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.: PACTR202003901399017 Date of Approval: 26/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Point-of-care Urine Monitoring of Adherence (PUMA): Testing a Real-Time Urine Assay of Tenofovir in PrEP
Official scientific title Pilot trial to examine the feasibility, acceptability, and impact on longer-term adherence of an intervention using a new urine-based tenofovir adherence assay
Brief summary describing the background and objectives of the trial Worldwide expansion of pre-exposure prophylaxis (PrEP) will be critical to ending the HIV epidemic. The original PrEP clinical trials showed us that 1) adherence is critical to effectiveness; 2) daily PrEP adherence was difficult to maintain, especially among women not in serodiscordant relationships; 3) objective adherence measures (e.g. measuring PrEP drug levels) are more reliable than self-reported adherence, and 4) real-time monitoring of PrEP drug levels with feedback to the patient could improve subsequent adherence. Objective measures of PrEP adherence, especially point-of-care measures that enable real-time assessment, intervention, and feedback, will be important for both interpreting and optimizing effectiveness during PrEP implementation. Our group has developed a novel point of care urine-based measure of PrEP adherence which has been validated among HIV-uninfected volunteers who were administered TDF/FTC. The test has now been developed into a lateral flow assay (LFA), allowing real-time monitoring. This test is cheap, easy to perform and can be done at the point-of-care. However, this tool has not yet been tested among participants on PrEP in a trial to see if real-time monitoring of adherence using the urine assay is feasible, acceptable and motivates better adherence in the future. Aim #1: To perform a pilot randomized controlled trial (RCT) in Kenya to establish the impact of real-time adherence monitoring/feedback via the urine POC TFV immunoassay on increasing PrEP adherence over time (as established by a long-term metric of adherence using hair levels). Aim #2: To assess the acceptability of the urine-based test to participants and feasibility administering the test for research healthcare providers. Specifically, we seek to understand user and provider experiences, preferences, barriers, and facilitators related to POC urine tenofovir adherence testing among women receiving PrEP and providers after the pilot trial.
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 01/07/2020
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
0126 3921 KEMRI SERU
ECCT 19 11 05 PPB ECCT
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 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 Point of care Urine Assay of Tenofovir in PrEP Tenofovir drug levels in urine will be tested real-time every 3 months 12 Months women not in serodiscordant couples on PrEP in Kenya will be randomized to standard of care adherence counseling (n=50) vs real-time adherence feedback using information from the POC urine assay (n=50). The effect of the feedback on long-term adherence over time measured via tenofovir (TFV) levels in hair samples will be assessed. 50
Control Group Standard of Care adherence counselling Adherence counselling will be done every 3 months 12 Months Women not in serodiscordant couples on PrEP in Kenya will be randomized to standard of care adherence counseling (n=50) vs real-time adherence feedback using information from the POC urine assay (n=50). The effect of the feedback on long-term adherence over time measured via tenofovir (TFV) levels in hair samples will be assessed. 50 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The eligibility criteria for this study are the following: • Female • Adult, age ≥18 years old • HIV-1 uninfected based on a negative HIV-1 rapid test • Not currently enrolled in an HIV-1 prevention clinical trial • Not currently in a serodiscordant relationship • Already taking PrEP and will be enrolled at the 3-month follow-up visit following PrEP initiation • Willing to be randomized to point-of-care tenofovir drug testing • Willing/able to provide informed consent to participate in the study • No contraindication to use of TDF or FTC • Note: Women who are pregnant at screening/enrollment are still eligible Not willing and/or not able to provide written informed consent to participate in the study In a HIV serodiscordant relationship Not willing to be randomized to either arms of the study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 16/10/2019 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
Mbagathi way 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 28/02/2020 UCSF IRB
Ethics Committee Address
Street address City Postal code Country
1001 Potrero Ave, San Francisco 94110 San Francisco 1001 United States of America
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Trial outcomes will be acceptability to participants, feasibility for healthcare providers, and long-term metrics of PrEP adherence as assessed via TFV concentrations in hair samples. At months 3, 6, 9, and 12 for all participants, the study team will collect urine, blood for plasma, whole blood for dried blood spots, and hair samples.
Secondary Outcome HIV-1 incidence will be measured but is expected to be low (0.2% per year in the Partners Demonstration Project, and 0% for those taking PrEP) and the study would need to be considerably larger to be powered to assess incident HIV-1 (and unnecessary, given the established relationship between PrEP adherence and efficacy). We will assess genotypic HIV-1 resistance among any seroconverters and provide that information to the healthcare providers assuming responsibility for the patient’s routine HIV care. At months 3, 6, 9, and 12 for all participants, the study team will collect urine blood for plasma, whole blood for dried blood spots, and hair samples.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI CCR PHRD THIKA PROJECT OAU Road Thika Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
US National Institute of Allergy and Infectious Diseases Bethesda, MD 20892-9806 Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of California San Fransisco Mission Bay San Fransisco United States of America University
Secondary Sponsor University of Washington 1410 NE Campus Parkway Seattle United States of America University
COLLABORATORS
Name Street address City Postal code Country
University of California San Francisco 400 Parnassus Ave. San Francisco United States of America
University of Washington 1410 NE Campus Parkway Seattle United States of America
Kenya Medical Research Institute Mbagathi way Nairobi Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nelly Mugo rwamba@uw.edu 0723914057 Mbagathi way
City Postal code Country Position/Affiliation
Nairobi Kenya Local Principal Investigator
Role Name Email Phone Street address
Principal Investigator Monica Gandhi Monica.Gandhi@ucsf.edu 14154764082 Mission Bay
City Postal code Country Position/Affiliation
San Fransisco United States of America Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Kenneth Ngure kngure@pipsthika.org 0722362219 OAU Road
City Postal code Country Position/Affiliation
Nairobi Kenya Local Co Principal Investigator
Role Name Email Phone Street address
Public Enquiries Peter Mogere patandi@pipsthika.org 0707177811 OAU
City Postal code Country Position/Affiliation
Nairobi Kenya Study Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Principal Investigators commit to share this data once the study is completed and published. Study Protocol This information will be shared once the data is analyzed and published. After data analyses, the PIs will seek to publish the study results in publicly accessible sites and journals. The PIs are ready and willing to circulate the published data to individuals who may reach out to them, individually.
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