HIV-1-infection, HIV/AIDS
Conditions
Keywords
Point-of-care test, Tenofovir, Adherence, HIV viral load
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.
Interventions
COMBINATION_PRODUCTPoint-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
Sponsors
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Centre for the AIDS Programme of Research in South Africa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks | 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. This outcome will also include retention in care. |
| Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots | 72 weeks after ART initiation | We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Africa
Contacts
PRINCIPAL_INVESTIGATORPaul Drain, MD, MPH
University of Washington
PRINCIPAL_INVESTIGATORNigel Garett, MBBS, PHD
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Participant flow
Pre-assignment details
The initial enrollment was planned for 540. However, one person was considered ineligible after enrollment. Therefore, this person was not enrolled per-protocol.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 8.5 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 165 Participants |
| Sex: Female, Male Male | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 270 | 5 / 269 |
| other Total, other adverse events | 0 / 270 | 0 / 269 |
| serious Total, serious adverse events | 0 / 270 | 0 / 269 |
Outcome results
None listed