Trial Outcomes & Findings for HIV Testing Strategies in the Perinatal Setting (NCT NCT00503308)
NCT ID: NCT00503308
Last Updated: 2015-05-22
Results Overview
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).
COMPLETED
NA
281 participants
same day as HIV test counseling (cross-sectional study)
2015-05-22
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Abbreviated Consenting Intervention
The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
|
|---|---|---|
|
Overall Study
STARTED
|
146
|
135
|
|
Overall Study
COMPLETED
|
144
|
134
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Abbreviated Consenting Intervention
The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
HIV Testing Strategies in the Perinatal Setting
Baseline characteristics by cohort
| Measure |
Standard Consenting Intervention
n=146 Participants
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.
|
Abbreviated Consenting Intervention
n=135 Participants
The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.99 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
26.39 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
26.7 years
STANDARD_DEVIATION 5.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
146 participants
n=5 Participants
|
135 participants
n=7 Participants
|
281 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard Consenting Intervention
n=144 Participants
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.
|
Abbreviated Consenting Intervention
n=134 Participants
The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
|
|---|---|---|
|
Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)
|
16.0 scores on scale
Interval 13.1 to 18.9
|
19.9 scores on scale
Interval 16.3 to 23.5
|
Adverse Events
Standard Consenting Intervention
Abbreviated Consenting Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place