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

• Sponsor: Boston Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01254669
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 37.9
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Behavioral: BNI-brief Negotiated Interview	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomized Clinical Trial To Improve HPV Immunization in Haitian and African American Girls
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: brief intervention to improve HPV vaccine in girls

Outcome Measures

Primary Outcome Measures

1. The Receipt of the First HPV Vaccination [within 1 month of randomization]

   Receipt of the first HPV vaccination among adolescent daughters of the participants

Secondary Outcome Measures

1. The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine. [1 hour after intervention]

   post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 15 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 11-15 HPV vaccine eligible adolescent girls

Exclusion Criteria:

• Prior receipt of the HPV vaccine

• pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston Medical Center

Investigators

• Principal Investigator: natalie joseph, MD, MPH, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Natalie Pierre-Joseph, Assistant Professor, Boston Medical Center
• ClinicalTrials.gov Identifier: NCT01254669
• Other Study ID Numbers: H26306
• First Posted: Dec 6, 2010
• Last Update Posted: May 19, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Natalie Pierre-Joseph, Assistant Professor, Boston Medical Center: Haitian girls, African American girls; Brief Negotiated Interview; cognitive behavioral intervention; HPV vaccine; cervical cancer
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Vaccines

Study Results

Participant Flow

Recruitment Details	We recruited 100 English- and 100 Haitian Creole-speaking mothers of adolescent girls between April 2011 and September 2013 at the medical clinic ( pediatrics and adolescent clinic). Of 1,703 mothers approached during the study period,1,201 were ineligible. Of the 502 eligible, 302 declined and 200 (40%) were recruited &consented to pilot trial.
Pre-assignment Detail	Following participant enrollment, but prior to group assignment, no significant event occurred. However, in our study after being randomized, participants provided demographic data. During data collection, one participants was excluded/self-withdrew from the trial for fear that demographic data may affect her immigration status/not documented.

Arm/Group Title	Standard of Care	Brief Negotiated Inteview (BNI) Intervention
Arm/Group Description	A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve Human Papilloma Virus (HPV) vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care. Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No Brief Negotiated Intervention (BNI) counseling was provided.	A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care. One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status
Period Title: Overall Study
STARTED	100	100
COMPLETED	97	96
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Standard of Care	BNI/Intervention	Total
Arm/Group Description	A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care. Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine.	One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status .	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
age	41 (7)	40 (9)	41 (8)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	100 100%	100 100%	200 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	100 100%	100 100%	200 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	100 100%	100 100%	200 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	100 100%	100 100%	200 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	100 100%	100 100%	200 100%
knowledge of HPV vaccine (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5 (4)	6 (4)	5 (4)

Outcome Measures

1. Primary Outcome

Title	The Receipt of the First HPV Vaccination
Description	Receipt of the first HPV vaccination among adolescent daughters of the participants
Time Frame	within 1 month of randomization

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined based on number of participants enrolled and who answered questions of interest.

Arm/Group Title	Standard of Care	BNI/Intervention
Arm/Group Description	A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care. Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine.	Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
Measure Participants	97	96
Number [percentage of participants]	51 51%	56 56%

2. Secondary Outcome

Title	The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.
Description	post-educational intervention assessment of HPV knowledge ranges from 0 (minimal knowledge) to 12 (maximal knowledge)
Time Frame	1 hour after intervention

Outcome Measure Data

Analysis Population Description

The number of participants for analysis was determined based on the total enrolled and who responded to knowledge questions

Arm/Group Title	BNI Post-educational Intervention Group	Control Group
Arm/Group Description	A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care. Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)	Did not receive any BNI intervention on the pre and post measure
Measure Participants	99	96
Mean (Standard Deviation) [units on a scale]	10 (2)	5 (2)

Adverse Events

Time Frame	1 year- no adverse event over
Adverse Event Reporting Description	no adverse event
Arm/Group Title	Standard of Care		BNI/Intervention
Arm/Group Description	A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care. Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine.		One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
All Cause Mortality
	Standard of Care		BNI/Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		BNI/Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		BNI/Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)

Limitations/Caveats

Limitations:small sample,Enrolling only mothers, of daughters who are African-American and Haitians lead to longer recruitment time/non-generalizable data. Future studies should include heterogeneous ethnicities,fathers, sons, and any legal guardian.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.