Women and Drug Users: The Changing Faces of HIV Clinical Drug Trails

Murphy, Timothy F.

doi:10.1016/s0097-5990(16)30417-1

“…women, lower socio-economic groups, minorities and those without stable addresses) in studies of HIV-infected populations. Several authors have written about the organizational structures that are required to achieve recruitment goals on or close to target and the need for information on the cost and effectiveness of various recruitment strategies (Brown-Peterside et al , 2000;Cunningham-Williams et al , 1999;Jenkins et al , 1998;Lovato et al , 1997;Murphy, 1991). To our knowledge, there are no published reports on the cost-effectiveness of recruitment strategies for enrolling HIV positive adults into a randomized trial; that is, evaluation of such strategies on the basis of participant yield.…”

Section: Cost-effectiveness Analysis Of Recruitment Strategies In a Cmentioning

confidence: 99%

Cost-effectiveness analysis of recruitment strategies in a community-based intervention study of HIV-infected persons

Baigis

¹

,

Francis

²

,

Hoffman³

2003

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This paper describes and evaluates recruitment methods used to reach adults with HIV infection and to enroll eligible candidates in a randomized trial of aerobic exercise. Potential participants residing in the metropolitan Washington DC area were recruited from January 1994 to December 1996. The yield and associated cost of clinic centre site-visit (CSV) recruitment are compared to similar outcomes for community-based (CB) recruitment strategies, which consisted of presentations to local groups, mail/phone canvasses of caregivers, neighbourhood network promotion, public site postings and print media notices. Of 833 HIV infected adults ascertained during the recruitment phase as prospective study candidates, 66.7% were initially contacted during CSV recruitment. The remainder, 33.3% were CB recruits. The percentage of screened candidates who were subsequently enrolled in the study was 13.5% for CSV recruitment and 21% for CB recruitment. Ascertainment and screening costs combined were $158 per CB recruit compared to $232 per CSV recruit. Using multiple recruitment approaches we successfully achieved our enrollment goal of at least 100 volunteers from diverse populations by the end of the planned recruitment period.

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“…Furthermore, these subpopulations of HIV-infected individuals-women, persons of color, and injection drug users-have not had the benefit of early access to new treatments and prophylaxis for HIV and its complications that clinical trials have provided for participants. [6][7][8][9][10][11][12] It has been hypothesized that the lower participation of women, persons of color, and drug users primarily reflects impaired access to trials, due to several factors. Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV [8][9][10] ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users.…”

mentioning

confidence: 99%

“…Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV [8][9][10] ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users. 11,[13][14][15] Finally, minority patients, especially African Americans, may avoid participation in clinical trials because of suspicions about medical research resulting from a legacy of past studies that misused subjects. 8,10,16,17 Currently, there is little information about the relative rates of participation of women, minorities, and drug users in clinical trials when an ACTU is located within the medical center in which they receive their care.…”

mentioning

confidence: 99%

Race, Gender, Drug Use, and Participation in AIDS Clinical Trials: Lessons from a Municipal Hospital Cohort

Stone

¹

,

Mauch²,

Steger

³

et al. 1997

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OBJECTIVES:To determine whether participation rates of women, persons of color, and injection drug users in AIDS clinical trials are similar to those of other HIV/AIDS patients, and to examine whether differences in patients' knowledge of clinical trials or reasons for not participating explain differences in participation rates by gender, race, or drug use. DESIGN: HIV infection and AIDS 1 are having an increasing impact on mortality and quality of life for women and persons of color in the United States. [2][3][4] In 1995, the AIDS incidence rate among blacks and Latinos was more than six times and two times, respectively, the rate among whites in the United States. 4 The incidence of AIDS is also increasing more rapidly among women than men; AIDS is now the third leading cause of death for all U.S. women aged 25 to 44 years. 2,5 This disease is increasingly afflicting women from all U.S. communities, but there has been a disproportionate increase in the prevalence of AIDS among minority women, particularly African Americans, Latinas, and Caribbean blacks. Women from communities of color together have accounted for nearly 76% of all reported cases of AIDS in women, while these groups represent only 21% of the general population of U.S. women. 2,5 And notably, the most common route of HIV acquisition among both women and persons of color diagnosed with AIDS to date has been injection drug use. 5 Despite their growing representation among AIDS cases, women, racial or ethnic minorities, and injection drug users have generally been underrepresented in clinical trials of drugs for the treatment of AIDS and early HIV disease. 6-10 To date, most clinical trials of treatment for HIV and HIV-related complications have been composed primarily of homosexual white men, with low participation of women, persons of color, and injection drug users. [6][7][8][9][10] Failure to include adequate numbers of women and persons of color may limit the generalizability and usefulness of study results for clinical practice. Furthermore, these subpopulations of HIV-infected individuals-women, persons of color, and injection drug users-have not had the benefit of early access to new treatments and prophylaxis for HIV and its complications that clinical trials have provided for participants. [6][7][8][9][10][11][12] It has been hypothesized that the lower participation of women, persons of color, and drug users primarily reflects impaired access to trials, due to several factors. Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV 8-10 ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users. 11,[13][14][15] Finally, minority patients, especially African Americans, may avoid participation in clinical trials because of suspicions about medical research resulting from a legacy of past studies that misused subjects. 8,10,16,17 Currently, there is little information about the relative rates of participation ...

