IPVPhase 3NCT03022370

Stepping Stones and Creating Futures Intervention Trial

A Phase 3 study testing Stepping Stones and Creating Futures in people with IPV and Sexual Violence, run by University of KwaZulu at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: IPV, Sexual Violence
What is being tested?: Stepping Stones and Creating Futures
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,351 participants
Where: 1 siteSouth Africa
Study dates: Oct 2015to Oct 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Gender and Health Research Unit, South African Medical Research Council
Durban, KwaZulu-Natal, 4001

Other trials in South Africa

About this study

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
Being tested: Stepping Stones and Creating Futures
Keywords: informal settlements, poverty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stepping Stones and Creating FuturesBehavioural
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.

Study groups in NCT03022370
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 24 months post baseline

Secondary outcomes (12)

Gender Attitudes
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)
Measured: 24 months post baseline
Depressive Symptomology
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.
Measured: 24 months post baseline
Number of Participants Reporting Suicidal Ideation
Past four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.
Measured: 24 months post baseline
Life Circumstances
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.
Measured: 24 months post baseline
Problem Alcohol Use
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.
Measured: 24 months post baseline
Number of People Quarreling With Partner About Alcohol Use
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.
Measured: 24 months post baseline
Last Sexual Partner of Participant is the Main Partner
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.
Measured: 24 months post baseline
Transactional Sex Past Year
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.
Measured: 24 months post baseline
Shame About Lack of Work
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)
Measured: 24 months post baseline
Stress About Lack of Work
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)
Measured: 24 months post baseline
Individual's Ability to Mobilise Money in an Emergency
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.
Measured: 24 months post baseline
Stolen Because of Hunger in Past Month
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.
Measured: 24 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Oct 2018

First posted16 Jan 2017 (estimated)
Study startOct 2015
Primary completionOct 2018
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for IPVStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03022370
Sponsor's protocol ID: BFC043/15
Status last verified: May 2020
First submitted: 5 Jan 2017
Last updated: 4 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 28427380
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.
PubMed 29624612
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.
PubMed 29659595
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.
PubMed 31784410
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.
PubMed 41562393
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.
PubMed 36927500
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.
PubMed 35487735
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.
PubMed 32424011
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.
PubMed 30281677

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stepping Stones and Creating Futures Intervention Trial
ClinicalTrials.gov ID: NCT03022370
Acronym / sponsor ID: BFC043/15
Conditions: IPV, Sexual Violence
Keywords: informal settlements, poverty
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,351 participants (actual)
Lead sponsor: University of KwaZuluUniversity, hospital or other
Collaborators: London School of Hygiene and Tropical Medicine, Department for International Development, United Kingdom, Project Empower
Study start: Oct 2015
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 16 Jan 2017 (estimated)
Results: Posted 4 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stepping Stones and Creating Futures	Experimental	Behavioral: Stepping Stones and Creating FuturesParticipants 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.
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.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stepping Stones and Creating FuturesStepping 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.	Behavioural	Stepping Stones and Creating Futures

Primary outcome

Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)
Time frame: 24 months post baseline
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.
Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)
Time frame: 24 months post baseline
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.
Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)
Time frame: 24 months post baseline
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.
Controlling Behaviours
Time frame: 24 months post baseline
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
Earnings in Past Month
Time frame: 24 months post baseline
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.

12 secondary outcomes

Gender Attitudes
Time frame: 24 months post baseline
Depressive Symptomology
Time frame: 24 months post baseline
Number of Participants Reporting Suicidal Ideation
Time frame: 24 months post baseline
Life Circumstances
Time frame: 24 months post baseline
Problem Alcohol Use
Time frame: 24 months post baseline
Number of People Quarreling With Partner About Alcohol Use
Time frame: 24 months post baseline
Last Sexual Partner of Participant is the Main Partner
Time frame: 24 months post baseline
Transactional Sex Past Year
Time frame: 24 months post baseline
Shame About Lack of Work
Time frame: 24 months post baseline
Stress About Lack of Work
Time frame: 24 months post baseline
Individual's Ability to Mobilise Money in an Emergency
Time frame: 24 months post baseline
Stolen Because of Hunger in Past Month
Time frame: 24 months post baseline

Results and safety

Results posted to the registry on 4 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stepping Stones and Creating Futures	677	497
Wait-list Control	674	553

Primary outcome: Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)

Time frame: 24 months post baseline. Count of participants. Unit: Participants

Measure	Women - Intervention n = 260	Men - Intervention n = 237	Women - Control n = 285	Men - Control n = 268
Value	134	86	155	118

Women - Intervention vs Women - Control: Odds Ratio (OR): 0.92 (95% CI 0.62 to 1.37), p =0.686, Regression, Logistic
Men - Intervention vs Men - Control: Odds Ratio (OR): 0.71 (95% CI 0.51 to 0.97), p =0.032, Regression, Logistic

Primary outcome: Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)

Time frame: 24 months post baseline. Count of participants. Unit: Participants

Measure	Women - Intervention n = 260	Men - Intervention n = 237	Women - Control n = 285	Men - Control n = 268
Value	86	52	101	73

Women - Intervention vs Women - Control: Odds Ratio (OR): 0.90 (95% CI 0.64 to 1.28), p = 0.555, Regression, Logistic
Men - Intervention vs Men - Control: Odds Ratio (OR): 0.74 (95% CI 0.54 to 1.03), p = 0.072, Regression, Logistic

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

Time frame: 24 months post baseline. Count of participants. Unit: Participants

Measure	Women - Intervention n = 260	Men - Intervention n = 237	Women - Control n = 285	Men - Control n = 268
Value	151	99	171	135

Women - Intervention vs Women - Control: Odds Ratio (OR): 0.93 (95% CI 0.66 to 1.31), p = 0.672, Regression, Logistic
Men - Intervention vs Men - Control: Odds Ratio (OR): 0.70 (95% CI 0.52 to 0.94), p = 0.019, Regression, Logistic

Primary outcome: Controlling Behaviours

Time frame: 24 months post baseline. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Women - Intervention n = 260	Men - Intervention n = 237	Women - Control n = 285	Men - Control n = 268
Value	9.75 (9.17 to 10.32)	9.96 (9.36 to 10.56)	9.70 (9.12 to 10.22)	9.96 (9.44 to 10.47)

Women - Intervention vs Women - Control: Slope: -0.01 (95% CI -0.88 to 0.86), p = 0.984, Regression, Linear
Men - Intervention vs Men - Control: Slope: 0.06 (95% CI -0.51 to 0.63), p = 0.839, Regression, Linear

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months of follow up. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Women - Intervention	3 of 339 (0.9%)	0 of 339 (0%)	5 of 339
Men - Intervention	2 of 338 (0.6%)	0 of 338 (0%)	3 of 338
Women - Control	0 of 338 (0%)	0 of 338 (0%)	3 of 338
Men - Control	0 of 336 (0%)	0 of 336 (0%)	7 of 336

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28427380Gibbs 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.
Background: PubMed 29624612Gibbs 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.
Background: PubMed 29659595Gibbs 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.
Background: PubMed 31784410Gibbs 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.
Derived from this study: PubMed 41562393Gibbs 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.
Derived from this study: PubMed 36927500Oyekunle 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.
Derived from this study: PubMed 35487735Mannell 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.
Derived from this study: PubMed 32424011Gibbs 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.
Derived from this study: PubMed 30281677Gibbs 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Gibbs, PhD 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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stepping Stones and Creating Futures in people with IPV and Sexual Violence, run by University of KwaZulu at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women) (time frame: 24 months post baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03022370, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.