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N/A N=60 Supportive Care

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

Therapeutic Adherence and Compliance

Bottom Line

View on ClinicalTrials.gov: NCT04333498 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: TFV-diphosphate (TFV-DP) Drug Level — 1377.82; 1156.79 fentomole/punch — p=.014

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Feedback on DBS Concentrations (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
New York State Psychiatric Institute
Primary completion
Dec 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
TFV-diphosphate (TFV-DP) Drug Level		 1377.82; 1156.79 .014 sig
PRIMARY
Viral Load (VL) Assay		 67.07; 1170.17 0.122
PRIMARY
Electronic Adherence (EA) Percentages		 81; 79 .218

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).

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • HIV-positive
  • Initiated ARV's containing tenofovir 4 or more months ago
  • Speaks English or Xhosa
  • Willing to attend 5 study visits approximately one month apart
  • Willing to allow the study team to contact his/her HIV care provider about his/her monthly TFV-diphosphate (TFV-DP) drug level
  • Willing to use Wise Pill to dispense ARVs for 4 months
  • Willing to receive text/short message service (SMS) and/or phone call reminders to charge the Wise Pill
  • Willing to allow the study team access to their medical chart/clinic folder

Exclusion Criteria

  • Unable to provide informed consent
  • Unwilling to participate in study procedures
  • Unwilling to allow the study team to contact his/her HIV care provider about his/her monthly TFV-DP drug level
  • Any condition that, in the opinion of the principal investigator would make participation in the study unsafe, complicated interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04333498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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