Clinical trial NCT02810249: Likely Use of PrEP for African American YMSM
Official title: Factors Affecting the Likely Use of PrEP for African American Young Men Who Have Sex With Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: African American YMSM
PrEP
HIV Pre-Exposure Prophylaxis
Common Sense Model
Healthcare
HIV Prevention
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 25
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 to 30 African American young men who have sex with men, aged 16-24

Brief summary: HIV Pre-Exposure Prophylaxis (PrEP), in the form of the anti-retroviral pill Truvada©, has been approved by the FDA as a method for reducing HIV transmission rates in the population, particularly young men who have sex with men (YMSM). This study will use a qualitative design to interview 20-30, HIV-negative, 16-24 year old African American YMSM to: 1) identify and understand African American YMSM's, aged 16-24, cognitive and emotional processes in response to using PrEP to reduce their risk for HIV and 2) identify what factors (sociocultural, individual, experiences in health care, socioeconomic) influence African American YMSM's likely use of PrEP as a coping strategy for HIV prevention. Demographic information will be collected and analyzed using Statistical Analysis Software version 9.3. Individual interviews will be audio recorded and transcribed by a vetted transcription service for analysis. This is minimal risk to participants.

Detailed description: This study will use an exploratory, naturalistic qualitative design where participants will be interviewed to collect data on their emotional and cognitive processes (illness representation) in response to the threat of a potential HIV infection, and what factors (social, cultural, individual characteristics, and experiences in health care) influence their likely use of PrEP. The sample for this study will include 20 to 30 African American YMSM, aged 16-24, residing in Durham, Wake, and Orange counties of North Carolina.

The in-depth interview guide and the 26-item descriptive survey PrEP Knowledge, Sexual History, and Demographic Instrument were developed for this study using a combination of the concepts from the adapted Common Sense Model of Illness Representation (CSM) and questions adapted from the Adolescent Trial Network's (ATN) 082 study's questionnaire. Participants will be asked questions relating to African American YMSM's likely use of HIV Pre-Exposure Prophylaxis (PrEP) as an HIV risk-reduction strategy. Once informed consent is obtained, the interview will commence and study participants will be individually interviewed to discuss what factors influence their likely use of PrEP. Each participant will complete the descriptive survey and the one-on-one interview.

Eligibility criteria: Inclusion Criteria:

* between the ages of 16-24
* self-identify as African-American, Black, or mixed race including African American or Black
* have been assigned male sex at birth
* self-identify as gay, bisexual, or queer, or self-identify as a heterosexual male who has had a past voluntary sexual experience with another man or currently has sexual desires for men
* report being uninfected with HIV
* be mentally capable of providing informed consent
* be able to speak and read English
* not currently using PrEP for HIV.

Exclusion Criteria:

* HIV-infected men are excluded because this study is focused on the prevention of HIV transmission
* Men who were not assigned male sex at birth are excluded from this study, because transgender men face very different and distinct issues with access to care compared to YMSM
* Men who are currently using PrEP are excluded from this study because this study is exploring the barriers and facilitators to use of PrEP in African American YMSM aged 16-24. Men who are currently using PrEP may have a different illness representation compared to men who are not using PrEP.

Primary outcomes:
measure: Factors that influence African American YMSM's likely use of PrEP
timeFrame: During patient interview, approximately 1.5 hours
measure: Cognitive processes in response to using PrEP to reduce risk for HIV
timeFrame: During patient interview, approximately 1.5 hours
measure: Emotional processes in response to using PrEP to reduce risk for HIV
timeFrame: During patient interview, approximately 1.5 hours
Secondary outcomes:
Other outcomes:
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