Factors Affecting PrEP Adherence
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

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.
    

Intervention name(s): Emtricitabine/tenofovir disoproxil
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Truvada®; FTC/TFV
Intervention MeSH terms: Tenofovir; Emtricitabine
Observational model: Case-Only
Time perspective: Retrospective
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.
      
Keywords: PrEP; HIV Prevention