Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.
Clin Infect Dis
; 71(5): 1300-1305, 2020 08 22.
Article
em En
| MEDLINE
| ID: mdl-31563942
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Infecções por HIV
Tipo de estudo:
Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Screening_studies
Limite:
Female
/
Humans
/
Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Clin Infect Dis
Assunto da revista:
DOENCAS TRANSMISSIVEIS
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos