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

ART Adherence Clinical Trial

— ROVING-PUMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423612
• Other study ID #: A143057
• Secondary ID: R01AI143340-06
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: August 30, 2029

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Monica Gandhi
• Phone: 415 476 4082
• Email: monica.gandhi[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized hybrid type 1 effectiveness study design to assess the factors related to implementation of a point-of-care urine TFV assay test into routine HIV clinical care. We plan to recruit a total of 500 adults living with HIV who received primary HIV care from one of the selected study clinics in BCM, Eastern Cape. Individuals who have been prescribed ART for at least 6 months who have not achieved VS will be randomized in a 1:1 fashion at the baseline visit to the intervention arm vs. the SoC arm.

Total duration of the study is 18 months from the time of enrollment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 30, 2029
• Est. primary completion date: August 30, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

Aim 1: Individuals =16 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• ART Adherence

Intervention

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

Locations

Country	Name	City	State
South Africa	Desmond Tutu HIV Foundation	East London

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Desmond Tutu HIV Foundation, National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Suppression at 6 months	The primary outcome of effectiveness will be viral suppression at 6 months.	18 months
Secondary	Viral suppression at 9, 12, and 18months	Durability of the 6-month intervention on viral suppression at 9, 12, and 18months	18 months
Secondary	Resistance testing and genotype results @ 6 and 18 months	The effect of the intervention on need for resistance testing and genotype results @ 6 and 18 months	18 months
Secondary	Feasibility and Acceptability of the intervention	Assess the feasibility and acceptability of the intervention using a survey and in-depth interviews	18 months
Secondary	Cost-effectiveness of the intervention	Assess the cost per patient, cost per additional patient with VS, and cost per disability-adjusted life-year averted from a society perspective with using the urine-based TFV adherence assay to inform adherence counseling vs. standard of care counseling.	18 months