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Draft Recommendation Statement


Note: This draft Recommendation Statement is not the final recommendation of the U.S. Preventive Services Task Force. This draft is distributed solely for the purpose of pre-release review. It has not been disseminated otherwise by the USPSTF. It does not represent and should not be interpreted to represent a USPSTF determination or policy.

This draft Recommendation Statement is based on an Evidence Report that is also available for public comment. To read the accompanying draft Evidence Report on Behavioral Counseling Interventions to Prevent Sexually Transmitted Infections and provide comments, go to http://www.uspreventiveservicestaskforce.org/draftrep3.htm.

The USPSTF makes recommendations about the effectiveness of specific clinical preventive services for patients without related signs or symptoms.

It bases its recommendations on the evidence of both the benefits and harms of the service, and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.

The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.

This draft Recommendation Statement is available for comment from April 29 until May 26, 2014, at 5:00 PM ET. You may wish to read the entire Recommendation Statement before you comment. A fact sheet that explains the draft recommendations in plain language is available here.


Behavioral Counseling Interventions to Prevent Sexually Transmitted Infections: U.S. Preventive Services Task Force Recommendation Statement
DRAFT

Summary of Recommendation and Evidence

The U.S. Preventive Services Task Force (USPSTF) recommends intensive behavioral counseling for all sexually active adolescents and adults at increased risk for sexually transmitted infections (STIs).

This is a B recommendation.

See the Clinical Considerations section for a description of high-risk populations.

Table 1 describes the USPSTF grades, and Table 2 describes the USPSTF classification of levels of certainty about net benefit.

Rationale

Importance

The Centers for Disease Control and Prevention (CDC) estimate that approximately 20 million new cases of STIs occur each year in the United States. Half of these cases occur in persons ages 15 to 24 years. These STIs are frequently asymptomatic, leading to unwitting transmission to others. Serious sequelae of STIs include pelvic inflammatory disease, infertility, and cancer. Consequences to infants when an untreated STI is present during pregnancy or birth may include perinatal infection, death, and serious physical and mental disabilities. Despite the seriousness and prevalence of STIs, primary care physicians often do not provide counseling regarding sexual activity, contraception, or STIs during routine periodic health examinations or other health care visits, and many clinicians believe that counseling is ineffective.

Recognition of Behavior

Primary care clinicians can identify adolescents and adults who are at increased risk for STIs (see the Clinical Considerations for more information).

Benefits of Behavioral Counseling Interventions

The USPSTF found adequate evidence that intensive behavioral counseling interventions reduce the likelihood of STIs in sexually active adolescents and adults at increased risk. The USPSTF determined that this benefit is of moderate magnitude. The USPSTF also found adequate evidence that intensive interventions reduce risky sexual behaviors and increase the likelihood of condom use and other protective sexual practices.

Harms of Behavioral Counseling Interventions

The USPSTF found adequate evidence that the harms of behavioral interventions to reduce the likelihood of STIs are at most small. The primary harm is the opportunity cost associated with intensive behavioral counseling interventions.

USPSTF Assessment

The USPSTF concludes with moderate certainty that intensive behavioral counseling interventions reduce the likelihood of STIs in sexually active adolescents and adults at increased risk, resulting in a moderate net benefit.

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 counseled. Other risk groups that have been included in counseling studies include adults with current STIs or infections within the past year, adults who have multiple current sexual partners, and adults who do not consistently use condoms.

Clinicians should be aware of populations with a particularly high prevalence of STIs. African Americans have the highest STI prevalence of any racial/ethnic group, and STI prevalence is higher in American Indians/Alaska Natives and Latinos than in whites. Increased STI prevalence rates are also found in men who have sex with men, persons with low income living in urban settings, current or former inmates, military recruits, persons who exchange sex for money or drugs, persons with mental illness or a disability, current or former intravenous drug users, persons with a history of sexual abuse, and patients at public STI clinics.

Behavioral Counseling Interventions

The USPSTF concluded that interventions of increasing intensity generally had increasing evidence of benefit; high-intensity counseling interventions (contact time of >2 hours) were the most effective, moderate-intensity interventions (30 to 120 minutes) were less consistently beneficial, and low-intensity interventions (<30 minutes) were least likely to be effective.

Most successful approaches provided basic information about STIs and STI transmission, assessed the individual's risk for transmission, and provided training in pertinent skills such as condom use, communication about safe sex, problem solving, and goal setting. Many successful interventions used a targeted approach to the age, sex, and ethnicity of the participants and also aimed to increase motivation or commitment to safe sex practices. Interventions were delivered by the primary care provider or trained behavioral counselors. Intervention methods included face-to-face counseling, videos, written materials, and telephone support.

