Behavioral Counseling to Prevent Sexually Transmitted Infections

A Systematic Review for the U.S. Preventive Service Task Force

October 2008

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Prepared by Jennifer S. Lin, MD, MCR; Evelyn Whitlock, MD, MPH; Elizabeth O'Connor, PhD; and Vance Bauer, MA.

Corresponding Author: Jennifer S. Lin, MD, MCR, Center for Health Research, Kaiser Permanente Northwest, 3800 North Interstate Avenue, Portland, Oregon 97227; E-mail, jennifer.s.lin@kpchr.org.

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This study was conducted by the Oregon Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality, Rockville, Maryland (contract no. 290-02-0024, task order 1). It was also supported by the Oregon Clinical and Translational Research Institute (grant no. UL1 RR024140) from the National Center for Research Resources, National Institutes of Health.

The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.

This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

This report was first published in Annals of Internal Medicine in September 2008 (Ann Intern Med 2008;149:497-508; http://www.annals.org).

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Contents

Abstract
Introduction
Methods
Results
Discussion
Conclusion
References

Abstract

Background: Despite advances in prevention and treatment, sexually transmitted infections (STIs) remain an important cause of morbidity and mortality in the United States.

Purpose: To systematically review the evidence for behavioral counseling interventions to prevent STIs in adolescents and adults (nonpregnant and pregnant).

Data Sources: English-language articles in MEDLINE, PsycINFO, Centers for Disease Control and Prevention's Prevention Synthesis Research Project database, and Cochrane databases (1988 through December 2007), supplemented with expert recommendations and the bibliographies of previous systematic reviews.

Study Selection: Reviewers included 21 articles representing 15 fair- or good-quality randomized, controlled trials that evaluated behavioral counseling interventions feasible in primary care and 1 fair-quality and 1 good-quality controlled trial with study samples representative of primary care populations in English-speaking countries. Comparative effectiveness trials that did not include a true control group were excluded.

Data Extraction: Investigators abstracted, critically appraised, and synthesized 21 articles that met inclusion criteria.

Data Synthesis: Most evidence suggests a modest reduction in STIs at 12 months among high-risk adults receiving multiple intervention sessions and among sexually active adolescents. Evidence also suggested that these interventions increase adherence to treatment recommendations for women in STI clinics and general contraception use in male adolescents and decrease nonsexual risky behavior and pregnancy in sexually active female adolescents. No evidence of substantial behavioral or biological harms for risk reduction counseling was found.

Limitation: Significant clinical heterogeneity in study populations, interventions, and measurement of outcomes limited the reviewers' ability to meta-analyze trial results and to suggest important intervention components.

Conclusion: Good-quality evidence suggests that behavioral counseling interventions with multiple sessions conducted in STI clinics and primary care effectively reduces STI incidence in “at-risk” adult and adolescent populations. Additional trial evidence is needed for both lower-intensity behavioral counseling interventions and lower-risk patient populations.

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Introduction

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 exceed 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 burden—the 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.^5-7 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 digit–dialing telephone survey of low-income adolescents, only 50% re-ported 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 methods¹¹, we developed an analytic framework (Figure 1) that included 5 updated questions to guide the current systematic review:

1. Is there direct evidence that primary care counseling to reduce risky sexual behavior can reduce STI incidence or related morbidity and mortality?
2. Does primary care behavioral counseling to prevent STI result in safer sexual behaviors among those counseled?
3. Does primary care behavioral counseling to prevent STI result in benefits other than safer sexual behaviors and reductions in STI incidence?
4. Are there harms from primary care behavioral counseling to prevent STI?
5. Do sexual behavior changes lead to a reduced incidence of STI or related morbidity and mortality?

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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

Study Characteristic	Inclusion Criteria	Exclusion Criteria
Clinical conditions	Sexual transmission of bacteria or virus (e.g., HIV, hepatitis B and C, herpes simplex virus, human papillomavirus, chlamydia, gonorrhea, syphilis, and trichomonas)	Other modes of transmission for bloodborne STIs (e.g., maternal–fetal transmission, transfusions, inadvertent needlesticks, and sharing needles or injection equipment)
Study design	English-language RCTs and non-RCTs; control group with no intervention (e.g., wait-list control, usual care), minimal intervention (e.g., usual care limited to no more than 15 min of information), or attention control (e.g., similar format and intensity intervention on a different content area)	Comparative effectiveness trials without a control group; all observational studies
Population	Adults (pregnant and nonpregnant); adolescents (sexually active and pre-sexually active)	Persons with HIV
Setting	Primary care settings (e.g., pediatric, OB/GYN, internal medicine, family practice, family planning, military, adolescent and school-based health clinics) Specialty clinics (e.g., STI, genitourinary clinics, HIV testing sites, mental health clinics) considered because of limited trials in primary care	Correctional facilities, school-based programs, substance abuse treatment facilities, HIV clinics, and inpatient hospital units Nonindustrialized countries, as defined by the UN Human Development Index
Intervention	Conducted in primary care Judged to be feasible in primary care: a) involve individual-level identification; b) usually involve primary care staff, or the intervention will be seen as connected to the health care system by the participant; c) delivered to individuals or small groups; d) group-level interventions generally do not involve > 8 group sessions and the intervention period is no longer than 12 mo Referable from primary care: conducted as part of a health care setting, or be widely available in the community at a national level	Community-based programs (e.g., worksite programs, school programs); social marketing interventions (e.g., media campaigns); policy-level interventions (e.g., local and state public or health policy)
Outcomes	Minimum of a 3-mo outcome assessment of biological (laboratory-tested or self-reported) or self-reported behavioral outcomes	Self-reported measures of attitude, knowledge, beliefs, ability, and self-efficacy