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“…Furthermore, these subpopulations of HIV-infected individuals-women, persons of color, and injection drug users-have not had the benefit of early access to new treatments and prophylaxis for HIV and its complications that clinical trials have provided for participants. [6][7][8][9][10][11][12] It has been hypothesized that the lower participation of women, persons of color, and drug users primarily reflects impaired access to trials, due to several factors. Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV [8][9][10] ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users.…”

mentioning

confidence: 99%

Race, Gender, Drug Use, and Participation in AIDS Clinical Trials Lessons from a Municipal Hospital Cohort

Stone

¹

,

Mauch²,

Steger

³

et al. 1997

View full text Add to dashboard Cite

OBJECTIVES:To determine whether participation rates of women, persons of color, and injection drug users in AIDS clinical trials are similar to those of other HIV/AIDS patients, and to examine whether differences in patients' knowledge of clinical trials or reasons for not participating explain differences in participation rates by gender, race, or drug use. DESIGN: HIV infection and AIDS 1 are having an increasing impact on mortality and quality of life for women and persons of color in the United States. [2][3][4] In 1995, the AIDS incidence rate among blacks and Latinos was more than six times and two times, respectively, the rate among whites in the United States. 4 The incidence of AIDS is also increasing more rapidly among women than men; AIDS is now the third leading cause of death for all U.S. women aged 25 to 44 years. 2,5 This disease is increasingly afflicting women from all U.S. communities, but there has been a disproportionate increase in the prevalence of AIDS among minority women, particularly African Americans, Latinas, and Caribbean blacks. Women from communities of color together have accounted for nearly 76% of all reported cases of AIDS in women, while these groups represent only 21% of the general population of U.S. women. 2,5 And notably, the most common route of HIV acquisition among both women and persons of color diagnosed with AIDS to date has been injection drug use. 5 Despite their growing representation among AIDS cases, women, racial or ethnic minorities, and injection drug users have generally been underrepresented in clinical trials of drugs for the treatment of AIDS and early HIV disease. 6-10 To date, most clinical trials of treatment for HIV and HIV-related complications have been composed primarily of homosexual white men, with low participation of women, persons of color, and injection drug users. [6][7][8][9][10] Failure to include adequate numbers of women and persons of color may limit the generalizability and usefulness of study results for clinical practice. Furthermore, these subpopulations of HIV-infected individuals-women, persons of color, and injection drug users-have not had the benefit of early access to new treatments and prophylaxis for HIV and its complications that clinical trials have provided for participants. [6][7][8][9][10][11][12] It has been hypothesized that the lower participation of women, persons of color, and drug users primarily reflects impaired access to trials, due to several factors. Most initial AIDS Clinical Trials Units (ACTUs) were in centers that cared for few minorities, women, or drug users with HIV 8-10 ; and until recently, AIDS clinical trials have had restrictive eligibility criteria for women and injection drug users. 11,[13][14][15] Finally, minority patients, especially African Americans, may avoid participation in clinical trials because of suspicions about medical research resulting from a legacy of past studies that misused subjects. 8,10,16,17 Currently, there is little information about the relative rates of participation ...

show abstract

Women and Drug Users: The Changing Faces of HIV Clinical Drug Trails

Cited by 8 publications

References 11 publications

Cost-effectiveness analysis of recruitment strategies in a community-based intervention study of HIV-infected persons

Cost-effectiveness analysis of recruitment strategies in a community-based intervention study of HIV-infected persons

Race, Gender, Drug Use, and Participation in AIDS Clinical Trials: Lessons from a Municipal Hospital Cohort

Race, Gender, Drug Use, and Participation in AIDS Clinical Trials Lessons from a Municipal Hospital Cohort

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