Human PapillomavirusNCT00937287
Human Papilloma Virus (HPV) Vaccination Among Rural African American Primary Caregivers and Daughters
An observational study of Human Papillomavirus, run by University of Georgia at 1 site in United States.
Trial summary
African American women living in the rural South are twice as likely as Caucasian women to develop cervical cancer and die of invasive cervical cancer at a higher rate than any other racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African Americans are not well understood. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2012
- 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 13 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Study population: The sample will include rural, female African American youth aged 13-17 (n=200) and their primary caregivers (n=200) who reside in the same household.
Who may be able to join
- Rural African American girls aged 13-17
- Female parent or primary caregiver of participating daughter
Who cannot join
- Girls can not be younger than age 13, or older than 17
- The target's female parent or primary caregiver must also live in the same household and agree to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Family Research
Athens, Georgia, 30602
About this study
Official title: Understanding HPV Vaccination Among Rural African American Primary Caregivers and Daughters
African American women living in the rural South are twice as likely as Caucasian women to develop cervical cancer and die of invasive cervical cancer at a higher rate than any other racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African Americans are not well understood. HPV vaccination compliance is likely influenced by barriers to health care access, misinformation regarding vaccinations, religious beliefs related to sexual health and behaviors, and mistrust of the medical community (2, 3). Because the vaccination of minors requires primary caregiver consent, vaccination commitment and compliance is strongly influenced by family beliefs and communication regarding health and sexuality. To date, little research has examined the cultural, familial, and intrapersonal influences on HPV vaccination compliance among rural African American women. This study will address these gaps in the literature and provide data needed to develop effective interventions and health promotion materials to encourage HPV vaccination among rural African American women.
From a pool of approximately 800 families who are participating in ongoing longitudinal research through the Center for Family Research at the University of Georgia, the investigators will recruit 200 rural female African American youth aged 13-17 who have not received the HPV vaccine and their primary caregivers (n=200) into an observational, prospective study on vaccination commitment and compliance. The investigators hypotheses are as follows:
- Sociocultural factors that rural African Americans experience, including discrimination, previous health care experience, religious beliefs, and community norms regarding HPV vaccination and adolescent sexual behavior, will forecast primary caregivers' HPV vaccination commitment and compliance for their daughters. The investigators also predict that primary caregivers' HPV-related knowledge and attitudes will mediate this association.
- Sociocultural factors will influence sexual health-related family communication and interaction, primary caregivers' and youths' HPV-related attitudes, and HPV vaccination commitment and compliance.
- Primary caregivers' attitudes, youths' attitudes, and family health communication will contribute to youths' and caregivers' vaccination commitment and compliance.
- Youths' sexual behavior will influence their attitudes, family health communication, and vaccination commitment and compliance.
- Conditions
- Human Papillomavirus
- Being tested
- There is no intervention in this study.
- Keywords
- HPV, African American, Rural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this study.Other
No intervention is provided in this study as it is exploratory.
| Study group | Role | What they receive |
|---|---|---|
| youth and caregivers | Not described Receives: Other: There is no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccination compliance
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 posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Kogan, University of Georgia
- Investigators
- Stephanie R. Burwell, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937287
- Sponsor's protocol ID
- MISP 36701
- Status last verified
- Aug 2013
- First submitted
- 9 Jul 2009
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Saraiya M, Ahmed F, Krishnan S, Richards TB, Unger ER, Lawson HW. Cervical cancer incidence in a prevaccine era in the United States, 1998-2002. Obstet Gynecol. 2007 Feb;109(2 Pt 1):360-70. doi: 10.1097/01.AOG.0000254165.92653.e8.
PubMed 17267837Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
PubMed 17628649Cates JR, Brewer NT, Fazekas KI, Mitchell CE, Smith JS. Racial differences in HPV knowledge, HPV vaccine acceptability, and related beliefs among rural, southern women. J Rural Health. 2009 Winter;25(1):93-7. doi: 10.1111/j.1748-0361.2009.00204.x.
PubMed 19166567
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding HPV Vaccination Among Rural African American Primary Caregivers and Daughters
- ClinicalTrials.gov ID
- NCT00937287
- Acronym / sponsor ID
- MISP 36701
- Conditions
- Human Papillomavirus
- Keywords
- HPV, African American, Rural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Jul 2009 (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.
African American women living in the rural South are twice as likely as Caucasian women to develop cervical cancer and die of invasive cervical cancer at a higher rate than any other racial/ethnic group in the US (1). Reasons for low HPV vaccination rates among rural African Americans are not well understood. HPV vaccination compliance is likely influenced by barriers to health care access, misinformation regarding vaccinations, religious beliefs related to sexual health and behaviors, and mistrust of the medical community (2, 3). Because the vaccination of minors requires primary caregiver consent, vaccination commitment and compliance is strongly influenced by family beliefs and communication regarding health and sexuality. To date, little research has examined the cultural, familial, and intrapersonal influences on HPV vaccination compliance among rural African American women. This study will address these gaps in the literature and provide data needed to develop effective interventions and health promotion materials to encourage HPV vaccination among rural African American women.
From a pool of approximately 800 families who are participating in ongoing longitudinal research through the Center for Family Research at the University of Georgia, the investigators will recruit 200 rural female African American youth aged 13-17 who have not received the HPV vaccine and their primary caregivers (n=200) into an observational, prospective study on vaccination commitment and compliance. The investigators hypotheses are as follows:
- Sociocultural factors that rural African Americans experience, including discrimination, previous health care experience, religious beliefs, and community norms regarding HPV vaccination and adolescent sexual behavior, will forecast primary caregivers' HPV vaccination commitment and compliance for their daughters. The investigators also predict that primary caregivers' HPV-related knowledge and attitudes will mediate this association.
- Sociocultural factors will influence sexual health-related family communication and interaction, primary caregivers' and youths' HPV-related attitudes, and HPV vaccination commitment and compliance.
- Primary caregivers' attitudes, youths' attitudes, and family health communication will contribute to youths' and caregivers' vaccination commitment and compliance.
- Youths' sexual behavior will influence their attitudes, family health communication, and vaccination commitment and compliance.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| youth and caregivers | – | Other: There is no intervention in this study. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The sample will include rural, female African American youth aged 13-17 (n=200) and their primary caregivers (n=200) who reside in the same household.
Key inclusion criteria (2 listed)
- Rural African American girls aged 13-17
- Female parent or primary caregiver of participating daughter
Key exclusion criteria (2 listed)
- Girls can not be younger than age 13, or older than 17
- The target's female parent or primary caregiver must also live in the same household and agree to participate
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 |
|---|---|---|
| There is no intervention in this study.No intervention is provided in this study as it is exploratory. | Other | youth and caregivers |
Primary outcome
HPV vaccination compliance
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 14 Aug 2013.
- Background: PubMed 17267837Saraiya M, Ahmed F, Krishnan S, Richards TB, Unger ER, Lawson HW. Cervical cancer incidence in a prevaccine era in the United States, 1998-2002. Obstet Gynecol. 2007 Feb;109(2 Pt 1):360-70. doi: 10.1097/01.AOG.0000254165.92653.e8.
- Background: PubMed 17628649Brewer NT, Fazekas KI. Predictors of HPV vaccine acceptability: a theory-informed, systematic review. Prev Med. 2007 Aug-Sep;45(2-3):107-14. doi: 10.1016/j.ypmed.2007.05.013. Epub 2007 Jun 2.
- Background: PubMed 19166567Cates JR, Brewer NT, Fazekas KI, Mitchell CE, Smith JS. Racial differences in HPV knowledge, HPV vaccine acceptability, and related beliefs among rural, southern women. J Rural Health. 2009 Winter;25(1):93-7. doi: 10.1111/j.1748-0361.2009.00204.x.
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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.
Stephanie R. Burwell, PhD principal investigator
University of Georgia
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 Human Papillomavirus, run by University of Georgia 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 2 inclusion and 2 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 Aug 2013. 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?
HPV vaccination compliance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937287, which also lists 3 linked publications.
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 Aug 2013.