Enrollment of Racial/Ethnic Minorities and Women with ... - NCBI - NIH

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Angela Hutchinson, PhD, MPH; and Victoria A. Cargill, MD, MSCE. Atlanta, Georgia and Rockville, Maryland. The findings and conclusions in this report are ...
Enrollment of Racial/Ethnic Minorities and Women with HIV in Clinical Research Studies of HIV Medicines Patrick S Sullivan, DVM, PhD; A.D. McNaghten, PhD, MHSA; Elin Begley, MPH; Angela Hutchinson, PhD, MPH; and Victoria A. Cargill, MD, MSCE Atlanta, Georgia and Rockville, Maryland The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention or the National Institutes of Health. Purpose: Inclusion of women and racial/ethnic minorities is a requirement for federally supported clinical research, but data on clinical research participation from women and racial/ethnic minorities with HIV are few. To describe participation in clinical research of HIV medicines among women and racial/ethnic minorities, and associated factors, we used data from a cross-sectional behavioral surveillance interview project conducted in 15 U.S. states. Methods: Data were from 6,892 persons living with HIV infection, recruited in facilities in seven U.S. states and using population-based methods in eight other states, between 2000-2004. We calculated self-reported participation in a clinical research study of HIV medicines, factors associated with self-reported study participation among men and women, and reasons for not participating in a study among nonparticipants. Main Findings: Overall, 17% of respondents had ever participated in a clinical research study. For men, the odds of participation were lower for black or Hispanic men (versus white men) and were higher for men whose rsk for HIV infection was male-male sex (versus men with male-female sex rsk) and for men with AIDS. For men who had not participated in a study, black men were more likely than white men to report not participating in a study because they were unaware of available studies or were not offered enrollment (75% vs. 69%), and because they did not want to be a "guinea pig" (11% vs. 8%). Among women, participation was not associated with race/ethnicity or rsk for HIV infection but was associated with living in an area with an NIH- or CDC- supported clinical research network. HIV-infected women were more likely than HIV-infected men with comparable modes of HIV acquisition to have participated in a study. Conclusions: Among persons with HIV interviewed in these 15 states, self-reported participation in clinical research studies was higher among women than men, but racial/ethnic minority men were less likely to report study participation. Our data suggest that clinicians and researchers should make increased efforts to offer study participation to racial and ethnic minority men. Key words: HIV * clinical investigation A African Americans 242 JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION

© 2007. From the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA (Sullivan, McNaghten, Begley, Hutchinson); and the National Institutes of Health, Bethesda, MD (Cargill). Send correspondence and reprint requests for J NatI Med Assoc. 2007;99:242-250 to: Dr. Patrick Sullivan, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS E46, Atlanta, GA 30333; phone: (404) 639-2090; fax: (404) 6398640; e-mail: [email protected]

INTRODUCTION In 1993, Congress, through the NIH Revitalization Act (PL 103-43), made into public law what had been policy-the inclusion of women and minorities as subjects in clinical research.' NIH research guidelines were revised in response to this law, were published in March 1994 and took effect in September 1994. This policy, amended in October 2001, mandated the inclusion of women and racial/ethnic minorities as research subjects in federally funded research and further required that for phase-II clinical trials, sufficient numbers of women and minorities be included to allow valid analyses of differences in the effect of interventions in subpopulations.2 To evaluate progress toward these requirements, analyses of published research reports have been undertaken both with respect to the enrollment of women,3 and the enrollment of racial/ethnic minorities.45 Both disease-nonspecific4 and disease-specific analyses (especially focused on cancer) have been reported.6 In addition to observing the proportions of women and racial/ethnic minorities who accept enrollment in clinical res'earch studies, it is also important to understand how those who enroll in studies may differ from those who do not choose to enroll or are never offered enrollment. Understanding the characteristics of nonparticipants helps to characterize the selection bias presented by those who are approached and agree to participate. By understanding the characteristics of nonparticipants and the reasons that they do not participate in clinical research, important insights may emerge for the development of interventions to encourage enrollment of diverse populations in clinical research studies. Participation of women and racial/ethnic minorities VOL. 99, NO. 3, MARCH 2007

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in clinical research studies may also differ by disease, but at present there are few data on enrollment of patients with HIV infection. In the case of HIV infection, specific racial/ethnic minority community attitudes toward the federal government, including mistrust, may negatively impact HIV clinical research study participation.7'8 To explore these gaps in knowledge about the enrollment of women and racial/ethnic minorities with HIV in clinical research, we analyzed data from a multistate survey of people with living HIV infection from 2000-2004.

