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.: PACTR202109545700165 Date of Approval: 15/09/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The PrEDIRA Study
Official scientific title Piloting HIV Pre-exposure Prophylaxis (PrEP) Integration into Services for Early Pregnancy Loss
Brief summary describing the background and objectives of the trial Adolescent girls and young women (AGYW) in Kenya face parallel epidemics for unintended pregnancy and HIV. Existing reproductive health and family planning programs are acceptable and effective entry points to reach AGYW with comprehensive services to prevent these events. AGYW seeking care for an early pregnancy loss- whether from a spontaneous miscarriage or induced abortion- face these epidemics and integrating HIV prevention services, particularly daily oral PrEP, into PAC services is an opportune method to reach them. PrEP is widely available in Kenya for people with substantial risk for HIV. Prior formative work by the protocol investigators found that young women accessing PAC had characteristics (existing STI infection and sexual behavior) that render them susceptible to HIV acquisition. More than half of the women indicated willingness to use PrEP. An additional important finding from the study was that PrEP screening and initiation could be integrated into services provided through the PAC clinic and follow-up for PrEP refills conducted outside of these clinics (e.g. family planning-FP- clinics). Through the proposed work, we plan to pilot PrEP integration into PAC services among 14 health facilities (public and private) providing PAC to AGYW in Thika, Nairobi, and Kisumu. The project will enroll 2000 AGYW accessing PAC services and engage a subset of 400 for research procedures to evaluate: 1) uptake, adherence, and continuation of PrEP and FP 2) linkage and follow-up on PrEP and FP services 3) impact of enhanced adherence support on PrEP continuation and adherence 4) experiences of young women and providers with an integrated PrEP program, and 5) factors associated with adherence to PrEP and FP. Specifically, we hope that the work will result in robust recommendations for how to optimize and advance long-standing delivery of HIV prevention as part of PAC services in Kenya and similar settings.
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 13/09/2021
Actual trial start date
Anticipated date of last follow up 06/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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 Foundational PrEP Program 9 months PrEP delivery will be done in line with existing programs in public and private/non-governmental facilities providing Post Abortive Care to Adolescent Girls and Young Women. PrEP will be delivered according to national guidelines. 200 Uncontrolled
Experimental Group Enhanced Adherence Support 9 months PrEP delivery will be done as part of existing programs in public and private/non-governmental facilities providing Post Aboortive Care to Adolescent Girls and Young Women but we will add a package of enhanced adherence support tools. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Aged 15-30 years ● HIV-negative, according to national HIV testing algorithm ● Accessing services for early pregnancy loss at one of the participating facilities and other facilities within the program area ● Not currently using PrEP ● Eligible for PrEP, according to Kenya national guidelines ● Living with HIV, according to national HIV testing algorithm ● Has any condition (social or medical) which in the opinion of the investigator would make program participation unsafe Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 30 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 30/07/2021 KEMRI SCIENTIFIC ETHICS REVIEW UNIT
Ethics Committee Address
Street address City Postal code Country
MBAGATHI RD Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Increased uptake of HIV PrEP and Family Planning at the Post Abortive Care sites Continuation of PrEP and Family Planning Increased retention in PrEP and Family planning programs. 24 months
Secondary Outcome Improved adherence to PrEP and Family planning protocols as a result of enhanced adherence support. 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI RCTP KISUMU SITE ONDIEK STREET KISUMU 40100 Kenya
Partners in Health Research and Development Thika THIKA THIKA 01000 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Childrens Investment Fund Foundation 7 Clifford Street London W1S 2FT United Kingdom London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Childrens Investment Fund Foundation 7 Clifford Street London, W1S 2FT United Kingdom London United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Bukusi ebukusi@rctp.or.ke +254720018880 Mbagathi Rd
City Postal code Country Position/Affiliation
Nairobi Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Nelly Mugo rwamba@uw.edu +254672222561 Thika
City Postal code Country Position/Affiliation
Thika Kenya Principal Investigator
Role Name Email Phone Street address
Principal Investigator Renee Heffron rheffron@uw.edu +12065203800 4333 Brooklyn Ave.NE, Box 359470 Seatle, WA 98195-9470
City Postal code Country Position/Affiliation
Seattle United States of America Principal Investigator
Role Name Email Phone Street address
Public Enquiries Josephine Odoyo orajose@kemri-ucsf.org +254720018880 Kisumu
City Postal code Country Position/Affiliation
Kisumu Kenya Co Investigator
Role Name Email Phone Street address
Scientific Enquiries Felix Mogaka fmogaka@kemri-ucsf.org +254720018880 Kisumu
City Postal code Country Position/Affiliation
Kisumu Kenya Co Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Permission to review the individual study records will be granted by the Principal Investigator and the records will not have any personal identifying information. Informed Consent Form,Study Protocol 12 months Permission to review the individual study records will be granted by the Principal Investigator and the records will not have any personal identifying information.
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