Sponsored by:

The Centers for Disease Control and Prevention (CDC)

Principal Investigator:

David J. McKirnan, Ph.D. The University of Illinois at Chicago, and Howard Brown Health Center, Chicago. davidmck@uic.edu.

GENERAL OVERVIEW

Purpose and approach. This research tests a behavioral intervention for sexual safety and treatment adherence among gay and bisexual men infected with HIV. The incidence of STD and HIV infections is increasing (CDC, 1997, 2001; Wolitski, 2001), consistent with general increases in unprotected sex among men who have sex with men (CDC, 2001; Fox, 2001). Increases in sexual risk stem from a growing sense that new treatments make HIV less “serious” than it was, and variables such as depression or alcohol and drug use (Kelly, 1993; Vanable, 2000). Anti-Retroviral Treatments (ART) now allow HIV+ men to lead full social and sexual lives, moving the focus of HIV prevention toward the increasing population of sexually active, HIV infected men.

HIV treatments are successful in delaying or preventing AIDS, but require strict adherence to drug schedules (Mulder, et al.,1999). Treatment adherence is a general problem in chronic disease. In HIV care poor adherence has limited the effectiveness of anti-retroviral medications, and given rise to drug-resistant strains of the virus (Stephenson, 1999). Adherence is limited by the complexity and side effects of the drugs themselves, lack of skills, and factors such as depression or alcohol and drug use (Rabkin, 1999). New sexually transmitted diseases in an HIV patient can increase HIV infectiousness and decrease the effectiveness of HIV drugs (Haase et al., 1998). Thus, both long-term treatment adherence and safer sex are crucial in HIV disease (CDC, 1997).

The core outcomes of this study are clinical health and sexual safety. Health will be assessed by: 1) the amount of virus in the bloodstream, called HIV viral load; 2) the number of CD4 cells, a key white blood cell that signals immune system competence; 3) any changes in effectiveness of drug treatments, and; 4) the presence of opportunistic infections or other AIDS symptoms. Viral load and CD4 count are among the best predictors of long-term health in HIV treatment (Deeks et al., 1999; Mellors et al., 1997), and are used as the criteria for initiating or changing anti-retroviral drug treatment, and for a diagnosis of AIDS (CDC, 1999). Both are typically taken every three months as part of the patient’s normal health care, and are responsive to drug adherence (AIDS Alert, 1997; Deeks, 1998; Hecht, 1998). Sexual safety will be assessed by standard self-report measures used in epidemiological and prevention studies in HIV. Self-report measures are collected specifically for this study, using 45-minute interviews conducted at baseline and every six months.

The intervention combines sexual risk reduction, medication adherence, and general coping skills into an integrated, structured package. This configuration follows general descriptions of the needs of infected men, and literature showing both adherence and sexual risk to be affected by similar variables, e.g., negative affect or social isolation (Rabkin, 1999). The intervention is delivered in the primary care setting by trained, HIV+ peers (“treatment advocates”). Primary care is the natural setting for this programming, since HIV patients must establish long-term relationship with a care setting for their HIV treatment, and typically receive care and clinical assessment every three months. The use of a peer counselor is based on considerable evidence of the effectiveness of peer support in behavioral change generally, and among infected men (Hodgkins, 1996). The program uses highly structured advocate training, supervision, and intervention protocol materials, consistent with literature indicating that paraprofessional counselors can be highly effective when using structured approaches (Bright, 1999; Neilson, 1995).

Investigators and Collaborators.: The intervention will be conducted in conjunction with, and funded by, the Centers for Disease Control and Prevention (CDC).

Investigators, project officers, coordinators, and host institutions:

Centers for Disease Control and Prevention, Behavioral Interventions Research Branch, DHAP-IRS: Dogan Eroglu, Ph.D., Project Officer

Cari Courtenay-Quirk, MPH, Study Coordinator.

Howard Brown Health Center, Chicago. (Host institution and clinical site)

David J. McKirnan, Ph.D., Principal Investigator

Scott Cook, Ph.D., Clinical Coordinator

Patty Delaney, Project Coordinator

Jeff Savage, Lead Treatment Advocate

The University of Illinois at Chicago.

David McKirnan, P.I., Associate Professor

Marina Tolou-shams, Research Associate

Collaborating clinical sites:

Uptown Clinic of The Chicago Department of Public Health

Sherrell McDearmon, Clinical Coordinator

Slotten and French Medical Associates of St. Joseph’s Hospital, Chicago

Ross Slotten, M.D., Lead clinical / research contact

Minority Outreach Intervention Project, Chicago.

Brandon Armani, Executive Director

Overall Study Design. The study is an 18-month, randomized controlled trial, with a 12-month wait-list control group. Participants are randomly assigned to get the coping program immediately, or to receive standard clinic care for 12 months before receiving the coping program. The core analysis will be an “intent to treat” comparison of the experimental v. control group in clinical health and sexual safety after the 12 month contrast period. Secondary analyses will examine individual differences in long-term health/safety after 18 months in the group first randomized to the care condition (all participants will have at least 6 months of program experience, allowing for more powerful analyses of short-term within-group outcomes.) Finally, the intervention is aggressively individually tailored, so participants may differ significantly in the content and “dose” of the intervention they receive. Secondary analyses will model the effect of intervention dose on outcomes.

