- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00790959
The SASA! Study: An Evaluation of a Community Intervention to Address Gender-based Violence and Reduce HIV/AIDS Risk in Uganda (SASA!)
The SASA! Study: a Cluster Randomised Controlled Trial of a Community Mobilisation Intervention to Prevention Violence Against Women and Reduce HIV/AIDS Risk in Kampala, Uganda
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background : Physical and sexual violence against women is widespread in Uganda, and is increasingly recognized as a major global social, public health and human rights problem. Epidemiological evidence demonstrates that violence may also be intimately tied in with HIV risk, with violence being both a risk factor for and a consequence of HIV infection.Behaviours that often form the cornerstone of HIV prevention messages such as refusal of sex, inquiring about other partners, or suggesting condom use, have all been identified as triggers of intimate partner violence (IPV) in various settings.
There is now growing interest in integrated HIV/violence prevention strategies to tackle the underlying notions of masculinity that condone both male infidelity and male control over women. Promising research from South Africa and Brazil suggests that interventions which explicitly aim to challenge gender inequalities (either through economic empowerment of women or discussion with men and women about gender inequalities, norms and their implications), may influence levels of violence and HIV risk behaviours. However, such interventions remain few in number, as do scientifically rigorous evaluations of them.
Intervention Design :
SASA! uses a community mobilization approach to address gender inequity and try to change attitudes and behaviours that support both HIV risk behaviours and the perpetration of violence against women.
SASA! supports communities through a four-phase process of social change (based on a social-level adaptation of the Stages of Change Theory):
- Start to think about violence against women and HIV/AIDS as interconnected issues and the need to personally address these issues
- Awareness raising about how communities accept men's use of power over women, fueling violence against women and HIV/AIDS
- Support women and men directly affected by/involved in these issues to change
- Action to prevent violence against women and HIV/AIDS
The intervention team engages with four major groups of actors: community volunteers selected from the general public; community leaders (e.g. religious, cultural and local council leaders); resource persons (health care providers, police, etc); and institutional leaders. The community volunteers are key agents to raise awareness about power imbalances between men and women, discuss the impacts of HIV and violence against women, discuss the benefits of non-violence and gender equity, and most importantly to mobilize others in the community to take action thereby promoting sustainable change.
Study design:
The SASA! Study randomized four pairs of communities that were matched on population density and stability/transience. The intervention communities received the SASA! intervention from early 2008. Comparison communities will receive the intervention approximately three years later.
A cross-sectional survey will be conducted among community members prior to the implementation of SASA! in their communities. Another cross-sectional survey was initially planned for three years post-implementation, but later delayed to four years post-implementation due to political disturbances that caused interruptions to programme activity. The primary outcomes are: past year experience of physical IPV (among partnered women); past year experience of sexual IPV (among partnered women); acceptability of violence against women; acceptability of a woman refusing sex; community response to women experiencing violence (among women reporting past year physical and/or sexual IPV); and past year concurrent sexual partners (among partnered men). Data analysis will be appropriate to the cluster-randomized study design. The target sample size per arm at each round of data collection is 800.
Complementary qualitative and quantitative data will also be collected (from community volunteers and resource people as well as from community members) to document processes of change and potential pathways of impact.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kampala, Uganda
- Recruiting
- Raising Voices
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Principal Investigator:
- Lori Michau, MA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lived in the community for at least one year
- Aged 18-49 years
- Satisfy gender requirement for sampling sub-cluster
Exclusion Criteria:
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: SASA!
