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.: PACTR202206540830197 Date of Registration: 02/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PrEP My Way
Official scientific title PrEP My Way”: A Novel PrEP Delivery System to Meet the Needs of Young African Women
Brief summary describing the background and objectives of the trial Young women (16-24 years old) in sub-Saharan Africa are a vulnerable population in terms of HIV acquisition with ~7,000 new infections occurring per week. Oral daily pre-exposure prophylaxis (PrEP) is a highly effective means of HIV prevention when taken regularly. Early experience with the global rollout of PrEP in this population indicates enthusiasm for PrEP, but also barriers to adherence and program retention. PrEP My Way is a novel PrEP delivery system consisting of clinic-based PrEP initiation, followed by peer-delivered kits for HIV self-testing, PrEP refills, vaginal swabs for gonorrhea and chlamydia self-sampling, pregnancy tests, and contraception refills, if desired. Based on Social Cognitive Theory, our overall hypothesis is that PrEP My Way will overcome critical stigma and structural barriers that currently limit PrEP use and thus empower young women to promote their sexual health. We will first develop, tailor, and refine PrEP My Way for use with young women in Kisumu, Kenya where we will use a client-centered, iterative approach, involving individual interviews and focus group discussions to optimally design the PrEP My Way kit and peer delivery system. We will then test the intervention for feasibility, acceptability, and preliminary impact on PrEP adherence and program retention. We will randomize 100 Kenyan women to PrEP My Way versus standard of care (i.e., clinic-based delivery of PrEP and sexual health services) and follow them for 6 months. Feasibility will be assessed by receipt of the kit at 1, 3, and 6 months and ability to use its components per protocol. Acceptability will be determined through a mixed-methods interview at 6 months. Preliminary impact will be evaluated by dried blood spot tenofovir levels (adherence) and kit use/clinic attendance at 6 months (retention) as primary outcomes. Mediators and moderators of PrEP use (e.g., empowerment and mental health) will be explored through questionnaires at baseline and 6 months.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PrEP My Way
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 28/07/2021
Actual trial start date 28/07/2021
Anticipated date of last follow up 28/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care 6 months Tenofovir Emtricitabine administered as per the Standard of care requirements 50 Active-Treatment of Control Group
Experimental Group PrEP My Way 6 months Tenofovir Emtricitabine delivered to participants based on their preferences. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Young woman (age 16-24 years); we will enroll emancipated minors (e.g., those who have been pregnant) per Kenyan national guidelines [39] or 16-17 year-olds with parental consent o Initiating PrEP (this criterion subsumes all necessary safety assessments for starting PrEP, including HIV-negative status, normal renal function, and lack of Hepatitis B infection) o Residence in the Kisumu region (maximum of 20 km from our study offices at RCTP) o Phone ownership o Ability to understand KiSwahili, DhoLuo, and/or English • Inability to provide informed consent (e.g., intoxication, mental disability) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 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 20/05/2022 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi Way Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Preliminary impact on PrEP adherence and program retention at 6 months. PrEP adherence will be assessed primarily by DBS for tenofovir diphosphate (TFV-DP) concentration. The TFV-DP concentration will provide an estimate of doses taken over the prior 3 months. Retention will be assessed by kit receipt in the intervention arm and clinic attendance per clinic records in the control arm at Month 6. Potential influencing and mediating socio-behavioral factors will be explored. 6 months
Secondary Outcome We will assess the following: • Self-reported PrEP adherence at Months 1, 3, and 6 (intervention arm) and Month 6 (control arm). We will use the 3-item scale developed by Wilson et al, which involves different recall tasks (frequency, percent, and rating of adherence) over the prior 30 days. • PrEP persistence over the 6-month period. • Rates of STI testing at Months 1, 3, and 6 • Rates of pregnancy test and contraception pick up at Months 1, 3, and 6. • Cost estimates. 6 Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI RCTP LUMUMBA SUBCOUNTY HOSPITAL ONDIEK STREET KISUMU 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
US National Institute of Mental Health NIH Bldg 49, Bethesda, MD 20894, United States Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Massachusetts General Hospital Harvard Medical School 55 Fruit St, Boston, MA 02114, United States Boston United States of America Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jessica Haberer jhaberer@partners.org +16177262000 55 Fruit St, Boston, MA 02114, United States
City Postal code Country Position/Affiliation
Boston 02114 United States of America Massachusetts General Hospital and Harvard Medical School
Role Name Email Phone Street address
Public Enquiries Kevin Kamolloh kkamolloh@kemri-rctp.org +254202600017 Ondiek Road
City Postal code Country Position/Affiliation
KISUMU 40100 Kenya Investigator
Role Name Email Phone Street address
Scientific Enquiries Benard Nyerere bnyerere@kemri-rctp.org +254202600017 Ondiek Road
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available.The Clinical study report will be available for researchers who provide a methodologically sound proposal immediately after study publication.This data shall only be used to achieve aims in the approved protocols. Clinical Study Report 2 years Controlled
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