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.: PACTR202003507062297 Date of Approval: 19/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title POWER STUDY
Official scientific title Evaluation of open-label Pre exposure prophylaxis (PrEP) delivery amongKenyan women
Brief summary describing the background and objectives of the trial Women of 16-25 years represent three of the four million young people living with HIV in Africa, with highest annual incidence rates reported globally. Open label Pre exposure prophylaxis (PrEP) studies demonstrated high PrEP uptake when adherence to PrEP use is high. PrEP is the use of anti-HIV medication that prevents HIV negative individuals at substantial risk of getting HIV by taking a daily pill. WHO recommends daily oral PrEP containing tenofovir for the prevention of HIV infection in persons at substantial HIV risk. Kenya regulatory authority approved an indication for PrEP based on clinical safety and efficacy data. Oral PrEP delivery has been defined as an emerging part of standard of care for HIV prevention in Kenya, thus, young women are key in PrEP implementation.This study seeks to evaluate PrEP delivery, uptake, use as it relates to contraceptive use, pregnancy, sexual exposure, timing and reasons for discontinuation, HIV incidence and HIV drug resistance among sero converters; the characteristics of young women who initiate PrEP or do not during follow-up.
Type of trial CCT
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 08/06/2018
Actual trial start date
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1000
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ANC clinic Daily oral PrEP 36 months The goals of the cohort are to assess PrEP uptake, adherence, and HIV protection when offered as part of standard of care (SOC) services. We will also conduct an evaluation of the implementation ofPrEP delivery 500 Active-Treatment of Control Group
Experimental Group Family planning clinics Daily oral PrEP 36 This is an implementation science project 500
Control Group Standard PrEP as per the guideline Daily oral PrEP 36 MONTHS Standard of care 500 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For HIV uninfected women - Age 16-25 o 16 and 17 year olds, where permissible by national regulations and local IRB approval - Able and willing to provide written informed consent - Recently sexually active (defined as having had vaginal intercourse at least once in the previous three months) - HIV uninfected based on negative HIV rapid tests, on the date of enrollment Not within the required age range Not willing to provide informed consent Not sexually active HIV infected Adult: 19 Year-44 Year 16 Year(s) 25 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 13/01/2020 KENYA MEDICAL RESEARCH INSTITUTE
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840 00200 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary goal of this project is to demonstrate feasibility of delivery of open-label PrEP to young women using three different delivery platforms. Thus, the principal justification for the sample size is inclusion of a sufficient number of HIV negative young women to indicate implementation feasibility, in a way that would inform normative guidance and public health recommendations. Importantly, in this way, the justification for the sample size is different than that of a comparative study (e.g., a randomized, placebo-controlled trial) In the proposed study, the informative evaluation is whether PrEP can be delivered to young women through these platforms, and for whom these strategies will be most acceptable and used
Primary Outcome Determine the persistence and patterns of PrEP use as they relate to contraceptive use, pregnancy and sexual exposure, and timing and reasons for PrEP discontinuation Persistance to PrEP measured in percentages ie 95 percent
Primary Outcome Demonstrate PrEP delivery models for young women in family planning setting in Kisumu Succesful intergration of PrEP in selected family planning clinics in Kisumu
Primary Outcome HIV incidence in relationship to PrEP use, and HIV drug resistance among seroconverters on PrEP HIV drug resistance among seroconverters on PrEP
Secondary Outcome Cost, and cost-effectiveness of PrEP when delivered in public health clinics. 36 MONTHS
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CMR KEMRI LUMUMBA Ondiek Street Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Washington Bothell.uw Washington 3808 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington Bothell.uw Washington 3808 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Ann Bukusi ebukusi@kemri.org +2540733617503 Ondiek Street
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal Invetigator
Role Name Email Phone Street address
Scientific Enquiries Jared Beaten jbaeten@uw.edu +0012065203808 Bothell.uw
City Postal code Country Position/Affiliation
Washington 3808 United States of America Principal Invetigator
Role Name Email Phone Street address
Public Enquiries Peter Mwangi Mugo pmugo@kemri-wellcome.org 0730162000 Ondiek Street
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Pharmacist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data in the trial after de-identification Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol After the completion of the trial Through IRBs
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