Behavioral Counseling to Prevent Sexually Transmitted Infections: A Systematic Review for the U.S. Preventive Services Task Force

Despite advances in both prevention and treatment, sexually transmitted infections (STIs) remain an important cause of morbidity in the United States. The Centers for Disease Control and Prevention estimate that 19 million new STIs occur each year, almost half of which are among persons 15 to 24 years of age (1). Rates of STIs in the United States exceed those in all other industrialized countries, as well as goals set by Healthy People 2010. In 2005, rates of bacterial and viral STI acquisition continued to increase in the United States, with the exception of HIV, which has remained relatively stable over the last 5 years. Sexually transmitted infections cause a substantial economic burdenthe direct medical costs associated with STIs in the United States are estimated at $15 billion annually (2). Individual risk factors for STI acquisition are based on risky behaviors (for example, sex with multiple or new partners, sex with high-risk partners, unprotected sex, sex while intoxicated, and sex in exchange for money). These behaviors are theoretically influenced by an individual's preexisting knowledge, attitudes, skills, and self-efficacy and the presence of environmental factors that promote, reinforce, or inhibit change (3). Therefore, risk factors based on an individual's risky behavior are generally considered modifiable. Population risk factors are based on the higher-than-average incidence of STIs in a particular group (for example, adolescents and young adults; black, Hispanic, American Indian, and Alaskan Native persons; men who have sex with men; mentally ill persons; and persons living in low-income urban areas). Population risk factors also lead to increased morbidity of STIs in particular groups, such as pregnant women (2, 4). Several national organizations, including the U.S. Preventive Services Task Force (USPSTF) and the Centers for Disease Control and Prevention, recommend periodic sexual risk assessment to determine which patients are most likely to benefit from STI screening or risk reduction counseling (57). There remains, however, great variability in taking a sexual history and risk assessment in clinical practice, ranging from 15% to 90% in primary care (8). In addition, STI and condom use counseling in primary care is low, documented in only about one third to one half of appropriate encounters (8). In a random digitdialing telephone survey of low-income adolescents, only 50% reported being counseled on preventing STIs (9). A survey of primary care physicians showed that only 40% of physicians reported screening all their adolescent patients for sexual activity, and only 31% reported educating their adolescent patients about STI transmission (10). In 1996, the USPSTF recommended that all adolescent and adult patients be advised about risk factors for STIs and counseled about effective measures to reduce risk for infection, which was based on the proven efficacy of risk reduction, although the effectiveness of clinical counseling in a primary care setting had not been adequately evaluated. Thus, we examined the evidence for the benefits and harms of counseling primary care patients to prevent STIs, including HIV. Using the USPSTF's methods (11), we developed an analytic framework (Figure 1) that included 5 updated questions to guide the current systematic review: Figure 1. Analytic framework. KQ = key question. Key question 5 (Do sexual behavior changes lead to a reduced incidence of STI, or related morbidity and mortality? ) is not addressed in this article; please see the full evidence report (available at www.ahrq.gov/clinic/uspstfix.htm). Is there direct evidence that primary care counseling to reduce risky sexual behavior can reduce STI incidence or related morbidity and mortality? Does primary care behavioral counseling to prevent STI result in safer sexual behaviors among those counseled? Does primary care behavioral counseling to prevent STI result in benefits other than safer sexual behaviors and reductions in STI incidence? Are there harms from primary care behavioral counseling to prevent STI? Do sexual behavior changes lead to a reduced incidence of STI or related morbidity and mortality? Methods Data Sources We searched MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and PsycINFO from 1988 through December 2007, as well as the Centers for Disease Control and Prevention's Prevention Research Synthesis Project database through August 2006. We examined the literature since 1988 because that was the initial year for published studies on sexual behavioral counseling in the post-HIV era. We supplemented literature searches with outside source material from experts in the field and the bibliographies of existing relevant systematic reviews. Study Selection We included trials that evaluated behavioral counseling interventions conducted in primary care or judged to be feasible for delivery