Additional Approaches to Prevention

The CDC provides information about STI prevention, testing, and resources (available at http://www.cdc.gov/std/prevention/default.htm). It recommends that health care providers inform patients on how to reduce their risk for STI transmission, including abstinence, correct and consistent condom use, and limiting the number of sex partners.

The CDC also maintains an inventory of effective interventions for HIV risk reduction, including more than 25 behavioral interventions tailored for different patient populations (available at https://www.effectiveinterventions.org/en/Home.aspx).

The Community Preventive Services Task Force has issued several recommendations on the prevention of HIV/AIDS, other STIs, and teen pregnancy (available at http://www.thecommunityguide.org/hiv/index.html).

The CDC's Advisory Committee on Immunization Practices has issued recommendations on the control of vaccine-preventable diseases, including hepatitis B and human papillomavirus (available at http://www.cdc.gov/vaccines/hcp/acip-recs/index.html).

Useful Resources

The USPSTF has issued a number of recommendations related to screening for STIs, including screening for chlamydia, gonorrhea, hepatitis B, genital herpes, HIV, and syphilis. These recommendations can be found at http://www.uspreventiveservicestaskforce.org.

Other Considerations

Implementation

Intensive behavioral counseling may be delivered in primary care settings or in other sectors of the health care system after referral from the primary care clinician or system. In addition, risk-reduction counseling may be offered by community organizations, schools, or health departments. Strong linkages between the primary care setting and the community may greatly improve the delivery of this service.

Research Needs and Gaps

Most of the identified studies were in high-risk populations of adults or sexually active girls. Research is needed on interventions to reduce the risk for STIs in sexually active boys, as well as interventions to prevent STIs in younger adolescents who are not yet sexually active. Another research gap is the effectiveness of low-intensity interventions that are more practical in the typical primary care setting; promising approaches have been identified that need replication.

Discussion

Burden of Disease

According to the CDC, approximately 20 million new cases of STIs occur each year in the United States, and half of these cases occur in persons ages 15 to 24 years (1). A recent nationally representative survey found that in females ages 14 to 19 years, STI prevalence (not including HIV) was 24.1% overall and 37.7% among those who were sexually active (2). In 2010, the inflation-adjusted annual direct medical costs of STIs (including HIV) were an estimated $16.9 billion in the United States (3). According to the CDC, STI incidence rates are consistently eight or more times higher in African Americans than whites (4), and African American youth accounted for 57% of all new HIV infections among persons ages 13 to 24 years in 2009 (5).

Scope of Review

The USPSTF commissioned a systematic review (6, 7) of the benefits and harms of behavioral counseling interventions on sexual risk reduction in primary care to prevent STIs in adolescents and adults in order to update its 2008 recommendation. The review included randomized, controlled trials (RCTs) and nonrandomized, controlled clinical trials of interventions targeting risky sexual behaviors to prevent STIs (alone or in combination with other behaviors) in adults and adolescents (including pregnant women) of any sexual orientation or level of reported sexual activity.

The review included studies that were conducted in or recruited from primary care, mental health clinics, reproductive health clinics (including STI clinics), or broader health care systems in developed countries. Included studies reported health outcomes (STI incidence or related morbidity), behavioral outcomes (changes in sexual behavior), or adverse effects of sexual risk reduction counseling (e.g., care avoidance, shame, guilt, or stigma). For all outcomes except harms, included studies had to have at least 3 months postbaseline followup.

High-, moderate-, and low-intensity interventions were defined as having contact time of more than 2 hours, 30 minutes up to 2 hours, and less than 30 minutes, respectively.

Effectiveness of Counseling to Change Outcomes and Behavior

In adolescents, seven trials (8–14) with eight treatment arms (n=3,407) reported STI outcomes. STI incidence was reduced in all eight comparisons, although results were not statistically significant in two trials. Pooled results showed a 62% reduction in the odds of contracting an STI with high-intensity counseling after 12 months (odds ratio [OR], 0.38 [95% CI, 0.24 to 0.60]; I2=65%; k=5) and a 43% reduction in the odds of an STI with the two moderate-intensity interventions (OR, 0.57 [95% CI, 0.37 to 0.86]; I2=0%). In all of the trials, the majority of participants were not white, and most were limited to females.

In adolescents, six trials (8, 11, 12, 14–16) (n=3,030) reported a sexual behavioral outcome. Interventions yielded benefit in three of five trials that reported effects on condom use or unprotected sex and four of five trials that reported other sexual behavior outcomes (e.g., number of sexual partners or use of birth control).

