A total of 1,183 HIV-infected persons (825 men, 350 women, and eight transgendered persons) and 297 controls were enrolled in the FRAM Study between June 2000 and September 2002. Of 4,208 patients listed on clinic rosters whose names were randomly ordered and provided to the 16 HIV sites, a contact attempt was made for 3,164. No contact was attempted for 1,044 patients, for various reasons (e.g., the patient was known not to be HIV-infected or had been lost to follow-up, had moved away, or no longer had valid contact information). shows the outcome of the contact attempts for the 3,164 HIV-infected patients. Of the 1,828 persons who were reached and determined to be eligible, 404 (22 percent) declined to participate; 241 (13 percent) agreed to participate but did not appear for the examination; and 1,183 (65 percent) agreed to participate and were examined. Twenty-three participants were examined at the two HIV sites at which the study was discontinued. The numbers of participants examined at the remaining 14 sites ranged from 38 to 148.
Schema of results of recruitment at human immunodeficiency virus (HIV) study sites, Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM), United States, 2000–2002.
The percentages of men and women who declined to participate were the same (22 percent); the percentages were similar among persons who agreed to participate but never appeared for the examination (12 percent of men vs. 16 percent of women) and persons who were examined (65 percent of men vs. 62 percent of women). The percentages of African Americans (n =764) and Caucasians (n =844) who declined to participate (21 percent vs. 24 percent) or did not appear for the examination after agreeing to participate (11 percent vs. 16 percent) were similar. The percentage of Caucasian participants examined was greater than the percentage of African Americans examined (67 percent vs. 60 percent; 95 percent confidence interval (CI) for difference in percentage: 1, 13).
shows the baseline characteristics of the 1,183 HIV-infected men and women examined in comparison with a national probability sample of HIV-infected US men and women receiving regular medical care that was assembled in HCSUS (29
). Because HCSUS was conducted during the first 2 months of 1996, the ages of FRAM participants on January 31, 1996, were determined and were used in the comparison of age ranges between FRAM and HCSUS. After adjustment for the age of the FRAM participants, the percentages in different age ranges were similar in FRAM and HCSUS for both men and women. Percentages in different racial groups and HIV risk categories appeared fairly similar for men and women in comparison with their corresponding groups in HCSUS. More FRAM men and women had a CD4 cell-count nadir under 200 cells/mm3
than did HCSUS men and women. The prevalence of a history of a clinical acquired immunodeficiency syndrome (AIDS) diagnosis was similar between FRAM men and HCSUS men but was greater in FRAM women than in HCSUS women.
TABLE 2 Demographic and clinical characteristics of human immunodeficiency virus (HIV)-infected men and women from the Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM) as compared with men and women from the HIV Cost and Services Utilization (more ...)
When the HIV-infected FRAM men were compared with the HIV-infected FRAM women, the women were more likely to be African-American (55 percent of women vs. 33 percent of men; 95 percent CI for difference: 13, 31), to have a lower educational status (58 percent vs. 37 percent; 95 percent CI: 12, 30), to be unemployed (60 percent vs. 39 percent; 95 percent CI: 12, 30), and to have a lower income (67 percent vs. 50 percent; 95 percent CI: 10, 25). These differences between HIV-infected men and women in FRAM were similar to the differences observed between HIV-infected men and women in HCSUS.
shows the recruitment outcome for the 377 VIM/ CARDIA participants who were contacted and reached regarding participation in both the 2000 VIM follow-up examination and FRAM. Because of the original VIM sampling strategy, there were similar proportions of African Americans and Caucasians. HIV testing was not done in the CARDIA cohort, but on the basis of previous medication data and demographic factors, the prevalence of HIV infection in CARDIA is estimated to be less than 1 percent (unpublished data), and none of the CARDIA participants included in FRAM were found to be taking antiretroviral medications.
Schema of results of recruitment at control study sites, Study of Fat Redistribution and Metabolic Change in HIV Infection (FRAM), United States, 2000–2002. HIV, human immunodeficiency virus.
The anthropometric characteristics of the 297 FRAM controls (155 men and 142 women) were compared with those of similar-aged men and women in the Third National Health and Nutrition Examination Survey (NHANES III) (30
). Among Caucasian men, average body mass indexes were similar in FRAM controls and NHANES III participants (27.3 vs. 27.5; 95 percent CI for difference: −0.9, 1.3). Among African-American men, body mass index was higher in FRAM controls than in NHANES III participants (28.2 vs. 26.7; 95 percent CI: 0.2, 2.8). Among Caucasian women, FRAM controls had a lower body mass index than NHANES III participants (25.4 vs. 27.6; 95 percent CI: 0.5, 3.9). Among African-American women, there was no difference in body mass index between FRAM controls and NHANES III participants (31.2 vs. 29.9; 95 percent CI: −0.6, 3.2).