in primary care. We defined behavioral counseling as any intervention that included some provision of education, skills training, and guidance on how to change sexual behavior, delivered alone or in combination with other interventions intended to promote sexual risk reduction or risk avoidance. Table 1 summarizes inclusion and exclusion criteria. Table 1. Summary of Inclusion and Exclusion Criteria for Key Questions 1 through 4 Data Extraction and Quality Assessment Two investigators independently screened all abstracts for inclusion. We reviewed a total of 3197 abstracts and 287 complete articles for key questions 1 through 4. Two investigators independently rated all articles meeting inclusion criteria for quality assessment by using the USPSTF's study designspecific quality criteria (11, 12). This review included 21 articles representing 15 unique trials for key questions 1 through 4 (Figure 2). One primary reviewer abstracted relevant information into standardized evidence tables for each included article. A second reviewer checked the abstraction process. Figure 2. Study flow diagram. KQ = key question; SER = systematic evidence review. * Articles for KQ3 and KQ4 were reviewed from articles from KQ1 and KQ2. Data Synthesis Because of the heterogeneity in study populations, settings, interventions, and outcomes, we did not attempt quantitative synthesis of study results, but report our qualitative synthesis. Given the large variation in intensity of behavioral counseling interventions studied, we use the term low intensity to describe single-visit counseling interventions lasting less than 30 minutes or any intervention that could be added to usual primary care without significant additional visit time; moderate intensity to describe interventions lasting longer than 30 minutes but less than 2 hours in total; and high intensity to describe multiple-visit interventions requiring more than 2 hours in total. Role of the Funding Source The authors worked with 4 USPSTF liaisons at key points throughout the review process to develop and refine the scope, analytic framework, and key questions; to resolve issues around the review process; and to finalize the evidence synthesis. Staff from the Agency for Healthcare Research and Quality (AHRQ) provided project oversight, reviewed the draft report, and assisted in external review of the draft evidence report. The draft report was subsequently revised after review by 5 experts, including representatives of federal agencies. The final evidence report is available at www.ahrq. gov/clinic/uspstfix.htm. Interested readers can refer to the full report for further details on methods and results. However, this article includes 2 additional trials that were identified (13, 14), but not yet published, at the time we prepared the final evidence report. Results Key Question 1 Is there direct evidence that primary care counseling to reduce risky sexual behavior can reduce STI incidence or related morbidity and mortality? Adults We identified 8 fair- or good-quality trials in adults examining the effect of behavioral counseling interventions on reducing STI incidence (Table 2) (1320). Only 3 randomized, controlled trials (RCTs) were conducted in a primary care setting (13, 14, 20). Five trials included only women (1316, 20). All trial populations, except for one (14), were considered at high risk for STIs on the basis of sociodemographic population risk factors or individual risk factors, including participants with a history of current or previous STI ranging from 20% to 100%. Behavioral counseling interventions ranged from low intensity (for example, distribution of tailored self-help materials) to high intensity (for example, multiple-session counseling interventions up to 10 sessions). Table 2. Effectiveness of Behavioral Counseling Interventions to Reduce STIs in Adults and Adolescents Based on Randomized, Controlled Trials (Key Question 1) Most evidence (5 RCTs; n = 8122) suggests a modest reduction in bacterial STIs at 12 months among high-risk adults receiving moderate- to high-intensity counseling interventions (13, 1517, 19). Only 1 of these 5 trials was conducted in a primary care setting, which was identified after the completion of the final evidence report for the USPSTF (13). This good-quality trial, by Jemmott and colleagues (n = 564), showed that women receiving either low-intensity individual counseling or high-intensity group counseling had fewer incident bacterial STIs than did control participants (14% to 15% vs. 27%, respectively). The results are reported only for the low-intensity and high-intensity intervention groups combined, probably because the counseling intervention groups were not independently statistically significant. Three trials conducted in STI clinics (n = 7150) showed a moderate decrease in bacterial STI incidence at 12 months, compared with usual care that included only minimal counseling. The largest STI clinic trial, Project RESPECT (Review, Enhance, Situations, Plan, Examine, Ch