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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04333498

Collaborator

Research Foundation for Mental Hygiene, Inc. (Other), Desmond Tutu HIV Foundation (Other), University of Cape Town (Other), University of Colorado, Denver (Other)

Enrollment

Locations

Arm

25.4

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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 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).

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Adherence and Compliance	Behavioral: Feedback on DBS Concentrations	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 18, 2020

Actual Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Receiving Feedback From DBS This arm of participants will receive monthly feedback from medical providers on their adherence measured through DBS.	Behavioral: Feedback on DBS Concentrations The study team will examine the feasibility and acceptability of a feedback system based on DBS concentration amounts.

Arm

Intervention/Treatment

Experimental: Receiving Feedback From DBS

This arm of participants will receive monthly feedback from medical providers on their adherence measured through DBS.

Behavioral: Feedback on DBS Concentrations

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

Outcome Measures

Primary Outcome Measures

TFV-diphosphate (TFV-DP) drug level [6 - 8 Months]
Viral load (VL) assay [6 - 8 Months]
The Exit Interview with participants and in the provider Focus Group Discussions. [6 - 8 Months]
e.g. Wisepill use, self-reported medication adherence, and responses to queries

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1051 Riverside Drive	New York	New York	United States	10032
2	Gugulethu Clinic	Cape Town	Western Cape	South Africa	7750

Sponsors and Collaborators

New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
Desmond Tutu HIV Foundation
University of Cape Town
University of Colorado, Denver

Investigators

Principal Investigator: Robert H Remien, Ph.D, NY State Psychiatric Institute: Columbia University Department of Psychiatry, College of Physicians and Surgeons
Principal Investigator: Catherine Orrell, Ph.D MBChB, Desmond Tutu HIV Centre/Foundation: University of Cape Town

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Remien, Research Scientist, New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT04333498

Other Study ID Numbers:

7213

First Posted:

Apr 3, 2020

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 2, 2022