Sexually Transmitted DiseasesNCT02811848
Recruiting African American Fathers/ Sons
An observational study of Sexually Transmitted Diseases and HIV, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test recruitment methods for a future study of prevention of sexually transmitted infections (STI), including the human immunodeficiency virus (HIV), among Black adolescent boys through sexual health education by their fathers. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, HIV
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2016to Feb 2017
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Barbers who serve majority African American fathers and male youth.
Who may be able to join
- a full time barber
- age 18 years or older
- willing to participate in a 2-hour focus group session
- able to provide written consent
- serving primarily young to middle age Black males.
- Fathers are selected by the following inclusion criteria:
Show all 11Show fewer
- self-identification as Black or African American
- father of an adolescent male child age 11-18 (father in this study will be defined as biological father, stepfather, or father by adoption)
- residence in or outside of the home
- a consistent relationship with son (defined as communicating with son at least weekly)
- willingness to participate in a 2-hour focus group session, and written consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Feasibility Study: Recruiting African American Fathers and Their Adolescent Sons for Qualitative, Sexual Health Research
The purpose of this study is to develop and pilot test recruitment methods for a future study of prevention of sexually transmitted infections (STI), including the human immunodeficiency virus (HIV), among Black adolescent boys through sexual health education by their fathers.
Read the detailed description
Sexually transmitted infections (STIs), including the human immunodeficiency virus (HIV), are a health problem for all adolescents, regardless of race. Presently, there are nearly 110 million cases of sexually transmitted infections (STI) in the United States. Annually, there are more than 19.7 million new STI cases, of which half are accounted for by youth. Of those, more than half are accounted for by youth ages 15 to 24 years. However, Black males between the ages of 13 and 17 are disproportionately affected by STIs such as chlamydia, gonorrhea, syphilis, and HIV/AIDS; they currently account for 50% of HIV infections among all youth. Additionally, the rate of HIV infection among young black gay or bisexual men is twice that of young white men. Researchers have pointed to the need to involve Black men who are fathers in interventions to decrease the epidemic of STIs and HIV among Black adolescent boys. However, youth-focused interventions from the Centers for Disease Control and Prevention (CDC) include only one intervention with a focus on the father and son as a dyad. Thus more research is clearly needed with this focus, but challenges with recruitment need to first be addressed. Challenges in recruiting Black men for health research are reflected in efforts by the National Institutes of Health (NIH) to promote research that includes minorities and in particular Black fathers. Barriers to research participation include ongoing distrust of health researchers because of the historic failing of the medical field in the Tuskegee syphilis study of rural Black men; this occurred more than 47 years ago but still remains important today. Barriers also include lack of knowledge of the benefits of research. Because of this lack of participation of Black men in research we have only limited understanding of their perceptions of many health issues. In order to involve this population in research, barriers and challenges to their involvement must be overcome. One way to begin this is to engage with leaders in their communities, to effectively communicate research objectives and begin building trusting relationships. Establishing relationships with community leaders can facilitate recruitment in research and help to overcome some of the barriers and challenges for Black men. Important elements of building those relationships include discussing research procedures, hypotheses, pilot data, and plans to bring results of research back to the community for future utilization. This proposed study will therefore seek to implement these elements of trust with local barbers and barbershops. In the Black community, barbers have been identified as community leaders and a great recruiting source for work on health promotion and disease prevention in the areas of hypertension and prostate cancer. However, few studies have used barbershops for sexual health related content focusing on Black fathers and their adolescent boys.
To create a successful recruitment process for Black men and their sons, a strategic plan of action is necessary prior to implementing a study. The first step is to gain a deeper understanding of effective strategies to include Black men in research. Therefore, the proposed pilot study will develop and test the feasibility of a recruitment process for Black men who are fathers and their adolescent sons, using barbershops and barbers as recruiters and advocates. Barbers will be assessed for their willingness to serve as recruiters and advocates for sexual health related studies involving Black fathers and their adolescent sons, and their ideas for recruitment for this group. With this information we will develop and pilot a recruitment strategy, to be used in a future qualitative study: Assessing Black fathers' attitudes towards discussing sexual health with their adolescent son and Assessing Black adolescent boys' attitudes towards their father as a sexual health educator. This future study will identify fathers' attitudes towards their adolescent sons and sex and major influences on sexual behaviors of adolescent boys, identify fathers' perspectives on what and who is important to include in an intervention focused on STI and HIV prevention, develop a survey tool to assess a larger sample of African American fathers for a future study, and gain adolescent males' perspectives on the role of their fathers in their sexual health. Research has suggested that clear communication between Black parents and their youth about sexual health is associated with higher rates of sexual abstinence, condom use, and intent to delay initiation of sexual intercourse, which can prevent infectious diseases. However, barriers exist for parents in educating their youth about sexual health, including lack of knowledge and discomfort in talking about safe sex. Further, little research has been conducted specifically on the parental role of Black fathers in educating their sons. This study will identify the best strategies for recruiting Black fathers and their sons for research on the parental role of Black fathers in helping their sons avoid risky sex.
