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HIV Testing & Womens Attitudes on HIV Vaccine Trials

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
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;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: HIV
Intervention: Behavioral: Message Sidedness

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Hide 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. ]

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.  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Logistic
P Value [4] 0.05
Odds Ratio (OR) [5] .69
95% Confidence Interval .50 to .96
Standard Error of the mean (.17)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] 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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Logistic
P Value [4] .10
Odds Ratio (OR) [5] .75
95% Confidence Interval .54 to 1.04
Standard Error of the mean (.17)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] 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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Regression, Logistic
P Value [4] .63
Odds Ratio (OR) [5] .92
95% Confidence Interval .65 to 1.30
Standard Error of the mean (.176)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] 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. ]

Measure Type Primary
Measure Title Willingness to Participate in a HIV Vaccine Clinical Trial
Measure Description Willingness to Participate in a HIV Vaccine Clinical Trial. Assessed via participant self-report with 6 items on Part 2 of the questionnaire. Item responses measured on 5-point Likert-type scale ranging from Strongly Disagree (value = 1) to Strongly Agree (value = 5).
Time Frame Approximately 60 minutes into the study visit, at the end of Part 2 of the questionnaire.  

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.
Only participants who answered the Willingness to Participate questions on the survey were included in these analyses.

Reporting Groups
  Description
Control/Control No message intervention control condition regarding HIV testing AND No message intervention control condition regarding HIV vaccine clinical trial participation.
1-Sided No message intervention control condition regarding HIV testing AND 1-Sided message intervention experimental condition regarding HIV vaccine clinical trial participation.
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.
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.

Measured Values
   Control/Control   1-Sided   2-Sided Trivial   2-Sided Major 
Participants Analyzed 
[Units: Participants]
 500   480   530   502 
Willingness to Participate in a HIV Vaccine Clinical Trial 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.46  (1.15)   2.52  (1.18)   2.55  (1.18)   2.47  (1.12) 


Statistical Analysis 1 for Willingness to Participate in a HIV Vaccine Clinical Trial
Groups [1] Control/Control vs. 1-Sided
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] <.60
Marginal Means [5] 2.49
95% Confidence Interval 2.42 to 2.56
Standard Error of the mean (.037)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  One-way Analysis of Variance
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Degrees of freedom = (1,978)
[4] 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.
[5] Other relevant estimation information:
  There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.

Statistical Analysis 2 for Willingness to Participate in a HIV Vaccine Clinical Trial
Groups [1] Control/Control vs. 2-Sided Trivial
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] <.25
Marginal Means [5] 2.51
95% Confidence Interval 2.44 to 2.58
Standard Error of the mean (.036)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  One-Way Analysis of Variance
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  degrees of freedom = (1,1028)
[4] 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.
[5] Other relevant estimation information:
  There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.

Statistical Analysis 3 for Willingness to Participate in a HIV Vaccine Clinical Trial
Groups [1] Control/Control vs. 2-Sided Major
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] <.91
Marginal Means [5] 2.47
95% Confidence Interval 2.40 to 2.54
Standard Error of the mean (.036)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  One-Way Analysis of Variance
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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.
[5] Other relevant estimation information:
  There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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