Factors Affecting PrEP Adherence

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411630
• Other study ID #: ATN 123
• Status: Completed
• Phase: N/A
• First received: January 23, 2014
• Last updated: February 27, 2017
• Start date: June 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Denver	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Fenway Institute	Boston	Massachusetts
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	Wayne State University-Children's Hospital of Michigan	Detroit	Michigan
United States	Baylor College of Medicine - Texas Children's Hospital	Houston	Texas
United States	Children's Hopsital of Los Angeles	Los Angeles	California
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	University of Miami School of Medicine	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of South Florida	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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