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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: BNI-brief Negotiated Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 11-15 HPV vaccine eligible adolescent girls Exclusion Criteria: Prior receipt of the HPV vaccine pregnant

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haitian girls, African American girls, Brief Negotiated Interview, cognitive behavioral intervention, HPV vaccine, cervical cancer