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

A Randomized Clinical Trial To Improve HPV Immunization in Haitian and African American Girls

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.

Study Overview

• Status: Completed
• Conditions: Cervical Cancer
• Intervention / Treatment: Behavioral: BNI-brief Negotiated Interview

Detailed Description

In the U.S., Black women have higher rates of cervical cancer than White women. Women in Haiti and Haitian immigrant women have among the highest rates of cervical cancer in the world. The recent introduction of the HPV vaccine provides an opportunity to reduce the disparity in cervical cancer rates between White and Black non-White (Haitians and US born African-Americans (AA)). Unfortunately, females ages 11-14 have low rates, 25%, of HPV vaccination. For the vaccine to be effective it must be given prior to the onset of sexual activity. Parents are a central audience for interventions to promote HPV vaccine uptake in children < 18 since parents have to consent.

Hypothesis: The objective of this study is to increase HPV immunization rates in Haitian and African American adolescent girls. My 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.

Specific Aim 1a: Develop a script that will use BNI to address low-income Haitian immigrant and African American mothers' concern about HPV immunization

Specific Aim 1b: Teach community health workers to use BNI to enhance HPV acceptability Specific aim 2: Conduct a pilot, randomized clinical trial to determine feasibility effectiveness of BNI, and to obtain empirical estimates of study parameters to assess logistical aspects of a larger Randomized Clinical Trial (RCT). This will include assessing recruitment and retention of subjects, intervention delivery, and effect size.

Study design: The primary study design will be a RCT which will follow the CONSORT requirements for data reporting and analysis. One-hundred immigrant Haitian mothers bringing their adolescent daughters (age range 11 to 15) to clinic for routine care will be randomized to BNI (n=80) or to standard care (N=80) information about HPV vaccine). The primary outcome will be receipt of the first HPV vaccination in the adolescent within 1 month of randomization. The secondary outcome will be maternal knowledge about HPV vaccine. This study will provide key estimates so that we can conduct a fully-powered RCT, which will include completion of the primary HPV series (3 vaccinations) as the primary outcome.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 11-15 HPV vaccine eligible adolescent girls

Exclusion Criteria:

• Prior receipt of the HPV vaccine
• pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control, standard of care; Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV-vaccine information sheet
Experimental: BNI-brief Negotiated Interview; 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; use of a cognitive behavioral intervention to improve uptake of HPV vaccine; Other Names: brief intervention to improve HPV vaccine in girls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.	post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)	1 hour after intervention

Collaborators and Investigators

• Sponsor: Boston Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: December 3, 2010
• First Posted (Estimate): December 6, 2010

Study Record Updates

• Last Update Posted (Actual): May 19, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: cervical cancer; HPV vaccine; cognitive behavioral intervention; Haitian girls, African American girls; Brief Negotiated Interview
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: H26306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No