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.: PACTR202209545755418 Date of Approval: 19/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Assessment of effects of peer social networks on uptake of HIV testing and linkage to care among youth in Migori County
Official scientific title Assessment of effects of peer social networks on uptake of HIV testing and linkage to care among youth in Migori County
Brief summary describing the background and objectives of the trial Globally, over 39% of new HIV infections among people aged 15 and above are currently estimated to occur among youth aged 15 to 25 years. Among the young people living with HIV, most (4 million) live in sub-Saharan Africa. Sub-Saharan Africa bears the greatest burden of HIV among the young people mainly due to risky sexual behaviours. Youth in sub-Saharan Africa often have early sexual debut, enter into early marriages and practice condomless sex, among other risky sexual behaviours. According to Kenya Population based HIV Impact Assessment (KENPHIA), one in every four adolescents living with HIV is not on Anti-Retroviral Treatment (ART). With HIV prevalence estimated at 13.3% in Migori County, it means about 4% of adolescents living with HIV are not yet on ART. Youth social networks are hypothesized to improve their access to HIV testing and prompt linkage to care and empower them for advocacy and support on HIV prevention. Sporting events usually pull crowds and facilitate information sharing and access to HIV testing among youth. The main objective of this study is to assess effectiveness of youth peer social networks’ strategy on uptake of HIV testing and linkage to care among youth in Migori County. Specifically, it strives to determine efficiency and acceptability of youth peer social networks in promoting HIV preventive behaviours; to assess the effects of youth peer social networks on the uptake of HIV testing; to assess the effects of youth peer social networks on linkage to care among youth who test HIV positive; to assess the effects peer social networks to mobilize adolescents for tournaments; and to collect information on intervention delivery approaches 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 Prevention
Anticipated trial start date 15/11/2021
Actual trial start date 16/12/2021
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 31/07/2022
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 713 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 Approximately 30 youth peers will be given basic training on HIV prior to a grassroots soccer event. After the training, each youth peer will be given 30 HIV testing referral coupons to take to their peers while sensitizing them on the importance of knowing their HIV status during the one week tournament. The one week tournament will include mainly soccer (both girls and boys) as well as netball, volleyball, tug of war and dancing competition. The event is expected to attract at least 500 youth aged 15-24. Those referred will present their coupons to the HTS provider in the facilities they visit to know their status. Six health facilities within the study area will be chosen to form intervention and control arms- three each. Three facilities from within the program catchment area will form the intervention arm while an equal number of facilities outside the program catchment area will be chosen by matching against the set criteria to form the controls. Matching will be based on the following criteria: being public or private hospital, catchment population served, and health facility level (dispensary or health centre). The facilities will have a HIV Testing and Counselling Service (HTS) provider who will remain offering HTS services for at least three months post-tournament. Arrangements will be made with the facilities such that when a youth aged 15-24 comes for HTS, they are asked if by any chance they were referred by their peers in the tournament. The HTS provider will collect basic information from the youth such as socio-demographics, date of referral, HIV testing history (their experience accessing HIV testing services in the past) and what should be done to promote HIV testing among the youth. 150 Uncontrolled
Experimental Group Not Applicable Not applicable 6 months Approximately 30 youth peers will be given basic training on HIV prior to a grassroots soccer event. After the training, each youth peer will be given 30 HIV testing referral coupons to take to their peers while sensitizing them on the importance of knowing their HIV status during the one week tournament. The one week tournament will include mainly soccer (both girls and boys) as well as netball, volleyball, tug of war and dancing competition. The event is expected to attract at least 500 youth aged 15-24. Those referred will present their coupons to the HTS provider in the facilities they visit to know their status. Six health facilities within the study area will be chosen to form intervention and control arms- three each. Three facilities from within the program catchment area will form the intervention arm while an equal number of facilities outside the program catchment area will be chosen by matching against the set criteria to form the controls. Matching will be based on the following criteria: being public or private hospital, catchment population served, and health facility level (dispensary or health centre). The facilities will have a HIV Testing and Counselling Service (HTS) provider who will remain offering HTS services for at least three months post-tournament. Arrangements will be made with the facilities such that when a youth aged 15-24 comes for HTS, they are asked if by any chance they were referred by their peers in the tournament. The HTS provider will collect basic information from the youth such as socio-demographics, date of referral, HIV testing history (their experience accessing HIV testing services in the past) and what should be done to promote HIV testing among the youth. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adolescent and youth aged 15-24 years old 2. Living in the study area and not planning to move out for at least 6 months. 1. Any condition that makes a youth ineligible for HIV testing services based on the national guidelines for HIV testing and Counseling. 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 23/04/2021 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 06/09/2021 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 11/05/2022 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. Enhanced uptake of HIV testing among adolescents and young people. Evaluated by measuring the Proportion of youth who take up testing, assessed by a two-way comparison data at participating health facilities: i) testing rate 3-6 months before the intervention and 3-6 months during the intervention, and ii) comparing testing uptake between health facilities in the intervention and control arms. 2. Youth who test HIV positive linked to care and treatment. Evaluated by measuring the Proportion of youth linked to care, assessed by a two-way comparison data at participating health facilities: i) linkage rate 3-6 months before the intervention and 3-6 months during the intervention, and ii) comparing proportion of youths linked to care between health facilities in the intervention and control arms. At 6 months pre- intervention, monthly for 6 months during the intervention and at endline in month 6
Secondary Outcome 1. Reception of the intervention by the targeted population. Assessed by measuring the number of particpants reached and screened in the targeted population against those who are enrolled in the study. 2. Adolescents and young people mobilized for the tournaments. Assessed by measuring the proportion of adolescents mobilized who eventually turn up for the tournament. 3. Identification of the barriers and facilitators of implementing the intervention. Assessed by evaluating feedback collected from study participants reached with the intervention. Acceptability of the intervention at baseline month 1, AYP mobilized for the tournament measured after the end of the tournament and Feasibility of the intervention at endline month 6.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Migori County Not Applicable Migori County N/A 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 Harrison Ayallo hayalo@stowelink.com +254702140366 81 Rapogi
City Postal code Country Position/Affiliation
Migori 40403 Kenya Stowelink Kenya
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