Draft Recommendation Statement
Sexually Transmitted Infections: Behavioral Counseling
This opportunity for public comment expired on January 21, 2020 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Draft: Recommendation Summary
|Sexually active adolescents and adults at increased risk|
The USPSTF recommends behavioral counseling for all sexually active adolescents and for adults who are at increased risk for sexually transmitted infections (STIs).
See the “Practice Considerations” section for more information on populations at increased risk for acquiring STIs.
Bacterial and viral STIs are common in the United States. Approximately 20 million new cases of bacterial or viral STIs occur each year in the United States and about one half of these cases occur in persons ages 15 to 24 years.1, 2 Rates of chlamydial, gonococcal, and syphilis infection continue to rise in all regions.2 STIs are frequently asymptomatic, which may delay diagnosis and treatment and lead persons to unknowingly transmit STIs to others. Serious consequences of STIs include pelvic inflammatory disease, infertility, cancer, and AIDS. Untreated STIs that present during pregnancy or birth may cause harms to the mother and infant, including perinatal infection, serious physical and developmental disabilities, and rarely, death.3, 4
Draft: USPSTF Assessment of Magnitude of Net Benefit
The USPSTF concludes with moderate certainty that behavioral counseling interventions reduce the likelihood of acquiring STIs in sexually active adolescents and in adults at increased risk, resulting in a moderate net benefit.
Draft: Practice Considerations
Patient Population Under Consideration
This recommendation applies to all sexually active adolescents and to adults at increased risk for STIs.
Definition of STIs
STIs are transmitted through sexual activity and intimate physical contact. In the United States, common STIs with significant clinical and public health effects include HIV, herpes simplex virus (HSV), human papillomavirus (HPV), hepatitis B virus (HBV), Chlamydia trachomatis, Neisseria gonorrhea, Treponema pallidum (syphilis), and Trichomonas vaginalis.1-4
Assessment of Risk
All sexually active adolescents are at increased risk for STIs because of the high rates of STIs in this age group and should receive behavioral counseling interventions. Adults at increased risk for STIs include those who currently have an STI or were diagnosed with one within the past year, do not consistently use condoms, have multiple sex partners, or have sex partners within populations with a high prevalence of STIs. Populations with a high prevalence of STIs include persons who seek STI testing or attend STI clinics; gay, bisexual, and other men who have sex with men (collectively referred to as MSM); persons who are infected with HIV, inject drugs, have exchanged sex for money or drugs, or have entered correctional facilities; and some racial/ethnic minority groups.1-4
Behavioral Counseling Interventions
Intervention approaches include in-person counseling, videos, websites, written materials, telephone support, and text messages. Most successful approaches provide information on common STIs and STI transmission; assess the person’s risk for acquiring STIs; aim to increase motivation or commitment to safer sex practices; and provide training in condom use, communication about safer sex, problem solving, and other pertinent skills. Interventions that include group counseling and involve high total contact times (defined in the evidence review as more than 120 minutes), often delivered over multiple sessions, are associated with larger STI prevention effects. However, some less intensive interventions have been shown to reduce STI acquisition, increase condom use, or decrease number of sex partners. There is not enough evidence to determine whether several intervention characteristics were independently related to effectiveness, including degree of cultural tailoring, counselor characteristics, or setting.
Primary care clinicians can deliver in-person behavioral counseling interventions, refer patients to behavioral counseling interventions in other settings, or inform patients about media-based interventions. For more information about risk assessment methods and behavioral counseling interventions, see the “Additional Resources” section and Table 2.
Additional Tools and Resources
Several resources may help clinicians implement this recommendation:
- The CDC provides a tool for STI risk assessment suitable for primary care settings (https://www.cdc.gov/std/products/provider-pocket-guides.htm); provides information about behavioral counseling and other STI prevention strategies (https://www.cdc.gov/std/prevention); and maintains a compendium of evidence-based behavioral counseling interventions that have been shown to reduce STI acquisition or increase safer sexual behaviors (https://www.cdc.gov/hiv/research/interventionresearch/compendium/rr/complete.html).
