Stepping Stones and Creating Futures Intervention Trial

Sexual Violence Clinical Trial

Official title:

Stepping Stones and Creating Futures Intervention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022370
• Other study ID #: BFC043/15
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: May 2020
• Source: University of KwaZulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1351
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• IPV
• Sexual Violence

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of KwaZulu	Department for International Development, United Kingdom, London School of Hygiene and Tropical Medicine, Project Empower

Country where clinical trial is conducted

South Africa, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
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, with no upper limit.	24 months post baseline
Secondary	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)	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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)	24 months post baseline
Secondary	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)	24 months post baseline
Secondary	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.	24 months post baseline
Secondary	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.	24 months post baseline