This is the current release of the guideline.

This release updates a previously published guideline: U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Baltimore (MD): Williams & Wilkins; 1996. Chapter 62, Counseling to prevent HIV infection and other sexually transmitted diseases. p. 723-37. [111 references]

Sexually transmitted infections (STIs):

• Chlamydia trachomatis
• Hepatitis B
• Hepatitis C
• Herpes simplex
• Human immunodeficiency virus (HIV)
• Human papillomavirus
• Neisseria gonorrhea
• Syphilis
• Trichomonas vaginalis

Counseling
Prevention
Risk Assessment

Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Pediatrics
Preventive Medicine

Advanced Practice Nurses
Allied Health Personnel
Health Care Providers
Nurses
Physician Assistants
Physicians
Public Health Departments

• To summarize the U.S. Preventive Services Task Force (USPSTF) recommendations and supporting evidence on behavioral counseling to prevent sexually transmitted infections
• To update the 1996 USPSTF recommendations

All sexually active adolescents and adults

High-intensity behavioral counseling

Key Question 1: Is there direct evidence that behavioral counseling interventions to reduce risky sexual behaviors and increase protective sexual behaviors reduce sexually transmitted infection (STI) incidence and/or related morbidity and mortality?

Key Question 2: Do behavioral counseling interventions to prevent STIs in primary care reduce risky sexual behaviors or increase protective sexual behaviors?

Key Question 3: Are there other positive outcomes besides sexual behavioral changes and reduced incidence of STI resulting from behavioral counseling interventions to prevent STIs in primary care?

Key Question 4: What are the adverse effects associated with behavioral counseling interventions to prevent STIs in primary care to reduce risky sexual behaviors and increase protective sexual behaviors?

Key Question 5: Do sexual behavioral changes, including reducing risky sexual behaviors and increasing protective sexual behaviors, lead to a reduced incidence of STIs and/or related morbidity and mortality?

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

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.

This review included 19 articles representing 13 unique trials for key questions (KQs) 1, 2, and 3, and three articles for KQ 4.

Expert Consensus

Not applicable

Systematic Review with Evidence Tables

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).

Data Abstraction

One primary reviewer abstracted relevant information into standardized evidence tables for each included article (see Appendix B of the evidence synthesis [see the "Availability of Companion Documents" field]). A second reviewer checked the abstraction process.

Literature Synthesis

EPC staff members were unable to conduct quantitative synthesis for any key question due to the heterogeneity of intervention methods, populations addressed, and settings. Instead, they qualitatively synthesized their results within categories focusing first on the population(s) addressed, and second on the setting in which the population was identified and the counseling intervention delivered. The results text and corresponding summary tables reflect these qualitative summaries.

Balance Sheets
Expert Consensus

The U.S. Preventive Services Task Force (USPSTF) systematically reviews the evidence concerning both the benefits and harms of widespread implementation of a preventive service. It then assesses the certainty of the evidence and the magnitude of the benefits and harms. On the basis of this assessment, the USPSTF assigns a letter grade to each preventive service signifying its recommendation about provision of the service (see Table below). An important, but often challenging, step is determining the balance between benefits and harms to estimate "net benefit" (that is, benefits minus harms).

Table 1. U.S. Preventive Services Task Force Recommendation Grid*

*A, B, C, D, and I (Insufficient) represent the letter grades of recommendation or statement of insufficient evidence assigned by the U.S. Preventive Services Task Force after assessing certainty and magnitude of net benefit of the service (see the "Rating Scheme for the Strength of the Recommendations" field).

The overarching question that the Task Force seeks to answer for every preventive service is whether evidence suggests that provision of the service would improve health outcomes if implemented in a general primary care population. For screening topics, this standard could be met by a large randomized, controlled trial (RCT) in a representative asymptomatic population with follow-up of all members of both the group "invited for screening" and the group "not invited for screening."

Direct RCT evidence about screening is often unavailable, so the Task Force considers indirect evidence. To guide its selection of indirect evidence, the Task Force constructs a "chain of evidence" within an analytic framework. For each key question, the body of pertinent literature is critically appraised, focusing on the following 6 questions:

1. Do the studies have the appropriate research design to answer the key question(s)?
2. To what extent are the existing studies of high quality? (i.e., what is the internal validity?)
3. To what extent are the results of the studies generalizable to the general U.S. primary care population and situation? (i.e., what is the external validity?)
4. How many studies have been conducted that address the key question(s)? How large are the studies? (i.e., what is the precision of the evidence?)
5. How consistent are the results of the studies?
6. Are there additional factors that assist us in drawing conclusions (e.g., presence or absence of dose–response effects, fit within a biologic model)?