- The Community Preventive Services Task Force has issued recommendations on preventing HIV, other STIs, and teenage pregnancy and has described effective individual- and group-level community interventions for school-age youth (https://www.thecommunityguide.org/findings/hivaids-other-stis-and-teen-pregnancy-group-based-comprehensive-risk-reduction-interventions) and for MSM (https://www.thecommunityguide.org/findings/hivaids-interventions-reduce-sexual-risk-behaviors-or-increase-protective-behaviors-prevent).
- The National Coalition of Sexually Transmitted Disease Directors and the National Alliance of State and Territorial AIDS Directors have developed optimal care checklists for providers serving MSM patients (http://www.ncsddc.org/wp-content/uploads/2017/08/provider_brochure2.pdf).
Other Related USPSTF Recommendations
The USPSTF has issued several recommendations about screening for STIs (chlamydia,6 gonorrhea,6 syphilis,7 HIV,8 HBV,9 and HPV10) and cervical cancer10 and offering preexposure prophylaxis to prevent HIV acquisition.11
Draft: Update of Previous USPSTF Recommendation
In 2014, the USPSTF recommended intensive behavioral counseling (defined as total contact time of 30 or more minutes) to prevent STIs for all sexually active adolescents and for adults at increased risk for STIs (B recommendation).12 This updated recommendation statement is consistent with, but slightly differs from, the 2014 USPSTF statement by recommending a broader range of effective counseling approaches, including those involving less than 30 minutes of total contact time. The USPSTF continues to conclude that the current evidence is lacking on the benefits and harms of behavioral counseling to prevent STIs in nonsexually active adolescents and in adults not at increased risk for STIs.
Draft: Supporting Evidence
Scope of Review
To update its 2014 recommendation, the USPSTF commissioned a systematic review of the benefits and harms of behavioral counseling interventions for preventing STI acquisition.13 The review included randomized and nonrandomized controlled trials in adolescents or adults of any sexual orientation, level of reported sexual activity, or pregnancy status that were published after 1999.
Benefits of Behavioral Counseling Interventions
Twenty trials assessed STI acquisition in persons at increased risk for STIs based on followup test results or diagnoses in medical records or public health registries at least 3 months after interventions started. Most reported STI outcomes after 12 or more months of followup. About one half of trials were conducted in, or recruited participants from, U.S. STI clinics. Other trials recruited participants from primary care, adolescent health, family planning, women’s health, or behavioral health clinics, mostly in the United States. A few trials recruited participants directly from the community. Nine of the trials enrolled members of populations with higher rates of STIs such as sexually active adolescents or young adults and persons who reported unprotected intercourse, sex with multiple concurrent sex partners, or other STI risk behaviors. Eleven trials enrolled persons classified as at “highest risk for STI” who had current, recent, or suspected STI diagnosis or were attending STI clinics. Most participants were younger than age 25 years, female, heterosexual, and reported African American or Hispanic race/ethnicity, and most trials specifically enrolled subpopulations defined by race/ethnicity, sexual orientation, age, gender, pregnancy, or other factors.
Many interventions used techniques or concepts from motivational interviewing, cognitive behavioral therapy, or other established behavioral counseling approaches that aimed to increase STI risk perception, knowledge, motivation, and skills for preventing STI acquisition; to increase consistent condom use; and to reduce unprotected intercourse and the number and concurrency of sex partners. Interventions for adolescents who were not yet sexually active aimed to delay sexual activity or encourage abstinence. Interventions were delivered in person and through computer, video, telephone, text message, or print formats over one or more sessions. Control conditions included usual care, attention controls, wait list, or minimal interventions (such as less than 15 minutes of STI information).