In adults, 19 trials (9, 10, 14, 17–32) (n=61,909) reported STI outcomes, four of which had multiple treatment arms with varying intervention intensity. High-intensity interventions resulted in a 30% reduction in the odds of contracting an STI (OR, 0.70 [95% CI, 0.56 to 0.87]; I2=23%; k=9). The pooled effects for low- and moderate-intensity trials did not show a reduction in the odds of contracting an STI. Two low- and two moderate-intensity interventions, however, did prove effective in preventing STIs (20, 21). For example, one large (n=40,282) good-quality RCT (20) created a 23-minute video, “Safe in the City,” that participants watched in the waiting rooms of STI clinics. The video covered basic information on HIV/STI risk and prevention and attempted to build condom use skills, self-efficacy for condom use, and a positive attitude toward condom use. Vignettes of young couples of various races/ethnicities and sexual orientations demonstrated communication about partner notification and the acquisition, negotiation, and use of condoms. This trial found a small but statistically significant reduction in the proportion of participants with an STI. After an average of almost 15 months, 4.9% of intervention participants had an STI compared with 5.7% of control group participants (adjusted hazard ratio [HR], 0.91 [95% CI, 0.84 to 0.99]; unadjusted OR, 0.85 [95% CI, 0.73 to 0.99]), or a number needed to treat of 123 (95% CI, 68 to 1,859). Planned subgroup analyses, however, revealed that the effect was statistically significant for men (adjusted HR, 0.88 [95% CI, 0.80 to 0.98]) but not women (adjusted HR, 1.02 [95% CI, 0.86 to 1.21]).

In adults, 21 trials reporting behavioral outcomes yielded mixed results, but high-intensity interventions were fairly consistent in reporting beneficial results. In a meta-analysis of nine trials (with 11 comparisons) (10, 17, 19, 25, 27, 32–35) reporting condom use or related outcomes, the odds of condom use increased by 29% with high-intensity interventions (OR, 1.29 [95% CI, 1.13 to 1.48]; I2=0%; k=4) and by 21% with moderate-intensity interventions (OR, 1.21 [95% CI, 1.00 to 1.46]; I2=28%; k=4).

The evidence review evaluated variations in treatment effect for different population characteristics. Trials and subgroup analyses targeting adolescents were highly likely to be effective, with most showing reductions of at least 50% in the odds of contracting an STI after behavioral counseling. There was no consistent evidence of differential effectiveness by sex or race/ethnicity. There was also no evidence of differential effectiveness associated with sexual orientation, low-income setting, mental illness, or history of abuse; however, these groups were poorly represented in the available studies.

The evidence review also evaluated the effects of different intervention characteristics. Intensity was the most important factor; high-intensity interventions were most likely to be effective, moderate-intensity interventions were less consistently beneficial, and low-intensity interventions were least likely to be effective. Pooled effect estimates were similar for trials with a single session and those with more than one session.

Although most trials of low-intensity interventions did not show treatment benefit, two low-intensity trials effectively reduced the odds of contracting an STI: one very large trial of a video-based intervention, which was powered to detect a small effect (described above) (20), and the low-intensity arm of a trial of African American women (21). In the latter trial, the intervention included a 20-minute individualized and culturally sensitive counseling session with trained African American nurse educators. In this trial, STIs were lower in both of the skill-based intervention groups at 12 months (14% [high-intensity] and 15% [low-intensity]) than in the control group (27%). The two skill-based intervention groups were not statistically different from the two information-based intervention groups (19% [high-intensity] vs. 22% [low-intensity]).

Potential Harms of Counseling

Two fair-quality studies (18, 30) and one good-quality trial (24) explicitly reported no adverse effects (n=6,837). There were no statistically significant paradoxical effects in the incidence of STIs, except for a single trial of men who have sex with men (24). There was no consistent evidence that interventions increased sexual activity in adolescents.

Estimate of Magnitude of Net Benefit

The USPSTF concludes with moderate certainty that intensive behavioral counseling interventions reduce the likelihood of STIs in sexually active adolescents and adults at high risk, resulting in a moderate net benefit.

Update of Previous USPSTF Recommendation

In 2008, the USPSTF recommended high-intensity behavioral counseling to prevent STIs for all sexually active adolescents and for adults at increased risk for STIs (B recommendation). At that time, the USPSTF also found the evidence insufficient to assess the balance of benefits and harms of behavioral counseling to prevent STIs in nonsexually-active adolescents and in adults not at increased risk for STIs (I statement). This updated recommendation reaffirms that the evidence is adequate to recommend high-intensity behavioral counseling for persons at increased risk (including all sexually active adolescents), but recognizes that some interventions of lesser intensity are also effective.

