Stepping Stones and Creating Futures Intervention Trial

NCT ID: NCT03022370

Last Updated: 2020-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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IPV Sexual Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Stepping Stones and Creating Futures

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stepping Stones and Creating Futures

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Department for International Development, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Project Empower

OTHER

Sponsor Role collaborator

University of KwaZulu

OTHER

Sponsor Role lead

Responsible Party

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Andrew Gibbs

Principal Investigator, Senior Specialist Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Gibbs, PhD

Role: PRINCIPAL_INVESTIGATOR

Gender and Health Research Unit, South African Medical Research Council (SAMRC); Health Economics and HIV/AIDS Research Division (HEARD), University of KwaZulu Natal

Locations

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Gender and Health Research Unit, South African Medical Research Council

Durban, KwaZulu-Natal, South Africa

Site Status

Countries

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South Africa

References

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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.

Reference Type BACKGROUND
PMID: 28427380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29624612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29659595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31784410 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36927500 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35487735 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32424011 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30281677 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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BFC043/15

Identifier Type: -

Identifier Source: org_study_id

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