- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022370
Stepping Stones and Creating Futures Intervention Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Normally resident in informal settlement cluster
- Not formally employed
- Able to communicate in main study languages (English, isiZulu, iXhosa)
Exclusion Criteria:
- Under 18
- Mental deficit (learning difficulty, mental illness or substance abuse)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Stepping Stones and Creating Futures
Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators.
Each session last approximately 3 hours.
Sessions are delivered twice a week.
Sessions are primarily single sex, with 20 participants per group.
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Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills. Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending. |
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No Intervention: Wait-list control
Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)
Time Frame: 24 months post baseline
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Physical intimate partner violence is assessed using five items based on the WHO VAW scale.
A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year.
With 0=none, 1=yes.
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24 months post baseline
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Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)
Time Frame: 24 months post baseline
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Sexual intimate partner violence is assessed using three items based on the WHO VAW scale.
A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year.
With 0=none, 1=yes.
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24 months post baseline
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Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)
Time Frame: 24 months post baseline
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Severe sexual and/or physical intimate partner violence perpetration (men) and experience (women) is assessed using 8 items.
Past year severe sexual and/or physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.
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24 months post baseline
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Controlling Behaviours
Time Frame: 24 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.
A mean score is calculated with higher scores indicating more controlling (bad).
Range: 0-24
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24 months post baseline
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Earnings in Past Month
Time Frame: 24 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, with no upper limit.
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24 months post baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gender Attitudes
Time Frame: 24 months post baseline
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Modified gender equitable men's scale (GEMS) assess participant's gender attitudes.
A mean score is calculated with higher scores indicative of more gender inequitable attitudes (range: 0-60)
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24 months post baseline
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Depressive Symptomology
Time Frame: 24 months post baseline
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Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items (range 0-60).
A mean score is calculated, with higher scores indicating more depression.
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24 months post baseline
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Number of Participants Reporting Suicidal Ideation
Time Frame: 24 months post baseline
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Past four week suicidal ideation was assessed using a single item question.
Responses are either 0=no, or 1=yes.
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24 months post baseline
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Life Circumstances
Time Frame: 24 months post baseline
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Four items modified from the Satisfaction with Life Scale (SWLS) by Denier et al. (1985), with items on a five point Likert Scale (range 0-20) higher scores indicative of greater life satisfaction.
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24 months post baseline
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Problem Alcohol Use
Time Frame: 24 months post baseline
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Problem drinking in the past year is assessed using the AUDIT (alcohol use disorders identification test) scale.
With a range of 0-40, and recoded with scores of 8 or more classifing a participant as having potentially problematic alcohol use.
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24 months post baseline
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Number of People Quarreling With Partner About Alcohol Use
Time Frame: 24 months post baseline
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A single item binary response question asks whether participants have argued about alcohol with their sexual partner in the past year (0=no; 1=yes).
Only asked to those who reported alcohol use in the past year.
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24 months post baseline
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Last Sexual Partner of Participant is the Main Partner
Time Frame: 24 months post baseline
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A single item assess who the participant last had sex with, with possible responses being: "main partner", "casual partner", "once-off sex partner" or "ex-partner".
As per the protocol, we recategorised this into either "1=main partner" or "0=other".
Positive change is towards main partner.
And the reported number (proportion) is those reporting Main partner.
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24 months post baseline
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Transactional Sex Past Year
Time Frame: 24 months post baseline
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Five item scale asks about transactional sex with casual or once-off sexual partners in the past year based on the scale developed and tested by Dunkle et al (2004).
Each item has a no/yes response.
A response of yes to any is classified as having engaged in transactional sex.
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24 months post baseline
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Shame About Lack of Work
Time Frame: 24 months post baseline
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Four items assess participants' feelings of shame about not enough work, based on a scale developed for use in the IMAGES study, with .
Mean score calculated, with higher scores indicative of more shame (range: 4-16)
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24 months post baseline
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Stress About Lack of Work
Time Frame: 24 months post baseline
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Four items assess participants' feelings of stress about not enough work, based on a scale developed for the IMAGES study.
