Dataset Information

Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.

ABSTRACT:

Background

Women are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis.

Methods

We conducted an analysis of screening and enrollment during 2003-2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling ("screen out") varied by various individual, trial, or site characteristics.

Results

Of 10 744 persons screened, 18.9% were women. The percentages of women and men who screened out were 27.9% and 26.5%, respectively (P = .19); this small difference did not significantly vary by race, ethnicity, or age group. Most common reasons for screening out were not meeting eligibility criteria (30-35%) and opting out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing.

Conclusions

In the absence of evidence of significantly higher trial screen-out for women, approaching more women to screen may increase female representation in HIV trials.

SUBMITTER: Smeaton LM

PROVIDER: S-EPMC7442845 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Publications

Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.

Smeaton Laura M LM Kacanek Deborah D Mykhalchenko Kateryna K Coughlin Kristine K Klingman Karin L KL Koletar Susan L SL Barr Elizabeth E Collier Ann C AC

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20200801 5

<h4>Background</h4>Women are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis.<h4>Methods</h4>We conducted an analysis of screening and enrollment during 2003-2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex diffe ...[more]

PMID: 31563942

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Project description:BackgroundHuman immunodeficiency virus (HIV)-experienced clinicians are critical for positive outcomes along the HIV care continuum. However, access to HIV-experienced clinicians may be limited, particularly in nonmetropolitan areas, where HIV is increasing. We examined HIV clinician workforce capacity, focusing on HIV experience and urban-rural differences, in the Southern United States.MethodsWe used Medicaid claims and clinician characteristics (Medicaid Analytic eXtract [MAX] and MAX Provider Characteristics, 2009-2011), county-level rurality (National Center for Health Statistics, 2013), and diagnosed HIV cases (AIDSVu, 2014) to assess HIV clinician capacity in 14 states. We assumed that clinicians accepting Medicaid approximated the region's HIV workforce, since three-quarters of clinicians accept Medicaid insurance. HIV-experienced clinicians were defined as those providing care to ≥ 10 Medicaid enrollees over 3 years. We assessed HIV workforce capacity with county-level clinician-to-population ratios, using Wilcoxon-Mann-Whitney tests to compare urban-rural differences.ResultsWe identified 5012 clinicians providing routine HIV management, of whom 28% were HIV-experienced. HIV-experienced clinicians were more likely to specialize in infectious diseases (48% vs 6%, P < .001) and practice in urban areas (96% vs 83%, P < .001) compared to non-HIV-experienced clinicians. The median clinician-to-population ratio for all HIV clinicians was 13.3 (interquartile range, 38.0), with no significant urban-rural differences. When considering HIV experience, 81% of counties had no HIV-experienced clinicians, and rural counties generally had fewer HIV-experienced clinicians per 1000 diagnosed HIV cases (P < .001).ConclusionsSignificant urban-rural disparities exist in HIV-experienced workforce capacity for communities in the Southern United States. Policies to improve equity in access to HIV-experienced clinical care for both urban and rural communities are urgently needed.

Dataset Information

Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.

Background

Methods

Results

Conclusions

Publications

Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.

Similar Datasets

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