The current study investigated the feasibility and efficacy of an HIV-risk-reduction intervention developed specifically for a vulnerable but understudied population, namely, adults receiving outpatient treatment for a persistent mental illness. We sought to test predictions that (a) the HIV-risk-reduction intervention would reduce sexual behavior risk more than the SUR intervention, which, in turn, would reduce risk more than the CTL condition; (b) the HIV and the SUR interventions would lead to equivalent improvements for the skills and communication outcomes because both conditions used interpersonal-skills training; and (c) the HIV condition would lead to improved HIV-specific knowledge and motivation relative to both the SUR and control conditions. We also explored whether any observed intervention effects were moderated by patients’ gender and psychiatric diagnosis.
Recruitment data indicated that 41% of the eligible and available patients completed the baseline assessment and consented to the clinical trial. Although authors of prior studies with psychiatric patients typically have not provided data regarding recruitment, recent large studies with other clinical populations have reported such data. For example, the NIMH Multisite Study (1998)
succeeded in recruiting 33% of eligible patients to a seven-session intervention, and Project Respect recruited 44% of eligible patients (Kamb et al., 1998
) to a two- or four-session intervention. Thus, the 41% recruitment rate obtained in the current study—for a 10-session intervention, with a lower functioning sample of psychiatric outpatients—compares favorably to these studies.
Attendance patterns indicated that three quarters of the patients invited to attend risk reduction sessions did so; and two thirds of those invited completed the intervention (defined as attending at least 50% of the sessions). In a preliminary report regarding this trial, we compared patients who completed the baseline portion of this study with those who did not (Vanable, Carey, Carey, & Maisto, 2002
). As reported there, we found that study completion was associated with older age, a more severe psychiatric diagnosis, and a recent STI diagnosis. We interpreted these findings as suggestive that patients who could most benefit from risk-reduction interventions were more likely to participate. Thus, findings from the current trial corroborate findings obtained in earlier trials with fewer sessions (Kalichman et al., 1995
; Kelly et al., 1997
; Otto-Salaj et al., 2001
; Weinhardt et al., 1997
). Taken together, the recruitment and retention data demonstrate the feasibility of implementing HIV-risk-reduction interventions with psychiatric outpatients. Nevertheless, efforts to enhance patient participation and optimize retention in psychiatric and prevention research represent a promising direction for future research.
Outcome analyses demonstrate that the small-group HIV intervention helped psychiatric outpatients to increase their HIV-related knowledge and interpersonal skills, develop attitudes more favorable to condom use, and express stronger intentions to avoid unsafe sexual practices. More important, patients who received the HIV intervention reported that they communicated more with their sexual partners, reduced the number of casual sexual partners, were less likely to engage in unprotected vaginal intercourse, and experienced fewer sexually transmitted infections. The pattern of findings clearly documents that a theoretically based, behavioral intervention can help psychiatric patients to reduce their risk of HIV infection.
The favorable outcomes obtained by the HIV intervention are even more encouraging because (a) baseline levels of risk behavior in this sample were not high (relative to other population groups at elevated risk for HIV), which afforded less opportunity to observe risk reduction, and (b) because many of these outcomes were obtained in comparison to a structurally equivalent substance-use-reduction intervention. The latter provided a rigorous methodological control for two reasons. First, the SUR condition controlled for the time and attention received by HIV-group members (Ostrow & Kalichman, 2000
). Thus, it is unlikely that the gains observed in the HIV condition can be attributed simply to the nonspecific effects of additional contact with a therapist or facilitator. Second, the SUR condition was also expected to reduce HIV-related risk behavior, albeit indirectly. Thus, the present study corroborates findings obtained from earlier investigations with psychiatric patients that have used less rigorous comparison conditions and smaller samples (e.g., Kalichman et al., 1995
; Susser, Valencia, et al., 1998
; Weinhardt, Carey, et al., 1998
Exploratory analyses revealed that gender and psychiatric diagnosis moderated some of the observed intervention effects. Women who received the HIV intervention showed greater reductions in unprotected sex relative to men, whereas men demonstrated greater improvements in HIV-related knowledge. Interestingly, these findings replicate findings from the only other HIV-risk-reduction study that has explored gender differences (Otto-Salaj et al., 2001
). The other extant intervention studies with psychiatric patients have examined only men (e.g., Susser, Valencia, et al., 1998
) or women (e.g., Weinhardt, Carey, et al., 1998
), or they did not have a large enough sample to examine differential intervention response as a function of gender. The risk reduction demonstrated by women, who are more likely to become infected with HIV through heterosexual intercourse (Padian, Shiboski, Glass, & Vittinghoff, 1997
), may reflect women’s tendency to perceive HIV as more of a health threat than do men (Schiemen, 1998
). Alternatively, the interpersonal and self-management-skills components of the intervention may have been seen as more relevant to women who often need to negotiate safer sex with male partners (Amaro, 1995
). Given the enhanced vulnerability to sexual coercion experienced by women receiving psychiatric care (Coverdale & Turbott, 2000
; Weinhardt, Bickham, & Carey, 1999
), continued development of sexual health promotion interventions is warranted.
