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Use of Antiretroviral (ARV) Drug Levels in Dried Blood Spots (DBS) to Assess and Manage ART Adherence in South Africa

NCT04333498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-20

Study results available
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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).

Conditions

  • Therapeutic Adherence and Compliance

Interventions

BEHAVIORAL

Feedback on DBS Concentrations

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

Sponsors & Collaborators

  • Research Foundation for Mental Hygiene, Inc.

    collaborator OTHER

  • Desmond Tutu HIV Foundation

    collaborator OTHER

  • University of Cape Town

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Robert H Remien, Ph.D · NY State Psychiatric Institute: Columbia University Department of Psychiatry, College of Physicians and Surgeons

  • Catherine Orrell, Ph.D MBChB · Desmond Tutu HIV Centre/Foundation: University of Cape Town

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2021-12-15
Completion
2022-11-29

Countries

  • United States
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04333498 on ClinicalTrials.gov