Factors Affecting PrEP Adherence

NCT ID: NCT02411630

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 167 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-06-30

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.

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.

Conditions

HIV Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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®).

Emtricitabine/tenofovir disoproxil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Truvada®; FTC/TFV

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamina M Gorbach, MHS, DrPH

Role: STUDY_CHAIR

University of California, Los Angeles

Michelle Lally, MD, MSc

Role: STUDY_CHAIR

Alpert Medical School, Brown University

Locations

Children's Hopsital of Los Angeles

Los Angeles, California, United States

Children's Hospital of Denver

Aurora, Colorado, United States

University of Miami School of Medicine

Miami, Florida, United States

University of South Florida

Tampa, Florida, United States

Stroger Hospital of Cook County

Chicago, Illinois, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Fenway Institute

Boston, Massachusetts, United States

Wayne State University-Children's Hospital of Michigan

Detroit, Michigan, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St. Jude Childrens Research Hospital

Memphis, Tennessee, United States

Baylor College of Medicine - Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

ATN 123

Identifier Type: -

Identifier Source: org_study_id