HIV Testing Strategies in the Perinatal Setting

• 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: University of California, San Francisco
• Collaborator: Pfizer
• Information provided by: University of California, San Francisco

Tracking Information

• First Submitted Date: July 16, 2007
• First Posted Date: July 18, 2007
• Results First Submitted Date: September 24, 2009
• Results First Posted Date: July 1, 2011
• Last Update Posted Date: May 22, 2015
• Study Start Date: October 2006
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 7, 2011)

Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) [ Time Frame: same day as HIV test counseling (cross-sectional study) ]

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).

• Original Primary Outcome Measures (submitted: July 17, 2007): Satisfaction with HIV testing experience (Decisional Conflict Scale) [ Time Frame: same day as HIV test counseling (cross-sectional study) ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HIV Testing Strategies in the Perinatal Setting
• Official Title: Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial
• Brief Summary: The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at San Francisco General Hospital [SFGH]).

Detailed Description

Approximately 40% of HIV-infected infants in the United States in 2000 were born to women not diagnosed with their HIV prior to delivery. (1) There are now effective medical therapies to prevent perinatal transmission, including anti-retroviral therapy, but this requires diagnoses of maternal HIV prior to delivery. Both the Centers for Disease Control and Prevention (CDC) and Institute of Medicine (IOM) have published strong recommendations for universal HIV-antibody testing of pregnant women.

This will be a randomized controlled, non-inferiority trial comparing two HIV testing strategies among English and Spanish-speaking patients presenting for prenatal care at SFGH WHC over the course of approximately one year. Eligible participants will be randomized by study personnel to either standard HIV counseling and testing (control arm) or abbreviated counseling and testing (study arm). Participants will receive a standard prenatal HIV testing brochure, undergo one of two HIV counseling/testing strategies, submit blood for an HIV-1 antibody test, and will follow-up with their medical provider for HIV test results. Upon completion of counseling, participants will undergo a short, structured (Pre-test) questionnaire administered by study staff. Following testing and receipt of results, participants will complete a second (Post-test) structured questionnaire administered by study staff.

Eligible women presenting to SFGH physician or midwife prenatal clinics will be recruited, consented and randomized by study staff to either the standard or abbreviated testing strategy. The outcomes studied will be patient satisfaction and the proportion of study participants who undergo HIV testing. Potential confounder variables to be measured will include demographic characteristics, prior HIV testing history, knowledge about HIV/AIDS, attitudes towards HIV testing, HIV test result, and type of provider (physician versus midwife).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Health Services Research

Condition

• HIV Infections
• Pregnancy Related

Intervention

Procedure: Abbreviated HIV test counseling

abbreviated HIV pre-test counseling

Other Name: opt-out HIV testing

Study Arms

• Experimental: Abbreviated Consenting
  Intervention: Procedure: Abbreviated HIV test counseling
• No Intervention: Standard Consenting

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.
• Sambamoorthi U, Akincigil A, McSpiritt E, Crystal S. Zidovudine use during pregnancy among HIV-infected women on Medicaid. J Acquir Immune Defic Syndr. 2002 Aug 1;30(4):429-39.
• Centers for Disease Control and Prevention (CDC). From the Centers for Disease Control and Prevention. Progress toward elimination of perinatal HIV infection--Michigan, 1993-2000. MMWR Morb Mortal Wkly Rep. 2002 Feb 8;51(5):93-7.
• Kalish LA, Pitt J, Lew J, Landesman S, Diaz C, Hershow R, Hollinger FB, Pagano M, Smeriglio V, Moye J. Defining the time of fetal or perinatal acquisition of human immunodeficiency virus type 1 infection on the basis of age at first positive culture. Women and Infants Transmission Study (WITS). J Infect Dis. 1997 Mar;175(3):712-5.
• Newell ML. Mechanisms and timing of mother-to-child transmission of HIV-1. AIDS. 1998 May 28;12(8):831-7. Review.
• Frenkel LM, Cowles MK, Shapiro DE, Melvin AJ, Watts DH, McLellan C, Mohan K, Murante B, Burchett S, Bryson YJ, O'Sullivan MJ, Mitchell C, Landers D. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997 Apr;175(4):971-4.
• 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.
• Phillips KA, Bayer R, Chen JL. New Centers for Disease Control and Prevention's guidelines on HIV counseling and testing for the general population and pregnant women. J Acquir Immune Defic Syndr. 2003 Feb 1;32(2):182-91.
• Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):63-85; quiz CE1-19a2-CE6-19a2.
• Centers for Disease Control and Prevention (CDC). HIV testing among pregnant women--United States and Canada, 1998-2001. MMWR Morb Mortal Wkly Rep. 2002 Nov 15;51(45):1013-6.
• CDC. Progress Toward Elimination of Perinatal HIV Infection - Michigan, 1993-2000. MMWR 2002;51.
• Centers for Disease Control and Prevention (CDC). Advancing HIV prevention: new strategies for a changing epidemic--United States, 2003. MMWR Morb Mortal Wkly Rep. 2003 Apr 18;52(15):329-32.
• Ruiz JD, Molitor F, Prussing E, Peck L, Grasso P. Prenatal HIV counseling and testing in California: women's experiences and providers' practices. AIDS Educ Prev. 2002 Jun;14(3):190-5.
• Simpson WM, Johnstone FD, Goldberg DJ, Gormley SM, Hart GJ. Antenatal HIV testing: assessment of a routine voluntary approach. BMJ. 1999 Jun 19;318(7199):1660-1.
• Walmsley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ. 2003 Mar 18;168(6):707-8. Review.
• Stringer EM, Stringer JS, Cliver SP, Goldenberg RL, Goepfert AR. Evaluation of a new testing policy for human immunodeficiency virus to improve screening rates. Obstet Gynecol. 2001 Dec;98(6):1104-8.
• Simpson WM, Johnstone FD, Boyd FM, Goldberg DJ, Hart GJ, Prescott RJ. Uptake and acceptability of antenatal HIV testing: randomised controlled trial of different methods of offering the test. BMJ. 1998 Jan 24;316(7127):262-7.
• Carusi D, Learman LA, Posner SF. Human immunodeficiency virus test refusal in pregnancy: a challenge to voluntary testing. Obstet Gynecol. 1998 Apr;91(4):540-5.
• Cohan D, Gomez E, Greenberg M, Washington S, Charlebois ED. Patient perspectives with abbreviated versus standard pre-test HIV counseling in the prenatal setting: a randomized-controlled, non-inferiority trial. PLoS One. 2009;4(4):e5166. doi: 10.1371/journal.pone.0005166. Epub 2009 Apr 15.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 7, 2011): 281
• Original Estimated Enrollment (submitted: July 17, 2007): 278
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Women 16 years of age or above seeking prenatal care at San Francisco General Hospital

Exclusion Criteria:

• Women who do not speak Spanish or English
• Women younger than 16 years of age
• Women who obtained an HIV test during the index pregnancy prior to initiation of prenatal care at SFGH
• Women known to be infected with HIV at initiation of prenatal care at SFGH

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00503308
• Other Study ID Numbers: 2004-0319
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Deborah Cohan, UCSF
• Study Sponsor: University of California, San Francisco
• Collaborators: Pfizer

Investigators

• Principal Investigator: Deborah Cohan, MD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: May 2015