HIV Testing Strategies in the Perinatal Setting

University of California, San Francisco281 enrolled

Overview

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 \[SFGH\]).

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

281

Conditions

HIV Infections Pregnancy Related

Interventions

Abbreviated HIV test counselingPROCEDURE

abbreviated HIV pre-test counseling

Eligibility

Sex: FEMALEMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCSF, San Francisco General Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

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).

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

Data from ClinicalTrials.gov

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