Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910671626213 Date of Approval: 18/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Using Community Health Clubs to develop a Community Sexual and Gender Based Violence Scorecard to reduce Sexual and Gender Based Violence in Mayuge district, Uganda
Official scientific title Evaluating the effect of empowered Community Health Clubs and a Community Scorecard on Sexual and Gender Based Violence in Mayuge district, Uganda: A quasi-experimental study
Brief summary describing the background and objectives of the trial In Uganda, 22% of women have experienced some form of sexual violence, and this is commonest among the disabled, those with the least education and wealth. Moreover, 51% of all these victims neither seek help nor tell anyone about the violence. This lack of reporting, because of the stigma attached to Sexual and Gender Based Violence (SGBV), leaves many women suffering in silence and exposes them to many health risks, including HIV. This violence affects their quality of life and productivity. Community Health Clubs (CHCs) have been used previously to improve sanitation and hygiene. They are participatory and purposeful, and empower the community to take responsibility and action against health problems. However, their potential to address the community drivers of SGBV has not been explored. This study will leverage CHCs to empower communities to take a lead role in identifying solutions to SGBV and advocate for better services for victims in four villages in Mayuge district, Uganda. Through these clubs, the community will receive information about SGBV and the available post-violence care services. CHCs will also be used to empower women financially by equipping them with entrepreneurial and savings skills so as to enhance financial independence and reduce their vulnerability to SGBV. Additionally, a community SGBV score card will be developed and tested through the CHCs and community dialogues to enhance reporting and generate more evidence on SGBV in Mayuge district. With this intervention, the study aims to reduce the occurrence of SGBV, increase its reporting rate and the utilization of victim support services and also increase the number of women enrolled in savings groups in Mayuge district.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/10/2019
Actual trial start date
Anticipated date of last follow up 31/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 908
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community Health Clubs and a Community SGBV Scorecard 9 months Community Health Clubs focused on SGBV will be formed in 4 villages and supported to carry out activities such as educating other community members about SGBV, linking victims of SGBV to care and reporting cases of SGBV. The club members will be facilitated to identify the main drivers of SGBV in their community, agree on actions to take, act on them, evaluate effects of their actions and take further action where there is a need. Club members will also be provided with financial literacy by a financial adviser on saving, business and financial management and loan application. Through these clubs and community interface meetings, a Community SGBV Scorecard will also be developed and piloted in the district. Interface meetings involving community members and service providers of post-violence services to victims of SGBV will be held every 3 months to score and assess community progress towards reducing SGBV. 454
Control Group Standard of Care 9 months No Community Health Clubs will be formed in the 4 control villages and no Community Scorecard will be piloted there. Prevention of SGBV and the management of victims of SGBV will continue as per national guidelines. 454 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women and men living in the selected villages in Mayuge district aged 18 years and older or aged 15 to 17 years but considered to be emancipated minors will be eligible to participate in the study. These will be women and men who normally live in the visited household, domestic servants who have slept for five nights a week or more in the household and visitors who have slept in the household for at least the past four weeks. All women and men living in the selected villages aged 15 years and older who cannot give consent for one reason or the other will not be eligible to participate in the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/08/2019 Makerere University School of Public Health Higher Degrees Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
New Mulago Hill Rd, Kampala Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rates of SGBV over a six-month period among both women and men 3 and 9 months
Primary Outcome Rates of SGBV reporting by victims 3 and 9 months
Primary Outcome Utilization of support services by victims of SGBV 3 and 6 months
Secondary Outcome Number of women enrolled in savings groups 3 and 9 months
Secondary Outcome Knowledge about SGBV and support services for victims of SGBV among both women and men 3 and 6 months
Secondary Outcome Social acceptance of SGBV among both women and men 3 and 6 months
Secondary Outcome Community perceptions about SGBV 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Makerere University School of Public Health New Mulago Hill Rd, Kampala Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada 661 University Avenue Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University School of Public Health New Mulago Hill Rd, Kampala Kampala 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Noel Namuhani New Mulago Hill Road Kampala Uganda
Christine Nalwadda Kayemba New Mulago Hill Road Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jacquellyn Ssanyu sanyukajacque@gmail.com +256783279549 New Mulago Hill Rd, Kampala
City Postal code Country Position/Affiliation
Kampala Uganda Project Team Lead
Role Name Email Phone Street address
Public Enquiries Christine Nalwadda cnalwadda@musph.ac.ug +256772495169 New Mulago Hill Rd, Kampala
City Postal code Country Position/Affiliation
Kampala Uganda Project advisor
Role Name Email Phone Street address
Scientific Enquiries Noel Namuhani noelnamuhani@gmail.com +256778708631 New Mulago Hill Rd, Kampala
City Postal code Country Position/Affiliation
Kampala Uganda Co Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant qualitative and quantitative data after de-identification. Informed Consent Form,Study Protocol Within 12 months following project completion. No end date. Data will be accessible to anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://figshare.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information