Clinical trial NCT02411630: Factors Affecting PrEP Adherence
Official title: Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: PrEP
HIV Prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
First posted: 2015-04-08
Enrollment: 167
Sex: MALE
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
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.

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.

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.

Primary outcomes:
measure: Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire
timeFrame: Week 0
measure: Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire
timeFrame: Week 24
measure: Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill
timeFrame: Week 0
measure: Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill
timeFrame: Week 24
measure: Adherence to Pre-Exposure Prophylaxis (PrEP) Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)
timeFrame: Week 0
measure: Adherence to Pre-Exposure Prophylaxis (PrEP)Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
measure: 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
timeFrame: Week 0 and Week 24
measure: Association of components of the PETF (physical setting (structural) and social climate (partnership factors)) with change over time.
timeFrame: Week 0 and Week 24
Locations:
city: Los Angeles
country: United States
facility: Children's Hopsital of Los Angeles
state: California
city: Aurora
country: United States
facility: Children's Hospital of Denver
state: Colorado
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Fenway Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University-Children's Hospital of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Childrens Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine - Texas Children's Hospital
state: Texas
Study officials:
affiliation: University of California, Los Angeles
name: Pamina M Gorbach, MHS, DrPH
role: STUDY_CHAIR
affiliation: Alpert Medical School, Brown University
name: Michelle Lally, MD, MSc
role: STUDY_CHAIR
References: