Status:
ACTIVE_NOT_RECRUITING
Simplifying Treatment and Monitoring for HIV (STREAM HIV)
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Centre for the AIDS Programme of Research in South Africa
Conditions:
HIV/AIDS
HIV-1-infection
Eligibility:
All Genders
16+ years
Phase:
NA
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 vi...
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, fi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
539 Patients enrolled
Trial Details
Trial ID
NCT04341779
Start Date
February 4 2021
End Date
June 30 2025
Last Update
January 14 2025
Active Locations (1)
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1
Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa, 4013