This study was funded by linked cooperative agreements between NIMH and the Research Foundation for Mental Hygiene, Inc. (N.Y. State Psychiatric Institute/Columbia University, HIV Center); the Medical College of Wisconsin; the University of California, Los Angeles; and the University of California, San Francisco.

Collaborating Institutions and Key Personnel:

HIV Center:
Principal Investigator: Anke A. Ehrhardt, Ph.D.
Co-Principal Investigator: Robert H. Remien, Ph.D.

Medical College of Wisconsin:
Principal Investigator: Jeffrey A. Kelly, Ph.D.

University of California, Los Angeles:
Principal Investigator: Mary Jane Rotheram-Borus, Ph.D.

University of California, San Francisco:
Principal Investigator: Margaret A. Chesney, Ph.D.
Co-Principal Investigator: Stephen F. Morin, Ph.D.

National Institute of Mental Health:
Willo Pequegnat, Ph.D.

Beth Israel Medical Center, New York:
Don C. DesJarlais, Ph.D.; Jackie Correale, M.P.H.

St. Luke's-Roosevelt Medical Center, New York:
Hannah Wolfe, Ph.D.; Rachel Wolfe, Ph.D.

Project Overview

More Americans than in the past are people living with HIV (PLH), and they will have longer anticipated life spans and better potential health. However, research indicates that a substantial number of HIV-infected persons continue to engage in high-risk sexual and substance use behaviors. Many studies have shown that 30% to 40% of PLH continue to engage in acts that place themselves and others at risk. Medical adherence and skills needed to interact with the medical profession are also low, especially among disenfranchised populations now most likely to become infected. The goal of this project was to design and test an intervention to reduce sexual and injection practice risk behaviors among 942 HIV-infected men and women in order to decrease the likelihood that PLH would transmit infection to others and to promote other health-related behavior changes in PLH. Although sexual and drug use transmission risk acts were the primary outcomes, the intervention also sought to a) to enhance health care behaviors that may increase individuals' prospects for long-term survival; and b) to maintain positive behavioral and mental health changes over time to enhance the quality of life of PLH. Heterosexual women and men, men who have sex with men (MSM), and injection drug users (IDUs) were the four subgroups included in the research, which was undertaken collaboratively by research teams at four sites: Los Angeles, New York City, San Francisco, and Milwaukee.

NY took the lead on the one-year period of formative Phase 1 studies . Interviews were conducted with 152 HIV+ women, MSM, and IDUs at each site. The formative research consisted of qualitative life-history interviews to characterize the psychical, social, and interpersonal contexts that influence risk behavior among PLH: stages of adaptation to serostatus; barriers to implementation of safer sex, positive health care acts, and quality of life; and ways to tailor the intervention's theoretical framework, the social action model (Ewart, 1990; Ewart, 1995), for each subpopulation. Based on findings of the formative studies and the constructs of the social action model, an individually-delivered intervention of 15 sessions, organized into three modules (health behavior promotion, transmission risk behavior reduction, and psychological coping enhancement) was developed.

In the Phase 2 main intervention trial, four subgroups of infected persons, all of whom have engaged in high-risk transmission acts in the past six months, were recruited at each site. Altogether 936 PLH's project-wide were randomly assigned in equal numbers to an immediate or lagged (control) intervention condition. Following the baseline interview, assessment interviews were conducted at 5-month intervals for the next 25 months. In addition to anticipating changes in the primary outcomes of sexual and drug use transmission risk acts over time, we examined the impact of intervention on secondary outcomes related to health care behaviors and quality of life. In response to each module, we examined 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), and participant background factors (gender, ethnicity, and history of transmission behaviors) on outcomes.

