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HIV Testing Strategies in the Perinatal Setting

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00503308
First received: July 16, 2007
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
Results First Received: September 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Health Services Research
Conditions: HIV Infections
Pregnancy Related
Intervention: Procedure: Abbreviated HIV test counseling

  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
A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit.

Reporting Groups
  Description
Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds.

Participant Flow:   Overall Study
    Standard Consenting Intervention     Abbreviated Consenting Intervention  
STARTED     146     135  
COMPLETED     144     134  
NOT COMPLETED     2     1  
Protocol Violation                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
Total Total of all reporting groups

Baseline Measures
    Standard Consenting Intervention     Abbreviated Consenting Intervention     Total  
Number of Participants  
[units: participants]
 		  146     135     281  
Age  
[units: participants]
 		     
<=18 years     8     5     13  
Between 18 and 65 years     138     130     268  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  26.99  ± 6.1     26.39  ± 5.3     26.7  ± 5.73  
Gender  
[units: participants]
 		     
Female     146     135     281  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     146     135     281  



  Outcome Measures

1.  Primary:   Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)   [ Time Frame: same day as HIV test counseling (cross-sectional study) ]
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Measure Type Primary
Measure Title Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)
Measure Description We measured decisional conflict, the primary outcome of the study, using the English or Spanish language 10-item Low Literacy Decisional Conflict Scale. We considered a DCS score of 25 or less to be low, corresponding to limited conflict. All questions have 3 response categories: yes, no, unsure. Items are scored as 0 = yes, 2 = unsure, 4 = no. Scores for each of the 10 items are summed, divided by 2 and multiplied by 25 to calculate the total score. The final scores range from 0(no decisional conflict) to 100 (extremely high decisional conflict).
Time Frame same day as HIV test counseling (cross-sectional study)  
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
Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds.

Measured Values
    Standard Consenting Intervention     Abbreviated Consenting Intervention  
Number of Participants Analyzed  
[units: participants]
 		  144     134  
Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)  
[units: scores on scale]
Mean ( 95% Confidence Interval ) 		  16.0  
  ( 13.1 to 18.9 )   		  19.9  
  ( 16.3 to 23.5 )  

No statistical analysis provided for Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)




  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Deborah Cohan, MD
Organization: UCSF, San Francisco General Hospital
phone: 415 206 3658
e-mail: cohand@obgyn.ucsf.edu


Publications:
Shapiro DE, Tuomala R, Samelson R, et al. Mother-to-Child HIV Transmission Rates According to Antiretroviral Therapy, Mode of Delivery, and Viral Load (PACTG 367): Abstract #114. 9th Conference on Retroviruses and Opportunistic Infections. Seattle, WA, 2002.

Publications automatically indexed to this study:


Responsible Party: Deborah Cohan, UCSF
ClinicalTrials.gov Identifier: NCT00503308     History of Changes
Other Study ID Numbers: 2004-0319
Study First Received: July 16, 2007
Results First Received: September 24, 2009
Last Updated: June 7, 2011
Health Authority: United States: Institutional Review Board