Stepping Stones and Creating Futures Intervention Trial

NCT03022370 | Completed Phase 3 Results

• 1 other identifier: BFC043/15
• Study Type: interventional
• Target: 1,351
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether the behavioural/structural interventions of Stepping Stones and Creating Futures can reduce the incidence of intimate partner violence in urban informal settlements amongst young people. Half the participants will receive the interventions, while the other half will be in a control wait-list, only receiving the intervention after final data collection.

Conditions

IPV; Sexual Violence

Keywords

informal settlements; poverty

Outcome Measures

Primary Outcomes (5)

• Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)

  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.

  24 months post baseline

• Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)

  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.

  24 months post baseline

• Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)

  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.

  24 months post baseline

• 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. A mean score is calculated with higher scores indicating more controlling (bad). Range: 0-24

  24 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, with no upper limit.

  24 months post baseline

Secondary Outcomes (12)

• Gender Attitudes

  24 months post baseline

• Depressive Symptomology

  24 months post baseline

• Number of Participants Reporting Suicidal Ideation

  24 months post baseline

• Life Circumstances

  24 months post baseline

• Problem Alcohol Use

  24 months post baseline

Study Arms (2)

Stepping Stones and Creating Futures

EXPERIMENTAL

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.

Behavioral: Stepping Stones and Creating Futures

Wait-list control

NO INTERVENTION

Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.

Interventions

Stepping Stones and Creating Futures BEHAVIORAL

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.

Stepping Stones and Creating Futures

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normally resident in informal settlement cluster
• Not formally employed
• Able to communicate in main study languages (English, isiZulu, iXhosa)

You may not qualify if:

• Under 18
• Mental deficit (learning difficulty, mental illness or substance abuse)

Sponsors & Collaborators

• University of KwaZulu: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Department for International Development, United Kingdom: collaborator
• Project Empower: collaborator

Study Sites (1)

Gender and Health Research Unit, South African Medical Research Council

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (9)

• 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.

  PMID: 28427380 BACKGROUND

• 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.

  PMID: 29624612 BACKGROUND

• 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.

  PMID: 29659595 BACKGROUND

• 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.

  PMID: 31784410 BACKGROUND

• Gibbs A, Mkhwanazi S, Khaula S, Washington L, Sikweyiya Y. A Prospective Analysis of Associations Between Changes in Mental Health and Men's Perpetration of Intimate Partner Violence: Post-Hoc Analysis of Young Men Involved in the Stepping Stones and Creating Futures Trial. J Interpers Violence. 2026 Jan 21:8862605251408126. doi: 10.1177/08862605251408126. Online ahead of print.

  PMID: 41562393 DERIVED

• Oyekunle V, Gibbs A, Tomita A. Assessing the role of depression in reducing intimate partner violence perpetration among young men living in urban informal settlements using a mediation analysis of the Stepping Stones and Creating Futures intervention. Glob Health Action. 2023 Dec 31;16(1):2188686. doi: 10.1080/16549716.2023.2188686.

  PMID: 36927500 DERIVED

• 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.

  PMID: 35487735 DERIVED

• 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.

  PMID: 32424011 DERIVED

• 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.

  PMID: 30281677 DERIVED

Results Point of Contact

• Title: Dr Andrew Gibbs
• Organization: SAMRC

andrew.gibbs@mrc.ac.za

+27(0)312034899

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Specialist Scientist

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 16, 2017
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)