The specific aims of the study were (1) to determine the physical, social and interpersonal contexts that characterize continued risk behavior in the lives of PLH and to tailor intervention to salient factors in these contexts; (2) to evaluate the effectiveness of an individually-delivered intervention to reduce HIV-related sexual and substance use transmission acts and to improve health care practices and quality of life for PLH (women, MSM, and IDUs) who have recently engaged in high-risk practices and who are randomly assigned to an immediate or lagged (control) intervention condition; (3) to evaluate factors that may mediate the impact of the intervention including participant exposure category and background factors; the acquisition of theoretically-based targeted skills; attitudes, norms, environmental contexts; and site factors; and (4) to evaluate the cost effectiveness of the intervention and to disseminate its findings.

The study is in its final phase and activities consist solely of data analyses.

Publications (selected):

Wight, R.G., Rotheram-Borus, M.J., Klosinski, L., Ramos, B., Calabro, M., & Smith, R. (2000). Screening for transmission behaviors among HIV-infected adults. AIDS Education and Prevention, 12, 431-41.

Hirky, A.E., Kirshenbaum, S.B., Melendez, R.M., Rollet, C., Perkins, S.L., & Smith, R.A. (2003). The female condom: Attitudes and experiences among HIV-positive heterosexual women and men. Women and Health, 37, 71-89.

Johnson, M.O., Catz, S., Remien, R.H., Rotheram-Borus, M.J., Morin, S.F., Charlebois, E., Gore-Felton, C., Goldstein, R.B., Wolfe, H., Lightfoot, M., Chesney, M.A., & The NIMH HLP Team. (2003). Theory guided, empirically supported avenues for intervention on HIV medication nonadherence: Findings from the Healthy Living Project. AIDS Patient Care and STDs, 17, 645-656.

Remien, R.H., Hirky, A.E., Johnson, M.O., Le, G.M., Whittier, D., & Weinhardt, L.S. (2003). Adherence to medication treatment: A qualitative study of facilitators and barriers among a diverse sample of HIV+ men and women in four U.S. cities. AIDS and Behavior, 7, 61-72.

Kirshenbaum, S.B., Hirky, A.E., Correale, J., Goldstein, R.B., Johnson, M.O., Rotheram-Borus, M.J., & Ehrhardt, A.A. (2004). "Throwing the Dice": Pregnancy decision making among HIV+ women in four U.S. cities. Perspectives on Sexual and Reproductive Health, 36, 106-113.

Klitzman, R.L., Kirshenbaum, S.B., Dodge, B., Remien, R.H. Ehrhardt, A.A., Johnson, M.O., Kittel, L.E., Daya, S., Morin, S.F., Kelly, J., Lightfoot, M.J., Rotheram-Borus, M.J., and the NIMH Healthy Living Trial Group (2004). Intricacies and inter-relationships between HIV disclosure and HAART: A qualitative study. AIDS Care, 16, 628-640.

Klitzman, R.L., Kirshenbaum, S.B., Kittel, L., Morin, S.F., Daya, S., Mastrogiacomo, M., & Rotheram-Borus, M.J. (2004). Naming Names: Perceptions of Name-Based HIV Reporting, Partner Notification, and Criminalization of Non-disclosure Among Persons Living With HIV. Sexuality Research and Social Policy, 1, 38-57.

Melendez, R.M., Exner, T.M., Ehrhardt, A.A., Dodge, B., Remien, R.H., Rotheram-Borus, M.J., Lightfoot, M., & Hong, D. (2004). Health and healthcare among HIV-positive male-to-female transgender persons. American Journal of Public Health, In press.

Weinhardt, L.S., Kelly, J.A., Brondino, M.J., Rotheram-Borus, M.J., Kirshenbaum, S., Chesney, M., Remien, R.H., Morin, S. Lightfoot, M., Ehrhardt, A.A., Johnson, M.O., Catz, S.L., Pinkerton, S.D., Benotsch, E.G., Hong, D., Gore-Felton, C., and the NIMH Healthy Living Project Team. (2004). HIV transmission risk behavior among men and women living with HIV in four US cities. Journal of Acquired Immune Deficiency Syndromes, 36, 1057-1066.

