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HIV Testing Strategies in the Perinatal Setting

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.
ClinicalTrials.gov Identifier: NCT00503308
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : July 1, 2011
Last Update Posted : May 22, 2015
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Conditions: HIV Infections
Pregnancy Related
Intervention: Procedure: Abbreviated HIV test counseling

  Participant Flow

  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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 146   135   281 
[Units: Participants]
<=18 years   8   5   13 
Between 18 and 65 years   138   130   268 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 26.99  (6.1)   26.39  (5.3)   26.7  (5.73) 
[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) ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

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: Deborah Cohan, MD
Organization: UCSF, San Francisco General Hospital
phone: 415 206 3658
e-mail: cohand@obgyn.ucsf.edu

Rapid HIV testing of women in labor and delivery: www.cdc.gov/hiv/pubs/rt-women.htm: Centers for Disease Control and Prevention: Divisions of HIV/AIDS Prevention, 2002.
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.
CDC. Progress Toward Elimination of Perinatal HIV Infection - Michigan, 1993-2000. MMWR 2002;51.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Deborah Cohan, UCSF
ClinicalTrials.gov Identifier: NCT00503308     History of Changes
Other Study ID Numbers: 2004-0319
First Submitted: July 16, 2007
First Posted: July 18, 2007
Results First Submitted: September 24, 2009
Results First Posted: July 1, 2011
Last Update Posted: May 22, 2015