Although vigorous efforts (eg, appointment cards, phone reminders, incentives, and other outreach) were made to engage and retain women in the interventions, dropout rates were sizeable. In HE, 62% completed the 1-group session. In SSB, 61% completed at least one group session whereas 43% completed 3 or more sessions. When completer status (3 or more sessions of the 5-session SSB condition) was added as a covariate to the MEM, a significant intervention by completion status by time effect (F = 46.1, P < 0.001) was obtained. As predicted, among treatment completers, the advantage for the SSB condition was enhanced (predicted mean USOs in SSB at 3-month follow-up: 13.37, at 6-month follow-up: 10.52 compared with HE at 3-month follow-up: 16.07, at 6-month follow-up: 26.38). Results are presented in Table 5. Figures 3 and 4, respectively, display results for intervention non-completers and completers. This reflects an effect size of 0.60 at 6-month follow-up. Based on the marginal model, women in the SSB condition had 43% fewer USOs than those in the HE condition at 6-month follow-up. This reflects a significant difference between the 2 intervention conditions (P < 0.0093).
There were a total of 52 serious adverse events (26 in each intervention condition). None of the adverse events were determined to be study related.
The present study demonstrates the effectiveness of a brief, gender-specific, group intervention oriented toward SSB and condom use, in reducing unprotected sexual encounters among a high-risk group of women in treatment for drug dependence. Both the SSB intervention and the HE control condition, designed to reflect current usual care in the community, reduced unprotected sexual occasions at 3 months after the intervention. At 6 months after the intervention, the SSB and HE interventions significantly differed in change in USOs, from 3- to 6-month follow-up. Unprotected sex returned to baseline level in the control condition whereas the reductions in high-risk sex were sustained and even further decreased, at 6 months among patients who received SSB, with an effect size (standardized difference between means) of 0.42 favoring SSB over control. This exceeds the smaller effect size of 0.26 noted in meta-analyses of prior clinical trials of HIV risk reduction interventions in similar at-risk populations.10,13 This also surpasses the tendency for deterioration over time frequently observed.4,13
These results demonstrate an important caution in this literature. Although psychoeducational intervention can be successful in initiating safer sexual behavior, maintenance of this behavior requires more hands-on, evocative, and empowering methods of intervention.4,5,13 Due to gendered constraints in heterosexual relationships, this may be especially true for women. Thus, although both interventions were effective in prompting initial postintervention change in USOs, only SSB maintained this change in the complex sexual risk outcomes of the study. A possible mechanism for this may be a so-called sleeper effect-used to describe the “delayed emergence of effects for cognitive behavioral therapy over a psychotherapy control condition” in a trial of pharmacotherapy and psychotherapy for cocaine dependence.37 Sleeper effects have also been observed in trials of contraception outreach in heterosexual couples in Ethiopia.38 Thus, the persistence of reduced sexual risk behavior after 6 months among patients receiving the SSB intervention in this trial is particularly encouraging.
Several features of the study design suggest that the effectiveness of the SSB intervention should have broad generalizability. The use of a hybrid efficacy/effectiveness trial, comparing SSB to treatment-as-usual HE, provided the research frame in which to pose the question of whether or not SSB was effective under real-world circumstances.16 To account for variation between different treatment programs and to be able to infer the statistical results to larger populations of clinical programs, site was treated as a random effect,39,40 as recommended for effectiveness trials. The participating programs were all affiliates of the NIDA CTN and thus do not represent a purely random sample of all US programs. Nonetheless, these were all community-based treatment programs, not otherwise university affiliated or part of tertiary care centers. The effect of the random factor site was significant, meaning there is variation in outcome overall across treatment programs. The current analysis does not assess variation in the intervention effect size (SSB versus HE difference) across program type (eg, methadone versus outpatient psychosocial) or region. Importantly, the interventions in this trial were conducted by local drug counselors, after a brief initial training and with some ongoing supervision. This suggests that the SSB intervention does not necessarily require advanced degrees or specialized expertise but rather is effective in the hands of practicing community-based clinicians.
The study also has limitations and highlights opportunities for further improvement of HIV risk reduction efforts. Although the use of the (1-session) HE control condition provided comparison of (5-session) SSB with standard community practice, it also presented the problem of imbalance in intensity. This design does not permit definitive attribution of outcome differences between these conditions and intervention modality rather than dose. Research, comparing SSB skill modules (male and female condom use skill, safer sex negotiation skill, etc), is needed to unpack the impact of the major components of SSB, of equal attention.
As hypothesized, and consistent with prior observations,17-19 women reporting only a main male partner had more unprotected sexual occasions at follow-up than those reporting multiple partners. Monogamy itself may be protective against risk of contracting HIV or STDs, especially in regions where the prevalence of disease is low. However, high rates of hidden male infidelity or seropositivity may undermine the protective effects of monogamy.41,42 Thus, future interventions should focus more on monogamy and condom use.
The rate of nonadherence to treatment was greater than desired and may have reflected, in part, the well-known difficulty of engaging drug-dependent patients in treatment due to chaotic lifestyles. At the same time, the effect size of 0.60 achieved among women who attended at least 3 of 5-group sessions represents an impressive reduction in high-risk behavior and suggests what might be achieved with greater adherence. It is likely that if, as meta-analyses suggest,4,10 these interventions could be fully integrated into the core substance abuse treatment curriculums of these programs, adherence would be greatly enhanced. There are precedents for this in the adoption of contingency management and motivational interviewing in community-based drug treatment settings.43,44 Further, adding contingency management or motivational interviewing, to improve adherence to SSB intervention, would be a worthwhile next step for future study.
Loss to follow-up was also greater than anticipated or desired and poses a potential threat to the external validity of the outcome results. To attempt to correct for this, we conducted intent-to-treat analyses, incorporating the broadest possible sample and affording us the most realistic view of the effectiveness of the intervention. It should also be noted that much of the attrition was linked to drop out from the drug treatment program itself rather than from the trial alone. This observation offers an important practical caution for the integration of HIV prevention intervention into standard community practice. That is, it is probably more practical to initiate adjunct HIV prevention intervention once attendance in drug treatment has been established. Had there been an attendance criterion for entry into the trial, attrition would likely have been reduced and the sample would have been more representative of individuals “engaged” in community drug treatment. One might expect an increased intervention dose to result in more robust treatment effects.
The study did not measure actual disease transmission (new incidence of HIV or other STDs) as this would have required a much larger sample. However, the primary outcome of unprotected vaginal or anal intercourse has been clearly linked to transmission risk. Further, even modest reductions in unprotected sex have been shown to have public health significance in reducing disease transmission.10
HIV and other STDs remain a substantial and costly threat to public health. By demonstrating the effectiveness of a brief, gender-specific, skills-oriented risk reduction intervention, delivered by drug treatment staff at community-based clinics, this study suggests a model that could be applied more widely in primary care settings where high-risk women are treated (ie, urban primary care, obstetrics-gynecology, or HIV clinics). A key ingredient of the effectiveness observed here, in addition to the design of the intervention itself, may have been the ongoing supervision the counselor-interventionists received. This is consistent with the literature on continuing medical education, which shows that feedback and supervision are essential to the development of new clinical skills.45 The train-the-trainer model implemented here, where local clinicians trained and functioned as supervisors with backup from experts, has particular promise for sustainability. Future research should examine the effectiveness of this or similar HIV risk reduction interventions conducted by nursing or other allied health care workers across various primary care settings.
The authors would like to thank the women who participated in all phases of the study and for sharing information with us about their lives. The authors also thank the 2 anonymous reviewers for their thoughtful and constructive suggestions. Role of the sponsor: The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) collaborated in the design and conduct of the study and NIDA CTN staff assisted in the management, analysis, and interpretation of the data and provided comments for consideration in drafts of the manuscript. Safer Sex for Women Study Research Group: The NIDA CTN is made up of “nodes” comprised of a Regional Research and Training Center (RRTC) housed at an academic institution and 5-10 Community Treatment Programs (CTPs). The Long Island Node served as the lead node. The contributions from each participating CTN node are provided: Washington Node RRTC, University of Washington Alcohol and Drug Abuse Institute, Seattle, WA. Colead investigator and RRTC investigator: Donald Calsyn; national project managers, Sara Berns, Mary Hatch-Maillette; local project manager, Mary Hatch-Maillette; lead quality assurance, Donna Hertel; lead data management, Molly Carney, Michael Dudley, Brooke Leary, Viki Stanmour, Katie Weaver; lead node coordinator, Brenda Stuvek; lead training director, John Baer. Washington Node CTP, Evergreen Treatment Services, Seattle, WA. Site investigator, T. Ron Jackson; research coordination, Megan Swan Foster, Esther Ricardo-Bullis; intervention therapists and supervisors, Carol Davidson, Denise Ledbetter, Lorna McKenzie. Delaware Valley Node RRTC, University of Pennsylvania, Philadelphia, PA. data/QA/protocol management, Charlotte Royer-Malvestuto. Delaware Valley Node CTP, The Consortium, Philadelphia, PA. Site investigator, Mark Hirschman; research coordination, Sheila Clark, Evette Wilson; intervention therapists and supervisors, Shahidah Faruqui, Marie Guerrier, Tyra Hadley, Evette Wilson. Delaware Valley Node CTP, Thomas Jefferson Intensive Substance Abuse Treatment Program, Philadelphia, PA. Site investigators, Robert Sterling, Stephen Weinstein; research coordination, Ellen Fritch, Carolynn Laurenza, Diane Losardo; intervention therapists and supervisor, Tomeka Ragin, Sari Trachtenberg, Debora Wittington. Long Island Node RRTC, Columbia University, New York, NY. Colead investigator and RRTC investigator, Susan Tross; protocol/data/quality assurance management, Aimee Campbell, Terri DeSouza, Megan Ghiroli, Jennifer Lima, Karen Loncto, Jennifer Manual, Jim Robinson. Long Island Node CTP, Staten Island University Hospital, Staten Island, NY. Research coordination, Megan Ghiroli, Marissa Malick; intervention therapist and supervisor, Joe Grossman. North Carolina Node RRTC, Duke University Medical Center, Durham, NC. RRTC investigator, Leonard Handelsman (This staff member passed away prior to the publication of this manuscript and written permission for acknowledgment could not be obtained.); data/QA/protocol management, Tammy Day, Tamara Owens; North Carolina Node CTP, Alcohol Drug Services, Highpoint, NC. Site investigator, Jackie Butler; research coordination, Makeba Casey, Lester Flemming (This staff member passed away prior to the publication of this manuscript and written permission for acknowledgment could not be obtained.); Intervention therapist and supervisor, Allanda Edwards. North Carolina Node CTP, Southlight, Inc, Raleigh, NC. Site investigator, Tad Clodfelter; research coordination, Allison Hartsock, Denise McRae, Tracey Vann. New England Node RRTC, Yale University, New Haven, CT. RRTC investigator, Samuel Ball; data/QA/protocol management, Julie Matthews, Kristie Smith. New England Node CTP, Hartford Dispensary, Hartford, CT. Research coordination, Brandi Buchas, Nicole Moodie; intervention therapists and supervisors, Leyla Miranda, Sarah Sperrazza, Denisse Vazquez. Ohio Valley Node, University of Cincinnati College of Medicine, Cincinatti, OH. RRTC investigator, Judy Harrer; data/QA/protocol management, Emily DeGarmo, Peggy Samoza. Ohio Valley Node CTP, Comprehensive Addiction Services System, Toledo, OH. Research coordination, Al Woods; intervention therapist and supervisor, Al Woods. Ohio Valley Node CTP, Prestera Center for Mental Health Services, Inc, Huntington, WV. Site investigator, Genise Lalos; research coordination, Parrish Harless, Tara Lee; intervention therapist and supervisor, April Fetty. Pacific Node RRTC, University of California-Los Angeles, Los Angeles, CA. RRTC investigator, Sara Simon; data/QA/protocol management, David Bennett, Sara Simon. Pacific Node CTP, Bay Area Addiction Research & Treatment, Los Angeles, CA. Site investigator, Al Cohen. South Carolina Node RRTC, Medical University of South Carolina, Charleston, SC. RRTC investigator, Therese Killeen; data/QA/protocol management, Stephanie Gentilin, Royce Sampson. South Carolina Node CTP, Lexington/Richland Alcohol and Drug Council, Columbia, SC. Site investigator, Louise Haynes; research coordination, Beverly Holmes, Kimberly Pressley; intervention therapists and supervisors, Louise Haynes, Susan H. Coggins, Cynthia Longworth (Many additional investigators, research staff, and intervention therapists and supervisors across sites contributed to this project but could not be contacted for written permission to be acknowledged in this paper). Trial Registration: ClinicalTrials.gov, A Service of the US National Institutes of Health, Number NCT00084188, http://www.clinicaltrials.gov/.
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Keywords:© 2008 Lippincott Williams & Wilkins, Inc.
HIV prevention intervention; drug treatment; skills building; randomized control trial