Behavioral counseling interventions were effective for reducing STI acquisition by approximately 30% based on pooled analysis of 19 trials in persons at increased risk for STIs, of which 10 enrolled persons at highest risk (n=52,072; odds ratio (OR), 0.66 [95% CI, 0.54 to 0.81]; I2=74%). STI prevention effects were stronger for interventions involving group counseling (8 trials; n=6,567; OR, 0.47 [95% CI, 0.28 to 0.78]; I2=75%) than for interventions without group counseling (11 trials; n=45,505; OR, 0.90 [95% CI, 0.74 to 1.08]; I2=43%) (p=0.02). Effects were also stronger for interventions with high total contact times (>120 minutes) (8 trials; n=3,974; OR, 0.46 [95% CI, 0.28 to 0.75; I2=65%) (p=0.02) than for interventions with moderate total contact times (30 to 120 minutes) (8 trials; n=9,072; OR, 0.90; [95% CI, 0.66 to 1.25] I2=59%) or low total contact times (<30 minutes) (4 trials; n=39,230; OR, 0.66 [95% CI, 0.36 to 1.24]; I2=44%). However, it was unclear whether group counseling format, contact time, or both were responsible for intervention effects because all but one group counseling intervention entailed more than 120 minutes.13
Although interventions with more than 120 minutes of contact time, group counseling, or both were generally more effective, three interventions with moderate14, 15 or low16 contact times and two interventions without group counseling15, 16 yielded statistically significant reductions in STI acquisition in STI clinic patients. One brief, video-based intervention without in-person counseling was tested in a nonrandomized controlled trial of 40,282 adults in STI clinic waiting rooms.16 Patients who viewed 23 minutes of information about HIV and STI prevention; how couples communicate about newly diagnosed STIs; building skills, self-efficacy, and positive attitudes about condom use; and how to acquire, negotiate, and use condoms were significantly less likely than patients receiving usual care to acquire STIs after a mean of 15 months of followup (adjusted hazard ratio, 0.91 [95% CI, 0.84 to 0.99]).
Meta-regression analysis revealed that intervention effects were stronger in trials limited to adolescents (3 trials; n=1,166; OR, 0.22 [95% CI, 0.02 to 2.30]; I2 =73%) than in trials not limited to adolescents (16 trials; n=50,906; OR, 0.78 [95% CI, 0.67 to 0.91]; I2 =51%). However, it was difficult to isolate specific effects because the most effective intervention format (interventions involving group counseling) was tested in trials with similar participant characteristics (girls and women who identified as racial/ethnic minorities), and only one trial of adolescents included boys.13
Thirty-four trials evaluated self-reported behavioral outcomes at least 3 months after interventions started in adolescents, young adults, or older adults, most of whom were at increased risk for STIs (30 trials). Intervention and participant characteristics were similar to those in trials that assessed STI outcomes. Behavioral counseling interventions were effective for increasing condom use, specifically dichotomous measures of consistent condom use or condom use at last sexual encounter (13 trials; n=5,253; OR, 1.31 [95% CI, 1.10 to 1.56]; I2=40%) and for decreasing unprotected intercourse based on number of sexual acts or days of intercourse without a condom (14 trials; n=9,183; mean difference, -0.94 [95% CI, -1.40 to -0.48]; I2=16%).13
Several trials found that interventions with high contact time were significantly associated with increased condom use or reductions in unprotected sex or the number of sex partners.13 Two interventions with moderate contact time were also significantly associated with increased condom use15, 17 or abstinence from vaginal sex.18 One intervention with low contact time that sent adolescents and young adults numerous emails with links to STI information and motivational content was significantly associated with a reduction in unprotected sex.19 Most of the eight trials that reported both STI acquisition and behavioral outcomes found that persons reporting more consistent condom use were less likely to acquire STIs.13
Four trials evaluated behavioral counseling interventions in adults or adolescents at average STI risk who were recruited without respect to individual STI risk factors from primary care clinics (3 trials) or through community advertising (1 trial).13 None reported significant effects on STI acquisition. One trial found a significant effect on self-reported sexual behavior in adolescents ages 11 to 14 years (of whom most were not yet sexually active) who enrolled with their mothers in a multisession, family therapy intervention that was endorsed by their physicians and aimed to reduce adolescent sexual activity. After 9 months of followup, adolescents in the intervention group were less likely to report vaginal intercourse than adolescents offered usual care (OR, 0.24 [95% CI, 0.11 to 0.55]).18
Harms of Behavioral Counseling Interventions
Seven of the trials that assess STI or behavioral outcomes (n = 3,458) also reported on potential harms of interventions in adolescents or adults at increased risk for STIs. None of these trials reported significant harms.13 There was no consistent evidence that interventions increased sexual activity in adolescents, unintended pregnancy, perceptions of shame or stigma, or mental health problems.
