An Intervention Study To Improve Human PapillomaVirus ( HPV) Immunization in Haitian and African American Girls

NCT01254669 | Completed Results

• 1 other identifier: H26306
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, Black women are more likely to die of cervical cancer than White women. In developing countries and globally, Haitian immigrant women are more likely to die of cervical cancer than any other women in the world. Studies have shown a disparity in parental acceptance of the HPV vaccine with parents of Black adolescent girls being less likely to accept and comply with HPV immunization schedules than Whites. The objective of this study is to increase HPV immunization rates in Haitian and African American adolescent girls. The investigator's hypothesis is that a validated behavior change mechanism, brief-negotiating interviewing (BNI), will effectively increase the proportion of mothers who give consent for their daughters' HPV vaccine, which will ultimately lead to higher vaccination rates, and increase knowledge of HPV infection and the vaccine in Haitian immigrant and African American mothers.

Conditions

Cervical Cancer

Keywords

Haitian girls, African American girls; Brief Negotiated Interview; cognitive behavioral intervention; HPV vaccine; cervical cancer

Outcome Measures

Primary Outcomes (1)

• The Receipt of the First HPV Vaccination

  Receipt of the first HPV vaccination among adolescent daughters of the participants

  within 1 month of randomization

Secondary Outcomes (1)

• The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.

  1 hour after intervention

Study Arms (2)

control, standard of care

NO INTERVENTION

Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV-vaccine information sheet

BNI-brief Negotiated Interview

EXPERIMENTAL

The BNI intervention addressed mothers' beliefs, values, and concerns about HPV prevention and takes their priorities for health and well-being into account.

Behavioral: BNI-brief Negotiated Interview

Interventions

BNI-brief Negotiated Interview BEHAVIORAL

use of a cognitive behavioral intervention to improve uptake of HPV vaccine

Also known as: brief intervention to improve HPV vaccine in girls

BNI-brief Negotiated Interview

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• HPV vaccine eligible adolescent girls

You may not qualify if:

• Prior receipt of the HPV vaccine
• pregnant

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

Limitations:small sample,Enrolling only mothers, of daughters who are African-American and Haitians lead to longer recruitment time/non-generalizable data. Future studies should include heterogeneous ethnicities,fathers, sons, and any legal guardian.

Results Point of Contact

• Title: Dr. Natalie Joseph
• Organization: Boston Medical Center

napierre@bu.edu

1-617-414-5202

Study Officials

• natalie joseph, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: December 6, 2010
• Study Start: January 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 19, 2017
• Results First Posted: October 24, 2014

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)