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HIV Testing & Womens Attitudes on HIV Vaccine Trials

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771537
First Posted: October 13, 2008
Last Update Posted: July 9, 2013
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 Nursing Research (NINR)
Information provided by (Responsible Party):
Gregory Zimet, Indiana University
Results First Submitted: April 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: HIV
Intervention: Behavioral: Message Sidedness

  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
Message intervention details are in the Brief Summary

Reporting Groups
  Description
HIV TEST MSG Control/ VACCINE TRIAL MSG Control No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial No message intervention control condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major No message intervention control condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided 1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided 2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.

Participant Flow:   Overall Study
    HIV TEST MSG Control/ VACCINE TRIAL MSG Control   HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major
STARTED   135   124   151   114   127   118   128   132   115   119   133   137   128   124   124   122 
COMPLETED   135   124   151   114   127   118   128   132   115   119   133   137   128   124   124   122 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   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
HIV TEST MSG Control/ VACCINE TRIAL MSG Control No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided 1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided 2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
Total Total of all reporting groups

Baseline Measures
   HIV TEST MSG Control/ VACCINE TRIAL MSG Control   HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major   Total 
Overall Participants Analyzed 
[Units: Participants]
 135   124   151   114   127   118   128   132   115   119   133   137   128   124   124   122   2031 
Age 
[Units: Participants]
                                 
<=18 years   0   1   0   0   1   1   1   2   1   0   1   2   0   0   0   0   10 
Between 18 and 65 years   126   115   137   104   119   111   121   124   111   112   126   128   118   120   118   119   1909 
>=65 years   9   8   14   10   7   6   6   6   3   7   6   7   10   4   6   3   112 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (14)   44  (14)   47  (13)   45  (15)   44  (13)   44  (12)   44  (14)   45  (14)   42  (13)   44  (13)   44  (13)   43  (13)   46  (13)   44  (13)   44  (12)   42  (13)   44  (13) 
Gender 
[Units: Participants]
                                 
Female   135   124   151   114   127   118   128   132   115   119   133   137   128   124   124   122   2031 
Male   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
                                 
United States   135   124   151   114   127   118   128   132   115   119   133   137   128   124   124   122   2031 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Accepted Rapid HIV Testing.   [ Time Frame: During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed. ]

2.  Primary:   Willingness to Participate in a HIV Vaccine Clinical Trial   [ Time Frame: Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire. ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description Adverse events were not collected.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
HIV TEST MSG Control/ VACCINE TRIAL MSG Control No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial No message intervention control condition regarding HIV testing AND 2-Sided trivial message experimental intervention condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major No message intervention control condition regarding HIV testing AND 2-Sided Major message experimental intervention condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided 1-Sided message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major 1-Sided message intervention experimental condition regarding HIV testing AND 2-Sided Major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major 2-Sided Trivial message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided 2-Sided major message intervention experimental condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided trivial message intervention experimental condition regarding HIV vaccine clinical trial participation.
HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major 2-Sided major message intervention experimental condition regarding HIV testing AND 2-Sided major message intervention experimental condition regarding HIV vaccine clinical trial participation.

Other Adverse Events
    HIV TEST MSG Control/ VACCINE TRIAL MSG Control   HIV TEST MSG Control/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG Control/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG Control   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG 1-Sided/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG Control   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Trivia   HIV TEST MSG 2-Sided Trivial/ VACCINE TRIAL MSG 2-Sided Major   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG Control   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 1-Sided   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Trivial   HIV TEST MSG 2-Sided Major/ VACCINE TRIAL MSG 2-Sided Major
Total, Other (not including serious) Adverse Events                                 
# participants affected / at risk   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0   0/0 



  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
No text entered.


  More Information