An Intervention Study To Improve Human PapillomaVirus ( HPV) Immunization in Haitian and African American Girls
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): BNI-brief Negotiated Interview
Intervention type(s): Behavioral
Intervention description(s): use of a cognitive behavioral intervention to improve uptake of HPV vaccine
Other intervention name(s): brief intervention to improve HPV vaccine in girls
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haitian girls, African American girls; Brief Negotiated Interview; cognitive behavioral intervention; HPV vaccine; cervical cancer