Likely Use of PrEP for African American YMSM

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.

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Key information

Conditions

HIV

Age range

16 year–24 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention used

Other

Primary outcomes

Factors that influence African American YMSM's likely use of PrEP

Time frame: During patient interview, approximately 1.5 hours
Cognitive processes in response to using PrEP to reduce risk for HIV

Time frame: During patient interview, approximately 1.5 hours
Emotional processes in response to using PrEP to reduce risk for HIV

Time frame: During patient interview, approximately 1.5 hours

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Factors Affecting the Likely Use of PrEP for African American Young Men Who Have Sex With Men

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jun 22, 2016
Registry last updated: Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed