## Protocol Section
### Identification Module
**NCT ID:** NCT04341779

**Brief Title:** Simplifying Treatment and Monitoring for HIV (STREAM HIV)

**Official Title:** Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa

#### Organization Study ID Info
**ID:** STUDY00007544
#### Organization
**Class:** OTHER
**Full Name:** University of Washington
#### Secondary ID Infos
**ID:** R01AI147752
**Link:** https://reporter.nih.gov/quickSearch/R01AI147752
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-04

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2020-04-10
**Type:** ACTUAL
**Study First Submit Date:** 2020-04-07
**Study First Submit QC Date:** 2020-04-07
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

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

**Class:** NETWORK

**Name:** Centre for the AIDS Programme of Research in South Africa

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Washington

#### Responsible Party

**Investigator Affiliation:** University of Washington

**Investigator Full Name:** Paul Drain

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in improving ART adherence, maintaining durable VL suppression, and improving retention in care among HIV-positive individuals initiating first-line tenofovir disoproxil fumarate (TDF)-based ART in South Africa.

**Detailed Description:** This study will be a two-arm, open-label, randomized controlled superiority trial at an HIV clinic in Durban. HIV-positive individuals aged 16 years and above, who are initiating a tenofovir-based, first-line ART will be randomized to receive POC VL testing and POC TFV adherence testing, versus standard-of-care (SoC) viral load testing. The schedule for VL testing and management of VL test results will follow South African guidelines for HIV VL testing after ART initiation. 540 participants will be randomized (1:1) at ART initiation into the intervention arm (routine POC TFV adherence testing with POC VL monitoring) or the standard-of-care (SoC) arm (no objective TFV adherence testing and SoC VL monitoring).

Participants will be followed to compare concentrations between study arms at 24 weeks after ART initiation and a composite outcome of VL suppression and retention in care between the study arms at 72 weeks after ART initiation. The study will use process evaluation data, interviews and focus groups with patients and staff to assess implementation of the POC assays. Micro-costing will be conducted to estimate intervention costs.

### Conditions Module

**Conditions:**

- HIV/AIDS

- HIV-1-infection

**Keywords:**

- Point-of-care test

- Tenofovir

- Adherence

- HIV viral load

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 540

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Point-of-care adherence testing and Point-of-care viral load testing

**Intervention Names:**

- Combination Product: Point-of-care viral load testing and tenofovir adherence testing

**Label:** Intervention arm

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No adherence testing and lab-based viral load testing

**Label:** Standard-of-care arm

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention arm

**Description:** Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants

**Name:** Point-of-care viral load testing and tenofovir adherence testing

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.

**Measure:** Mean tenofovir diphosphate concentration levels in dried blood spots

**Time Frame:** 24 weeks after ART initiation

**Description:** We will measure viral load by a laboratory-based reference assay, performed by the South African National Health Laboratory Services. Viral suppression will be defined as a viral load \<200 copies/mL. Retention in care will be defined as having collected ART from the study clinic within 8 weeks of study exit.

**Measure:** Combined measure of virological suppression and retention in care (binary)

**Time Frame:** 72 weeks after ART initiation

#### Secondary Outcomes

**Description:** We will measure viral load by a laboratory-based reference assay, performed by the South African National Health Laboratory Services. Viral suppression will be defined as a viral load \<200 copies/mL. Retention in care will be defined as having collected ART from the study clinic within 8 weeks of their 6-month study visit.

**Measure:** Combined measure of viral suppression and retention in care (binary)

**Time Frame:** 24 weeks after ART initiation

**Description:** We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.

**Measure:** Tenofovir-diphosphate concentration in dried blood spots (continuous)

**Time Frame:** 72 weeks after ART initiation

**Description:** We will assess acceptability of point-of-care tenofovir and viral load testing by conducting semi-structured in-depth interviews and focus group discussions with study participants.

**Measure:** Acceptability of point-of-care tenofovir and viral load testing

**Time Frame:** 24 and 72 weeks after ART initiation

**Description:** We will conduct a micro-costing of the costs associated with point-of-care tenofovir and viral load testing and will estimate the cost-effectiveness of the intervention using an existing individual-based, stochastic HIV model for KwaZulu-Natal for simulating health and economic outcomes.

**Measure:** Cost-effectiveness of providing routine point-of-care tenofovir and viral load testing as compared to standard-of-care viral load monitoring

**Time Frame:** 24 and 72 weeks after ART initiation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* HIV-positive
* ≥16 years old
* Initiating a TDF-based, first-line ART regimen
* Do not self-report being on an ART regimen in the prior month
* Willing/able to provide written informed consent

Exclusion Criteria:

* Does not plan to continue receiving HIV care at the CDC Clinic
* Per the decision or opinion of the PI (for example, a clinically significant acute or chronic medical condition or circumstances that would make the patient unsuitable for participation or jeopardize the safety or rights of the participant

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zarnam@uw.edu

**Name:** Zarna Marfatia

**Phone:** +12065203800

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Durban

**Contacts:**

***Contact 1:***

- **Email:** pedzisai.manatsi@caprisa.org

- **Name:** Pedzisai Munatsi

- **Phone:** +27 (0)31 655 0604

- **Role:** CONTACT

***Contact 2:***

- **Email:** nigel.garrett@caprisa.org

- **Name:** Nigel Garrett, MBBS, PhD

- **Phone:** +27312604453

- **Role:** CONTACT

***Contact 3:***

- **Name:** Nigel Garrett, MBBS, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** South Africa

**Facility:** Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal

**State:** KwaZulu-Natal

**Status:** RECRUITING

**Zip:** 4013

#### Overall Officials

**Official 1:**

**Affiliation:** University of Washington

**Name:** Paul Drain, MD, MPH

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Centre for the AIDS Programme of Research in South Africa (CAPRISA)

**Name:** Nigel Garett, MBBS, PHD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** De-identified data generated under this project will be administered in accordance with University of Washington, CAPRISA, and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.

**Description:** De-identified data from the study will be made available

**Info Types:**

- STUDY_PROTOCOL

- ICF

**IPD Sharing:** YES

**Time Frame:** Beginning 9 months and ending 36 months following publication of primary results.

### References Module

#### References

**Citation:** Bardon AR, Dorward J, Sookrajh Y, Sayed F, Quame-Amaglo J, Pillay C, Feutz E, Ngobese H, Simoni JM, Sharma M, Cressey TR, Gandhi M, Lessells R, Moodley P, Naicker N, Naidoo K, Thomas K, Celum C, Abdool Karim S, Garrett N, Drain PK. Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes. BMJ Open. 2021 Oct 5;11(10):e050116. doi: 10.1136/bmjopen-2021-050116.

**PMID:** 34610939

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012897

- Term: Slow Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: HIGH

- As Found: HIV/AIDS

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV/AIDS

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15700

- Name: Slow Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

- ID: D000015658

- Term: HIV Infections

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000018894

- Term: Reverse Transcriptase Inhibitors

- ID: D000019384

- Term: Nucleic Acid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M296

- Name: Tenofovir

- Relevance: HIGH

- As Found: 1000

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20935

- Name: Reverse Transcriptase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068698

- Term: Tenofovir

### Misc Info Module

- Version Holder: 2024-05-24
