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Patient perspectives with abbreviated versus standard pre-test HIV counseling in the prenatal setting: a randomized-controlled, non-inferiority trial.

Cohan D, Gomez E, Greenberg M, Washington S, Charlebois ED - PLoS ONE (2009)

Bottom Line: There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: -0.65, 8.41) did not exceed the non-inferiority margin.Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36).However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p<0.01).

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America. cohand@obgyn.ucsf.edu

ABSTRACT

Background: In the US, an unacceptably high percentage of pregnant women do not undergo prenatal HIV testing. Previous studies have found increased uptake of prenatal HIV testing with abbreviated pre-test counseling, however little is known about patient decision making, testing satisfaction and knowledge in this setting.

Methodology/findings: 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. Patient decision making experience was compared between abbreviated versus standard HIV counseling strategies among a sample of low-income, urban, ethnically diverse prenatal patients. The primary outcome was the decisional conflict score (DCS) using O'Connor low-literacy scale and secondary outcomes included satisfaction with test decision, basic HIV knowledge and HIV testing uptake. We conducted an intention-to-treat analysis of 278 women--134 (48.2%) in the abbreviated arm (AA) and 144 (51.8%) in the standard arm (SA). There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: -0.65, 8.41) did not exceed the non-inferiority margin. HIV testing uptake was very high (97. 8%) and did not differ significantly between the 2 groups (99.3% in AA vs. 96.5% in SA, p = .12). Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36). However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p<0.01).

Conclusions/significance: This study suggests that streamlining the pre-test counseling process, while associated with slightly lower knowledge, does not compromise patient decision making or satisfaction regarding HIV testing.

Trial registration: ClinicalTrials.gov NCT00503308.

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Flow Diagram Legend.* Women who were excluded for “other reasons” included women who initially consented to participate in the study but then changed their mind prior to undergoing the questionnaire. # Women who received the Standard instead of the Abbreviated consent due to nurse “error”. @ Women were discontinued from study after pre-test survey completed and they were excluded from the analysis. They were identified as being ineligible only after randomization and administration of pre-test survey.
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pone-0005166-g001: Flow Diagram Legend.* Women who were excluded for “other reasons” included women who initially consented to participate in the study but then changed their mind prior to undergoing the questionnaire. # Women who received the Standard instead of the Abbreviated consent due to nurse “error”. @ Women were discontinued from study after pre-test survey completed and they were excluded from the analysis. They were identified as being ineligible only after randomization and administration of pre-test survey.

Mentions: Between October 3, 2006 and September 24, 2007, study staff approached 496 pregnant patients initiating prenatal care at the Women's Health Center at San Francisco General Hospital to participate in the study. We excluded 215 patients from participation in the study. See Figure 1. Of the 281 women randomized to one of the study arms, 3 women were discontinued from the study and excluded from the analysis because they were identified as being ineligible only after randomization. In all 3 cases, the women had been tested for HIV during the index pregnancy prior to the initial prenatal visit at SFGH.


Patient perspectives with abbreviated versus standard pre-test HIV counseling in the prenatal setting: a randomized-controlled, non-inferiority trial.

Cohan D, Gomez E, Greenberg M, Washington S, Charlebois ED - PLoS ONE (2009)

Flow Diagram Legend.* Women who were excluded for “other reasons” included women who initially consented to participate in the study but then changed their mind prior to undergoing the questionnaire. # Women who received the Standard instead of the Abbreviated consent due to nurse “error”. @ Women were discontinued from study after pre-test survey completed and they were excluded from the analysis. They were identified as being ineligible only after randomization and administration of pre-test survey.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2666158&req=5

pone-0005166-g001: Flow Diagram Legend.* Women who were excluded for “other reasons” included women who initially consented to participate in the study but then changed their mind prior to undergoing the questionnaire. # Women who received the Standard instead of the Abbreviated consent due to nurse “error”. @ Women were discontinued from study after pre-test survey completed and they were excluded from the analysis. They were identified as being ineligible only after randomization and administration of pre-test survey.
Mentions: Between October 3, 2006 and September 24, 2007, study staff approached 496 pregnant patients initiating prenatal care at the Women's Health Center at San Francisco General Hospital to participate in the study. We excluded 215 patients from participation in the study. See Figure 1. Of the 281 women randomized to one of the study arms, 3 women were discontinued from the study and excluded from the analysis because they were identified as being ineligible only after randomization. In all 3 cases, the women had been tested for HIV during the index pregnancy prior to the initial prenatal visit at SFGH.

Bottom Line: There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: -0.65, 8.41) did not exceed the non-inferiority margin.Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36).However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p<0.01).

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Francisco, San Francisco, California, United States of America. cohand@obgyn.ucsf.edu

ABSTRACT

Background: In the US, an unacceptably high percentage of pregnant women do not undergo prenatal HIV testing. Previous studies have found increased uptake of prenatal HIV testing with abbreviated pre-test counseling, however little is known about patient decision making, testing satisfaction and knowledge in this setting.

Methodology/findings: 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. Patient decision making experience was compared between abbreviated versus standard HIV counseling strategies among a sample of low-income, urban, ethnically diverse prenatal patients. The primary outcome was the decisional conflict score (DCS) using O'Connor low-literacy scale and secondary outcomes included satisfaction with test decision, basic HIV knowledge and HIV testing uptake. We conducted an intention-to-treat analysis of 278 women--134 (48.2%) in the abbreviated arm (AA) and 144 (51.8%) in the standard arm (SA). There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: -0.65, 8.41) did not exceed the non-inferiority margin. HIV testing uptake was very high (97. 8%) and did not differ significantly between the 2 groups (99.3% in AA vs. 96.5% in SA, p = .12). Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36). However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, p<0.01).

Conclusions/significance: This study suggests that streamlining the pre-test counseling process, while associated with slightly lower knowledge, does not compromise patient decision making or satisfaction regarding HIV testing.

Trial registration: ClinicalTrials.gov NCT00503308.

Show MeSH