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Trial record 11 of 1216 for:    "Observational" [STUDY-TYPES] AND HIV [CONDITION]

Factors Affecting PrEP Adherence

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ClinicalTrials.gov Identifier: NCT02411630
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment
HIV Infection 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
Actual Enrollment : 167 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men
Study Start Date : June 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire [ Time Frame: Week 0 ]
    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.

  2. Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire [ Time Frame: Week 24 ]
    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.

  3. Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill [ Time Frame: Week 0 ]
    Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.

  4. Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill [ Time Frame: Week 24 ]
    Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.

  5. Adherence to Pre-Exposure Prophylaxis (PrEP) Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI) [ Time Frame: Week 0 ]
    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)

  6. Adherence to Pre-Exposure Prophylaxis (PrEP)Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI) [ Time Frame: Week 24 ]
    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)


Other Outcome Measures:
  1. 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 [ Time Frame: Week 0 and Week 24 ]
    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.

  2. Association of components of the PETF (physical setting (structural) and social climate (partnership factors)) with change over time. [ Time Frame: Week 0 and Week 24 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411630


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

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02411630     History of Changes
Other Study ID Numbers: ATN 123
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: December 2016

Keywords provided by University of North Carolina, Chapel Hill:
PrEP
HIV Prevention

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents