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.: PACTR202003804048902 Date of Approval: 26/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Monitoring Pre-exposure Prophylaxis for Young Adult women (MPYA)
Official scientific title Next generation real-time monitoring for PrEP adherence in young Kenyan women
Brief summary describing the background and objectives of the trial Real-time electronic monitoring is the optimal approach for understanding patterns of adherence, which is critical for determining if adherence to daily oral pre-exposure prophylaxis (PrEP) aligns with an individual’s risk for human immunodeficiency virus (HIV) acquisition. Compared with earlier adherence measurement devices, next generation Wisepill technology offers significant innovations in data storage and transmission reliability, cost, and usability and is ready for implementation in resource-limited settings. Coupling Wisepill monitoring to short message service (SMS) adherence reminders has great potential to support adherence at the precise time it is needed. Real-time strategies may be particularly important for young women- a population in need of self-controlled HIV prevention strategies, but one that has previously struggled with PrEP adherence. Triangulating weekly SMS measurement of sexual behavior with adherence may explain how PrEP can be used most effectively for HIV prevention (i.e., prevention-effective adherence). This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered PrEP for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive SMS reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence. Design: Prospective study of open-label PrEP Randomization (1:1) of SMS reminders on PrEP adherence Periodic surveys of risk behavior and perception, including by weekly SMS Two years of follow-up per participant Population: Young women at high risk for HIV infection who are interested in taking PrEP. Objectives: Aim 1. Use the next generation Wisepill device in a cohort
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MPYA
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 01/12/2016
Actual trial start date 21/12/2016
Anticipated date of last follow up 31/05/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 175
Actual target sample size (number of participants) 175
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
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS Reminders Daily SMS reminders 2 years Participants chose when to receive SMS reminders before taking their PrEP medication 87
Control Group No SMS reminders N/A 6 Months Half of the girls on PrEP were not to receive SMS reminders 88 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female · HIV-uninfected (as determined by Kenya national testing algorithms) · Age 18-24 years · Wanting to start PrEP with an initial recommendation of 6 months of use · Clinically safe to receive PrEP, in accordance with CDC guidelines: Creatinine clearance >60 mL/min Not infected with hepatitis B No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study · Sexually active (defined as vaginal or anal sex) within the last 3 months · At high risk for HIV infection based on a score of >5 or being in an HIV serodiscordant relationship · Not pregnant · Owns a personal cell phone (not shared) compatible with the technology used in the study and the ability to charge it · Intending to stay in the area for at least the next year Unable to provide consent Breast-feeding (Truvada is not currently approved for use during breast-feeding) Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study. Adult: 19 Year-44 Year 18 Year(s) 65 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 04/05/2016 KEMRI Scientific Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
Mbagathi way Nairobi 0100 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 04/12/2016 PPB ECCT
Ethics Committee Address
Street address City Postal code Country
Lenana Road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome  Wisepill adherence (enacted adherence and persistence)  Tenofovir concentration as a marker of adherence  Feasibility of Wisepill monitoring and SMS reminders  Acceptability of Wisepill monitoring and SMS reminders  Ease of use, health care associated costs, and cost-effectiveness of Wisepill monitoring and SMS reminders  Validity of Wisepill monitoring compared to tenofovir concentration in DBS Month 6, 12, 18 and 24
Secondary Outcome Completion of PrEP refills 6,12,18 and 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Thika Level 5 hospital General Kago Road, Thika Thika 00202 Kenya
Ruiru SubCounty hosptial Ruiru Kiambu Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
US National Institute of Mental Health 9000 Rockville Pike Bethesda, Maryland 20892 301-496-4000 TTY 301-402-9612 Bethesda Maryland 208923014 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington Forks Seattle Washington United States of America University
COLLABORATORS
Name Street address City Postal code Country
Massachusetts General Hospital 55 Fruit street MA 02114 Boston 02114 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nelly Mugo rwamba@uw.edu 0723914057 Ngong Road
City Postal code Country Position/Affiliation
Nairobi Kenya Chief Research Officer Kenya Medical Research Institute
Role Name Email Phone Street address
Public Enquiries Catherine Kiptinness catherine@pipsthika.org 0721323898 OAU Road
City Postal code Country Position/Affiliation
Thika Kenya Study Coordinator
Role Name Email Phone Street address
Scientific Enquiries Kenneth Ngure k_ngure@hotmail.com 0722362219 OAU
City Postal code Country Position/Affiliation
Nairobi Kenya Senior Lecturer JKUAT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study investigators commit to providing this important information once the study is concluded and analyses is done with and published. Study Protocol The IPD will be shared once the study is completed and analyses are done with and published. After data analyses, study results will be published is publicly accessible platforms including journals and the PIs will be glad to share the results if requested directly.
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