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.: PACTR202209594615638 Date of Approval: 19/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Capacity building as a means of increasing uptake of sexual and reproductive health and rights Services among adolescent and young key populations in Nairobi County.
Official scientific title Capacity building as a means of increasing uptake of sexual and reproductive health and rights Services among adolescent and young key populations in Nairobi County.
Brief summary describing the background and objectives of the trial Adolescents and young people aged 15 to 24 years have the highest rate of new Human Immunodeficiency Virus (HIV) infections compared to all other age groups. Transactional sex provides a livelihood for those in poverty and those facing peer pressures to keep up with their friends. Sex work is outlawed in Kenya and those involved in the practice face increased risk of arrest and violence, more so adolescents, who face increased violence and abuse. In addition to the social discrimination this population faces, sexual activities with multiple partners, coupled with low uptake of Sexual Reproductive Health and Rights (SRHR) Services, results in greater risk of HIV infection. Low uptake of SRHR services by Key Populations (KPs) can be the result of lack of adequate services which cater to their unique needs, fear of identification as KPs and poor friendliness of services. General objective To assess the effectiveness of using trained Adolescent and Young Key Populations (AYKPs) peers to improve uptake of SRHR services among Adolescents and Young Key Populations (AYKPs). Specific Objectives 1. To determine the acceptability and feasibility of using AYKPs peer educators to improve SRHR service uptake among AYKPs. 2. To measure the proportion of AYKPs having access to and continuance on SRHR services. 3. To document facilitators of and barriers to intervention implementation 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,Sexually Transmitted infections/ Diseases
Purpose of the trial Prevention
Anticipated trial start date 01/04/2022
Actual trial start date 02/05/2022
Anticipated date of last follow up 30/08/2022
Actual Last follow-up date 31/10/2022
Anticipated target sample size (number of participants) 330
Actual target sample size (number of participants) 330
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 723 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 The main objective of the study is to assess the effectiveness of using trained AYKPs peers to improve uptake of Sexual Reproductive Health and Rights (SRHR) services among Adolescent and Young Key Populations (AYKPs). Under the intervention arm, trained Youth Engagement Agents are to reach out to their AYKPs peers with information on SRHR and hand out SRHR leaflets containing the information on SRHR and a list of the youth friendly SRHR facilities identified among which they will be referred to Participants enrolled in the control group will have no intervention but data will be collected from them at the same time and on the same variables as the intervention. 165 Uncontrolled
Experimental Group Not applicable Not applicable 6 months The study will engage AYKP peers from the study area by training them on SRHR and commissioning them as Youth Empowerment Agents (YEA) to share information with their peers. The selected AYKPs to be trained as YEA’s will be AKYPs engaged in transactional sex. Participant in the intervention group will be reached out to with information on SRHR and SRHR services by the YEAs. During the SRHR peer sensitization, the trained YEA will reach out to their AYKPs peers with information on SRHR and hand out SRHR leaflets containing the information shared and a list of the youth friendly SRHR facilities identified among which they will be referred to. The SRHR sensitization shall be conducted once per month over an approximately 6 month period. Each engagement will last for 40 minutes where the youth empowerment agent will use the training manual to guide his/her interaction with their fellow peers. All the AYKP who will go for SRHR services at the participating facilities will be asked what prompted them to go for the service and all the responses will be recorded by the assigned staff and handed over to the study investigators. 165
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Individuals 15-24 years of age.  Adolescent girls and boys and young adults who have identify themselves as transactional sex workers  Adolescents and young adults who will have consented to participate in the study  Adolescents and young adults living in the study area for the next 6-9 months when the study kicks off.  Individuals not of 15-24 years of age.  Adolescents and young adults who do not identify themselves as transactional sex workers  Adolescents and young adults who shall not have consented to participate in the study  Adolescents and young adults will not be living in the study area for the next 6-9months when the study kicks off. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 24 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 24/06/2021 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 26/08/2021 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 Uptake of and continuance on SRHR services among the AYKPs, assessed by a comparison of data at participating health facilities: service uptake rate 6 months before the intervention and 6 months during the intervention and between health facilities in the intervention and control arms. 6 months before the intervention and 6 months during the intervention
Secondary Outcome Reception of the intevertion by the targeted group. This will be assessed by looking at the proportion of AYKPs approached who agree to join the study and allow the Youth Empowerment Agents (YEA) to share information on SRHR to improve their uptake of SRHR services. Identification of the barriers and facilitators of implementing the intervention identified by collecting feedback from the Youth Empowerment Agents (YEA) and AYKP peers reached with the intervention Acceptability will be measeured in on th one while barriers and facilitators of the intervention collected at endline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nairobi County Kasarani Nairobi 00200 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 Nkirote Muriithi nkirotemuriithi@gmail.com 0751328893 Kasarani
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Imagine Kenya Trust
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 We are committed to public dissemination of results of the study to participants, local stakeholders in Kenya, the scientific community and policymakers. Dissemination of study results will follow principles of good participatory practice. Results will be published in conference abstracts and peer-reviewed journals. Study results will be disseminated through presentations to the relevant stakeholders. 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