CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Feedback on DBS Concentrationsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04333498
NCT04333498N/ACompleted
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Use of ARV Drug Levels in Dried Blood Spots to Assess and Manage ART Adherence in South Africa

New York State Psychiatric Institute·interventional·Posted Apr 3, 2020·Updated Jan 20, 2023

In Brief

A clinical study evaluating Feedback on DBS Concentrations for Therapeutic Adherence and Compliance. Completed, enrolled 60 participants across 2 sites in 2 countries.

Detailed Summary

This is a prospective, pilot study of HIV-positive individuals who have been on tenofovir-containing antiretroviral therapy for at least 4 months. The overall goal of this research is to determine the feasibility of giving patients and their providers monthly feedback about Tenofovir-Diphosphate (TFV-DP) drug levels and to examine patient and provider behaviors in response to receiving this information. This study will build upon the Aim 1 observational study and the subsequent patient and providerFeedback Development Workgroups (FDWs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTherapeutic Adherence and Compliance
CountriesSouth Africa, United States
CollaboratorsResearch Foundation for Mental Hygiene, Inc., Desmond Tutu HIV Foundation, University of Cape Town, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 3, 2020
Enrollment StartSep 18, 2020
Primary CompletionDec 15, 2021
Study CompletionNov 29, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.2 years ago

Interventions

Feedback on DBS Concentrationsbehavioral

The study team will examine the feasibility and acceptability of a feedback system based on DBS concentration amounts.