## Protocol Section
### Identification Module
**NCT ID:** NCT06423612

**Acronym:** ROVING-PUMA

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

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

#### Organization Study ID Info
**ID:** A143057
#### Organization
**Class:** OTHER
**Full Name:** University of California, San Francisco
#### Secondary ID Infos
**ID:** R01AI143340-06
**Link:** https://reporter.nih.gov/quickSearch/R01AI143340-06
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2029-08-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-08-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Desmond Tutu HIV Foundation

**Class:** OTHER

**Name:** University of Cape Town

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, San Francisco

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- ART Adherence

**Keywords:**

- ART

- Adherence

- South Africa

- Viral Suppression

- ART resistance

- POC urine assay

- TDF assay

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized hybrid type 1 effectiveness trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** POC Urine Test Informed ART Adherence Counselling

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Standard-of-care Enhanced Adherence Counselling

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- POC Urine Test Informed ART Adherence Counselling

**Description:** 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.

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

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Viral Suppression at 6 months

**Time Frame:** 18 months

#### Secondary Outcomes

**Description:** Durability of the 6-month intervention on viral suppression at 9, 12, and 18months

**Measure:** Viral suppression at 9, 12, and 18months

**Time Frame:** 18 months

**Description:** The effect of the intervention on need for resistance testing and genotype results @ 6 and 18 months

**Measure:** Resistance testing and genotype results @ 6 and 18 months

**Time Frame:** 18 months

**Description:** Assess the feasibility and acceptability of the intervention using a survey and in-depth interviews

**Measure:** Feasibility and Acceptability of the intervention

**Time Frame:** 18 months

**Description:** 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.

**Measure:** Cost-effectiveness of the intervention

**Time Frame:** 18 months

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** monica.gandhi@ucsf.edu

**Name:** Monica Gandhi

**Phone:** 415 476 4082

**Phone Ext:** 127

**Role:** CONTACT

**Contact 2:**

**Email:** purba.chatterjee@ucsf.edu

**Name:** Purba Chatterjee

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** East London

**Contacts:**

***Contact 1:***

- **Email:** sammy.nena@hiv-research.org.za

- **Name:** Sammy Nena

- **Phone:** +27715153785

- **Role:** CONTACT

***Contact 2:***

- **Name:** Andrew Marino, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** South Africa

**Facility:** Desmond Tutu HIV Foundation

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, San Francisco

**Name:** Monica Gandhi

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Investigators conducting ART adherence research.

**Description:** We will share de-identified data in publicly accessible databases once study is complete and study findings disseminated.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** 48 months from start of study

### References Module

#### References

**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.

**PMID:** 36004315

**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.

**PMID:** 32424549

**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.

**PMID:** 31634188

**Citation:** 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

**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.

**PMID:** 32627120

**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.

**PMID:** 32238341

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
