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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!)

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ClinicalTrials.gov Identifier: NCT00790959
Recruitment Status : Unknown
Verified February 2012 by Charlotte Watts, London School of Hygiene and Tropical Medicine.
Recruitment status was:  Recruiting
First Posted : November 14, 2008
Last Update Posted : February 22, 2012
Sponsor:
Collaborators:
Raising Voices
Centre for Domestic Violence Prevention, Uganda
Makerere University
Sigrid Rausing Trust
Irish Aid
Stephen Lewis Foundation
Information provided by (Responsible Party):
Charlotte Watts, London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE November 13, 2008
First Posted Date  ICMJE November 14, 2008
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE October 2007
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2012)
  • Past year experience of physical violence by an intimate partner (among women partnered in past year) [ Time Frame: 4 years after intervention implementation ]
  • Past year experience of sexual violence by an intimate partner (among women partnered in the past year) [ Time Frame: 4 years after intervention implementation ]
  • Acceptability of violence against women [ Time Frame: 4 years after intervention implementation ]
  • Acceptability of a woman refusing sex [ Time Frame: 4 years after intervention implementation ]
  • 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 ]
  • Past year concurrent sexual partner (among men partnered in past year) [ Time Frame: 4 years after intervention implementation ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
Past year experience of physical and/or sexual violence by an intimate partner (among ever-partnered women) [ Time Frame: 3 years after intervention implementation ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The SASA! Study: An Evaluation of a Community Intervention to Address Gender-based Violence and Reduce HIV/AIDS Risk in Uganda
Official Title  ICMJE 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
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):

  1. Start to think about violence against women and HIV/AIDS as interconnected issues and the need to personally address these issues
  2. Awareness raising about how communities accept men's use of power over women, fueling violence against women and HIV/AIDS
  3. Support women and men directly affected by/involved in these issues to change
  4. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Intimate Partner Violence
  • HIV
Intervention  ICMJE
  • Behavioral: SASA!

    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.

  • Other: Control

    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.

Study Arms  ICMJE
  • Experimental: SASA!
    Intervention: Behavioral: SASA!
  • Active Comparator: Control
    Intervention: Other: Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2008)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790959
Other Study ID Numbers  ICMJE PHHPSASA1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charlotte Watts, London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Raising Voices
  • Centre for Domestic Violence Prevention, Uganda
  • Makerere University
  • Sigrid Rausing Trust
  • Irish Aid
  • Stephen Lewis Foundation
Investigators  ICMJE
Principal Investigator: Charlotte Watts, PhD London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP