Note from the National Guideline Clearinghouse (NGC): A systematic evidence review was prepared by the Oregon Evidence-based Practice Center (EPC) for use by the U.S. Preventive Services Task Force (USPSTF) (see the "Availability of Companion Documents" field).
Literature Search Strategy
EPC staff developed literature search strategies and terms for each key question (KQ) (see Appendix A, Table 1 in the Evidence Synthesis [see the "Availability of Companion Documents" field]) and conducted two separate literature searches (Search one was for KQ1, KQ2; and Search two was for KQ5). For behavioral counseling interventions that met the inclusion criteria for KQ1 and KQ2, EPC staff examined if there were other positive (KQ3) or potentially harmful (KQ4) behavioral or biological outcomes. Because the search for potential adverse effects was limited to behavioral or biological outcomes, which are the paradoxical effects of beneficial outcomes (i.e., increase in risky sexual behavior rather than a decrease in risky sexual behavior), the same study design criteria were used for beneficial (KQ1, 2, 3) and harmful (KQ4) outcomes. Therefore, EPC staff was able to use a single, broad search strategy for KQ1, 2, 3, and 4.
For KQs 1 and 2, EPC staff searched Medline (ML), Cochrane Central Registry of Controlled Trials (CCRCT), Cochrane Database of Systematic Reviews (CDSR), PsycINFO (PI), and the Centers for Disease Control and Prevention's (CDC) Prevention Synthesis Research (PRS) Project's database from 1988 to December 31, 2006. EPC staff explicitly chose to examine the literature since 1988 because it marks the initial year for published studies on sexual behavioral counseling in the post-HIV era. This approach is consistent with both the CDC's Guide to Community Preventive Services and the Prevention Research Synthesis (PRS) Project. For KQ5, ML and CCRCT were searched from 1988 to August 2006. KQ5 focused on the effectiveness of female condoms, which were first manufactured in 1988. Literature searches were supplemented with outside source material from experts in the field and from examining the bibliographies of existing systematic reviews on this topic (see Appendix A Table 4 in the Evidence Synthesis [see the "Availability of Companion Documents" field]).
While EPC staff did not conduct systematic searches for contextual questions, they searched the National Health Service Economic Evaluation Database (NHSEED) through October 2006 for any articles related to cost-effectiveness.
Article Review and Data Abstraction
EPC staff reviewed all abstracts for potential inclusion for any of the KQs using the inclusion/exclusion criteria described in Appendix A, Table 2 in the Evidence Synthesis (see the "Availability of Companion Documents" field). To be included, a study had to evaluate a primary care feasible behavioral counseling intervention addressing sexual behavior change (e.g., sexual risk reduction or sexual risk avoidance) with the primary intention of preventing sexually-transmitted infection (STI) transmission. Consistent with the USPSTF's scope, behavioral counseling interventions needed to be conducted in primary care settings, or judged to be feasible for delivery in primary care based. In general, primary care feasible counseling interventions had to involve individual-level participant identification; a primary care practitioner or related clinical staff; and individual or small-group format, with a limited number of sessions, or at a minimum be viewed as connected to the health care system. Behavioral counseling interventions that included an active component of community outreach, use of community members (e.g., opinion leaders, peer facilitators), use of community programs (e.g., worksite programs, school programs), use of social marketing, or use of public policy changes were not considered primary care feasible. School- and university-based trials were excluded unless conducted in a school- or university-based health clinic. (see Appendix A Table 2 in the Evidence Synthesis [see the "Availability of Companion Documents" field] for criteria details).
EPC staff also required that studies evaluating primary care feasible behavioral counseling interventions be conducted in populations representative of primary care patients. Therefore, they excluded studies that exclusively enrolled participants from correctional facilities, substance-abuse-treatment facilities, HIV clinics, and inpatient hospital units.
For inclusion, studies had to report either biological (e.g., STI incidence) or behavioral outcomes at 3 months after the counseling intervention or later. EPC staff excluded studies only reporting outcomes centered around knowledge, attitudes, self-esteem, and ability changes (skills).
All included studies were limited to those reported in English language. For KQs 1, 2, 3, and 4, studies were also limited to those conducted in English-speaking countries with cultural similarity to the United States (e.g., Australia, Canada, New Zealand, and United Kingdom). For KQ5, studies were not limited to English-speaking countries. The study design was limited to randomized controlled trials (RCTs) and controlled clinical trials (CCTs). For KQ5, however, comparative observational research designs were included in addition to RCTs and CCTs. Trials of comparative effectiveness (i.e., trials without a control arm) were excluded. Trials had to include a control arm with no intervention (e.g., wait-list control, usual care), minimal intervention (e.g., usual care limited to no more than 15 minutes of information), or matched control (e.g., similar format and intensity intervention on a different content area).
Two investigators independently screened all abstracts for potential inclusion.