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

NCT03935464 | Completed Results

• 3 other identifiers: AI143340R01AI167699R01AI143340
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Risk Reduction

Keywords

PrEP, women, Kenya, adherence, POC monitoring, urine test,TDF, immunoassay

Outcome Measures

Primary Outcomes (1)

• Long-term Adherence Metrics Via Hair Concentrations of Tenofovir and Short-term Adherence Metric of Urine Concentrations of Tenofovir.

  Primary outcome is number of participants in each arm with detectable hair concentrations of Tenofovir indicating long-term adherence at 12 months (undetectable levels defined long-term non-adherence), as well as urine concentrations of Tenofovir at 12 months as a short-term adherence metric.

  12 months for each participant from the time of enrollment

Secondary Outcomes (1)

• Feasibility Among Healthcare Providers of Providing Test Feedback to Participants

  Completed after the participants' 12-month follow-up visit

Study Arms (2)

Intervention Arm

EXPERIMENTAL

POC adherence testing by a urine TFV assay with feedback

Behavioral: PUMA

Standard of Care

NO INTERVENTION

Follow Kenya's PrEP guidelines on standard adherence counselling

Interventions

PUMA BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women 18 years and above who are HIV-negative on PrEP
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 sero-discordant 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 or breast feeding at screening/enrollment are still eligible

You may not qualify if:

• HIV positive women
• under 18 years old

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kenya Medical Research Institute: collaborator
• University of Washington: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

KEMRI Partners in Health and Research Development (PHRD), Thika

Thika, Near Nairobi, Kenya

Location

Related Publications (6)

• Gandhi M, Bacchetti P, Rodrigues WC, Spinelli M, Koss CA, Drain PK, Baeten JM, Mugo NR, Ngure K, Benet LZ, Okochi H, Wang G, Vincent M. Development and Validation of an Immunoassay for Tenofovir in Urine as a Real-Time Metric of Antiretroviral Adherence. EClinicalMedicine. 2018 Aug-Sep;2-3:22-28. doi: 10.1016/j.eclinm.2018.08.004. Epub 2018 Aug 31.

  PMID: 30906930 BACKGROUND

• Gandhi M, Bacchetti P, Spinelli MA, Okochi H, Baeten JM, Siriprakaisil O, Klinbuayaem V, Rodrigues WC, Wang G, Vincent M, Cressey TR, Drain PK. Brief Report: Validation of a Urine Tenofovir Immunoassay for Adherence Monitoring to PrEP and ART and Establishing the Cutoff for a Point-of-Care Test. J Acquir Immune Defic Syndr. 2019 May 1;81(1):72-77. doi: 10.1097/QAI.0000000000001971.

  PMID: 30664078 BACKGROUND

• Spinelli MA, Glidden DV, Rodrigues WC, Wang G, Vincent M, Okochi H, Kuncze K, Mehrotra M, Defechereux P, Buchbinder SP, Grant RM, Gandhi M. Low tenofovir level in urine by a novel immunoassay is associated with seroconversion in a preexposure prophylaxis demonstration project. AIDS. 2019 Apr 1;33(5):867-872. doi: 10.1097/QAD.0000000000002135.

  PMID: 30649051 BACKGROUND

• Okello P, Velloza J, Ogello V, Owidi E, Mogere P, Gakuo S, Chakravarty D, Biwott C, Chatterjee P, Mugo N, Gandhi M, Ngure K. Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya. AIDS Care. 2025 Feb;37(2):324-336. doi: 10.1080/09540121.2024.2444556. Epub 2024 Dec 28.

  PMID: 39733245 DERIVED

• Gandhi M, Glidden DV, Chakravarty D, Wang G, Biwott C, Mogere P, Maina G, Njeru I, Kiptinness C, Okello P, Spinelli MA, Chatterjee P, Velloza J, Ogello V, Medina-Marino A, Okochi H, Mugo NR, Ngure K. Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial. Lancet HIV. 2024 Aug;11(8):e522-e530. doi: 10.1016/S2352-3018(24)00125-5. Epub 2024 Jul 5.

  PMID: 38976993 DERIVED

• Drain P, Ngure K, Mugo N, Spinelli M, Chatterjee P, Bacchetti P, Glidden D, Baeten J, Gandhi M. Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 2;9(4):e15029. doi: 10.2196/15029.

  PMID: 32238341 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

As a result of the COVID-19 pandemic and associated lockdowns, protocol deviations occurred - specifically, dried blood spots were not collected for additional adherence monitoring and hair was only collected at 12 months. Further, the study had a relatively small sample size of 100 participants. Finally, the study results cannot be generalized to other populations on PrEP such as men.

Results Point of Contact

• Title: Dr. Monica Gandhi
• Organization: University of California San Francisco

monica.gandhi@ucsf.edu

415 260 6709

Study Officials

• Monica Gandhi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Randomized Trial

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 48 months from start of study
• Access Criteria: Investigators conducting PrEP research.

Locations

KE (1)