Randomized Trial to Optimize Virologic Suppression Rates Using a Point-of-Care Urine Monitoring Assay (ROVING PUMA)

NCT06423612 | Recruiting

• 2 other identifiers: A143057R01AI143340-06
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Antiretroviral therapy (ART) has significantly decreased the morbidity and mortality of HIV infection. However, adherence challenges in taking daily oral ART persist. A retrospective cohort study across 31 countries from 2010-19 reported that only 65% of people with HIV (PWH) on ART exhibited virologic suppression (VS) three years after starting ART;1 the rate of VS in South Africa among PWH on ART is 60-65%. Adherence barriers span individual and structural factors, such as stigma, recall difficulties, housing and/or food insecurity, mental illness, substance use, transportation, stock-outs, and other factors that vary by country and population. Adherence interventions can benefit from direct objective adherence monitoring. Pharmacologic metrics of adherence assess drug levels in plasma, dried blood spots, hair (a metric our group pioneered) or urine and predict outcomes more accurately than self-reported adherence. However, most of these metrics preclude real-time assessment, requiring expensive laboratory equipment and trained laboratory personnel. Thus, few adherence interventions have successfully incorporated objective metrics, likely due to laboratory and shipping delays. A low-cost (\<$2/test) point-of-care adherence metric - developed by our group - should allow for real-time biofeedback and improve the impact of metric-driven adherence interventions.

Conditions

ART Adherence

Keywords

ART; Adherence; South Africa; Viral Suppression; ART resistance; POC urine assay; TDF assay

Outcome Measures

Primary Outcomes (1)

• Viral Suppression at 6 months

  The primary outcome of effectiveness will be viral suppression at 6 months.

  18 months

Secondary Outcomes (4)

• Viral suppression at 9, 12, and 18months

  18 months

• Resistance testing and genotype results @ 6 and 18 months

  18 months

• Feasibility and Acceptability of the intervention

  18 months

• Cost-effectiveness of the intervention

  18 months

Study Arms (2)

POC Urine Test Informed ART Adherence Counselling

EXPERIMENTAL

Conduct enhanced ART adherence counselling informed by the results of the point-of-care urine assay for TFV to increase viral suppression.

Behavioral: POC urine assay informed enhanced ART adherence counselling for viral suppression

Standard-of-care Enhanced Adherence Counselling

NO INTERVENTION

Follow South Africa's standard-of-care enhanced ART adherence counselling for viral suppression.

Interventions

POC urine assay informed enhanced ART adherence counselling for viral suppression 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 ART adherence with provision of enhanced ART adherence counseling for viral suppression.

POC Urine Test Informed ART Adherence Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1: Individuals ≥18 years of age at the initial screening visit living with HIV, prescribed ART for at least three months, and are not virally suppressed.
• Aim 2: Same as Aim 1 for the acceptability survey and in-depth interviews. HIV care providers in the selected clinic sites for the feasibility survey and in-depth interviews.
• Aim 3: Same as Aim 1 for the cost-effectiveness study.

You may not qualify if:

• Currently enrolled in another ART adherence intervention
• Patients on ART regimen that does not include Tenofovir
• HIV care providers from non-study sites Failure to provide written consent

Sponsors & Collaborators

• University of California, San Francisco: lead
• Desmond Tutu HIV Foundation: collaborator
• University of Cape Town: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Desmond Tutu HIV Foundation

East London, South Africa

RECRUITING

Related Publications (6)

• Niu X, Kubiak RW, Siriprakaisil O, Klinbuyaem V, Sukrakanchana PO, Cressey R, Okochi H, Gandhi M, Cressey TR, Drain PK. Tenofovir-Diphosphate in Dried Blood Spots vs Tenofovir in Urine/Plasma for Oral Preexposure Prophylaxis Adherence Monitoring. Open Forum Infect Dis. 2022 Aug 10;9(8):ofac405. doi: 10.1093/ofid/ofac405. eCollection 2022 Aug.

  PMID: 36004315 BACKGROUND

• Spinelli MA, Haberer JE, Chai PR, Castillo-Mancilla J, Anderson PL, Gandhi M. Approaches to Objectively Measure Antiretroviral Medication Adherence and Drive Adherence Interventions. Curr HIV/AIDS Rep. 2020 Aug;17(4):301-314. doi: 10.1007/s11904-020-00502-5.

  PMID: 32424549 BACKGROUND

• Gandhi M, Wang G, King R, Rodrigues WC, Vincent M, Glidden DV, Cressey TR, Bacchetti P, Spinelli MA, Okochi H, Siriprakaisil O, Klinbuayaem V, Mugo NR, Ngure K, Drain PK, Baeten JM. Development and validation of the first point-of-care assay to objectively monitor adherence to HIV treatment and prevention in real-time in routine settings. AIDS. 2020 Feb 1;34(2):255-260. doi: 10.1097/QAD.0000000000002395.

  PMID: 31634188 BACKGROUND

• Cressey TR, Siriprakaisil O, Kubiak RW, Klinbuayaem V, Sukrakanchana PO, Quame-Amaglo J, Okochi H, Tawon Y, Cressey R, Baeten JM, Gandhi M, Drain PK. Plasma pharmacokinetics and urinary excretion of tenofovir following cessation in adults with controlled levels of adherence to tenofovir disoproxil fumarate. Int J Infect Dis. 2020 Aug;97:365-370. doi: 10.1016/j.ijid.2020.06.037. Epub 2020 Jun 14.

  PMID: 32553717 BACKGROUND

• Drain PK, Bardon AR, Simoni JM, Cressey TR, Anderson P, Sevenler D, Olanrewaju AO, Gandhi M, Celum C. Point-of-care and Near Real-time Testing for Antiretroviral Adherence Monitoring to HIV Treatment and Prevention. Curr HIV/AIDS Rep. 2020 Oct;17(5):487-498. doi: 10.1007/s11904-020-00512-3.

  PMID: 32627120 BACKGROUND

• 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 BACKGROUND

Study Officials

• Monica Gandhi

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Gandhi

CONTACT

415 476 4082; monica.gandhi@ucsf.edu

Purba Chatterjee

CONTACT

purba.chatterjee@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized hybrid type 1 effectiveness trial

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: May 8, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

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 ART adherence research.

Locations

ZA (1)