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OpenTrials
Completed

NCT Number: NCT00503308

HIV Testing Strategies in the Perinatal Setting

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]).

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCSF, San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abbreviated HIV test counseling

Procedure

abbreviated HIV pre-test counseling

Other names: opt-out HIV testing

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Pfizer

Registry information

Official study title

Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jul 18, 2007
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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