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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209509084222 Date of Registration: 19/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transitioning adolescent girls and young women on PrEP from community sites (DREAMS safe spaces) to government health facilities: a pilot implementation study in Rarieda Sub-County Siaya County, Kenya.
Official scientific title Transitioning adolescent girls and young women on PrEP from community sites (DREAMS safe spaces) to government health facilities: a pilot implementation study in Rarieda Sub-County Siaya County, Kenya.
Brief summary describing the background and objectives of the trial Adolescent Girls and Young Women (AGYW) are a priority population at higher risk of acquiring HIV. However, they are not adherent to most HIV prevention programs including PrEP. Pre-exposure prophylaxis (PrEP) is the use of an antiretroviral medication by HIV negative people at a substantial on-going risk of acquiring HIV to prevent the acquisition of HIV infection by uninfected persons. PrEP has been shown to be an effective biomedical HIV prevention strategy in individuals at high risk for HIV infection (Buchbinder & Liu, 2017). While adolescents at high HIV risk generally have positive attitudes towards PrEP (Krakower & Mayer, 2012), PrEP uptake among AGYW has been low in government facilities, for various reasons, including non-friendly service provision. As DREAMS is coming to an end in the next 6-9 months, there is urgent need to prepare AGYW on PrEP to continue receiving the services at government health facilities so they do not terminate the life-saving intervention.The purpose of this project is to integrate PrEP services in the facilities by preparing AGYW for the transition while also working with health facility staff to make the facilities ready to receive AGYW on PrEP. ObjectiveS: 1. To assess institutional readiness of government health facilities to offering PrEP to AGYW. 2. To assess retention of AGYW on PrEP in government health facilities. 3. To determine efficiency and acceptability of providing transition readiness sessions to AGYW on PrEP in promoting PrEP retention among the AGYW who transition to government health facilities. 4. 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 To assess the impact of providing transition readiness sessions to AGYW on PrEP and making government health facilities youth friendly on transitioning AGYW on PrEP from DREAMS Safe Spaces to government health facilities.
Anticipated trial start date 30/09/2022
Actual trial start date 30/09/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 15/12/2022
Anticipated target sample size (number of participants) 154
Actual target sample size (number of participants) 154
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
NON KEMRI 729 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 3 months The study is a cluster randomized-controlled trial in which 4 health facilities will be engaged and paired according to patient population being served. The health facilities will be purposively selected and paired in terms of their workload i.e. high and low workload facilities before one in each pair is randomized to either intervention arm or control arm. The study team will approach the service providers of the partner that implemented DREAMS in Siaya the last 5 years. A designated service provider will go to the DREAMS data base and identify eligible participants (18 – 24 years and ever been on PrEP) and call to inform them about the study. For those interested in learning more about the study, the service provider will share contacts of the Principal Investigator (PI) with AGYW who are interested in the study. In addition, the service provider will also share the date, time and venue of a meeting to be held for sensitization and enrolment of interested AGYW in the study. Approximately 154 AGYW on PrEP will be enrolled. They will be randomized to intervention arm (77 participants) and control arm (77 participants). Those in the control arm will have normal PrEP service delivery only. In all the 4 facilities, gaps in youth friendly service provision will be identified and filled. 77 Uncontrolled
Experimental Group Not applicable Not applicable 3 months The study is a cluster randomized-controlled trial in which 4 health facilities will be engaged and paired according to patient population being served. The health facilities will be purposively selected and paired in terms of their workload i.e. high and low workload facilities before one in each pair is randomized to either intervention arm or control arm. The study team will approach the service providers of the partner that implemented DREAMS in Siaya the last 5 years. A designated service provider will go to the DREAMS data base and identify eligible participants (18 – 24 years and ever been on PrEP) and call to inform them about the study. For those interested in learning more about the study, the service provider will share contacts of the Principal Investigator (PI) with AGYW who are interested in the study. In addition, the service provider will also share the date, time and venue of a meeting to be held for sensitization and enrolment of interested AGYW in the study. Approximately 154 AGYW on PrEP will be enrolled. They will be randomized to intervention arm (77 participants) and control arm (77 participants). The participants in the intervention arm will have 10 counselling sessions and normal PrEP service delivery. The AGYW will be taken through 10 counselling sessions, one session per week, in preparation for their transition. 77
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Those between 18 to 24 years 2. Currently on PrEP at the safe spaces or on PrEP in the last 12-24 months. 3. Willing to give consent to join the study 4. Are eligible for PrEP per NASCOP guidelines 1. Below 18 years or 25+ years 2. AGYW who are no longer at risk hence not on PrEP 3. Those who are not interested to participate in the study. 4. Ineligible for PrEP per NASCOP guidelines Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 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 01/10/2021 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 07/09/2022 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 23/08/2021 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
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1.Government health facilities offering PrEP to AGYW transitioned from DREAMS safe spaces. 2. Transitioned AGYW reporting satisfaction with the services at the facilities. Monthly for 3 months
Secondary Outcome 1. Uptake of the interventions among those eligible for the study. Assessed by measuring the proportion of eligible AGYW who agree to join and remain in the study. 2. Documented barriers to and facilitators of intervention delivery among participants in the intervention arm. This will be achieved by reviewing the barriers and facilitators listed by the intervention implementers, and proportion of those enrolled in intervention arm. Acceptability will be measured at baseline month 1and Feasibility will be measured at endline month 3
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Health Centres Rarieda Sub-County, Siaya County, Kenya. Siaya County 40600 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 Christine Obinju christie142@gmail.com +254727787977 P. O. Box 4826 40100, Kisumu
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Henry Jackson Foundation Medical Research International
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 study participants, participating health facilities as well as the Ministry of Health officials in Rarieda Sub-County Siaya County, Kenya. 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