Biomaterial Database

Determinants of accrual of women to a large, multicenter clinical trials program of human immunodeficiency virus infection. The AIDS Clinical Trials Group. 1993

D J Cotton, and D M Finkelstein, and W He, and J Feinberg

Department of Medicine, Beth Israel Hospital, Boston, Massachusetts.

To determine factors influencing the enrollment of women in a large multicenter human immunodeficiency virus (HIV) clinical trials program in the United States, we analyzed enrollment and demographic data of the AIDS Clinical Trials Group (ACTG) during the period 1987-90. Women comprised 6.7% of 11,909 ACTG participants enrolled in 1987-90. Women entering ACTG trials were significantly more likely to be white (48.5%) and less likely to have ever used i.v. drugs (22.6%) than U.S. women reported to have AIDS (26.5% were white; 51.0% had ever used i.v. drugs, p < 0.0001). In a multiple logistic regression model, specific attributes of individual trials did not influence enrollment of women with the exception that trials that targeted asymptomatic persons had greater enrollment of women. There was wide variation among research units in the percentage of women enrolled (1.0-37.5%), and evidence of significant regional variation in the ability of units to recruit available women. Units with female principal or coprincipal investigators had more than twice the percentage of female enrollment as units headed by men (10.8 vs. 5.3%, p < 0.001). Enrollment of women in a large HIV clinical trials program was low and appeared to be influenced more by demographic and geographic factors that attributes of specific trials. An apparent positive influence of female leadership on the enrollment of women warrants further study.

UI	MeSH Term	Description	Entries
D001741	Black or African American	A person having origins in any of the black racial groups of Africa (https://www.federalregister.gov/documents/1997/10/30/97-28653/revisions-to-the-standards-for-the classification-of-federal-data-on-race-and-ethnicity). In the United States it is used for classification of federal government data on race and ethnicity. Race and ethnicity terms are self-identified social construct and may include terms outdated and offensive in MeSH to assist users who are interested in retrieving comprehensive search results for studies such as in longitudinal studies.	African American,African Americans,African-American,Afro-American,Afro-Americans,Black Americans,Blacks,Negroes,African-Americans,Negro,Afro American,Afro Americans,American, African,American, Black,Black American
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D003710	Demography	Statistical interpretation and description of a population with reference to distribution, composition, or structure.	Demographer,Demographic,Demographic and Health Survey,Population Distribution,Accounting, Demographic,Analyses, Demographic,Analyses, Multiregional,Analysis, Period,Brass Technic,Brass Technique,Demographers,Demographic Accounting,Demographic Analysis,Demographic Factor,Demographic Factors,Demographic Impact,Demographic Impacts,Demographic Survey,Demographic Surveys,Demographic and Health Surveys,Demographics,Demography, Historical,Demography, Prehistoric,Factor, Demographic,Factors, Demographic,Family Reconstitution,Historical Demography,Impact, Demographic,Impacts, Demographic,Multiregional Analysis,Period Analysis,Population Spatial Distribution,Prehistoric Demography,Reverse Survival Method,Stable Population Method,Survey, Demographic,Surveys, Demographic,Analyses, Period,Analysis, Demographic,Analysis, Multiregional,Demographic Analyses,Demographies, Historical,Demographies, Prehistoric,Distribution, Population,Distribution, Population Spatial,Distributions, Population,Distributions, Population Spatial,Family Reconstitutions,Historical Demographies,Method, Reverse Survival,Method, Stable Population,Methods, Reverse Survival,Methods, Stable Population,Multiregional Analyses,Period Analyses,Population Distributions,Population Methods, Stable,Population Spatial Distributions,Prehistoric Demographies,Reconstitution, Family,Reconstitutions, Family,Reverse Survival Methods,Spatial Distribution, Population,Spatial Distributions, Population,Stable Population Methods,Technic, Brass,Technique, Brass
D005260	Female		Females
D006630	Hispanic or Latino	A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race (https://www.federalregister.gov/documents/1997/10/30/97-28653/revisions-to-the-standards-for-the-classification-of-federal-data-on-race-and-ethnicity). In the United States it is used for classification of federal government data on race and ethnicity. Race and ethnicity terms are self-identified social construct and may include terms outdated and offensive in MeSH to assist users who are interested in retrieving comprehensive search results for studies such as in longitudinal studies.	Cuban Americans,Hispanic Americans,Latin Americans, US,Latinas,Latinos,Latinx,Puerto Ricans,Spanish Americans,Hispanics,American, Hispanic,American, US Latin,Cuban American,Hispanic American,Hispanic or Latinos,Latin American, US,Latina,Latino,Puerto Rican,Spanish American,US Latin American,US Latin Americans
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000163	Acquired Immunodeficiency Syndrome	An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.	AIDS,Immunodeficiency Syndrome, Acquired,Immunologic Deficiency Syndrome, Acquired,Acquired Immune Deficiency Syndrome,Acquired Immuno-Deficiency Syndrome,Acquired Immuno Deficiency Syndrome,Acquired Immuno-Deficiency Syndromes,Acquired Immunodeficiency Syndromes,Immuno-Deficiency Syndrome, Acquired,Immuno-Deficiency Syndromes, Acquired,Immunodeficiency Syndromes, Acquired,Syndrome, Acquired Immuno-Deficiency,Syndrome, Acquired Immunodeficiency,Syndromes, Acquired Immuno-Deficiency,Syndromes, Acquired Immunodeficiency
D000704	Analysis of Variance	A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable.	ANOVA,Analysis, Variance,Variance Analysis,Analyses, Variance,Variance Analyses
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014930	Women	Human females as cultural, psychological, sociological, political, and economic entities.	Girls,Woman,Women's Groups,Girl,Women Groups,Women's Group

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