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Trial record 5 of 22 for:    " July 04, 2007":" August 03, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

HIV Testing Strategies in the Perinatal Setting

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ClinicalTrials.gov Identifier: NCT00503308
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : July 1, 2011
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco

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
Enrollment 281
Recruitment Details 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 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.
Arm/Group Title Standard Consenting Intervention Abbreviated Consenting Intervention
Hide Arm/Group Description 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. The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
Period Title: Overall Study
Started 146 135
Completed 144 134
Not Completed 2 1
Reason Not Completed
Protocol Violation             2             1
Arm/Group Title Standard Consenting Intervention Abbreviated Consenting Intervention Total
Hide Arm/Group Description 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. The intervention arm used a 2-sentence script which lasted approximately 30 seconds. Total of all reporting groups
Overall Number of Baseline Participants 146 135 281
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 135 participants 281 participants
<=18 years
8
   5.5%
5
   3.7%
13
   4.6%
Between 18 and 65 years
138
  94.5%
130
  96.3%
268
  95.4%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants 135 participants 281 participants
26.99  (6.1) 26.39  (5.3) 26.7  (5.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants 135 participants 281 participants
Female
146
 100.0%
135
 100.0%
281
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 146 participants 135 participants 281 participants
146 135 281
1.Primary Outcome
Title Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Consenting Intervention Abbreviated Consenting Intervention
Hide Arm/Group Description:
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.
The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
Overall Number of Participants Analyzed 144 134
Mean (95% Confidence Interval)
Unit of Measure: scores on scale
16.0
(13.1 to 18.9)
19.9
(16.3 to 23.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Consenting Intervention Abbreviated Consenting Intervention
Hide Arm/Group Description 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. The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
All-Cause Mortality
Standard Consenting Intervention Abbreviated Consenting Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Consenting Intervention Abbreviated Consenting Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)   0/135 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Consenting Intervention Abbreviated Consenting Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/146 (0.00%)   0/135 (0.00%) 
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
Publications:
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.
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