ART Adherence
Conditions
Keywords
ART, Adherence, South Africa, Viral Suppression, ART resistance, POC urine assay, TDF assay
Brief summary
Antiretroviral therapy (ART) has significantly decreased the morbidity and mortality of HIV infection. However, adherence challenges in taking daily oral ART persist. A retrospective cohort study across 31 countries from 2010-19 reported that only 65% of people with HIV (PWH) on ART exhibited virologic suppression (VS) three years after starting ART;1 the rate of VS in South Africa among PWH on ART is 60-65%. Adherence barriers span individual and structural factors, such as stigma, recall difficulties, housing and/or food insecurity, mental illness, substance use, transportation, stock-outs, and other factors that vary by country and population. Adherence interventions can benefit from direct objective adherence monitoring. Pharmacologic metrics of adherence assess drug levels in plasma, dried blood spots, hair (a metric our group pioneered) or urine and predict outcomes more accurately than self-reported adherence. However, most of these metrics preclude real-time assessment, requiring expensive laboratory equipment and trained laboratory personnel. Thus, few adherence interventions have successfully incorporated objective metrics, likely due to laboratory and shipping delays. A low-cost (\<$2/test) point-of-care adherence metric - developed by our group - should allow for real-time biofeedback and improve the impact of metric-driven adherence interventions.
Detailed description
This is a randomized hybrid type 1 effectiveness study design to assess the factors related to implementation of a point-of-care urine TFV assay test into routine HIV clinical care. We plan to recruit a total of 500 adults living with HIV who received primary HIV care from one of the selected study clinics in BCM, Eastern Cape. Individuals who have been prescribed ART for at least 6 months who have not achieved VS will be randomized in a 1:1 fashion at the baseline visit to the intervention arm vs. the SoC arm. Total duration of the study is 18 months from the time of enrollment.
Interventions
BEHAVIORALPOC urine assay informed enhanced ART adherence counselling for viral suppression
Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their ART adherence with provision of enhanced ART adherence counseling for viral suppression.
Sponsors
University of California, San Francisco
Desmond Tutu HIV Foundation
University of Cape Town
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized hybrid type 1 effectiveness trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Aim 1: Individuals ≥18 years of age at the initial screening visit living with HIV, prescribed ART for at least three months, and are not virally suppressed. Aim 2: Same as Aim 1 for the acceptability survey and in-depth interviews. HIV care providers in the selected clinic sites for the feasibility survey and in-depth interviews. Aim 3: Same as Aim 1 for the cost-effectiveness study.
Exclusion criteria
* Currently enrolled in another ART adherence intervention * Patients on ART regimen that does not include Tenofovir * HIV care providers from non-study sites Failure to provide written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression at 6 months | 18 months | The primary outcome of effectiveness will be viral suppression at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral suppression at 9, 12, and 18months | 18 months | Durability of the 6-month intervention on viral suppression at 9, 12, and 18months |
| Resistance testing and genotype results @ 6 and 18 months | 18 months | The effect of the intervention on need for resistance testing and genotype results @ 6 and 18 months |
| Feasibility and Acceptability of the intervention | 18 months | Assess the feasibility and acceptability of the intervention using a survey and in-depth interviews |
| Cost-effectiveness of the intervention | 18 months | Assess the cost per patient, cost per additional patient with VS, and cost per disability-adjusted life-year averted from a society perspective with using the urine-based TFV adherence assay to inform adherence counseling vs. standard of care counseling. |
Countries
South Africa
Contacts
CONTACTMonica Gandhi
CONTACTPurba Chatterjee
PRINCIPAL_INVESTIGATORMonica Gandhi
University of California, San Francisco
Outcome results
None listed