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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

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.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence HIV Behavioral: SASA! Other: Control Not Applicable

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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 : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2007
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SASA! 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.

Active Comparator: Control 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.




Primary Outcome Measures :
  1. Past year experience of physical violence by an intimate partner (among women partnered in past year) [ Time Frame: 4 years after intervention implementation ]
  2. Past year experience of sexual violence by an intimate partner (among women partnered in the past year) [ Time Frame: 4 years after intervention implementation ]
  3. Acceptability of violence against women [ Time Frame: 4 years after intervention implementation ]
  4. Acceptability of a woman refusing sex [ Time Frame: 4 years after intervention implementation ]
  5. 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 ]
  6. Past year concurrent sexual partner (among men partnered in past year) [ Time Frame: 4 years after intervention implementation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790959


Contacts
Contact: Lori Michau, MA +256 41 4531186 lori.michau@raisingvoices.org
Contact: Charlotte Watts, PhD +44 (0) 20 7927 2412 charlotte.watts@lshtm.ac.uk

Locations
Uganda
Raising Voices Recruiting
Kampala, Uganda
Principal Investigator: Lori Michau, MA         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Raising Voices
Centre for Domestic Violence Prevention, Uganda
Makerere University
Sigrid Rausing Trust
Irish Aid
Stephen Lewis Foundation
Investigators
Principal Investigator: Charlotte Watts, PhD London School of Hygiene and Tropical Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Charlotte Watts, Professor of Social and Mathematical Epidemiology, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00790959     History of Changes
Other Study ID Numbers: PHHPSASA1
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Charlotte Watts, London School of Hygiene and Tropical Medicine:
Intimate Partner Violence
HIV/AIDS
Gender
Prevention
Community mobilisation
Uganda