HIV Infections, Pregnancy Related
Conditions
Keywords
HIV Seronegativity
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).
Interventions
PROCEDUREAbbreviated HIV test counseling
abbreviated HIV pre-test counseling
Sponsors
Pfizer
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco.
Pre-assignment details
A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit.
Participants by arm
| Arm | Count |
|---|---|
| Standard Consenting Intervention The standardized HIV pre-test counseling and consent process took approximately 2-5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing. | 146 |
| Abbreviated Consenting Intervention The intervention arm used a 2-sentence script which lasted approximately 30 seconds. | 135 |
| Total | 281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | Abbreviated Consenting Intervention | Standard Consenting Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 8 Participants | 13 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 130 Participants | 138 Participants | 268 Participants |
| Age, Continuous | 26.39 years STANDARD_DEVIATION 5.3 | 26.99 years STANDARD_DEVIATION 6.1 | 26.7 years STANDARD_DEVIATION 5.73 |
| Region of Enrollment United States | 135 participants | 146 participants | 281 participants |
| Sex: Female, Male Female | 135 Participants | 146 Participants | 281 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 146 | 0 / 135 |
| serious Total, serious adverse events | 0 / 146 | 0 / 135 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Consenting Intervention | Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) | 16.0 scores on scale |
| Abbreviated Consenting Intervention | Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale) | 19.9 scores on scale |