The next step in the Task Force process is to use the evidence from the key questions to assess whether there would be net benefit if the service were implemented. In 2001, the USPSTF published an article that documented its systematic processes of evidence evaluation and recommendation development. At that time, the Task Force's overall assessment of evidence was described as good, fair, or poor. The Task Force realized that this rating seemed to apply only to how well studies were conducted and did not fully capture all of the issues that go into an overall assessment of the evidence about net benefit. To avoid confusion, the USPSTF has changed its terminology. Whereas individual study quality will continue to be characterized as good, fair, or poor, the term certainty will now be used to describe the Task Force's assessment of the overall body of evidence about net benefit of a preventive service and the likelihood that the assessment is correct. Certainty will be determined by considering all 6 questions listed above; the judgment about certainty will be described as high, moderate, or low.

In making its assessment of certainty about net benefit, the evaluation of the evidence from each key question plays a primary role. It is important to note that the Task Force makes recommendations for real-world medical practice in the United States and must determine to what extent the evidence for each key question—even evidence from screening RCTs or treatment RCTs—can be applied to the general primary care population. Frequently, studies are conducted in highly selected populations under special conditions. The Task Force must consider differences between the general primary care population and the populations studied in RCTs and make judgments about the likelihood of observing the same effect in actual practice.

It is also important to note that 1 of the key questions in the analytic framework refers to the potential harms of the preventive service. The Task Force considers the evidence about the benefits and harms of preventive services separately and equally. Data about harms are often obtained from observational studies because harms observed in RCTs may not be representative of those found in usual practice and because some harms are not completely measured and reported in RCTs.

Putting the body of evidence for all key questions together as a chain, the Task Force assesses the certainty of net benefit of a preventive service by asking the 6 major questions listed above. The Task Force would rate a body of convincing evidence about the benefits of a service that, for example, derives from several RCTs of screening in which the estimate of benefits can be generalized to the general primary care population as "high" certainty (see the "Rating Scheme for the Strength of Recommendations" field). The Task Force would rate a body of evidence that was not clearly applicable to general practice or has other defects in quality, research design, or consistency of studies as "moderate" certainty. Certainty is "low" when, for example, there are gaps in the evidence linking parts of the analytic framework, when evidence to determine the harms of treatment is unavailable, or when evidence about the benefits of treatment is insufficient. Table 4 in the methodology document listed below (see "Availability of Companion Documents" field) summarizes the current terminology used by the Task Force to describe the critical assessment of evidence at all 3 levels: individual studies, key questions, and overall certainty of net benefit of the preventive service.

Sawaya GF, et al. Update on the methods of the U.S. Preventive Services Task Force: estimating certainty and magnitude of net benefit. Ann Intern Med. 2007;147:871-875 [5 references].

What the United States Preventive Services Task Force (USPSTF) Grades Mean and Suggestions for Practice

USPSTF Levels of Certainty Regarding Net Benefit

Definition: The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.

A formal cost analysis was not performed and published cost analyses were not reviewed.

Comparison with Guidelines from Other Groups
External Peer Review
Internal Peer Review

Peer Review. Before the U.S. Preventive Services Task Force (USPSTF) makes its final determinations about recommendations on a given preventive service, the Evidence-based Practice Center (EPC) and the Agency for Healthcare Research and Quality (AHRQ) send a draft systematic evidence review to 4 to 6 external experts and to federal agencies and professional and disease-based health organizations with interests in the topic. They ask the experts to examine the review critically for accuracy and completeness and to respond to a series of specific questions about the document. After assembling these external review comments and documenting the proposed response to key comments, the topic team presents this information to the Task Force in memo form. In this way, the Task Force can consider these external comments before it votes on its recommendations about the service. Draft recommendations are then circulated for comment from reviewers representing professional societies, voluntary organizations, and federal agencies. These comments are discussed before the whole U.S. Preventive Services Task Force before final recommendations are confirmed.

Recommendations of Others. Recommendations regarding behavioral counseling to prevent sexually transmitted infections were considered from the following groups: the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG), and the American Medical Association (AMA).

The US Preventive Services Task Force (USPSTF) grades its recommendations (A, B, C, D, or I) and identifies the Levels of Certainty regarding Net Benefit (High, Moderate, and Low). The definitions of these grades can be found at the end of the "Major Recommendations" field.

Summary of Recommendations and Evidence

The USPSTF recommends high-intensity behavioral counseling to prevent sexually transmitted infections (STIs) for all sexually active adolescents and for adults at increased risk for STIs. This is a grade B recommendation.

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of behavioral counseling to prevent STIs in non–sexually-active adolescents and in adults not at increased risk for STIs. This is an I statement.

Clinical Considerations

Patient Population under Consideration

This recommendation applies to all sexually active adolescents and adults.