OB/GYN = obstetrics/gynecology; RCT = randomized, controlled trial; STI = sexually transmitted infection; UN = United Nations.

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 using the USPSTF's study design–specific 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.

Data Synthesis

Because of the heterogeneity in study populations, settings, interventions, and outcomes, we did not attempt quantitative synthesis of study results, but report here 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.

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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).^13-20 Only 3 randomized, controlled trials (RCTs) were conducted in a primary care setting.^13-14,20 Five trials included only women.^13-16,20 All trial populations, except for one¹⁴, 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).

Most evidence (5 RCTs; n = 8122) suggest a modest reduction in bacterial STI at 12 months among high-risk adults receiving moderate- to high-intensity counseling interventions.^13,15-17,19 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, likely 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, Challenge, Tell), by Kamb and colleagues (n = 5758)¹⁷, showed that individuals receiving either moderate- or high-intensity individual HIV counseling with testing, compared with usual care with 10-minute education, had fewer incident bacterial or viral STIs (11.5% to 12.0% vs. 14.6%, respectively).¹⁷ The moderate-intensity and high-intensity counseling interventions did not seem to have a difference in effect. However, Project RESPECT, otherwise a well-done RCT, had only 70% follow-up at 6 months and 66% follow-up at 12 months. In the remaining trial (n = 408) showing a treatment benefit, psychiatric clinic outpatients who received very-high-intensity group counseling (10 sessions) had a lower incidence of any self-reported STI at 6 months than did those receiving similarly formatted substance abuse counseling.¹⁹ However, this trial used self-reported, as opposed to laboratory or clinically diagnosed, STI.

In contrast, 3 treatment trials—1 trial in high-risk persons attending an STI clinic and 2 trials in primary care patients—showed no benefit. A fair-quality trial by Boyer and colleagues¹⁸ conducted in an STI clinic (n = 393) did not show a reduction in incident bacterial or viral STI at 6 months in participants receiving high-intensity individual counseling; however, this trial had a shorter duration and suboptimal follow-up (70% at 6 months). Two fair-quality trials in young women attending primary care clinics showed no statistically significant difference in self-reported or laboratory-tested STIs.^14,21 In both trials, the women had relatively low rates of STI outcomes, and 1 of the trials, by Scholes and colleagues²⁰, used self-reported outcomes and a shorter duration of follow-up. Thus, all 3 of these trials had limitations in study design that may have limited their ability to detect statistically significant differences in STI incidence.

Adolescents

We identified 4 fair- or good-quality RCTs that examined the effect of behavioral counseling interventions on reducing STI incidence explicitly in adolescents, one of which is an a priori subgroup analysis from Project RESPECT (Table 2).^17,21-23 Three of the 4 trials included only sexually active adolescents ^17,22-23, and 1 included both sexually active and pre–sexually active adolescents (age 12 to 15 years).²¹ Interventions ranged from low to high intensity and from 1 to 4 sessions and were in either an individual or a small-group format.

Most evidence (3 RCTs; n = 1998) showed a modest reduction in STI incidence at 12 months in sexually active adolescents receiving moderate- to high-intensity counseling. Two of these trials were exclusively in adolescent girls receiving high-intensity group counseling.^22-23 In a subgroup analysis of participants younger than age 20 years from Project RESPECT (n = 764), those receiving HIV counseling and testing had lower rates of STIs at 12 months than did those receiving usual care (approximately 17% to 18% vs. 26.6%, respectively).²⁴

We found only 1 fair-quality RCT that included pre–sexually active young adolescents (n = 219), in which a low-intensity counseling did not reduce the incidence of self-reported STI.²¹ This trial, by Boekeloo and colleagues²¹, was probably not powered to show a difference in STI incidence, given the small sample size, relatively short follow-up, and low percentages of incident STI.

Pregnant Women

We found no studies specifically addressing pregnant women that met our inclusion criteria. Project SAFE (Sexual Awareness for Everyone), which found a moderate reduction in incident gonorrhea and chlamydial infections at 12 months using a high-intensity group counseling intervention, included about 30% pregnant women. Their results, however, were not reported separately for this subgroup.¹⁶

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Key Question 2

Does primary care behavioral counseling to prevent STI result in safer sexual behaviors among those counseled?

