Simplifying Treatment and Monitoring for HIV (STREAM HIV)

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04341779
• Other study ID #: STUDY00007544
• Secondary ID: R01AI147752
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: University of Washington
• Contact: Zarna Marfatia
• Phone: +12065203800
• Email: zarnam[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: April 30, 2025
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-1-infection
• HIV/AIDS

Intervention

Combination Product:
• Point-of-care viral load testing and tenofovir adherence testing
Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants

Locations

Country	Name	City	State
South Africa	Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal	Durban	KwaZulu-Natal

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Centre for the AIDS Programme of Research in South Africa, National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean tenofovir diphosphate concentration levels in dried blood spots	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.	24 weeks after ART initiation
Primary	Combined measure of virological suppression and retention in care (binary)	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.	72 weeks after ART initiation
Secondary	Combined measure of viral suppression and retention in care (binary)	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.	24 weeks after ART initiation
Secondary	Tenofovir-diphosphate concentration in dried blood spots (continuous)	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.	72 weeks after ART initiation
Secondary	Acceptability of point-of-care tenofovir and viral load testing	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.	24 and 72 weeks after ART initiation
Secondary	Cost-effectiveness of providing routine point-of-care tenofovir and viral load testing as compared to standard-of-care viral load monitoring	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.	24 and 72 weeks after ART initiation