Factors Affecting PrEP Adherence

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.

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.