METHODS Subjects The Supplement to HIV and AIDS Surveillance (SHAS) Project was a cross-sectional interview study with the goal of collecting supplemental behavioral surveillance data from persons reported with HIV infection. The methods have been previously described,9 but briefly, adults (age .18 years) reported with HIV or AIDS through routine case surveillance were eligible for participation. Participants were enrolled using one of two methods: 1) facility-based recruitment of all eligible persons seeking treatment at selected healthcare facilities in Denver, CO; Hartford and New Haven, CT; Jacksonville,

Figure 1. Cities and states participating in the Supplement to HIV/AIDS Surveillance project, 2000-2004, by recruitment method

Vr~ ~ ~ ~ ~ ~ ~ ~ ~ ~ tecn NJ

I

200H4*1

states,

* * * * * * * [*

"It's not available in my area." "It's too far away/inconvenient to travel." "I didn't want to be a 'guinea pig."'i "I was too sick to participate." "I don't trust the researchers." "They wouldn't guarantee that was going to get the treatment and not placebo." "The protocol was too much of a bother." Other (specify)

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Miami and Tampa, FL; Atlanta, GA; Baltimore, MD; Detroit, MI; and Jersey City and Paterson, NJ; or 2) population-based recruitment of all eligible persons in Phoenix and Tucson, AZ; Delaware; Los Angeles County, CA; Minneapolis/St. Paul, MN; New Mexico; Edisto Health District, Richland County, and Charleston County, SC; Austin, TX; and Washington. In project areas with facility-based recruitment, patients attending a clinical care site (.1 or more sites per state or city were included) were offered participation in the SHAS project. In project areas with population-based recruitment, all cases of AIDS (or HIV infection without AIDS, as allowed by state laws) in the state, city or county were considered eligible for participation, and as many as possible were contacted and offered recruitment. All sites interviewed persons reported with AIDS. Certain sites also had HIV-infection reporting laws that allowed them to recruit persons living with HIV infection, but not AIDS, to the project: Arizona, Denver, Detroit, Florida, Minnesota, New Jersey, New Mexico, South Carolina and Texas interviewed persons with HIV that had not progressed to AIDS. Participants were interviewed in person by trained interviewers, and a small monetary incentive was provided to participants. Informed consent was obtained from all participants prior to the interview, and the study received institutional review board approval at both the CDC and local levels.

Measures Participants were asked a series of questions to allow them to describe their race and ethnicity. All participants were asked whether they considered themselves to be Hispanic or Latino; all participants were then asked which racial groups they considered themselves to be and were offered a list of choices created by the investigators (white, black, American Indian or Alaskan native, Asian, native Hawaiian or other Pacific Islander). Participants were also prompted to provide any other races they considered themselves to be, that had not been specified by the investigators. We collected information on race and ethnicity in the SHAS project because the project had as a primary purpose the documentation of care and service needs, and access to services for people living with HIV infection. The disparities in HIV infection rates and in access to care and services among racial/ethnic minorities are well-recognized.'0-12 Beginning in 2000, the SHAS project added questions on participation in clinical research studies. We utilized data from interviews conducted from May 2000 through June 2004. We ascertained history of clinical research study participation by asking respondents who had ever been prescribed antiretroviral therapy: "Have you ever participated in a clinical research study of HIV/AIDS medicines?" For those who had never participated in a study, we asked respondents, "What was the

Figure 2. Cities where NIH- or CDC-supported HIV research networks were funded, 2000-2004

OPORA: Community Programs for Clinical Research on AIDS; AACTG: Adult AIDS Clinical Trials Group; WITS: Women and Infants| Transmission Study; WIHS: Women's Interagency HIV Study; CFAR: Centers for AIDS Research; HERS; HIV Epidemiology Research Study; NYC: New York City

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main reason you didn't participate?" Respondents were allowed to answer the question in their own words, and responses were coded against a list of possible responses that was closest to the client's wording (Table 1).

Statistical Methods We used Chi square to test for differences in the characteristics of patients recruited by facility-based or population-based methods and for differences in the characteristics of patients prescribed and not prescribed antiretroviral therapy. We also used Chi square to test for differences in the characteristics of men and women who were prescribed antiretroviral therapy. In all cases, we conducted Chi-squared tests using 2-by-X tables and reported a single P value for each characteristic with multiple levels (e.g., a single P value for all levels of age group). In the course of the analysis, we determined that the relationship between female sex and participation in a clinical research study was significantly confounded with probable mode of infection with HIV Therefore,

we conducted separate multivariable analyses for men and women (PROC LOGISTIC, SAS Institute, Cary NC), to calculate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for demographic factors associated with ever having participated in a clinical research study. All of the factors listed in Table 2 were adjusted for in the model for women; all of the factors in Table 2 except for "pregnant after HIV diagnoses" were adjusted for in the model for men. As we were also interested in describing the extent to which women were comparably enrolled in clinical research studies, we calculated the odds of female participation within each stratum of risk for HIV infection that included both men and women (e.g., injection drug use, male-female sex, receipt of blood products and no reported risk) and a summary (Cochran Maentel Hansel) OR across the risk strata. We also tabulated self-reported reasons for nonparticipation in clinical research studies, by sex and by race/ethnicity. Comparisons between proportions of respondents in different racial/ethnic groups reporting specific reasons for

