HIV Testing Strategies in the Perinatal Setting

Not Applicable

Completed

Conditions: Pregnancy Related
HIV Infections

Interventions: Procedure: Abbreviated HIV test counseling

Registration Number: NCT00503308

Lead Sponsor: University of California, San Francisco

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 281

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abbreviated Consenting	Abbreviated HIV test counseling	-

Primary Outcome Measures

Name	Time	Method
Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)	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).

Secondary Outcome Measures