Simplifying Treatment and Monitoring for HIV (STREAM HIV)

University of Washington

Status

Active, not recruiting

Conditions

HIV-1-infection

HIV/AIDS

Treatments

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

Study type

Interventional

Funder types

Other

NETWORK

NIH

Identifiers

NCT04341779

R01AI147752 (U.S. NIH Grant/Contract)

STUDY00007544

Details and patient eligibility

About

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.

Full 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.

Enrollment

539 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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