Clinical trial NCT04341779: Simplifying Treatment and Monitoring for HIV (STREAM HIV)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
HIV-1-infection
Keywords: Point-of-care test
Tenofovir
Adherence
HIV viral load
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Centre for the AIDS Programme of Research in South Africa
First posted: 2020-04-10
Enrollment: 539
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean tenofovir diphosphate concentration levels in dried blood spots
timeFrame: 24 weeks after ART initiation
measure: Combined measure of virological suppression
timeFrame: 72 weeks after ART initiation
measure: Geometric mean TFV-DP concentrations similar among intervention and control participants
timeFrame: 24 weeks
measure: TFV-diphosphate (TVF-DP) concentrations in dried blood spots (DBS) as a long-term metric of adherence.
timeFrame: 24 weeks
Secondary outcomes:
measure: Acceptability of point-of-care tenofovir and viral load testing
timeFrame: 24 and 72 weeks after ART initiation
measure: Cost-effectiveness of providing routine point-of-care tenofovir and viral load testing as compared to standard-of-care viral load monitoring
timeFrame: 24 and 72 weeks after ART initiation
measure: Retention in care
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
state: KwaZulu-Natal
Study officials:
affiliation: University of Washington
name: Paul Drain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for the AIDS Programme of Research in South Africa (CAPRISA)
name: Nigel Garett, MBBS, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.