This application is in response to the Program Announcement entitled """"""""Enrolling Women and Minorities in HIV/AIDS Research Trials"""""""" (PAS-03-168). Racial/ethnic minorities are disproportionately over-represented among those with HIV/AIDS in the U.S. yet they are greatly under-represented in AIDS clinical trials (ACTs). Further, the number of women living with HIV is increasing, and the majority of these patients are minorities;they are also under-represented in ACTs. This four-year project, guided by the Theory of Triadic Influence (which integrates individual/intrapersonal, attitudinal, and social/structural influences), aims to evaluate the efficacy of a peer-driven intervention to improve ACT screening and enrollment rates among racial/ethnic minority and female persons living with HIV/AIDS (PLHA).
The specific aims of the proposed study are to (1) examine the effects of the pf er-driven intervention on rates of screening for and (secondarily) enrollment into ACTs;(2) examine whether the effects of the intervention on ACT screening and enrollment are mediated by changes in individual/intrapersonal, attitudinal, and social/structural influences;(3) explore the positive and negative effects of ACT screening for those not found eligible for ACTs;and (4) describe the clinical characteristics of minority and female PLHA who are found ineligible for current ACTs, to address a long- term objective of developing new ACT practices that will result in higher eligibility rates for minority and female PLHA. This is the first study to use a peer-driven intervention to address ACT disparities. To increase comparability between intervention and control arms, both will be recruited using respondent-driven sampling and the design is equivalent to a randomized controlled trial. Participants (N= 525;40% female;>90% racial/ethnic minority) will be interviewed at three intervals over 12 months. Grounded in theory, the empirical literature, and two years of preliminary research, the proposed study has great potential to yield efficacious intervention strategies to increase the numbers of minority and female PLHA in ACT screening and trials, and to influence the practices of ACTs themselves. Consistent with the NIH Roadmap for Medical Research and Healthy People 2010, study findings will also have valuable applications to other spheres where racial/ethnic and gender-related health disparities are found.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project (R01)
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Study Section
Behavioral and Social Consequences of HIV/AIDS Study Section (BSCH)
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Sharma, Usha K
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New York University
Schools of Nursing
New York
United States
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Gwadz, Marya; Cleland, Charles M; Belkin, Mindy et al. (2014) ACT2 peer-driven intervention increases enrollment into HIV/AIDS medical studies among African Americans/Blacks and Hispanics: A cluster randomized controlled trial. AIDS Behav 18:2409-22
Engel, Stephanie; Gwadz, Marya Viorst; Cleland, Charles M (2013) The Experience of Screening for HIV/AIDS Medical Studies among African-American/Black and Latino/Hispanic Persons Living with HIV/AIDS: A Mixed-Methods Exploration. J AIDS Clin Res 4:
Gwadz, Marya; Cleland, Charles M; Leonard, Noelle R et al. (2013) Predictors of screening for AIDS clinical trials among African-Americans and Latino/Hispanics enrolled in an efficacious peer-driven intervention: uncovering socio-demographic, health, and substance use-related factors that promote or impede screening. AIDS Behav 17:801-12
Leonard, N R; Banfield, A; Riedel, M et al. (2013) Description of an efficacious behavioral peer-driven intervention to reduce racial/ethnic disparities in AIDS clinical trials. Health Educ Res 28:574-90
Gwadz, Marya Viorst; Leonard, Noelle R; Cleland, Charles M et al. (2011) The effect of peer-driven intervention on rates of screening for AIDS clinical trials among African Americans and Hispanics. Am J Public Health 101:1096-102
Gwadz, Marya Viorst; Colon, Pablo; Ritchie, Amanda S et al. (2010) Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials. Curr HIV/AIDS Rep 7:194-200
Des Jarlais, Don C; Arasteh, Kamyar; Gwadz, Marya (2010) Increasing HIV prevention and care for injecting drug users. Lancet 375:961-3
Ilyushina, N A; Rudneva, I A; Khalenkov, A M et al. (2010) Readaptation of a low-virulence influenza H9 escape mutant in mice: the role of changes in hemagglutinin as revealed by site-specific mutagenesis. Arch Virol 155:107-10
Fasina, Folorunso O; Bisschop, Shahn P; Webster, Robert G (2007) Avian influenza H5N1 in Africa: an epidemiological twist. Lancet Infect Dis 7:696-7