Factors Affecting PrEP Adherence

University of North Carolina (UNC)

Status: Completed

Conditions: HIV Infection

Treatments: Drug: Emtricitabine/tenofovir disoproxil

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02411630

ATN 123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 patients

Sex: Male

Ages: 15 to 22 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

167 participants in 1 patient group

Interactive Questionnaire System (iQS)

Description:

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®).

Treatment:

Drug: Emtricitabine/tenofovir disoproxil