Mean score calculated, with higher scores indicating more stress (range: 4-20)
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24 months post baseline
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Individual's Ability to Mobilise Money in an Emergency
Time Frame: 24 months post baseline
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A single item asks participants how hard it would be to mobilise R200 (~US$15) in an emergency.
Those responding it would be "very difficult, or somewhat difficult" are classified as finding it hard (=1).
Those responding "fairly easy or easy" are classified as not finding it hard (=0).
Reported number (proportion) is of those finding it hard to mobilise money in an emergency.
A positive change is towards a lower proportion.
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24 months post baseline
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Stolen Because of Hunger in Past Month
Time Frame: 24 months post baseline
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Single item question asks about stealing because of lack of food or money in the past month with responses "never", "once", "every week" or "every day".
Responses are recoded, as per protocol, into "0=never" and "1=once or more".
The number/proportion of those stealing in the past month is reported.
A lower proportion is a positive change.
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24 months post baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew Gibbs, PhD, Gender and Health Research Unit, South African Medical Research Council (SAMRC); Health Economics and HIV/AIDS Research Division (HEARD), University of KwaZulu Natal
Publications and helpful links
General Publications
- Gibbs A, Dunkle K, Mhlongo S, Chirwa E, Hatcher A, Christofides NJ, Jewkes R. Which men change in intimate partner violence prevention interventions? A trajectory analysis in Rwanda and South Africa. BMJ Glob Health. 2020 May;5(5):e002199. doi: 10.1136/bmjgh-2019-002199.
- Gibbs A, Washington L, Willan S, Ntini N, Khumalo T, Mbatha N, Sikweyiya Y, Shai N, Chirwa E, Strauss M, Ferrari G, Jewkes R. The Stepping Stones and Creating Futures intervention to prevent intimate partner violence and HIV-risk behaviours in Durban, South Africa: study protocol for a cluster randomized control trial, and baseline characteristics. BMC Public Health. 2017 Apr 20;17(1):336. doi: 10.1186/s12889-017-4223-x.
- Gibbs A, Dunkle K, Washington L, Willan S, Shai N, Jewkes R. Childhood traumas as a risk factor for HIV-risk behaviours amongst young women and men living in urban informal settlements in South Africa: A cross-sectional study. PLoS One. 2018 Apr 6;13(4):e0195369. doi: 10.1371/journal.pone.0195369. eCollection 2018.
- Gibbs A, Dunkle K, Jewkes R. Emotional and economic intimate partner violence as key drivers of depression and suicidal ideation: A cross-sectional study among young women in informal settlements in South Africa. PLoS One. 2018 Apr 16;13(4):e0194885. doi: 10.1371/journal.pone.0194885. eCollection 2018.
- Gibbs A, Washington L, Abdelatif N, Chirwa E, Willan S, Shai N, Sikweyiya Y, Mkhwanazi S, Ntini N, Jewkes R. Stepping Stones and Creating Futures Intervention to Prevent Intimate Partner Violence Among Young People: Cluster Randomized Controlled Trial. J Adolesc Health. 2020 Mar;66(3):323-335. doi: 10.1016/j.jadohealth.2019.10.004. Epub 2019 Nov 26.
- Mannell J, Minckas N, Burgess R, Chirwa ED, Jewkes R, Gibbs A. Does experiencing a traumatic life event increase the risk of intimate partner violence for young women? A cross-sectional analysis and structural equation model of data from the Stepping Stones and Creating Futures intervention in South Africa. BMJ Open. 2022 Apr 29;12(4):e051969. doi: 10.1136/bmjopen-2021-051969.
- Gibbs A, Jewkes R, Willan S, Washington L. Associations between poverty, mental health and substance use, gender power, and intimate partner violence amongst young (18-30) women and men in urban informal settlements in South Africa: A cross-sectional study and structural equation model. PLoS One. 2018 Oct 3;13(10):e0204956. doi: 10.1371/journal.pone.0204956. eCollection 2018.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BFC043/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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