HIVNCT02810249
Likely Use of PrEP for African American YMSM
An observational study of HIV, run by Duke University.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 29 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: 20 to 30 African American young men who have sex with men, aged 16-24
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- No intervention used
- Keywords
- African American YMSM, PrEP, HIV Pre-Exposure Prophylaxis, Common Sense Model, Healthcare, HIV Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention usedOther
| Study group | Role | What they receive |
|---|---|---|
| African American YMSM | Not described Receives: Other: No intervention used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors that influence African American YMSM's likely use of PrEP
Measured: During patient interview, approximately 1.5 hours
Cognitive processes in response to using PrEP to reduce risk for HIV
Measured: During patient interview, approximately 1.5 hours
Emotional processes in response to using PrEP to reduce risk for HIV
Measured: During patient interview, approximately 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion29 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810249
- Sponsor's protocol ID
- Pro00070892
- Status last verified
- Apr 2017
- First submitted
- 25 May 2016
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Likely Use of PrEP for African American Young Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02810249
- Acronym / sponsor ID
- Pro00070892
- Conditions
- HIV
- Keywords
- African American YMSM, PrEP, HIV Pre-Exposure Prophylaxis, Common Sense Model, Healthcare, HIV Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African American YMSM | – | Other: No intervention used |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 20 to 30 African American young men who have sex with men, aged 16-24
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention used | Other | African American YMSM |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors that influence African American YMSM's likely use of PrEP (time frame: During patient interview, approximately 1.5 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.