Factors Affecting PrEP Adherence
Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men
1 other identifier
observational
167
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 28, 2017
December 1, 2016
2 years
January 23, 2014
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (2)
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
Week 0 and Week 24
Association of components of the PETF (physical setting (structural) and social climate (partnership factors)) with change over time.
Week 0 and Week 24
Study Arms (1)
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®).
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Children's Hopsital of Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital of Denver
Aurora, Colorado, 80045, United States
University of Miami School of Medicine
Miami, Florida, 33101, United States
University of South Florida
Tampa, Florida, 33606, United States
Stroger Hospital of Cook County
Chicago, Illinois, 60612, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Fenway Institute
Boston, Massachusetts, 02215, United States
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pamina M Gorbach, MHS, DrPH
University of California, Los Angeles
- STUDY CHAIR
Michelle Lally, MD, MSc
Alpert Medical School, Brown University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2014
First Posted
April 8, 2015
Study Start
June 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 28, 2017
Record last verified: 2016-12