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

Completed · Not applicable

Conditions studied: Therapeutic Adherence and Compliance

In brief

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).

Key facts

Study ID

NCT04333498

Run by

New York State Psychiatric Institute

People needed

60

Starts

2020-09-18

Expected to finish

2022-11-29

Last updated by the study team

2023-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 1051 Riverside Drive — New York, New York, United States
• Gugulethu Clinic — Cape Town, Western Cape, South Africa

Full record on ClinicalTrials.gov

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