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Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00739752
First Posted: August 22, 2008
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Gregory Zimet, Indiana University
Results First Submitted: April 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Hepatitis B Virus
Interventions: Behavioral: Non-Framed-Offered
Behavioral: Non-Framed-Recommended
Behavioral: Gain-Framed-Offered
Behavioral: Gain-Framed-Recommended
Behavioral: Loss-Framed-Offered
Behavioral: Loss-Framed-Recommended

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Non-Framed-Offered

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed-Offered: Subjects received information only and are offered the vaccine.

Non-Framed-Recommended

Non-Framed, Information Only Condition. Vaccine Recommended.

Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.

Gain-Framed-Offered

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed-Recommended

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed-Offered

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed-Recommended

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.


Participant Flow:   Overall Study
    Non-Framed-Offered   Non-Framed-Recommended   Gain-Framed-Offered   Gain-Framed-Recommended   Loss-Framed-Offered   Loss-Framed-Recommended
STARTED   299   284   292   288   291   293 
COMPLETED   299   284   292   288   291   293 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Non-Framed-Offered

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed-Offered: Subjects received information only and are offered the vaccine.

Non-Framed-Recommended

Non-Framed, Information Only Condition. Vaccine Recommended.

Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.

Gain-Framed-Offered

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed-Recommended

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed-Offered

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed-Recommended

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.

Total Total of all reporting groups

Baseline Measures
   Non-Framed-Offered   Non-Framed-Recommended   Gain-Framed-Offered   Gain-Framed-Recommended   Loss-Framed-Offered   Loss-Framed-Recommended   Total 
Overall Participants Analyzed 
[Units: Participants]
 299   284   292   288   291   293   1747 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.2  (9.7)   31.8  (9.8)   31.2  (9.8)   31.7  (9.4)   32.1  (10.1)   32.3  (10.6)   31.7  (9.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      178  59.5%      179  63.0%      175  59.9%      166  57.6%      179  61.5%      177  60.4%      1054  60.3% 
Male      121  40.5%      105  37.0%      117  40.1%      122  42.4%      112  38.5%      116  39.6%      693  39.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      7   2.3%      9   3.2%      9   3.1%      8   2.8%      6   2.1%      9   3.1%      48   2.7% 
Not Hispanic or Latino      284  95.0%      272  95.8%      278  95.2%      275  95.5%      282  96.9%      278  94.9%      1669  95.5% 
Unknown or Not Reported      8   2.7%      3   1.1%      5   1.7%      5   1.7%      3   1.0%      6   2.0%      30   1.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      1   0.3%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.1% 
Asian      0   0.0%      1   0.4%      2   0.7%      0   0.0%      1   0.3%      2   0.7%      6   0.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      1   0.3%      0   0.0%      0   0.0%      1   0.1% 
Black or African American      252  84.3%      233  82.0%      239  81.8%      233  80.9%      236  81.1%      233  79.5%      1426  81.6% 
White      32  10.7%      37  13.0%      37  12.7%      38  13.2%      35  12.0%      45  15.4%      224  12.8% 
More than one race      8   2.7%      8   2.8%      5   1.7%      6   2.1%      7   2.4%      9   3.1%      43   2.5% 
Unknown or Not Reported      6   2.0%      5   1.8%      9   3.1%      10   3.5%      12   4.1%      4   1.4%      46   2.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
             
United States   299   284   292   288   291   293   1747 


  Outcome Measures

1.  Primary:   Number of Participants Administered Hepatitis B Vaccine   [ Time Frame: Day of research visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Dr. Gregory Zimet
Organization: Indiana University
phone: 317-274-8812
e-mail: gzimet@iu.edu


Publications of Results:
Cox AD, Cox D, Zimet G. Promoting prevention and early detection: The impact of message framing, product function and perceived product risk. J Marketing 2006;70:79-91.


Responsible Party: Gregory Zimet, Indiana University
ClinicalTrials.gov Identifier: NCT00739752     History of Changes
Other Study ID Numbers: 0205-04
R01AI049644 ( U.S. NIH Grant/Contract )
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: April 6, 2017
Results First Posted: October 16, 2017
Last Update Posted: October 16, 2017