Table 2. Associations of participation in a clinical research study of HIV medicines and demographic factors, by sex, among 7,095 persons with HIV infection and ever prescribed antiretroviral drugs who participated in the Supplement to HIV and AIDS Surveillance project, an interview study conducted in 15 U.S. states from 2000-2004 Men (N=5,010) Ever Participated Univariate in a CRS OR n ()(95% Cl)

Characteristics Race/Ethnicity White, non-Hispanic 313 (23) Black, non-Hispanic 353 (15) Hispanic 162 (14) 32 (17) Other races Age at Interview (Years) 18-29 68 (15) 297 (16) 30-39 >40 495 (18) Educational Attainment < High school 162 (12) High school 248 (16) Some college 450 (22) Year of Interview 72 (15) 2000 2001 264 (19) 2002 288 (19) 2003 179 (14) 57 (17) 2004 Risk for HIV Infection Male-male sex 562 (20) Male-male sex and injecting drug use 118 (21) Male-female sex 43 (11) Injecting drug use 67(11) Receipt of blood 2 (10) products No reported risk 68 (12)

Adjusted OR (95% Cl)

Women (N=1,882) Ever Participated OR in a CRS n (%17) (95% Cl)

Adjusted OR

(95% CI)_

39 (16) 185 (15) 52 (17) 9 (16)

Referent 0.9 (0.6-1.3) 1.0 (0.7-1.5) 1.0 (0.7-1.6) 1.1 (0.7-1.8) 1.0 (0.4-2.2) 1.0 (0.4-2. 1)

Referent 43 (14) 1.1 (0.9-1.5) 1.0 (0.8-1.4) 105 (16) 1.2(1.0-1.4) 1.3 (1.0-1.7) 137 (15)

Referent 1.2 (0.8-1.8) 1.3 (0.9-1.9) 1.1 (0.8-1.4) 1.1 (0.8-1.7)

0.7 (0.6-0.9) 0.8 (0.7-1.0) 113 (14) 87 (14) Referent 2.0 (1.7-2.5) 1.2 (1.0-1.5)* 85 (19)

1.0 (0.7-1.3) 1.0 (0.7-1.3) Referent

Referent 0.6 (0.5-0.7) 0.8 (0.6-0.9) 0.6 (0.5-0.7) 0.8 (0.6-0.9) 0.7 (0.5-1.1) 0.8 (0.5-1.1 )

Referent 1.3 (1.0-1.7) 1.3 (1.0-1.7) 1.3 (1.0-1.8) 1.2 (0.9-1.6) 0.9 (0.7-1.2) 0.8 (0.6-1.3) 1.2 (0.8-1.7) 1.0 (0.7-1.5)

36 (20) 84 (15) 89 (16) 56 (12) 20 (14)

1.4(1.0-1.9)* 1.4(1.0-2.0)* Referent 0.7 (0.4-1.1) 0.7 (0.5-1.2) 0.8 (0.5-1.2) 0.8 (0.5-1.3) 0.6 (0.4-0.9) 0.6 (0.4-1.0)* 0.7 (0.4-1.2) 0.6 (0.4-1.2)

2.1 (1.5-2.9) 1.6 (1.2-2.3) -

-

2.2 (1.5-3.2) 1.7 (1.1-2.5) 114 (14) Referent 1.0 (0.7-1.5) 0.9 (0.6-1.3) 81 (17)

Referent 1.2 (0.9-1.6) 1.1 (0.8-1.6)

0.9 (0.2-4.2) 1.2 (0.8-1.8)

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0.9 (0.2-4.3) 5 (12) 1.1 (0.7-1.7) 85 (16)

-

0.8 (0.3-2.2) 0.8 (0.2-3.1) 1.1 (0.8-1.5) 0.9 (0.7-1.3)

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nonparticipation were made using ORs with 95% CIs (PROC FREQ, SAS Institute, Cary NC).

RESULTS From 2000-2004, 10,977 persons were offered enrollment in the SHAS project; 8,681 (79%) accepted the interview, and 2,296 (21%) refused. In sites with population-based methods, certain demographic information was available for those who refused to be interviewed; in these sites, those who refused were more likely to be males, >40 years of age or have an HIV acquisition mode of injection drug use. A total of 6,892 respondents (79% ofthe interviewees) had ever received antiretroviral drugs and were thus eligible for inclusion in this analysis (Table 3). The characteristics of those included in the analysis, by sex, are represented in Table 4. Most of the respondents were black, non-Hispanic, .40 years of age, had an AIDS diagnosis at some time in the past and had health insurance. The plurality of respondents had some college education and current household income