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The SASA! Study: An Evaluation of a Community Intervention to Address Gender-based Violence and Reduce HIV/AIDS Risk in Uganda (SASA!)

Primary Purpose

Intimate Partner Violence, HIV

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
SASA!
Control
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intimate Partner Violence focused on measuring Intimate Partner Violence, HIV/AIDS, Gender, Prevention, Community mobilisation, Uganda

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Raising VoicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SASA!

Control

Arm Description

Outcomes

Primary Outcome Measures

Past year experience of physical violence by an intimate partner (among women partnered in past year)
Past year experience of sexual violence by an intimate partner (among women partnered in the past year)
Acceptability of violence against women
Acceptability of a woman refusing sex
Community response to women experiencing physical and/or sexual IPV in past year (among women reporting physical/sexual IPV in past year)
Past year concurrent sexual partner (among men partnered in past year)

Secondary Outcome Measures

Full Information

First Posted
November 13, 2008
Last Updated
February 21, 2012
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Raising Voices, Centre for Domestic Violence Prevention, Uganda, Makerere University, Sigrid Rausing Trust, Irish Aid, Stephen Lewis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00790959
Brief Title
The SASA! Study: An Evaluation of a Community Intervention to Address Gender-based Violence and Reduce HIV/AIDS Risk in Uganda
Acronym
SASA!
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Raising Voices, Centre for Domestic Violence Prevention, Uganda, Makerere University, Sigrid Rausing Trust, Irish Aid, Stephen Lewis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The SASA! Study is a cluster randomized trial of a community mobilization intervention for the prevention of HIV and gender based violence. The study is being conducted in Kampala, Uganda.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intimate Partner Violence, HIV
Keywords
Intimate Partner Violence, HIV/AIDS, Gender, Prevention, Community mobilisation, Uganda

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SASA!
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
SASA!
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Past year experience of physical violence by an intimate partner (among women partnered in past year)
Time Frame
4 years after intervention implementation
Title
Past year experience of sexual violence by an intimate partner (among women partnered in the past year)
Time Frame
4 years after intervention implementation
Title
Acceptability of violence against women
Time Frame
4 years after intervention implementation
Title
Acceptability of a woman refusing sex
Time Frame
4 years after intervention implementation
Title
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
Title
Past year concurrent sexual partner (among men partnered in past year)
Time Frame
4 years after intervention implementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Michau, MA
Phone
+256 41 4531186
Email
lori.michau@raisingvoices.org
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Watts, PhD
Phone
+44 (0) 20 7927 2412
Email
charlotte.watts@lshtm.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Watts, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raising Voices
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Michau, MA

12. IPD Sharing Statement

Citations:
PubMed Identifier
30613427
Citation
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.
Results Reference
derived
PubMed Identifier
29751754
Citation
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.
Results Reference
derived
PubMed Identifier
27084116
Citation
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.
Results Reference
derived
PubMed Identifier
26924488
Citation
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.
Results Reference
derived
PubMed Identifier
26873948
Citation
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.
Results Reference
derived
PubMed Identifier
25377588
Citation
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.
Results Reference
derived
PubMed Identifier
25248996
Citation
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.
Results Reference
derived
PubMed Identifier
22747846
Citation
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.
Results Reference
derived

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The SASA! Study: An Evaluation of a Community Intervention to Address Gender-based Violence and Reduce HIV/AIDS Risk in Uganda

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