Likely Use of PrEP for African American YMSM

April 12, 2017 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
African American YMSM
Other: No intervention used

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Factors that influence African American YMSM's likely use of PrEP
Time Frame: During patient interview, approximately 1.5 hours
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
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
During patient interview, approximately 1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00070892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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