NCT00503308

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 \[SFGH\]).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2006

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

July 1, 2011

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

July 16, 2007

Results QC Date

September 24, 2009

Last Update Submit

May 6, 2015

Conditions

HIV InfectionsPregnancy Related

Keywords

HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)

    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).

    same day as HIV test counseling (cross-sectional study)

Study Arms (2)

Abbreviated Consenting

EXPERIMENTAL
Procedure: Abbreviated HIV test counseling

Standard Consenting

NO INTERVENTION

Interventions

Abbreviated HIV test counselingPROCEDURE

abbreviated HIV pre-test counseling

Also known as: opt-out HIV testing
Abbreviated Consenting

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF, San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (18)

  • 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.

    BACKGROUND

  • 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. doi: 10.1097/00042560-200208010-00009.

    PMID: 12138350BACKGROUND

  • 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.

    PMID: 11892955BACKGROUND

  • 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. doi: 10.1093/infdis/175.3.712.

    PMID: 9041351BACKGROUND

  • Newell ML. Mechanisms and timing of mother-to-child transmission of HIV-1. AIDS. 1998 May 28;12(8):831-7. doi: 10.1097/00002030-199808000-00004. No abstract available.

    PMID: 9631135BACKGROUND

  • 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. doi: 10.1086/514003.

    PMID: 9086162BACKGROUND

  • 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.

    BACKGROUND

  • 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. doi: 10.1097/00126334-200302010-00010.

    PMID: 12571528BACKGROUND

  • 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.

    PMID: 11718473BACKGROUND

  • 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.

    PMID: 12458916BACKGROUND

  • 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.

    PMID: 12733863BACKGROUND

  • 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. doi: 10.1521/aeap.14.3.190.23896.

    PMID: 12092921BACKGROUND

  • 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. doi: 10.1136/bmj.318.7199.1660. No abstract available.

    PMID: 10373168BACKGROUND

  • Walmsley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ. 2003 Mar 18;168(6):707-8. No abstract available.

    PMID: 12642426BACKGROUND

  • 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. doi: 10.1016/s0029-7844(01)01631-3.

    PMID: 11755561BACKGROUND

  • 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. doi: 10.1136/bmj.316.7127.262.

    PMID: 9472506BACKGROUND

  • 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. doi: 10.1016/s0029-7844(97)00714-x.

    PMID: 9540937BACKGROUND

  • 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.

    PMID: 19367335DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Deborah Cohan, MD
Organization
UCSF, San Francisco General Hospital
cohand@obgyn.ucsf.edu
415 206 3658

Study Officials

  • Deborah Cohan, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

February 1, 2008

Last Updated

May 22, 2015

Results First Posted

July 1, 2011

Record last verified: 2015-05

Locations

US(1)