Trial Outcomes & Findings for An Intervention Study To Improve Human PapillomaVirus ( HPV) Immunization in Haitian and African American Girls (NCT NCT01254669)

NCT ID: NCT01254669

Last Updated: 2017-05-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: within 1 month of randomization
• Results posted on: 2017-05-19

Participant Flow

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.

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.

Participant milestones

Measure	Standard of Care 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.	Brief Negotiated Inteview (BNI) Intervention 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
Overall Study STARTED	100	100
Overall Study COMPLETED	97	96
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Standard of Care 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.	Brief Negotiated Inteview (BNI) Intervention 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
Overall Study Withdrawal by Subject	0	1
Overall Study time constraint	2	2
Overall Study called to clinic during intervention	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care n=100 Participants 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.	BNI/Intervention n=100 Participants 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 n=200 Participants Total of all reporting groups
Age, Continuous age	41 years STANDARD_DEVIATION 7 • n=93 Participants	40 years STANDARD_DEVIATION 9 • n=4 Participants	41 years STANDARD_DEVIATION 8 • n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=93 Participants	100 Participants n=4 Participants	200 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	100 Participants n=93 Participants	100 Participants n=4 Participants	200 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	100 Participants n=93 Participants	100 Participants n=4 Participants	200 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=93 Participants	100 Participants n=4 Participants	200 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	100 participants n=93 Participants	100 participants n=4 Participants	200 participants n=27 Participants
knowledge of HPV vaccine	5 units on a scale STANDARD_DEVIATION 4 • n=93 Participants	6 units on a scale STANDARD_DEVIATION 4 • n=4 Participants	5 units on a scale STANDARD_DEVIATION 4 • n=27 Participants

PRIMARY outcome

Timeframe: within 1 month of randomization

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

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

Outcome measures

Measure	Standard of Care n=97 Participants 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.	BNI/Intervention n=96 Participants 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.
The Receipt of the First HPV Vaccination	51 percentage of participants	56 percentage of participants

SECONDARY outcome

Timeframe: 1 hour after intervention

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

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

Outcome measures

Measure	Standard of Care n=99 Participants 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.	BNI/Intervention n=96 Participants 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.
The Secondary Outcome Will be Maternal Knowledge About HPV Vaccine.	10 units on a scale Standard Deviation 2	5 units on a scale Standard Deviation 2

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BNI/Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Natalie Joseph

Boston Medical Center

Phone: 1-617-414-5202

Email: napierre@bu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place