Goldstein, R.B., Johnson, M.O., Rotheram-Borus, M.J., Kirshenbaum, S.B., Pinto, R.M., Kittel, L., Pequegnat, W., Mickalian, J.D., Weinhardt, L.S., Kelly, J.A., Lightfoot, M., & the NIMH Healthy Living Project Team.(2005). Psychological distress, substance use, and adjustment among parents living with HIV. Journal of the American Board of Family Practice, 18, 362-373.

Goldstein, R.B., Rotheram-Borus, M.J., Johnson, M.O., Weinhardt, L.S., Remien, R.H., Lightfoot, M., Catz, S., Gore-Felton, C., Kirshenbaum, S.B., Morin, S.F., & the NIMH Healthy Living Project Team. (2005). Insurance coverage, usual source of care, and receipt of clinically indicated care for comorbid conditions among adults living with HIV. Medical Care, 43, 401-410.

Gore-Felton, C., Rotheram-Borus, M.J., Weinhardt, L.S., Kelly, J.A., Lightfoot, M., Kirshenbaum, S.B., Johnson, M.O., Chesney, M.A., Catz, S.L., Ehrhardt, A.A., Remien, R.H., Morin, S.F., & the NIMH Healthy Living Project Team. (2005). The Healthy Living Project: An individually-tailored, multidimensional intervention for HIV-infected persons. AIDS Education and Prevention, 17, 21-39.

Johnson, M.O., Charlebois, E., Morin, S.F., Catz, S.L., Goldstein, R.B., Remien, R.H., Rotheram-Borus,M.J., Kitell, L., Samimy-Muzaffar, F., Lightfoot, M., Gore-Felton, C, Chesney, M.A., & the NIMH Healthy Living Project Team. (2005). Perceived adverse effects of antiretroviral therapy. Journal of Pain and Symptom Management, 29, 193-205.

Johnson, M.O., Chesney, M., Goldstein, R. B., Remien, R.H., Catz, S., Gore-Felton, C., Charlebois, E.D., Morin, S.F., & the NIMH Healthy Living Project Team. (in press). Positive provider interactions, adherence self-efficacy, and adherence to antiretroviral medications among HIV infected adults: A mediation model. AIDS Patient Care and STDs.

Lightfoot, M., Rogers, T., Goldstein, R.B., Rotheram-Borus, M.J., May, S., Kirshenbaum, S.B., Weinhardt, L.S., Zadoretzky, C., Kittel, L., Johnson, M. O., Gore-Felton, C., Morin, S.F., & the NIMH Healthy Living Project Team (2005). Predictors of substance use frequency and reductions in seriousness of use among persons living with HIV. Drug and Alcohol Dependence, 77, 129-138.

Melendez, R.M., Exner, T.M., Ehrhardt, A.A., Dodge, B., Remien, R.H., Rotheram-Borus, M.J., Lightfoot, M., Hong, D., & the NIMH Healthy Living Project Team. (2005). Health and health care among HIV-positive male-to-female transgenders. American Journal of Public Health, 95, 5-7.

Morin, S.F., Steward, W.T., Charlebois, E.D., Remien, R.H., Pinkerton, S.D., Johnson, M.O., Rotheram-Borus, M.J., Lightfoot, M., Goldstein, R.B., Kittel, L., Samimy-Muzaffar, F., Weinhardt, L., Kelly, J.A., Chesney, M.A., & the NIMH Healthy Living Project Team (2005). Predicting HIV transmission risk among HIV-infected men who have sex with men: Findings from the Healthy Living Project. Journal of Acquired Immune Deficiency Syndromes, 40, 226-235.

Remien, R.H., Exner, T.M., Kertzner, R.M., Ehrhardt, A.A., Rotheram-Borus, M.J., Johnson, M., Weinhardt. L.S., Kittel, L., Goldstein, R.B., Pinto, R.M., Morin, S.F., Chesney, M.A., Lightfoot, M., Gore-Felton, C., Dodge, B., Kelly, J., & the NIMH Healthy Living Project Team (in press). Depressive symptomatology among HIV positive women in the era of HAART: A stress and coping model. American Journal of Community Psychology.

Last Update: 3/13/06

HIV Center for Clinical and Behavioral Studies
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