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.: PACTR202209749947844 Date of Approval: 22/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Using Interactive Social Media to Promote Uptake of HIV Prevention, Care and Treatment among Young Female Sex Workers in Kisumu County.
Official scientific title Using Interactive Social Media to Promote Uptake of HIV Prevention, Care and Treatment among Young Female Sex Workers in Kisumu County.
Brief summary describing the background and objectives of the trial In sub-Saharan Africa, sex workers have been especially heavily affected by HIV and other sexually transmitted infections (STIs), with levels of infection higher than other groups. Female sex workers (FSWs) comprise an important sub-population in the epidemiology of HIV infection in many countries as evidenced by their HIV prevalence which is often 10–20 times higher than that of the general population. Institutions offering HIV prevention services to FSWs meet various challenges such as migration, stigma and discrimination among FSWs within themselves and from the community; making it hard for them to enrol for HIV prevention services. Such challenges promote high attrition rates among FSWs leading to low uptake of HIV prevention services which in turn leads to high HIV and STI infection rates among them. Overall, this project seeks to assess the effectiveness of social media on retention of female sex workers (FSWs) accessing HIV prevention, care and treatment services at Drop-In Centres (DiCEs) in Kisumu County. General Objective To assess the effectiveness of social media on enhancing retention of young female sex workers aged 18-24 years accessing HIV prevention, care and treatment services at Drop-in Centres (DiCEs) in Kisumu County. Specific Objectives 1. To assess the effect of using social media and text messaging among FSWs to enhance retention in Drop-in Centres. 2. To determine the acceptability of using social media and text messaging among FSWs to enhance retention at Drop-in Centres. 3. To collect information on barriers and facilitators of using social media and text messaging among young FSW to enhance retention in Drop-in Centres.
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 To assess the effectiveness of social media on enhancing retention of young female sex workers accessing HIV prevention, care and treatment services.
Anticipated trial start date 01/03/2022
Actual trial start date 01/05/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 15/09/2022
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 734 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 study seeks to assess the effectiveness of social media on enhancing retention of young female sex workers aged 18-24 years accessing HIV prevention, care and treatment services at Drop-in Centres (DiCEs) in Kisumu County. Under the WhatsApp and SMS control arms, participants will not be exposed to the social media and text messages discussions and sensitization. However, they will benefit from the routine health talks given at the DiCEs. Data will be collected from them at the same time and on the same variables as the intervention. 100 Uncontrolled
Experimental Group Not applicable Not applicable 6 months The intervention arm will be composed of the WhatsApp and SMS groups. Participants in the WhatsApp group will receive 12 messages on relevant topics of HIV and reproductive health: risk of HIV among KPs and effective prevention strategies, cervical cancer screening, family planning, ART, HIV testing, PrEP, PEP, sexually transmitted infections, urinary tract infections, voluntary medical male circumcision, condom use, sexual and gender based violence, drug and substance abuse. Each topic will start and end with a reminder to honour DiCE appointments. Discussion for each topic will run for 2 weeks, starting with an overview from an expert followed by discussion and questions and answers. The level of engagement will be assessed by the proportion of the group who participate in discussing each topic, ask questions, or make comments. For participants in the SMS group, an overview of the same topics will be shared with reminders to attend DiCE appointments. However, the interactive engagement in the WhatsApp forum will not be possible with SMS 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o FSWs aged 18-24 years enrolled at the two DiCEs in Kisumu. o FSWs able to read and write o Will remain a resident of Kisumu for the next 9 months. o Having missed at least one visit appointment in the past one year. o Having access to a basic or smart phone. o Able and willing to give informed consent for study participation o Less than 18 years of age or aged above 24 years o Unable to read and write o Intending to relocate from Kisumu during the project period (9 months). o Have no access to a basic or smart phone o Declining to give 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 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
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 07/07/2022 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
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Improved access to HIV prevention, care and treatment services in intervention compared to control arms assessed by a two-way comparison of data at participating DiCEs: i) Proportion of participants retained 6 months prior to the intervention compared to 6 months during the intervention, ii) proportion retained between WhatsApp intervention arm compared to WhatsApp control arm, iii) proportion retained between SMS intervention arm compared to SMS control arm, and iv) proportion retained between WhatsApp intervention arm compared to SMS intervention. 6 months prior to the intervention compared to 6 months during the intervention
Secondary Outcome 1. Uptake of the interventions among those eligible for the study. Assessed by measuring the proportion of eligible FSWs who agree to join and remain in the study. 2. Documented barriers to and facilitators of WhatsApp and SMS delivery among young FSW, and participation in WhatsApp discussions. This will be achieved by reviewing the barriers and facilitators listed by the intervention implementers, and proportion of those enrolled in WhatsApp who participate in the discussions Acceptability will be measured at baseline month 1 and Feasibility will be measured at baseline endline month 6
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KASH Drop in Centre Kisumu County Kisumu 40141 Kenya
NASELICA Drop in Centre Kisumu County Kisumu 40100 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 40141 Kenya Grants management
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Laura Joy laurjoy280@gmail.com +254713746404 P.O. Box 9171-40100 Kisumu
City Postal code Country Position/Affiliation
Kisumu 40100 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 We are committed to public dissemination of results of the study to participants, local stakeholders in Kenya, the global scientific community and global policymakers. Dissemination of study results will follow principles of good participatory practice. Study results will be disseminated through presentations to the relevant stakeholders, starting with the stuyd participants, participating health facilities as well as the Ministry of Health officials in Migori County. Results will be published in conference abstracts and peer-reviewed journals. 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