Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02810249
Status:
COMPLETED
Last Update Posted:
2017-04-14
First Post:
2016-05-25
Brief Title:
Likely Use of PrEP for African American YMSM
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Factors Affecting the Likely Use of PrEP for African American Young Men Who Have Sex With Men
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 YMSMs 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 YMSMs likely use of PrEP as a coping strategy for HIV prevention Demographic information will be collected and analyzed using Statistical Analysis Software version 93 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 Networks ATN 082 studys questionnaire Participants will be asked questions relating to African American YMSMs 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
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 Networks ATN 082 studys questionnaire Participants will be asked questions relating to African American YMSMs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None