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Point-of-care Urine Monitoring of Adherence (PUMA): Testing a Real-Time Urine Assay of Tenofovir in PrEP (PUMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03935464
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 3, 2021
Kenya Medical Research Institute
University of Washington
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
Worldwide expansion of pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to the interpretation of the PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. We now want to test the acceptability, feasibility and preliminary impact of monitoring adherence in real-time using this novel POC assay with adherence feedback provided to the patient with supportive messaging (versus standard of care adherence counseling).

Condition or disease Intervention/treatment Phase
Risk Reduction Behavioral: PUMA Not Applicable

Detailed Description:

The study is a pilot randomized trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine tenofovir test to provide real-time adherence feedback among women on PrEP in Kenya. Eligible women (n=100) will be HIV-negative, ≥18 years old, and on PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the urine assay versus standard-of-care adherence counseling. Acceptability will be assessed by a quantitative survey of participants at the end of the study, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups of 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed and messages delivered, while in-depth interviews with providers will explore the ease of administering the urine test. Tenofovir levels in hair serve as the long-term metric of adherence.

Feasibility outcome: The investigators will assess the feasibility of the intervention by interviewing health care providers, who will be administering this test at the clinical point of care in the future. The investigators will examine provider perceptions of the assay using in-depth interviews. These key informant interviews will be performed at the end of this study with the healthcare providers (up to 8) who delivered the counseling messages to intervention arm participants after performing the POC urine TFV test. The semi-structured interview guide will draw from the Unified Theory of Acceptance and Use of Technology (UTAUT) model.200 This model incorporates factors that influence technology acceptance (in this case, of the POC immunoassay): perceived usefulness (performance expectancy), complexity to use (effort expectancy), stigma/social harm (social influence), and benefits (facilitating PrEP adherence among patients). These interviews will also elicit barriers and facilitators to delivering the TFV assay-informed counseling messages.

Acceptability outcome: The investigators will conduct a mixed-methods assessment of the intervention arm participants' experiences with real-time monitoring and feedback at the end of the study. A quantitative survey and a qualitative interview guide for in-depth interviews of participants will draw from the Information-Motivation-Behavioral skills (IMB) model.205-212 Quantitative data collection will occur via standardized interviewer-administered questionnaires. Items to be assessed include the following: 1) Feelings about receiving their PrEP adherence results in real time; 2) Likelihood of participating in other studies using a similar design; 3) Likelihood of wanting to receive results of urine testing outside of a study while they are on PrEP; 4) Concern about the privacy and security of the data regarding their urine results; 5) Grading of the potential impact of knowing their urine TFV results on subsequent medication adherence; 6) Advantages and disadvantages of being told about their adherence in real time; 7) Likelihood of taking PrEP just before later study visits because they knew the urine test was being conducted; 8) Preferences regarding a yes/no assay versus an assay that provides information on "high", "moderate" or "low" adherence. A 5-point Likert item format will be used to assess graded items (such as the likelihood of wanting continued urine testing in the context of PrEP; feelings about the urine testing, ranging from negative to positive; concerns about privacy, ranging from low to high; the potential impact of real-time feedback on subsequent adherence, ranging from low to high). Other items (advantages and disadvantages of being told about adherence results) will provide pre-specified options with one "other" option for open-ended text fields.

Adherence outcome: A linear mixed effects linear regression model will estimate the effect of the intervention versus standard-of-care on logarithmically transformed levels of tenofovir in hair.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot Randomized Trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Trial to Examine the Feasibility, Acceptability and Impact of an Intervention Using a New Urine-based Tenofovir Adherence Assay
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention Arm
POC adherence testing by a urine TFV assay with feedback
Behavioral: PUMA
Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their adherence with provision of standard adherence counseling.

No Intervention: Standard of Care
Follow Kenya's PrEP guidelines on standard adherence counselling

Primary Outcome Measures :
  1. Feasibility of POC urine TFV testing among women receiving PrEP [ Time Frame: 12 months ]
    Interviews of health care providers

  2. Acceptability of POC urine TFV testing among women receiving PrEP [ Time Frame: 12 months ]
    Quantitative surveys and qualitative interviews of participants

Secondary Outcome Measures :
  1. Measure long-term adherence outcomes [ Time Frame: Assessed at 0 (baseline), 3, 6, 9, and 12-month clinic visits after enrollment ]
    Measure TFV and FTC levels in hair samples

  2. Establish preference for type of assay [ Time Frame: 12 months ]
    Via interviews with participants and providers assess if yes/no assay or assay with lines indicating high, moderate, or low adherence is preferred.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women 18 years and above who are HIV-negative on PrEP
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • HIV-negative women
  • women ≥18 years old
  • women receiving PrEP
  • estimated creatinine clearance >60 mL/min
  • returning for a follow-up visit 3 months after PrEP initiation

Exclusion Criteria:

  • HIV positive women
  • under 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03935464

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Contact: Monica Gandhi, MD 415 476 4082 ext 127
Contact: Purba Chatterjee, MSc 4154766714

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KEMRI Partners in Health and Research Development (PHRD), Thika Recruiting
Thika, Near Nairobi, Kenya
Contact: Kenneth Ngure, PhD         
Contact: Peter Mogere         
Principal Investigator: Nelly Mugo, MBChB         
Sponsors and Collaborators
University of California, San Francisco
Kenya Medical Research Institute
University of Washington
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Principal Investigator: Monica Gandhi, MD University of California, San Francisco
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of California, San Francisco Identifier: NCT03935464    
Other Study ID Numbers: AI143340
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 48 months from start of study
Access Criteria: Investigators conducting PrEP research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
PrEP, women, Kenya, adherence, POC monitoring, urine test,TDF, immunoassay