress 4 items ask about work stress because of a lack of work. Responses are on a likert scale. 12 months post baseline
Secondary Feelings about work shame 4 items ask about shame because of type and lack of work. Responses are on a likert scale. 12 months post baseline
Secondary Gender attitudes Modified gender equitable men's scale assess participant's gender attitudes. 12 months post baseline
Secondary 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. 12 months post baseline
Secondary Condom use at last sex Single item asking about condom use at last sex 12 months post baseline
Secondary Hunger in the past month Single item assesses hunger in the past month 12 months post baseline
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