Factors Affecting PrEP Adherence

Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men

The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another study, either ATN 110 or ATN 113.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Drug: Emtricitabine/tenofovir disoproxil

Detailed Description

Among Men who have Sex with Men (MSM) in the U.S., Human Immunodeficiency Virus (HIV) incidence has remained highest in those less than 30 years of age, demonstrating the need for new ways to prevent HIV in Young Men who have Sex with Men (YMSM). Pre-exposure Prophylaxis or PrEP is the use of a daily medication to prevent HIV infection. In order for PrEP to work the pills must be taken, so adherence is a very important part of PrEP. Efforts to accurately assess adherence to PrEP have been hindered because participants do not always accurately report adherence and the flawed methods that have been used to measure adherence. In previous studies it has been shown that participants over-report adherence when compared to drug concentration levels in blood. Although drug-levels can be used to monitor adherence, the cost can be prohibitive and specimens may be difficult to collect in real-time. This means that better and more accurate assessments of PrEP adherence from self-reports are needed in order for PrEP to achieve wide-spread use.

This longitudinal pilot sub-study of ATN 110 and ATN 113 (Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States) aims to assess how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP. This study will compare levels of adherence reported in the Interactive Questionnaire System (iQS) to those collected in ATN 110 or ATN 113 by Audio Computer Assisted Self Interview (ACASI), Wisepill, and drug concentration levels in blood and hair. The iQS will be administered at study entry and week 24 visits. PrEP, Emtricitabine/Tenofovir disoproxil fumarate (Truvada®), will be administered as part of the ATN 110 and ATN 113 protocols. Study drug will not be administered as part of this study, ATN 123.

• Study Type: Observational
• Enrollment (Actual): 167

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hopsital of Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital of Denver
  • Florida
    • Miami, Florida, United States, 33101
      • University of Miami School of Medicine
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Health Sciences Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Fenway Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University-Children's Hospital of Michigan
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Childrens Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will be HIV-1 uninfected YMSM, including transgender women, ages 15 through 22 years, inclusive at the time of consent into the parent protocol, currently enrolled in ATN 110 or ATN 113 and prescribed FTC/TDF (Truvada®) for PrEP.

Description

Inclusion Criteria:

• Concurrent enrollment in ATN 110 or ATN 113 and prescribed FTC/TDF (Emtricitabine/Tenofovir disoproxil fumarate (Truvada®)) for PrEP;
• Ability to understand written and spoken English; and
• Willing and able to provide written informed consent.

Exclusion Criteria:

• Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent; and
• Intoxicated or under the influence of alcohol or other substances at the time of consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Interactive Questionnaire System (iQS); An Interactive Questionnaire System (iQS) will be administered twice. First at study entry (ATN 110/113 week 24 visit) and second at week 24 (ATN 110/113 week 48 visit). The questionnaire will assess adherence as well as how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP with FTC/TDF (Truvada®).

Drug: Emtricitabine/tenofovir disoproxil; ATN 123 participants will not be administered Emtricitabine /Tenofovir disoproxil fumarate (Truvada®) as part of the ATN 123 study, but as part of the parent studies, ATN 110 or ATN 113. In order to be eligible for ATN 123, all participants must be co-enrolled in ATN 110 or ATN 113. The only intervention for ATN 123 is the administration of the Interactive Questionnaire System (iQS), which is a new method to collect data on adherence. It will be utilized to collect adherence data across a variety of devices (i.e., computer/laptop, smartphone, tablet, etc.). Accuracy of this method will be determined; preference for this mode of data collection compared to other methods for adherence reporting used in the parent studies will be assessed.; Other Names: Truvada®; FTC/TFV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire	To assess preference of the iQS as a way to measure adherence to Pre-Exposure Prophylaxis (PrEP) in PrEP clinical trials, completion rates; pattern of skipped or incomplete responses by variables will be analyzed.	Week 0
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire	To assess preference of the iQS as a way to measure adherence to Pre-Exposure Prophylaxis (PrEP) in PrEP clinical trials, completion rates; pattern of skipped or incomplete responses by variables will be analyzed.	Week 24
Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill	Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.	Week 0
Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill	Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.	Week 24
Adherence to Pre-Exposure Prophylaxis (PrEP) Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)	Self reports in iQS, Wisepill, and ACASI will be compared to measured drug concentration levels in blood and hair. The iQS is administered as part of this study (ATN 123). The ACASI, Wisepill and drug concentration levels in blood and hair are collected as part of the parent studies (ATN 110 or ATN 113)	Week 0
Adherence to Pre-Exposure Prophylaxis (PrEP)Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)	Self reports in iQS, Wisepill, and ACASI will be compared to measured drug concentration levels in blood and hair. The iQS is administered as part of this study (ATN 123). The ACASI, Wisepill and drug concentration levels in blood and hair are collected as part of the parent studies (ATN 110 or ATN 113)	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of components of the Person Environment Theoretical Framework (PETF) (specifically physical setting (structural) and social climate (partnership factors)) with adherence to PrEP among YMSM	Components of Person Environment Theoretical Framework (PETF), specifically physical setting (structural) and social climate (partnership factors)) and adherence change over time will be assessed by comparing reports between the first administration of the iQS at Week 0 and the second administration at week 24.	Week 0 and Week 24
Association of components of the PETF (physical setting (structural) and social climate (partnership factors)) with change over time.	To assess how components of the PETF (physical setting (structural) and social climate (partnership factors)) change over time by comparing reports between the first administration of the iQS at Week 0 and the second administration at Week 24.	Week 0 and Week 24

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Drug Abuse (NIDA); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Pamina M Gorbach, MHS, DrPH, University of California, Los Angeles; Study Chair: Michelle Lally, MD, MSc, Alpert Medical School, Brown University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: PrEP; HIV Prevention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: ATN 123