Recommendations of Others

The CDC recommends that all providers routinely obtain a sexual history from their patients and encourage risk reduction using various strategies (e.g., prevention counseling) (36). It also recommends that HIV prevention counseling be offered and encouraged in all health care facilities that serve patients at high risk (e.g., STI clinics) (37).

The American College of Obstetricians and Gynecologists recommends discussing contraception and STIs during the initial reproductive health visit for adolescent patients (38). It also recognizes that the annual well-woman visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks; the visit should include screening, evaluation and counseling, and immunizations based on the patient's age and risk factors (39). In addition, applying principles of motivational interviewing (e.g., prompting patients to use safe sex practices and to use contraception more consistently) to daily patient practices has proved effective in eliciting behavior change that contributes to positive health outcomes and improved patient-physician communication (40). Comprehensive care, including prevention of STIs, is recommended for lesbian and bisexual patients (41); education about the risks for STIs and dispelling the perception that STI transmission between women is negligible will help these patients make informed decisions. All patients should be encouraged to use safe sex practices to reduce the risk for transmitting or acquiring STIs and HIV, such as using condoms on sex toys, gloves, and dental dams, as well as avoidance of sharing other sex paraphernalia (41). Several approaches (e.g., gender-tailored and culturally appropriate interventions to reduce risk-taking behavior) can reduce the rate of HIV infection and optimize health in women of color (42). Practitioners should provide risk reduction counseling to prevent STIs in women participating in noncoital activities (e.g., mutual masturbation or anal sex) (43).

The American Academy of Family Physicians is currently updating its recommendation.

According to the Institute for Clinical Systems Improvement, counseling on sexual behaviors to prevent STIs could be recommended beginning at age 12 years (44) and for higher-risk adults (45). The National Institute for Health and Clinical Excellence recommends one-to-one structured discussions with patients who are identified as high risk for STIs (if the health professional is trained in sexual health) or arranging for these discussions to take place with a trained practitioner (46). When appropriate, practitioners should provide one-to-one sexual advice on how to prevent and/or get tested for STIs to vulnerable young persons younger than age 18 years,including pregnant women and mothers.

Table 1: What the Grades Mean and Suggestions for Practice

Grade Definition Suggestions for Practice
A The USPSTF recommends the service. There is high certainty that the net benefit is substantial. Offer or provide this service.
B The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Offer or provide this service.
C The USPSTF recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small. Offer or provide this service for selected patients depending on individual circumstances.
D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service.
I Statement The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. Read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.


Table 2: Levels of Certainty Regarding Net Benefit

Level of Certainty* Description
High The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.
Moderate The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by factors such as:
  • The number, size, or quality of individual studies.
  • Inconsistency of findings across individual studies.
  • Limited generalizability of findings to routine primary care practice.
  • Lack of coherence in the chain of evidence.

As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.

Low The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
  • The limited number or size of studies.
  • Important flaws in study design or methods.
  • Inconsistency of findings across individual studies.
  • Gaps in the chain of evidence.
  • Findings not generalizable to routine primary care practice.
  • A lack of information on important health outcomes.

More information may allow an estimation of effects on health outcomes.

*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.

References

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35. Cianelli R, Ferrer L, Norr KF, Miner S, Irarrazabal L, Bernales M, et al. Mano a Mano-Mujer: an effective HIV prevention intervention for Chilean women. Health Care Women Int. 2012;33(4):321-41.
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44. Wilkinson J, Bass C, Diem S, Gravley A, Harvey L, Maciosek M, et al; Institute for Clinical Systems Improvement. Preventive Services for Children and Adolescents. Bloomington, MN: Institute for Clinical Systems Improvement; 2013.
45. Wilkinson J, Bass C, Diem S, Gravley A, Harvey L, Maciosek M, et al; Institute for Clinical Systems Improvement. Preventive Services for Adults. Bloomington, MN: Institute for Clinical Systems Improvement; 2013.
46. National Institute for Health and Clinical Excellence. One to One Interventions to Reduce the Transmission of Sexually Transmitted Infections (STIs) Including HIV, and to Reduce the Rate of Under 18 Conceptions, Especially Among Vulnerable and at Risk Groups. London: National Institute for Health and Clinical Excellence; 2007.

AHRQ Publication No. 13-05180-EF-2
Current as of April 2014


Internet Citation:

U.S. Preventive Services Task Force. Behavioral Counseling Interventions to Prevent Sexually Transmitted Infections: Draft Recommendation Statement. AHRQ Publication No. 13-05180-EF-2. http://www.uspreventiveservicestaskforce.org/draftrec3.htm



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