Trial Information

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

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 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.