HIV Testing & Womens Attitudes on HIV Vaccine Trials

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Gregory Zimet, Indiana University
ClinicalTrials.gov Identifier:
NCT00771537
First received: October 10, 2008
Last updated: June 28, 2013
Last verified: June 2013
Results First Received: April 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Caregiver, 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  
Number of Participants  
[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
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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. ]
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Measure Type Primary
Measure Title Number of Participants Who Accepted Rapid HIV Testing.
Measure Description Acceptance of rapid HIV testing. Acceptance was assessed by actual administration of rapid oral HIV test by research staff.
Time Frame During study visit. At approximately 30 minutes into the study visit. After part 1 of the questionnaire was completed.  
Safety Issue No  

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
Control No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1-Sided 1-Sided message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
2-Sided Trivial 2-Sided Trivial message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
2-Sided Major 2-Sided major message intervention experimental condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.

Measured Values
    Control     1-Sided     2-Sided Trivial     2-Sided Major  
Number of Participants Analyzed  
[units: participants]
  524     505     504     498  
Number of Participants Who Accepted Rapid HIV Testing.  
[units: participants]
  458     401     410     418  


Statistical Analysis 1 for Number of Participants Who Accepted Rapid HIV Testing.
Groups [1] Control vs. 1-Sided
Method [2] Regression, Logistic
P Value [3] 0.05
Odds Ratio (OR) [4] .69
Standard Error of the mean ± .17
95% Confidence Interval ( .50 to .96 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).

Statistical Analysis 2 for Number of Participants Who Accepted Rapid HIV Testing.
Groups [1] Control vs. 2-Sided Trivial
Method [2] Regression, Logistic
P Value [3] .10
Odds Ratio (OR) [4] .75
Standard Error of the mean ± .17
95% Confidence Interval ( .54 to 1.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).

Statistical Analysis 3 for Number of Participants Who Accepted Rapid HIV Testing.
Groups [1] Control vs. 2-Sided Major
Method [2] Regression, Logistic
P Value [3] .63
Odds Ratio (OR) [4] .92
Standard Error of the mean ± .176
95% Confidence Interval ( .65 to 1.30 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)



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


  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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