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.: PACTR202209574419961 Date of Approval: 22/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessing the effectiveness of a reporting network and SGBV information in reducing the incidence of sexual violence among adolescent girls and young women in Homabay, Migori and Kisii Counties.
Official scientific title Assessing the effectiveness of a reporting network and SGBV information in reducing the incidence of sexual violence among adolescent girls and young women in Homabay, Migori and Kisii Counties.
Brief summary describing the background and objectives of the trial Globally more than half of the people living with HIV are composed of women aged between 15 and 49. In sub-Saharan Africa one out of every five new HIV infections occur among AGYW; in hard hit countries, 80% of new HIV infections among adolescents are among girls. The following factors have been attributed to causing high rates of HIV infection among AGYW; incorrect perception of HIV risk and/or low knowledge on sexual and reproductive health, engagement in unsafe sex practices (multiple sex partnerships, sex without condom use, anal sex), engagement in age- disparate and/or transactional relationships and sexual and gender based violence (SGBV). SGBV increases the risk of acquisition of HIV and other sexually transmitted infections (STIs) among AGYW since women who are violated or are in abusive relationships are vulnerable given they are not able to refuse or negotiate for safe sex. Despite the interventions put in place, incidences of SGBV against women and girls are still high. AGYW are reluctant to report SGBV incidents because of societal and structural barriers such as social stigma and shame, distrust of institutions, fear of retaliation by the perpetrators, lack of awareness and access to referral services, and in several cultural settings, high tolerance towards violence. The proposed study seeks to assess the effectiveness of an SGBV information and reporting network in reducing sexual violence among AGYW. Study Objectives 1. To determine the prevalence of SGBV among AGYW living in Homabay, Migori and Kisii Counties. 2. To assess the effectiveness of a reporting network and SGBV information, implemented separately and together, in reducing the incidence of sexual violence among AGYW in Homabay, Migori and Kisii Counties. 3. To identify the perpetrators of SGBV among AGYW in Homabay, Migori and Kisii Counties. 4. To assess barriers and facilitating factors of SGBV reporting to inform future scale-up.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Using a reporting network and sharing information on SGBV in reducing the incidence of sexual violence among adolescent girls and young women.
Anticipated trial start date 02/03/2022
Actual trial start date 12/04/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date 20/11/2022
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 4324 Kenya Medical Research Institute - Scientific Ethics Review Unit
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Not applicable Not applicable 6 months This will be a cluster randomized control study. The study staff will purposively select 12 locations that are geographically distant from each other, four in each county, and randomly assign them to 4 study arms; Intervention 1 composed of households where only AGYW will be targeted with information on reporting channels and how to avoid SGBV, Intervention 2 composed of households where the AGYW and caregiver will be targeted with information on reporting channels and how to avoid SGBV, Intervention 3 composed of information given to AGYW and their caregivers on how to avoid SGBV, and control arm composed of households where none of the interventions will be shared (current practice). 150 Uncontrolled
Experimental Group Not applicable Not applicable 6 months Under the intervention arms, the study staff will share a brochure with information on the types of sexual violence, likely perpetrators, and risk factors and how to reduce the risk; brochures for those in interventions 1 and 2 will also contain contact information of local organisations addressing SGBV issues and local administration to support SGBV response in their locations. The study staff will discuss with AGYW (in intervention 1) and young girls and women and their caregivers (in interventions 2 and 3) the contents on the brochure and answer questions. A call log will be developed to capture reports of SGBV cases that will have occurred in the study locations during the study period which and will be periodically collected by the study staff and stored at the office. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adolescent girls aged 12 years to 17 years and young women aged 18 years to 24 years 2. Adolescent girls and young women living in study locations and not planning to relocate within the follow up period of 6 months. 3. Adolescents aged 12-17 years who assent to participate in the study and obtain parental consent for participation. 4. Young women aged 18 – 24 years who consent to participate. 1. Adolescent girls below the age of 12 years and young women above the age of 24 years 2. Adolescent girls and young women not living in the study locations or those who are planning to relocate from the study are within the follow up period of 6 months. 3. AGYW Who are engaged in other research studies. 4. Young women aged 18 – 24 years who decline to provide consent to participate in the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 12 Year(s) 24 Year(s) Female
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 21/01/2022 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Off Raila Odinga Way. Nairobi, Kenya. Nairobi 00200 Kenya
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 14/02/2022 National Commission for Science Technology and Innovation
Ethics Committee Address
Street address City Postal code Country
Waiyaki Way, Nairobi Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reducing the incidence of sexual violence among AGYW in Homabay, Migori and Kisii Counties. At endlime, month 6
Secondary Outcome Identification of perpetrators of SGBV among AGYW in Homabay, Migori and Kisii Counties. Monthly for 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
HomaBay County Not applicable Homabay County. N/A Kenya
Migori County Not applicable Migori County 40331 Kenya
Kisii County Not applicable Kisii County 40200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation Seattle, WA98102, USA Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Impact Research and Development Organization Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway Kisumu Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Douglas Mochama douglasmochama254@gmail.com 0739743005 Kisii Town
City Postal code Country Position/Affiliation
Kisii 40200 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Public Enquiries Kawango Agot kawango@impact-rdo.org +254736505046 Tuungane Hospital, Tom Mboya Estate Mito Jura Road, off Kisumu-Kakamega Highway
City Postal code Country Position/Affiliation
Kisumu 40141 Kenya Impact Research and Development Organization
Role Name Email Phone Street address
Scientific Enquiries Charles Obonyo cobonyo@kemri.go.ke +254724993118 Off Raila Odinga Way. Nairobi, Kenya.
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Kenya Medical Research Institute
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Dissemination of study results will follow principles of good participatory practice. Results will be shared with the study participants, local administration, partnering organizations, Gender Based Violence (GBV) County technical working groups, Ministry of Gender (MOG), Ministry of Health (MOH) and Ministry of Education (MOE). Results will also be published in conference abstracts and peer-reviewed journals. The Study results can be used to spark off discussions with stakeholders about additional ways to reduce SGBV among AGYW thereby informing future scale up of the study. Statistical Analysis Plan,Study Protocol One year Upon completion of study analysis, the final dataset will be striped of identifiers prior to release for sharing. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Results from research conducted under this project will be shared in several ways. • Manuscripts will be submitted for publication in high-quality peer-reviewed journals • The MPI and Co-Investigator will also disseminate results from this research through presentations at public lectures, scientific institutions and meetings, as well as to the community in which the research took place as detailed in the enclosed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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