The goal of this project is to design and test an intervention to reduce sexual and injection practice risk behaviors among 1,200 HIV-infected men and women in order to decrease the likelihood that persons with HIV will transmit infection to others and to promote other health-related behavior changes in PLH. The research will be focused on three HIV+ subgroups: women, men who have sex with men (MSM), and injection drug users (IDUs). The study will be undertaken at four sites: Los Angeles, New York, San Francisco, and Milwaukee. The project will begin with a 1-year period of formative Phase 1 studies conducted with 150 PLH, using qualitative and life-history interviews to characterize the physical, social, and interpersonal contexts that influence risk behavior among PLH; understand stages of adaptation to serostatus; and identify barriers to implementation of safer sex, positive health care acts, and quality of life. The formative research phase will also allow the investigators to tailor the social action theoretical model guiding the intervention to address issues affecting each subpopulation. Following the formative research phase, a manual will be prepared for an intervention of 15 individually-delivered sessions organized into three modules with components that target health promotion, transmission risk reduction, and psychological coping/relationship issues. In the Phase 2 main intervention trial, three subgroups of HIV-infected person who have recently engaged in high-risk behavior will be recruited in equal numbers at each site yielding study-wide samples of HIV+ women (N=400), MSM (N=400), and IDUs (N=400). Altogether, 1,200 PLHs project-wide will be randomly assigned in equal numbers within each subgroup to an immediate intervention condition or to a lagged intervention control condition. Following two baseline interviews, participants will be evaluated at 5-month intervals for the next 35 months. In addition to anticipating changes in the primary (transmission risk acts) and secondary (health care behaviors and quality of life) outcomes over time and in response to each module, the investigators will examine the impact of mediating factors emerging from social action theory (coping skills, social support problem solving, HIV-related attitudes/beliefs, and environmental context of risk acts), as well as participant background factors (gender, ethnicity, history of transmission behaviors) or primary and secondary outcomes. The study will be implemented by a consortium of four sites in order to provide sufficient sample sizes to assess the impact of the intervention; to enhance generalizability of the findings; and to utilize the specialized expertise of each research team. Cost-effectiveness analyses and dissemination are planned as part of this study.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10MH057616-05S1
Application #
6750520
Study Section
Psychobiological, Biological, and Neurosciences Subcommittee (MHAI)
Program Officer
Gordon, Christopher M
Project Start
1998-09-05
Project End
2003-07-31
Budget Start
2002-08-01
Budget End
2003-07-31
Support Year
5
Fiscal Year
2003
Total Cost
$394,043
Indirect Cost
Name
University of California San Francisco
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
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Comulada, W Scott (2015) Model specification and bootstrapping for multiply imputed data: An application to count models for the frequency of alcohol use. Stata J 15:833-844
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Sevelius, Jae M; Carrico, Adam; Johnson, Mallory O (2010) Antiretroviral therapy adherence among transgender women living with HIV. J Assoc Nurses AIDS Care 21:256-64
Comulada, W Scott; Rotheram-Borus, Mary Jane; Pequegnat, Willo et al. (2010) Relationships over time between mental health symptoms and transmission risk among persons living with HIV. Psychol Addict Behav 24:109-18
Mosack, Katie E; Weinhardt, Lance S; Kelly, Jeffrey A et al. (2009) Influence of coping, social support, and depression on subjective health status among HIV-positive adults with different sexual identities. Behav Med 34:133-44
Carrico, Adam W; Chesney, Margaret A; Johnson, Mallory O et al. (2009) Randomized controlled trial of a cognitive-behavioral intervention for HIV-positive persons: an investigation of treatment effects on psychosocial adjustment. AIDS Behav 13:555-63
Johnson, Mallory O; Chesney, Margaret A; Neilands, Torsten B et al. (2009) Disparities in reported reasons for not initiating or stopping antiretroviral treatment among a diverse sample of persons living with HIV. J Gen Intern Med 24:247-51

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