NCT04333498

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 20, 2023

Completed
Last Updated

January 20, 2023

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

April 1, 2020

Results QC Date

November 2, 2022

Last Update Submit

December 27, 2022

Conditions

Therapeutic Adherence and Compliance

Outcome Measures

Primary Outcomes (3)

  • 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

  • Viral Load (VL) Assay

    5 months

  • Electronic Adherence (EA) Percentages

    The number of days recorded as intake on electronic medical device (EMD) divided by days on study

    5 months

Study Arms (1)

Receiving Feedback From DBS

EXPERIMENTAL

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

Behavioral: Feedback on DBS Concentrations

Interventions

Feedback on DBS ConcentrationsBEHAVIORAL

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

Receiving Feedback From DBS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1051 Riverside Drive

New York, New York, 10032, United States

Location

Gugulethu Clinic

Cape Town, Western Cape, 7750, South Africa

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Research Program Manager
Organization
New York State Psychiatric Institute/ HIV Center
christopher.ferraris@nyspi.columbia.edu
646-774-6904

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 3, 2020

Study Start

September 18, 2020

Primary Completion

December 15, 2021

Study Completion

November 29, 2022

Last Updated

January 20, 2023

Results First Posted

January 20, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)ZA(1)