Study Populations. Three-hundred male, HIV primary care patients will be recruited from four clinics in Chicago for an 18 month study of sexual safety, adherence and coping. The clinics are Howard Brown Health Center, the Uptown Clinic of the Chicago Department of Public Health, Minority Outreach Intervention Project, and Klein, Slotten and French Medical Associates of St. Joseph’s Hospital. (See Appendix 1, Letters of collaboration). Recruitment will take place during a 6-month period at the beginning of the study. During the recruitment period, collaborating providers will briefly describe the study to all HIV+ male patients age 18 and over. A brief screen administered by study staff will determine eligibility: Receiving HIV care (not necessarily taking HIV medications), and sexually active in the previous six months. All study activities are done in the participating clinics, scheduled to correspond to normal HIV care visits when possible.

We have chosen four clinical collaborators that cater to diverse patient populations, to reflect the larger population of infected Men who have Sex with Men (MSMs) in Chicago. Somewhat over 50% of MSM infections are among White men, with the bulk of the remainder among African-Americans (although these rates are shifting). Our cohort should roughly approximate those percentages, as we have selected clinics with higher census of ethnic minority participants. No participant will be specifically recruited or denied enrollment due to racial / ethnic group membership. The range of clinics will ensure a high proportion of lower socio-economic status participants, in addition to the relatively affluent MSM that constitute many cohort studies in HIV.

We address the general population rather designated “high-risk” participants (e.g., those with a recent STD) on the assumption that we are preventing as well as modifying risk, and to avoid the stigma of recruiting only some participants. Based on previous data, a high proportion of patients will report unprotected sex at some point during the study period, giving us adequate power to detect intervention effects with open enrollment. Since the intervention addresses both sexual safety and treatment adherence, there is no requirement that participants be taking HIV medications, only that they be receiving HIV care (current CDC guidelines specify that medications do not begin at diagnosis, but only after a given viral load or CD4 count).

2. BEHAVIORAL INTERVENTION The intervention begins with four individual counseling sessions to develop a base of skills and commitment to behavioral goals, followed by counseling sessions at each subsequent primary care visit (approx. each 3 months). Treatment Advocates deliver all sessions.

Treatment Advocate sessions. The four core counseling sessions are delivered during month 1 & 2 of the study. Additional sessions are available upon request. Materials are presented in modular format via PowerPoint® files. Modules guide the advocate and participant through structured probes to identify behavioral change targets. The advocate and participant then use structured exercises to set behavioral goals and plans, using basic cognitive-behavioral methods. Figure 1 presents the main intervention menu, illustrating the flow of intervention materials. For participants who are currently taking HIV medications, the intervention proceeds through medication skills and coping (1-2 sessions), an overview of sexual safety and intimacy (1 session), and “focus” modules addressing specific issues in sexual intimacy or risk (1-2 sessions). Participants not on medications begin with HIV coping and sexual safety.

The timing and choice of modules, and of topics within modules, are all guided by the participant’s responses to the intervention materials. The advocate uses computer “hot buttons” to link to topics or modules that capture needs or interests of the participant. Materials are in Appendix 5 and at www.uic.edu/depts/psch/tap. Advocates are trained to make referrals for issues that are beyond the scope of the intervention, e.g., substance abuse or depression.

Adherence training sessions review HIV information; basic adherence skills such as pill boxes and cue controls; medication and clinic overview sheets; communication with medical providers, and; provisions for storing and handling medications. The second session addresses “difficult doses”: how to stay adherent in sexual contexts, with family, while traveling, while experiencing depression, etc. This latter session addresses psychosocial variables that may inhibit adherence, and begins addressing sexuality and sexual risk. Each of these areas yields a behavioral plan if appropriate.

Sexual safety sessions begin with information about the importance of safety in HIV+ men, and a review of the participant’s sexual goals and concerns. These are then incorporated into a standard cognitive-behavioral approach to safety, where unsafe episodes are analyzed to discover their psychological or behavioral “active ingredients” that can be made into change plans. Later session(s) address any special topic(s) raised by the general analysis, given as “focus modules” in Figure 1.

Coping Profiles and Coping Worksheets. All sessions use participant responses to the materials and/or brief coping interviews to construct a profile of areas where the participant is coping well or poorly. After every session the participant and advocate complete a coping worksheet that identifies target change areas, behavioral goals, and “action plans” for behavioral modification. Profiles are used to individually tailor the intervention and provide feedback. The plans outlined on these sheets are the core of the intervention, and are returned to during “check-in” visits. An example of a Coping Worksheet (used as a slide in the intervention) is given to the right.

Telephone / e-mail / outreach contacts. Advocates are available via voice or e-mail for questions or problem solving.