- Conditions
- Sexually Transmitted Diseases, HIV
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Barbers | Barbers that service African American clientele mainly will be recruited for this study; there is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Strategy for the recruitment of African American father/son dyads
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start9 May 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Schenita Randolph, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811848
- Sponsor's protocol ID
- Pro00071686
- Status last verified
- May 2017
- First submitted
- 21 Jun 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study: Recruiting African American Fathers and Their Adolescent Sons for Qualitative, Sexual Health Research
- ClinicalTrials.gov ID
- NCT02811848
- Acronym / sponsor ID
- Pro00071686
- Conditions
- Sexually Transmitted Diseases, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health
- Study start
- 9 May 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 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.
The purpose of this study is to develop and pilot test recruitment methods for a future study of prevention of sexually transmitted infections (STI), including the human immunodeficiency virus (HIV), among Black adolescent boys through sexual health education by their fathers.
Detailed description
Sexually transmitted infections (STIs), including the human immunodeficiency virus (HIV), are a health problem for all adolescents, regardless of race. Presently, there are nearly 110 million cases of sexually transmitted infections (STI) in the United States. Annually, there are more than 19.7 million new STI cases, of which half are accounted for by youth. Of those, more than half are accounted for by youth ages 15 to 24 years. However, Black males between the ages of 13 and 17 are disproportionately affected by STIs such as chlamydia, gonorrhea, syphilis, and HIV/AIDS; they currently account for 50% of HIV infections among all youth. Additionally, the rate of HIV infection among young black gay or bisexual men is twice that of young white men. Researchers have pointed to the need to involve Black men who are fathers in interventions to decrease the epidemic of STIs and HIV among Black adolescent boys. However, youth-focused interventions from the Centers for Disease Control and Prevention (CDC) include only one intervention with a focus on the father and son as a dyad. Thus more research is clearly needed with this focus, but challenges with recruitment need to first be addressed. Challenges in recruiting Black men for health research are reflected in efforts by the National Institutes of Health (NIH) to promote research that includes minorities and in particular Black fathers. Barriers to research participation include ongoing distrust of health researchers because of the historic failing of the medical field in the Tuskegee syphilis study of rural Black men; this occurred more than 47 years ago but still remains important today. Barriers also include lack of knowledge of the benefits of research. Because of this lack of participation of Black men in research we have only limited understanding of their perceptions of many health issues. In order to involve this population in research, barriers and challenges to their involvement must be overcome. One way to begin this is to engage with leaders in their communities, to effectively communicate research objectives and begin building trusting relationships. Establishing relationships with community leaders can facilitate recruitment in research and help to overcome some of the barriers and challenges for Black men. Important elements of building those relationships include discussing research procedures, hypotheses, pilot data, and plans to bring results of research back to the community for future utilization. This proposed study will therefore seek to implement these elements of trust with local barbers and barbershops. In the Black community, barbers have been identified as community leaders and a great recruiting source for work on health promotion and disease prevention in the areas of hypertension and prostate cancer. However, few studies have used barbershops for sexual health related content focusing on Black fathers and their adolescent boys.
To create a successful recruitment process for Black men and their sons, a strategic plan of action is necessary prior to implementing a study. The first step is to gain a deeper understanding of effective strategies to include Black men in research. Therefore, the proposed pilot study will develop and test the feasibility of a recruitment process for Black men who are fathers and their adolescent sons, using barbershops and barbers as recruiters and advocates. Barbers will be assessed for their willingness to serve as recruiters and advocates for sexual health related studies involving Black fathers and their adolescent sons, and their ideas for recruitment for this group. With this information we will develop and pilot a recruitment strategy, to be used in a future qualitative study: Assessing Black fathers' attitudes towards discussing sexual health with their adolescent son and Assessing Black adolescent boys' attitudes towards their father as a sexual health educator. This future study will identify fathers' attitudes towards their adolescent sons and sex and major influences on sexual behaviors of adolescent boys, identify fathers' perspectives on what and who is important to include in an intervention focused on STI and HIV prevention, develop a survey tool to assess a larger sample of African American fathers for a future study, and gain adolescent males' perspectives on the role of their fathers in their sexual health. Research has suggested that clear communication between Black parents and their youth about sexual health is associated with higher rates of sexual abstinence, condom use, and intent to delay initiation of sexual intercourse, which can prevent infectious diseases. However, barriers exist for parents in educating their youth about sexual health, including lack of knowledge and discomfort in talking about safe sex. Further, little research has been conducted specifically on the parental role of Black fathers in educating their sons. This study will identify the best strategies for recruiting Black fathers and their sons for research on the parental role of Black fathers in helping their sons avoid risky sex.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Barbers | – | –Barbers that service African American clientele mainly will be recruited for this study; there is no intervention. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Barbers who serve majority African American fathers and male youth.
Key inclusion criteria (11 listed)
- Fathers are selected by the following inclusion criteria:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment Strategy for the recruitment of African American father/son dyads
Time frame: 1 year
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 4 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Schenita Randolph principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases and HIV, run by Duke University at 1 site in United States.
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 11 inclusion and 0 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Recruitment Strategy for the recruitment of African American father/son dyads (time frame: 1 year). 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 4 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.