An Intervention Study To Improve HPV Immunization in Haitian and African American Girls
| Status: | Completed |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 11 - 15 |
| Updated: | 11/8/2014 |
| Start Date: | January 2011 |
| End Date: | June 2013 |
| Contact: | natalie Joseph, MD, MPH |
| Email: | natalie.pierrejoseph@bmc.org |
| Phone: | 781-729-0517 |
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.
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.
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.
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.
Inclusion Criteria:
- 11-15 HPV vaccine eligible adolescent girls
Exclusion Criteria:
- Prior receipt of the HPV vaccine
- pregnant
We found this trial at
1
site
Boston Med Center Boston Medical Center (BMC) is a 496-bed academic medical center located in...
Click here to add this to my saved trials