Patients diagnosed with a major depressive disorder were more likely to benefit from the HIV intervention than were patients diagnosed with schizophrenia-spectrum or bipolar disorder. This finding may reflect greater cognitive and social impairment among patients with a more severe psychotic disorder, and it corroborates previous findings that indicate that psychiatric rehabilitation is often more successful with less impaired persons (Wykes & Dunn, 1992
). One implication of this finding is that the intervention as currently designed may be most appropriate for people with major depression who also have severe functional disabilities but not for those with psychotic illnesses. Patients with more severe schizophrenia-spectrum disorders may profit more from alternative interventions or different delivery strategies (e.g., individual interventions). However, the exploratory nature of the analyses suggests the need for replication and permits only cautious interpretations. Future research should investigate whether tailoring interventions specifically to patients’ levels of functioning can enhance intervention efficacy.
The results also supported our prediction that a substance-use-reduction intervention would help to indirectly reduce sexual risk behavior. As expected, patients who received the SUR intervention were more likely than control participants to demonstrate enhanced interpersonal skills and to reduce the number of sexual partners. They were also more likely than control patients to express more favorable attitudes toward condoms and to endorse stronger intentions to use condoms. They did not, however, report fewer instances of unprotected vaginal sex. These findings resulted from a prevention
-oriented intervention, but they are consistent with earlier reports that effective alcohol (Avins et al., 1997
) and drug treatment
(Metzger, Navaline, & Woody, 1998
) may have the secondary benefit of reducing HIV-related sexual risk behavior. Taken together, these prevention and treatment findings suggest that interventions designed primarily to reduce alcohol and drug use (or misuse) may also reduce sexual risk behavior. It is premature to assume a causal relationship between substance use reduction and HIV risk reduction, but such findings are intriguing and warrant further investigation.
The results of this study need to be considered in light of its strengths and limitations. Strengths of the study included the use of a randomized controlled trial, with the largest and most diagnostically diverse sample of psychiatric outpatients studied to date. Although a strength of this study, the diagnostic diversity of our sample does make comparison to earlier studies complex; earlier intervention studies (e.g., Kalichman et al., 1995
; Otto-Salaj et al., 2001
; Susser, Valencia, et al., 1998
; Weinhardt, Carey, et al., 1998
) used smaller, more diagnostically homogeneous samples. Another strength of this study was that both the HIV and the structurally equivalent comparison condition were guided by prior theory and formative research, and were implemented by trained facilitators who followed a detailed manual. Both interventions were compared with a standard care control condition using validated and established measures, and data analyses tested a priori hypotheses using procedures appropriate for nonnormally distributed count data (Schroder, Carey, & Vanable, 2003
Several limitations need to be acknowledged. First, most of the primary outcomes were measured by self-report, an assessment modality that can be vulnerable to bias. However, we took several steps to reduce potential biases and to optimize data quality. To minimize the cognitive burden on participants, the timeline followback method uses calendars, landmark events, and other cues (M. P. Carey, Carey, Maisto, Gordon, & Weinhardt, 2001
). To minimize demand characteristics, all assessments were completed by assessors not associated with the intervention and masked to the study’s hypotheses (Weinhardt, Forsyth, Carey, Jaworski, & Durant, 1998
). To optimize patient candor, we explained the public health importance of the research project and highlighted the opportunity that patients had to contribute to our understanding of HIV-risk reduction; we also explained that we obtained a Federal Certificate of Confidentiality, which protected our data from subpoena; and we assured patients that their research records were separate from clinical records and that the information that they shared with our research team could not be shared without their written approval.
The limitations of self-report are perhaps most apparent with respect to the self-report of STIs. Although self-report of STIs is necessary (because biological testing will not detect bacterial infections that have already been treated), it is not sufficient because some STIs (e.g., Chlamydia trachomatis
) are frequently asymptomatic; therefore, future research will be strengthened by the collection of biological samples to supplement self-report (Fishbein & Pequegnat, 2000
). Although such testing will be challenging because it requires coordination with the public health system for reporting infections and partner notification, the scientific, clinical, and public health benefits of supplemental testing warrant such efforts.
A second limitation of the current study was our use of a relatively brief follow-up interval. When designing this study, we chose to follow patients for 6 months to provide a sufficient opportunity to observe behavior change but also a brief enough interval to retain research participants. In this intent-to-treat trial, however, we were able to retain nearly 88% of patients enrolled in the intervention at the 6-month follow-up. Thus, future studies can extend the follow-up interval to investigate the stability of intervention gains over a longer interval. Previous research with a small sample of men that used longer follow-ups has been encouraging regarding the maintenance of risk reduction (Susser, Valenica, et al., 1998
), but this warrants future study.
Third, recruitment and retention of voluntary research participants always raises the possibility of a self-selection or participation bias, especially when the study protocol requires attendance at multiple assessment and intervention sessions over long periods. In this trial, 41% of the patients who were eligible consented to participate, a recruitment rate that compares favorably to other large-scale intervention trials (e.g., Kamb et al., 1998
; NIMH Multisite HIV Prevention Trial Group, 1998
). Previous analyses from this trial identified few clinically significant differences between patients who consented to participate and those who declined (Vanable et al., 2002
). Additional analyses reported herein identified few differences between patients who attended intervention and follow-up sessions and those who were lost to follow-up. In sum, no obvious self-selection biases emerged in this study; nevertheless, caution is always advised when generalizing results from a single sample to the larger population from which it is drawn.
Overall, the pattern of findings provides evidence that a theoretically based HIV preventive intervention that provides information, motivational enhancement, and behavioral skills training can help psychiatric outpatients to reduce their risk for HIV. The findings also suggest that a substance use reduction intervention provides some benefits for HIV-risk reduction. Given that psychiatric patients are disproportionately vulnerable to HIV, continued refinement, implementation, and dissemination of HIV-risk-reduction interventions is strongly encouraged.