Final Research Plan

Sexually Transmitted Infections: Behavioral Counseling

August 02, 2018

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.

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Panel 1

The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

The draft Research Plan was available for comment from April 19 to May 15, 2018.

The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic. The draft Research Plan was available for comment from June 29 to July 26, 2017.

Abbreviation: STI=sexually transmitted infection.

  1. Do behavioral counseling interventions to decrease risky sexual behaviors or increase protective behaviors, or both, reduce sexually transmitted infections (STIs) or related morbidity and mortality?
    1. Does the effectiveness of behavioral counseling interventions differ for subpopulations (e.g., by age, STI history, sexual orientation, gender, or pregnancy status)?
    2. Does the effectiveness of behavioral counseling interventions differ by intervention characteristics (e.g., intensity or mode)?
  2. Do behavioral counseling interventions decrease risky sexual behaviors or increase protective behaviors that can reduce the risk of STIs?
    1. Does the effectiveness of behavioral counseling interventions differ for subpopulations (e.g., by age, STI history, sexual orientation, gender, or pregnancy status)?
    2. Does the effectiveness of behavioral counseling interventions differ by intervention characteristics (e.g., intensity or mode)?
  3. What potential harms are associated with behavioral counseling interventions to reduce STI infections?

The contextual question will not be systematically reviewed and is not shown in the Analytic Framework.

  1. What patient characteristics or risk behaviors (e.g., substance use or STI history) are important for identifying persons at higher risk for STIs who may benefit from targeted interventions?

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the evidence report. Criteria are overarching as well as specific to each of the key questions (KQs).

  Included Excluded
Aim Studies targeting sexual behavior change to prevent STIs Studies aimed solely at targeting behavior change to prevent unintended pregnancy or to change behaviors associated with risky sexual behavior (e.g., substance use disorders, interpersonal violence)
Condition Any infection that is transmitted through sexual contact (i.e., oral, vaginal, or anal), including, but not limited to: HIV, human papillomavirus (HPV), herpes simplex virus (HSV) type 1 and 2, hepatitis B and C viruses, Zika virus, chlamydia, gonorrhea, syphilis, and trichomoniasis Infections acquired through nonsexual transmission routes (e.g., maternal-fetal transmission, blood transfusions, inadvertent needle sticks, sharing needles or injection equipment with an infected person)
Population
  • Adolescents and adults of any sexual orientation
  • Persons who are sexually active
  • Pregnant women
  • Persons who are not sexually active (e.g., adolescents before sexual debut)
 Studies limited to populations requiring specialized health care or interventions to address STI health risks (e.g., HIV serodiscordant couples, commercial sex workers)
Interventions

Interventions involving behavioral counseling to prevent or reduce STIs (i.e., some provision of education, skills training, or guidance on how to change sexual behaviors), delivered alone or in combination with other interventions intended to promote sexual risk reduction or risk avoidance, that can feasibly be implemented in or referred from primary care. Interventions may include, but are not limited to:

  • Individual-, family-, couple-, or group-based counseling (e.g., motivational interviewing, cognitive behavioral therapy)
  • Waiting room, multimedia, or other health system–based behavior change interventions
  • Telemedicine or technology-based behavior change interventions (e.g., text messages, Internet-based)
  • Trials within closed pre-existing social networks (e.g., worksite or church programs)
  • Social marketing (e.g., media campaigns)
  • Policy (e.g., State or local public or health policy; health care delivery)
  • Circumcision to prevent HIV/STIs; circumcision counseling
  • Trials solely focused on biomedical prevention interventions (e.g., HPV vaccination, pre-exposure prophylaxis for HIV)
  • STI testing only
  • Sexual abuse prevention
  • Cash and voucher reward-based incentives for behavior change (e.g., condom use)
  • Counseling to increase partner referral/notification only
  • Promoting noncondom contraceptive use only
Comparators
  • No intervention (e.g., waitlist)
  • Usual care
  • Minimal intervention (e.g., usual care limited to no ≤ 15 minutes of information)
  • Attention control (e.g., similar in format and intensity but intervention is on a different content area, such as general sex education, wellness promotion, or nutrition education)
 Active intervention (i.e., comparative effectiveness)
Outcomes KQ 1 (health outcomes):
  • STI incidence (based on testing/biologic confirmation)
  • Morbidity and mortality, including:
  • STI-related cancer (e.g., liver, oral, cervical, vulvar, vaginal, anal, penile)
  • Oral and genital lesions
  • Pelvic and genitourinary pain
  • Chronic conditions (e.g., AIDS, neurosyphilis, chronic liver disease)
  • Reproductive complications (e.g., pelvic inflammatory disease, ectopic pregnancy, spontaneous abortion, infertility)
  • Perinatal and infant morbidity/mortality (e.g., neonatal infection, stillbirth, low birth weight, ophthalmia neonatorum, neurologic damage, congenital abnormalities)
  • Mental health
  • Quality of life

