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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2012 by London School of Hygiene and Tropical Medicine.
Recruitment status was Recruiting

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

ClinicalTrials.gov Identifier:

NCT00790959

First received: November 13, 2008

Last updated: February 21, 2012

Last verified: February 2012

History of Changes

Purpose

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	Intervention
Intimate Partner Violence HIV	Behavioral: SASA! Other: Control


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

Past year experience of physical violence by an intimate partner (among women partnered in past year) [ Time Frame: 4 years after intervention implementation ] [ Designated as safety issue: No ]
Past year experience of sexual violence by an intimate partner (among women partnered in the past year) [ Time Frame: 4 years after intervention implementation ] [ Designated as safety issue: No ]
Acceptability of violence against women [ Time Frame: 4 years after intervention implementation ] [ Designated as safety issue: No ]
Acceptability of a woman refusing sex [ Time Frame: 4 years after intervention implementation ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Past year concurrent sexual partner (among men partnered in past year) [ Time Frame: 4 years after intervention implementation ] [ Designated as safety issue: No ]


Estimated Enrollment:	800
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided by London School of Hygiene and Tropical Medicine

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

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;17:19232. 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.


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
Study First Received:	November 13, 2008
Last Updated:	February 21, 2012
Health Authority:	Uganda: Makerere University Ethics Board Uganda: National Council of Science and Technology

Keywords provided by London School of Hygiene and Tropical Medicine:


Intimate Partner Violence HIV/AIDS Gender	Prevention Community mobilisation Uganda

ClinicalTrials.gov processed this record on February 27, 2015

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