Draft: Research Needs and Gaps
- Most studies identified by the USPSTF enrolled girls, women, and men at increased risk for STI acquisition. More research is needed in sexually active boys; pregnant persons; gay, bisexual, or transgender persons; and older adults at increased risk; as well as in adolescents who are not yet sexually active. Research on interventions that engage couples or sex partners of primary care patients is also needed.
- Few trials incorporated sexual risk assessment performed by primary care providers and less than one half of trials assessed interventions delivered by physicians, nurses, psychologists, or other health professionals. Because many trials were conducted in STI clinics, research that is more applicable to general primary care populations would be valuable, such as trials that test interventions delivered or endorsed by primary care providers for patients who report increased STI risk based on well-defined risk assessment methods.
- Trials that follow participants longer than 12 months are needed to assess the durability of intervention effects.
- Research is needed to develop and test interventions that could extend group counseling to remote participants (such as interactive telemedicine) and would be more feasible for asymptomatic patients in general primary care settings, such as brief or media-based interventions involving less than 30 minutes.
Draft: Recommendations of Others
The CDC recommends that all clinicians routinely obtain a sexual history and encourage abstinence, condom use, limiting number of sex partners, and other sexual risk-reduction strategies,4, 20 as well as routine vaccination against HPV and HBV infection.21, 22 Many organizations advise clinicians to periodically obtain sexual histories, conduct sexual risk assessments, discuss sexual risk reduction, or some combination thereof, including the American Academy of Pediatrics,23 the American Academy of Family Physicians,24 the American College of Obstetricians and Gynecologists;25-29 the Society for Adolescent Health and Medicine;30 the National Coalition of Sexually Transmitted Disease Directors and the National Alliance of State and Territorial AIDS Directors,31 and the National Health Care for the Homeless Council.32
Draft: Article Information
The US Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific preventive care services for patients without obvious 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 decision making 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.
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33. Champion JD, Collins JL. Comparison of a theory-based (AIDS risk reduction model) cognitive behavioral intervention versus enhanced counseling for abused ethnic minority adolescent women on infection with sexually transmitted infection: results of a randomized controlled trial. Int J Nurs Stud. 2012;49(2):138-50.
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Draft: Table 1. Summary of USPSTF Rationale
|Recognition of behavior||Primary care clinicians can identify sexually active adolescents and adults at increased risk for acquiring STIs.
(See the “Practice Considerations” section for information on risk assessment.)
|Benefits of behavioral counseling||Adequate evidence that behavioral counseling using in-person, media-based, or both formats can reduce the likelihood of acquiring STIs, resulting in a moderate benefit.|
|Harms of behavioral counseling||Evidence is adequate to bound the magnitude of the overall harms of interventions as no greater than small, based on the few studies reporting no serious harms, the nature of the interventions, and the low likelihood of serious harms.
