Status:
COMPLETED
Use of Antiretroviral (ARV) Drug Levels in Dried Blood Spots (DBS) to Assess and Manage ART Adherence in South Africa
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Research Foundation for Mental Hygiene, Inc.
Desmond Tutu HIV Foundation
Conditions:
Therapeutic Adherence and Compliance
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04333498
Start Date
September 18 2020
End Date
November 29 2022
Last Update
January 20 2023
Active Locations (2)
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1
1051 Riverside Drive
New York, New York, United States, 10032
2
Gugulethu Clinic
Cape Town, Western Cape, South Africa, 7750