Simplifying Treatment and Monitoring for HIV (STREAM HIV)

Not Applicable

Active, not recruiting

• Conditions: HIV/AIDS; HIV-1-infection
• Interventions: Combination Product: Point-of-care viral load testing and tenofovir adherence testing

• Registration Number: NCT04341779
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Study Start: 2021-02-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 539

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Point-of-care viral load testing and tenofovir adherence testing	Point-of-care adherence testing and Point-of-care viral load testing

Primary Outcome Measures

Name	Time	Method
Mean tenofovir diphosphate concentration levels in dried blood spots	24 weeks after ART initiation	We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry.
Combined measure of virological suppression	72 weeks after ART initiation	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.
Geometric mean TFV-DP concentrations similar among intervention and control participants	24 weeks	Participants with TFV-DP measured in the standard-of-care arm was 234, and in the intervention arm 242. With predetermined TFV-DP concentration thresholds for TFV-DP \>200 flol/punch was 217 (92.7%) on the standard-ofcare arm and 239 (98.8%) on the Intervention arm. TFV-DP \>750 fmol/punch was 199 (85.0%) and 210 (86.8%) with the intervention arm. However, predetermined analysis of TVF-DP thresholds showed more participants in the intervention arm achieved detectable TFV levels.
TFV-diphosphate (TVF-DP) concentrations in dried blood spots (DBS) as a long-term metric of adherence.	24 weeks	We will use Intracelllular TFV-DP concentrations (continuous) in DBS using liquid chromatography/tanem mass spectrometry at a certified lab.VL measured on stored samples across study arms using the Abbott Alinity assay--comparing continuaous log TFV-DP concentrations using t-tests and compared proportions with estimated risk rations (RR) using modified Poisson regression.

Secondary Outcome Measures

Name	Time	Method
Acceptability of point-of-care tenofovir and viral load testing	24 and 72 weeks after ART initiation	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.
Cost-effectiveness of providing routine point-of-care tenofovir and viral load testing as compared to standard-of-care viral load monitoring	24 and 72 weeks after ART initiation	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.
Retention in care	24 weeks	This will be measured through attendance logs to assess ability to meet visit window goals.

Trial Locations

Locations (1)

Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal; 🇿🇦 Durban, KwaZulu-Natal, South Africa