When direct evidence is limited, absent, or restricted to select populations or clinical scenarios, the USPSTF may place conceptual upper or lower bounds on the magnitude of benefit or harms.
|USPSTF Assessment||Moderate certainty that behavioral counseling for adolescents and adults at increased risk for acquiring STIs has a moderate net benefit.|
|In-Person Behavioral Counseling (Group Only or Group + Individual)‡||In-Person Behavioral Counseling (Individual Only)‡||Media-Based Interventions Without In-Person Counseling|
|Intervention intensity||Most interventions with group counseling involved total contact ties of more than 120 minutes and multiple sessions over 1 to 12 months.
Group counseling interventions often focused on specific demographic groups defined by age range, race/ethnicity, or both.
|Most individual counseling interventions involved more than 30 minutes of total contact time and a single session.
|Approximately one half of media-only interventions involved total contact times of 30 to 90 minutes; others involved less than 30 minutes.
Interventions involving video or computer interaction entailed fewer sessions than those involving repeated text messages or emails over many months.
Primary care clinics, research clinics, or STI clinics§
|Persons identified at STI, primary care, family planning, prenatal, and obstetrics-gynecology clinics or through advertisements or community media received interventions in homes, their community, or STI clinic waiting areas§|
|Intervention participants at increased risk for STIs†||Most study participants were adolescents or young adults younger than age 30 years and were members of racial/ethnic minority populations. The majority engaged in STI risk behaviors (such as unprotected intercourse or multiple sex partners) or had a history of STIs.|
|Person delivering intervention||Researchers, facilitators, nursing professionals, counselors, health educators, trained peer counselors, or physicians delivered group and individual counseling.||Self-directed (such as interactive computer-based intervention) or passively received (such as video)|
|Behavior change goals and techniques||Most interventions provided information about common STIs and how STIs are transmitted; aimed to increase motivation or commitment to safer sex practices; and provided training in pertinent skills, such as condom use and negotiation, communication about safer sex, and problem solving.
Interventions used varied therapeutic approaches (such as motivational interviewing and cognitive behavioral therapy) and some applied specific theoretical models of behavior change (such as social cognitive theory, the Information-Motivational-Behavioral Skills Model, and the AIDS Risk Reduction Model)
|Demonstrated benefit||Behavioral counseling for persons at increased risk for STIs can reduce the likelihood of acquiring STIs (OR, 0.66 [95% CI, 0.54 to 0.81]) and also increase condom use or decrease the occurrence of unprotected intercourse.13
Interventions with the largest effects for STI prevention tended to involve more than 120 minutes of total contact time and group counseling, often delivered over multiple sessions for up to a year. It is unclear whether the group counseling format, total contact time, or both were responsible for intervention effects because all but one intervention involving group counseling had total contact times of more than 120 minutes.A few interventions with less total contact time have been shown to reduce STI acquisition or promote safer sexual behaviors.
|References‖||14¶, 33¶, 34¶, 35¶, 36¶#, 37, 38¶, 39¶||15¶, 36¶#, 40, 41, 42||16¶, 43, 44, 45, 46, 47, 48|
* Table adapted from Appendix F Table 1 in the evidence review13 and a modified Template for Intervention Description and Replication (TIDieR) checklist.49
† The evidence review defined persons at increased risk for STI acquisition as sexually active adolescents or adults who reported STIs within the past year or current STIs, inconsistent condom use, multiple sex partners, or demographic characteristics associated with high STI incidence.
‡ Some interventions combined several methods, such as in-person counseling followed by personalized text messages or emails.
§ Studies in STI clinics tested interventions in persons who had sought care for STI symptoms or had known or suspected exposure to sex partners with STIs. Interventions for STI clinic patients with recent or current STIs often focus on reducing the risk for a subsequent STI, including those caused by reinfection by untreated partners.
‖ The USPSTF does not endorse any specific intervention.
¶ Study reported statistically significant reduction in one or more STI acquisition outcome.
# Study included multiple intervention arms, including those with group counseling or individual counseling.
Internet Citation: Draft Recommendation Statement: Sexually Transmitted Infections: Behavioral Counseling. U.S. Preventive Services Task Force. December 2019.