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A community mobilization approach to try to change community and individual attitudes and behaviours that support both the perpetration of violence against women and HIV risk behaviours The intervention team engages with four major groups of actors: community volunteers selected from the general public; community leaders (e.g. religious, cultural and local council leaders); resource persons (health care providers, police, etc); and institutional leaders. The community volunteers are a key component of the intensive intervention. |
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ACTIVE_COMPARATOR: Control
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Control communities will receive the full SASA! intervention after completion of the SASA! Study. For the duration of the study, they will receive a less intensive intervention comprising the Division-level elements of SASA! (involving community leaders, resource persons and institutional leaders) without the community volunteers. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Past year experience of physical violence by an intimate partner (among women partnered in past year)
Time Frame: 4 years after intervention implementation
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4 years after intervention implementation
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Past year experience of sexual violence by an intimate partner (among women partnered in the past year)
Time Frame: 4 years after intervention implementation
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4 years after intervention implementation
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Acceptability of violence against women
Time Frame: 4 years after intervention implementation
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4 years after intervention implementation
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Acceptability of a woman refusing sex
Time Frame: 4 years after intervention implementation
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4 years after intervention implementation
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Community response to women experiencing physical and/or sexual IPV in past year (among women reporting physical/sexual IPV in past year)
Time Frame: 4 years after intervention implementation
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4 years after intervention implementation
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Past year concurrent sexual partner (among men partnered in past year)
Time Frame: 4 years after intervention implementation
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4 years after intervention implementation
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charlotte Watts, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
General Publications
- Abramsky T, Musuya T, Namy S, Watts C, Michau L. Changing the norms that drive intimate partner violence: findings from a cluster randomised trial on what predisposes bystanders to take action in Kampala, Uganda. BMJ Glob Health. 2018 Dec 14;3(6):e001109. doi: 10.1136/bmjgh-2018-001109. eCollection 2018.
- Starmann E, Heise L, Kyegombe N, Devries K, Abramsky T, Michau L, Musuya T, Watts C, Collumbien M. Examining diffusion to understand the how of SASA!, a violence against women and HIV prevention intervention in Uganda. BMC Public Health. 2018 May 11;18(1):616. doi: 10.1186/s12889-018-5508-4.
- Abramsky T, Devries KM, Michau L, Nakuti J, Musuya T, Kiss L, Kyegombe N, Watts C. Ecological pathways to prevention: How does the SASA! community mobilisation model work to prevent physical intimate partner violence against women? BMC Public Health. 2016 Apr 16;16:339. doi: 10.1186/s12889-016-3018-9.
- Michaels-Igbokwe C, Abramsky T, Devries K, Michau L, Musuya T, Watts C. Cost and cost-effectiveness analysis of a community mobilisation intervention to reduce intimate partner violence in Kampala, Uganda. BMC Public Health. 2016 Feb 29;16:196. doi: 10.1186/s12889-016-2883-6.
- Abramsky T, Devries KM, Michau L, Nakuti J, Musuya T, Kyegombe N, Watts C. The impact of SASA!, a community mobilisation intervention, on women's experiences of intimate partner violence: secondary findings from a cluster randomised trial in Kampala, Uganda. J Epidemiol Community Health. 2016 Aug;70(8):818-25. doi: 10.1136/jech-2015-206665. Epub 2016 Feb 12.
- Kyegombe N, Abramsky T, Devries KM, Starmann E, Michau L, Nakuti J, Musuya T, Heise L, Watts C. The impact of SASA!, a community mobilization intervention, on reported HIV-related risk behaviours and relationship dynamics in Kampala, Uganda. J Int AIDS Soc. 2014 Nov 5;17(1):19232. doi: 10.7448/IAS.17.1.19232. eCollection 2014.
- Abramsky T, Devries K, Kiss L, Nakuti J, Kyegombe N, Starmann E, Cundill B, Francisco L, Kaye D, Musuya T, Michau L, Watts C. Findings from the SASA! Study: a cluster randomized controlled trial to assess the impact of a community mobilization intervention to prevent violence against women and reduce HIV risk in Kampala, Uganda. BMC Med. 2014 Jul 31;12:122. doi: 10.1186/s12916-014-0122-5.
- Abramsky T, Devries K, Kiss L, Francisco L, Nakuti J, Musuya T, Kyegombe N, Starmann E, Kaye D, Michau L, Watts C. A community mobilisation intervention to prevent violence against women and reduce HIV/AIDS risk in Kampala, Uganda (the SASA! Study): study protocol for a cluster randomised controlled trial. Trials. 2012 Jun 29;13:96. doi: 10.1186/1745-6215-13-96.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- PHHPSASA1
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