Assessment of Risk

All sexually active adolescents are at increased risk for STIs and should be offered counseling. Adults with current STIs or infections within the past year are at increased risk for future STIs. In addition, adults who have multiple current sexual partners should be considered at increased risk and offered counseling to prevent STIs. Married adolescents may be considered for counseling if they meet the criteria described for adults. Clinicians should also consider the communities they serve. If the practice's population has a high rate of STIs, all sexually active patients in nonmonogamous relationships may be considered to be at increased risk.

Effective Behavioral Counseling Interventions

Among the studies reviewed, successful high-intensity interventions were delivered through multiple sessions, most often in groups, with total durations from 3 to 9 hours. Little evidence suggests that single-session interventions or interventions lasting less than 30 minutes were effective in reducing STIs. Although 2 studies of moderate-intensity interventions did not demonstrate effect, a third study demonstrated that two 20-minute counseling sessions before and after human immunodeficiency virus (HIV) testing resulted in a clinically and statistically significant reduction in STIs. The USPSTF found no studies of abstinence-only counseling programs delivered in the clinical setting.

Suggestions for Practice Regarding the I Statement

Because of the lower incidence of STIs among adults who are not at increased risk, the potential net benefit of behavioral counseling is likely to be smaller for this population than for those at increased risk. Given the current lack of evidence of effectiveness; the substantial costs in time and money for clinicians, patients, and the health system; and the potential missed opportunity for the provision of higher-priority, evidence-based preventive services, primary care clinicians should consider not routinely offering behavioral counseling to prevent STIs to adults who are not at increased risk for infection. The USPSTF found limited evidence on the counseling of non–sexually-active adolescents, with no effect or harms from brief counseling in 1 small study. Although clinicians may not be able to identify all adolescents who are sexually active, intensive counseling for all adolescents to reach those who are not appropriately identified as at risk is not supported by current evidence and would require significant resources. The effectiveness of less intensive counseling has not been established and the benefits of intensive counseling for adolescents who are identified as at risk may not be generalizable to those who deny sexual activity.

Definitions:

What the United States Preventive Services Task Force (USPSTF) Grades Mean and Suggestions for Practice

USPSTF Levels of Certainty Regarding Net Benefit

Definition: The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.

None available

The type of supporting evidence is not specifically stated for each recommendation.

Effectiveness of Counseling to Change Behavior

• There is convincing evidence that high-intensity behavioral counseling interventions targeted to sexually active adolescents and adults at increased risk for sexually transmitted infections (STIs) reduce the incidence of STIs. These results were found 6 and 12 months after counseling took place.
• The U.S. Preventive Services Task Force (USPSTF) has identified the absence of studies and evidence on behavioral counseling interventions directed towards adults not at increased risk for STIs and non–sexually-active adolescents as a critical gap in the literature.

Harms of Counseling

No evidence of significant behavioral or biological harms resulting from behavioral counseling about risk reduction has been found. The U.S. Preventive Services Task Force (USPSTF) concluded that the potential harms of counseling are no greater than small.

• The U.S. Preventive Services Task Force (USPSTF) makes recommendations about preventive care services for patients without recognized signs or symptoms of the target condition.
• Recommendations are based on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit of the service.
• The USPSTF recognizes that clinical or policy decisions involve more considerations than this body of evidence alone. Clinicians and policy-makers should understand the evidence but individualize decision making to the specific patient or situation.

Staying Healthy

Effectiveness
Patient-centeredness

Not applicable: The guideline was not adapted from another source.

1996 (revised 2008 Oct)

United States Preventive Services Task Force - Independent Expert Panel

The U.S. Preventive Services Task Force (USPSTF) is a federally-appointed panel of independent experts. Conclusions of the U.S. Preventive Services Task Force do not necessarily reflect policy of the U.S. Department of Health and Human Services (DHHS) or its agencies.

United States Government

U.S. Preventive Services Task Force (USPSTF)

The U.S. Preventive Services Task Force has an explicit policy concerning conflict of interest. All members disclose at each meeting if they have a significant financial, professional/business, or intellectual conflict for each topic being discussed. Task Force members with conflicts may be recused from discussing or voting on recommendations about the topic in question.

This is the current release of the guideline.

This release updates a previously published guideline: U.S. Preventive Services Task Force. Guide to clinical preventive services. 2nd ed. Baltimore (MD): Williams & Wilkins; 1996. Chapter 62, Counseling to prevent HIV infection and other sexually transmitted diseases. p. 723-37. [111 references]

This summary was completed by ECRI on June 30, 1998. The information was verified by the guideline developer on December 1, 1998. This summary was updated by ECRI Institute on September 23, 2008. The updated information was verified by the guideline developer on October 10, 2008.