Adults

We identified 3 fair- or good-quality trials that examined the effect of behavioral counseling interventions on reducing self-reported risky sexual behaviors or increasing protective sexual behaviors in adults, but did not report biological health outcomes (Appendix Table 1, available at www.annals.org).^25-27 All of these RCTs were conducted in primary care or equivalent clinic settings. Behavioral counseling interventions in these studies ranged from low intensity (brief single-session counseling) to high intensity (multiple-session counseling up to 18 hours).

Only 1 good-quality trial, by Ehrhardt and colleagues (n = 360)²⁵, showed a decrease in self-reported unprotected sexual intercourse and an 18% increase in self-reported condom use in women receiving an extremely intensive counseling intervention consisting of nine 2-hour group sessions.²⁵ These women attending the family planning clinic were at similar risk to those attending STI clinics (almost 60% with a history of an STI). Two fair-quality trials did not show a reduction in self-reported risky sexual behaviors (unprotected sexual intercourse or multiple sex partners) or an increase in consistent condom use.^26-27 An RCT in Australia (n = 312) by Proude and colleagues²⁶, evaluated a low-intensity physician-counseling intervention, but had limited follow-up (3 months). The other RCT (n = 370) conducted at a university health clinic did not show any changes in condom use or number of sex partners with moderate-intensity counseling, but also had relatively limited follow-up (6 months).²⁷

Measures of self-reported behavioral outcomes (for example, unprotected sexual intercourse, condom use, and number of sexual partners) and methods of data collection (for example, interview or questionnaire) varied among trials, further limiting comparisons across trials.

Adolescents

We identified 1 fair-quality trial that examined the effect of general safe sex counseling in primary care among high school–age male adolescents.²⁸ This trial did not show an increase in condom use or abstinence with a single 1-hour counseling intervention, compared with the waitlist control group.

Pregnant Women

We found no studies meeting our inclusion criteria that specifically addressed pregnant women.

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Key Question 3

Does primary care behavioral counseling to prevent STI result in benefits other than safer sexual behaviors and reductions in STI incidence?

In general, few studies reported on other behavioral or biological outcomes (for example, self-reported measures of reduction in other risky behaviors, or reduction in unwanted pregnancy or pregnancy in adolescents). For adults, we found evidence from Project SAFE (n = 617) that high-intensity behavioral counseling can increase adherence to treatment recommendations for women in an STI clinic setting.^15-16,25 For adolescents, we found evidence that moderate- to high-intensity behavioral counseling may decrease other risky behavior and pregnancy in sexually active female adolescents^19-20,22 and may increase general contraception use in male adolescents.^21-23,28 Jemmott and colleagues' study (n = 682) showed that a high-intensity group counseling intervention decreased the mean number of days of sex while intoxicated.²² DiClemente and associates' study conducted with adolescent black girls (n = 522) showed that a high-intensity group counseling intervention reduce self-reported pregnancy.²³ Boekeloo and colleagues' trial in young adolescents (n = 219) showed that a low-intensity counseling intervention may be able to reduce self-reported pregnancy, although the trial's results were not statistically significant.²¹ Danielson and colleagues (n = 1195) showed that a moderate-intensity individual intervention can increase general contraception among high school boys.²⁸

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Key Question 4

Are there harms from primary care behavioral counseling to prevent STI?

Adults

Overall, the 11 trials (n = 11 826) evaluating risk reduction counseling in adult populations did not show any increased incidence of STIs or self-reported risky behaviors, including increased unprotected sex or increased number of sexual partners (Appendix Table 1).^13-20,25-27 The 8 trials (n = 10 462) that reported biological outcomes did not show an increased incidence of STIs, either by self-report or laboratory testing.^13-20 Ten trials showed no evidence of self-reported increased unprotected sex (or decreased use of condoms).^{13-14,16-20,25-27} Six trials showed no evidence of self-reported increase in the number of sexual partners.

Adolescents

Overall, the 5 trials (n = 3382) evaluating risk reduction counseling in adolescents did not show an increased incidence of STIs or self-reported risk behaviors, including increased unprotected sex, increased number of sexual partners, or earlier sexual debut (Appendix Table 1).^21-23,28 The 4 trials (n = 2187) that reported on biological outcomes did not show any increased incidence of STIs, either by self-report or laboratory testing. Five trials did not show an increase in self-reported unprotected sex (or decrease in self-reported use of condoms). Two trials showed no increase in the participants' self-reported number of sexual partners.

Boekeloo and colleagues' trial (n = 219) showed a transient increase in self-reported vaginal sex at 3 months, but not at 9 months, in adolescents age 12 to 15 years.²¹ Self-reported overall sexual intercourse (vaginal, oral, or anal sex), however, did not increase.

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