Intimate Partner ViolenceSASA!NCT00790959
The SASA! Study: An Evaluation of a Community Intervention to Address Gender-based Violence and Reduce HIV/AIDS Risk in Uganda
A study testing SASA! in people with Intimate Partner Violence and HIV, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence, HIV
- What is being tested?
- SASA!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2007to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lived in the community for at least one year
- Aged 18-49 years
- Satisfy gender requirement for sampling sub-cluster
Who cannot join
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Raising Voices
Kampala, Kampala
Lori Michau, MA
About this study
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
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.
Read the 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.
- Conditions
- Intimate Partner Violence, HIV
- Being tested
- SASA!, Control
- Keywords
- Intimate Partner Violence, HIV/AIDS, Gender, Prevention, Community mobilisation, Uganda
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SASA!Behavioural
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.
ControlOther
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 group | Role | What they receive |
|---|---|---|
| SASA! | Experimental | Not described Receives: Behavioral: SASA! |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Past year experience of physical violence by an intimate partner (among women partnered in past year)
Measured: 4 years after intervention implementation
Past year experience of sexual violence by an intimate partner (among women partnered in the past year)
Measured: 4 years after intervention implementation
Acceptability of violence against women
Measured: 4 years after intervention implementation
Acceptability of a woman refusing sex
Measured: 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)
Measured: 4 years after intervention implementation
Past year concurrent sexual partner (among men partnered in past year)
Measured: 4 years after intervention implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startOct 2007
- Primary completionMay 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Raising Voices, Centre for Domestic Violence Prevention, Uganda, Makerere University, Sigrid Rausing Trust, Irish Aid, Stephen Lewis Foundation
- Responsible party
- Principal investigator, Charlotte Watts, London School of Hygiene and Tropical Medicine
- Investigators
- Charlotte Watts, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790959
- Sponsor's protocol ID
- PHHPSASA1
- Acronym
- SASA!
- Status last verified
- Feb 2012
- First submitted
- 13 Nov 2008
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30613427Starmann 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.
PubMed 29751754Abramsky 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.
PubMed 27084116Michaels-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.
PubMed 26924488Abramsky 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.
PubMed 26873948Kyegombe 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.
PubMed 25377588Abramsky 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.
PubMed 25248996Abramsky 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.
PubMed 22747846
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00790959
- Acronym / sponsor ID
- SASA! / PHHPSASA1
- Conditions
- Intimate Partner Violence, HIV
- Keywords
- Intimate Partner Violence, HIV/AIDS, Gender, Prevention, Community mobilisation, Uganda
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Raising Voices, Centre for Domestic Violence Prevention, Uganda, Makerere University, Sigrid Rausing Trust, Irish Aid, Stephen Lewis Foundation
- Study start
- Oct 2007
- Primary completion
- May 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SASA! | Experimental | Behavioral: SASA! |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Lived in the community for at least one year
- Aged 18-49 years
- Satisfy gender requirement for sampling sub-cluster
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | SASA! |
| ControlControl 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. | Other | Control |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Derived from this study: PubMed 30613427Abramsky 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.
- Derived from this study: PubMed 29751754Starmann 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.
- Derived from this study: PubMed 27084116Abramsky 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.
- Derived from this study: PubMed 26924488Michaels-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.
- Derived from this study: PubMed 26873948Abramsky 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.
- Derived from this study: PubMed 25377588Kyegombe 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.
- Derived from this study: PubMed 25248996Abramsky 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.
- Derived from this study: PubMed 22747846Abramsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Watts, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SASA! in people with Intimate Partner Violence and HIV, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lori Michau, MA (+256 41 4531186, lori.michau@raisingvoices.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Past year experience of physical violence by an intimate partner (among women partnered in past year) (time frame: 4 years after intervention implementation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790959, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.