HIV Testing Strategies in the Perinatal Setting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
|Official Title:||Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting: A Randomized-Controlled, Non-Inferiority Trial|
- Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) [ Time Frame: same day as HIV test counseling (cross-sectional study) ] [ Designated as safety issue: No ]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).
|Study Start Date:||October 2006|
|Study Completion Date:||February 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Experimental: Abbreviated Consenting||
Procedure: Abbreviated HIV test counseling
abbreviated HIV pre-test counseling
Other Name: opt-out HIV testing
|No Intervention: Standard Consenting|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503308
|United States, California|
|UCSF, San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Deborah Cohan, MD||University of California, San Francisco|