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.: PACTR202209572179725 Date of Approval: 13/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Saving for a rainy day; reducing risky sexual behaviors and practices among female sex workers through increasing their financial security.
Official scientific title Saving for a rainy day; reducing risky sexual behaviors and practices among female sex workers through increasing their financial security.
Brief summary describing the background and objectives of the trial Primary Objective: 1. To assess if consistent savings by FSWs and other women engaged in transactional sex reduces risky sexual practices. Secondary objectives: 1. To assess the acceptability of a savings intervention among female sex workers (FSWs) in beach communities of Siaya County. 2. To determine the prevalence of selected risky sexual practices among FSWs. 3. To assess the effectiveness of a savings intervention in reducing the frequency of selected risky sexual practices among FSWs. 4. To determine the barriers and facilitators of implementing a savings intervention for reducing the frequency of risky sexual practices among FSWs.
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 Reduction of risky sexual behaviour among Female Sex Workers
Anticipated trial start date 15/03/2022
Actual trial start date 01/04/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants) 210
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 4253 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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Akiba Baadaye Not applicable One year Control group composed of those who will engage in a later phase, if the intervention works to reduce the risk of HIV (Akiba Baadaye). 105 Uncontrolled
Experimental Group Akiba Sasa Not Apllicable One year FSWs and other women selling sex will be trained on basic money management to be equipped to run an effective savings activity. Prior to being enlisted in the intervention group, the FSWs will be expected to have registered SIM cards (those who have not will be supported to do so), and a working cell phone. They will be prompted to set their own saving targets per month, broken into weeks. Money saved by individuals will be sent to a central Mpesa line managed by Impact Research and Development Organization – this will ensure trust from participants. The amount saved will not accrue interest and Mpesa transaction charges will be catered for by the Impact Research and Development Organization. 105
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 FSWs and women selling sex of age 18-24 years  Women who identify to be engaging in transactional sex  FSWs and women selling sex operating from or residing in or around the study areas (selected beaches in Bondo and Rarieda Sub-Counties).  FSWs and women selling sex intending to stay at any of the participating beaches for 9 months during follow up  FSWs and women selling sex willing to provide written consent for participation in the study  Females below the age of 18 and above 24 years.  Enrollment in another savings study.  Do not identify as transactional sex workers  Not operating from or residing in the study areas (selected beaches in Siaya County during the study period).  Not willing or able to provide written consent. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 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 14/10/2021 Kenya Medical Research Institute Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Raila Odinga way 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 06/01/2022 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 Access to sustainable income that will reduce their susceptibility to risky sexual behaviors and practices and also increase the frequency and duration of time away from transactional sex. Quarterly
Secondary Outcome 1. Uptake of the intervention among those eligible for the study. Assessed by measuring the proportion of FSWs who agree to join, and remain in the study, 2.The risky sexual practices to be assessed are; unprotected sex, one night stand, anal sex, and fish-for-sex. The prevalence of these practices will be ascertained during baseline survey, and cover 6 months prior to enrollment in the study, 3. Proportion of participants reporting reduced frequency of unprotected sex, one night stand, anal sex and fish-for sex. Assessed by a two way comparison of data: Sexual behaviours and practices 3-6 months before the intervention and 3-6 months during the intervention in the intervention and control groups, 4. Documented barriers to and facilitators of consistent savings among young FSW. This will be achieved by reviewing the barriers and facilitators listed by the intervention implementers, and proportion of FSWs enrolled in intervention arm. Quarterly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Siaya County Bondo Sub County Bondo 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 eKisumu Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Linet Achieng achienglinet@754gmail.com +254710562873 Bond town
City Postal code Country Position/Affiliation
Bondo 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 Rail way
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. Dissemination of study results will follow principles of good participatory practice. Study results will be disseminated in this sequence: i) study participants, ii) members of the Beach Management Units, iii) the rest of the population residing in participating beaches, iv) populations in non-participating beaches in the County (their respective BMUs will convene meetings), v) NASCOP and organizations and donors serving FSW, vi) meetings and conferences, and vii) publications in peer-reviewed journals. The results can be used to spark off discussions with stakeholders about additional ways to reduce the rates of HIV acquisition and transmission among Key Populations 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