Simplifying Treatment and Monitoring for HIV (STREAM HIV)

NCT ID: NCT04341779

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2025-06-30

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

HIV/AIDS; HIV-1-infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

Point-of-care adherence testing and Point-of-care viral load testing

Group Type: EXPERIMENTAL

Point-of-care viral load testing and tenofovir adherence testing

Intervention Type: COMBINATION_PRODUCT

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

Standard-of-care arm

No adherence testing and lab-based viral load testing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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 Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Centre for the AIDS Programme of Research in South Africa

NETWORK

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Paul Drain

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Drain, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Nigel Garett, MBBS, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Durban, KwaZulu-Natal, South Africa

Countries

South Africa

References

Wang M, Moodley P, Khanyile M, Bulo E, Zondi M, Naidoo K, Sookrajh Y, Dorward J, Gandhi M, Garrett N, Drain PK, Sharma M. Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa. J Int AIDS Soc. 2025 Jul;28(7):e70004. doi: 10.1002/jia2.70004.

Reference Type: DERIVED

PMID: 40660747 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34610939 (View on PubMed)

Other Identifiers

R01AI147752

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007544

Identifier Type: -

Identifier Source: org_study_id