NCT02810249

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2016

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

May 25, 2016

Last Update Submit

April 12, 2017

Conditions

Keywords

African American YMSMPrEPHIV Pre-Exposure ProphylaxisCommon Sense ModelHealthcareHIV Prevention

Outcome Measures

Primary Outcomes (3)

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

    During patient interview, approximately 1.5 hours

  • Cognitive processes in response to using PrEP to reduce risk for HIV

    During patient interview, approximately 1.5 hours

  • Emotional processes in response to using PrEP to reduce risk for HIV

    During patient interview, approximately 1.5 hours

Study Arms (1)

African American YMSM

Other: No intervention used

Interventions

African American YMSM

Eligibility Criteria

Age16 Years - 24 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

20 to 30 African American young men who have sex with men, aged 16-24

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 22, 2016

Study Start

June 1, 2016

Primary Completion

December 29, 2016

Study Completion

December 29, 2016

Last Updated

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share