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

Therapeutic Adherence and Compliance Clinical Trial

— ADD-ART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333498
• Other study ID #: 7213
• Secondary ID: R01AI122300
• Status: Completed
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: November 29, 2022

Study information

• Verified date: December 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 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 provider Feedback Development Workgroups (FDWs).

The study team will consent a sample (N=60) of HIV-positive patients for monthly assessments, including blood specimen collections to assess TFV-DP drug levels. Participants enrolled in this prospective, pilot study will be randomized to either the intervention arm in which they will receive monthly feedback on their TFV-DP drug levels (Feedback Group; N=30) or the control arm in which they will receive no feedback on TFV-DP drug levels (No Feedback Group; N=30).

The study will take place at the Gugulethu Research Offices (GRO) of the Desmond Tutu HIV Foundation (DTHF) in Gugulethu, 15km outside Cape Town, South Africa (SA). Study participants will be recruited from patients attending one of four public-sector ART clinics in the Klipfontein Health District, Western Cape, including (1) Hannan Crusaid Treatment Centre, (2) Nyanga Clinic, (3) Gugulethu Clinic (NY1), and (4) Vuyani Clinic.

Enrollment will occur over 3-4 months, during which study staff will recruit an average of 15-20 participants per month, for a total of 60 participants. Participants will remain in the study for 5 months, attending a baseline and 4 subsequent monthly study visits. At each monthly visit, study staff will obtain venous blood samples for dried blood spots (DBS) which will measure TFV-DP levels and a viral load (VL) assay. ART adherence will also be assessed through the Wise Pill electronic monitoring device (EMD) a medication dispenser that sends an electronic medication event record to the Wisepill server when medication is taken and monthly self-reported medication adherence. Socio-demographic characteristics, medical history, mental health, substance use, and other contextual factors will be assessed at baseline and at the final study visit. In addition, at each visit, participants randomized to the intervention arm will receive feedback on their previous month's TFV-DP drug levels. Clinic providers will also receive TFV-DP drug level results for the participants in the intervention arm.

For both intervention and control groups, the study will monitor any changes to ART adherence behavior on the part of patients and providers. Potential changes will be monitored by reviewing participants' clinic charts to determine if any actions were made to the medical or adherence management of patients since the previous visit (e.g., additional VL requests beyond those prescribed for a stable patient, referral for intensive counselor-based or group adherence counseling, outreach by Health Care Workers (HCWs) for adherence monitoring and support, additional doctor-requested patient appointments). The study will also conduct Exit Interviews with participants and hold Provider Focus Group Discussions (FGD) to further understand whether (and if so, how) TFV-DP drug level feedback influenced medication adherence and patient management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 29, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Therapeutic Adherence and Compliance

Intervention

Behavioral:
• Feedback on DBS Concentrations
The study team will examine the feasibility and acceptability of a feedback system based on DBS concentration amounts.

Locations

Country	Name	City	State
South Africa	Gugulethu Clinic	Cape Town	Western Cape
United States	1051 Riverside Drive	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Desmond Tutu HIV Foundation, National Institute of Allergy and Infectious Diseases (NIAID), Research Foundation for Mental Hygiene, Inc., University of Cape Town, University of Colorado, Denver

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TFV-diphosphate (TFV-DP) Drug Level	Tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) is used as a biomarker of antiretroviral therapy (ART) adherence. Recent treatment studies have shown that TFV-DP predicts future viremia in persons with HIV (PWH). Whole blood for DBS was collected at each study visit by venipuncture. To prepare the DBS, 25 mcl of whole blood were spotted five times onto a Whatman 903 ProteinSaver card and dried for a minimum of 3hrs and up to overnight before being individually packaged in a plastic bag with dessicant and a humidity indicator.	5 Months
Primary	Viral Load (VL) Assay		5 months
Primary	Electronic Adherence (EA) Percentages	The number of days recorded as intake on electronic medical device (EMD) divided by days on study	5 months