KQ 2 (behavioral outcomes):

  • Changes in STI risk behaviors (e.g., multiple sexual partners, concurrent sexual partners, sexual partners with high STI risk, unprotected sexual intercourse or contact, sex while intoxicated with alcohol or other substances, sex in exchange for money or drugs)
  • Changes in protective behaviors (e.g., sexual abstinence; mutual monogamy; delayed initiation of intercourse or age of sexual debut; use of condoms, other barrier methods, or chemical barriers; or other changes in sexual behavior)

KQ 3 (harms):

  • Increase in STI incidence or risky sexual behaviors or decrease in protective behaviors
  • Health care avoidance
  • Psychological harms (e.g., anxiety, shame, guilt, feelings of stigma)
  • Unintended pregnancy

Self-reported measures of infection, attitude, knowledge, ability, or self-efficacy, including:

  • Knowledge of risks and protective behaviors
  • Perception of STI risk in self or partners
  • Perceived relationship power
  • Sexual negotiation skills
  • Scheduling a health care appointment
  • Intention to use protective barriers
  • Carrying barrier protection
Setting Trials conducted in or recruited from primary care settings, including:
  • Health care systems
  • STI clinics
  • Family planning clinics
  • School-based health clinics
  • Prenatal care clinics
  • Military health clinics
  • Obstetrics-gynecology clinics
  • Behavioral/mental health clinics
  • Research laboratories
  • Correctional facilities
  • School classrooms
  • Worksites
  • Substance abuse treatment facilities or methadone maintenance clinics
  • Inpatient/residential facilities
  • Emergency departments
Study design Randomized, controlled trials and nonrandomized, controlled trials (i.e., controlled clinical trials) Observational studies, comparative effectiveness trials without a control group
Timing of outcome assessment ≥3 months postbaseline <3 months postbaseline
Publication date Published after 1999 (2000 to present) Published in or before 1999
Country Studies conducted in countries categorized as “Very High” on the 2016 Human Development Index (as defined by the United Nations Development Programme) Studies not conducted in countries categorized as “Very High” on the 2016 Human Development Index
Language English only Languages other than English
Study quality Fair or good-quality studies Poor-quality studies (according to design-specific USPSTF criteria)

Abbreviations: STI=sexually transmitted infection; USPSTF=U.S. Preventive Services Task Force.

The draft Research Plan was posted for public comment on the USPSTF Web site from April 17, 2018 to May 15, 2018. In response to comments, the USPSTF revised the scope of the review to include studies of persons living with HIV and to exclude studies published prior to 2000. These changes were made based on advances in HIV treatment, management, and survival with the introduction of effective antiretroviral treatments. In addition, the USPSTF expanded the list of STIs to include the hepatitis C virus and Zika virus. The USPSTF made other minor changes to clarify the scope and intention of the review. Some comments requested changes outside of the scope of the USPSTF, such as political and social policy approaches to STI prevention, including community-level interventions; the USPSTF made no changes in response to these comments.