Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503308
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2007-07-16
Brief Title:
HIV Testing Strategies in the Perinatal Setting
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Patient Perspectives and Testing Uptake With Abbreviated Versus Standard HIV Consenting in the Prenatal Setting A Randomized-Controlled Non-Inferiority Trial
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine whether an abbreviated pretestpost-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 counselingtesting 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 HIVAIDS attitudes towards HIV testing HIV test result and type of provider physician versus midwife
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 counselingtesting 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 HIVAIDS attitudes towards HIV testing HIV test result and type of provider physician versus midwife
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None