An Intervention Study To Improve Human PapillomaVirus ( HPV) Immunization in Haitian and African American Girls (HPV)
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|ClinicalTrials.gov Identifier: NCT01254669|
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : October 24, 2014
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Behavioral: BNI-brief Negotiated Interview||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial To Improve HPV Immunization in Haitian and African American Girls|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||March 2014|
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 Name: brief intervention to improve HPV vaccine in girls
- The Receipt of the First HPV Vaccination [ Time Frame: within 1 month of randomization ]Receipt of the first HPV vaccination among adolescent daughters of the participants
- The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine. [ Time Frame: 1 hour after intervention ]post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254669
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||natalie joseph, MD, MPH||Boston Medical Center|