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Draft Research Plan

Draft Research Plan for Sexually Transmitted Infections: Behavioral Counseling

This opportunity for public comment expired on May 16, 2018 at 8:00 PM EST

Note: This is a Draft Research Plan. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Research Plan will be 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.

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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In an effort to maintain a high level of transparency in our methods, we open our draft Research Plans to a public comment period before we publish the final version.

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Draft: Proposed Analytic Framework

Figure 1 is the analytic framework that depicts the three Key Questions to be addressed in the systematic review. The figure illustrates how behavioral counseling interventions to decrease risky sexual behaviors and increase protective behaviors lead to reduced sexually transmitted infections, morbidity and mortality, or both (Key Question 1). Additionally, the figure illustrates how behavioral counseling interventions lead to decreased risky sexual behaviors and increased protective behaviors that can reduce the risk of sexually transmitted infections (Key Question 2) and any related harms associated with these interventions (Key Question 3).

Abbreviation: STI=sexually transmitted infection.

Draft: Proposed Key Questions to Be Systematically Reviewed

  1. Do behavioral counseling interventions to decrease risky sexual behaviors and increase protective behaviors reduce sexually transmitted infections (STIs), related morbidity and mortality, or both?
    1. Does the effectiveness of behavioral counseling interventions differ for subpopulations at higher risk for STIs (e.g., adolescents)?
    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 and increase protective behaviors that can reduce the risk of STIs?
    1. Does the effectiveness of behavioral counseling interventions differ for subpopulations at higher risk for STIs (e.g., adolescents)?
    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?

Draft: Proposed Contextual Questions

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

  1. What risk factors or risk behaviors are important for identifying persons at higher risk for STIs (e.g., based on substance use or STI history) for targeted interventions?

Draft: Proposed Research Approach

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 solely to change behaviors associated with risky sexual behavior (e.g., alcohol misuse, drug abuse)
Condition Any infection that is transmitted through sexual contact (i.e., oral, vaginal, or anal), including but not limited to: HIV, human papillomavirus, herpes simplex virus (HSV) type 1 and 2, hepatitis B virus, chlamydia, gonorrhea, syphilis, and trichomoniasis Other methods by which bloodborne STIs can be acquired (e.g., maternal-fetal transmission, blood transfusions, inadvertent needle sticks, sharing needles or injection equipment with a potentially infected person)
  • Adolescents and adults of any sexual orientation, including pregnant women
  • Persons who are sexually active or not sexually active
  • Persons living with HIV (>10% of study population)
  • Studies limited to populations requiring specialized health care or interventions to address STI health risks (e.g., HIV-serodiscordant couples, commercial sex workers)

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, which 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)
  • Health systems interventions (e.g., electronic medical record prompts)
  • Abstinence contracts with health care provider
  • Virtual- or technology-based interventions (e.g., text messages, Internet-based)
  • HIV counseling and testing
  • Skills training
  • Trials within closed pre-existing social networks (e.g., worksite or church programs)
  • School programs outside school-based health clinics
  • Social marketing (e.g., media campaigns)
  • Policy (e.g., State or local public or health policy; health care delivery)
  • Circumcision to prevent HIV/STI; circumcision counseling
  • Biomedical HIV/STI prevention interventions (e.g., vaccinations, antiretroviral therapy for high-risk persons) or counseling to increase use
  • Promoting HIV/STI testing only
  • Maternal-fetal transmission prevention counseling
  • Sexual abuse prevention
  • Cash incentives for behavior change (e.g., condom use)
  • Counseling to increase partner referral/notification only
  • Promoting noncondom contraceptive use only
  • Complementary and alternative medicine (e.g., hypnosis)
  • No intervention (e.g., waitlist)
  • Usual care
  • Minimal intervention (e.g., usual care limited to ≤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)
  • Related morbidity and mortality, including: cancer (e.g., liver, oral, cervical, vulvar, vaginal, anal, penile) and other sequelae of STIs for reproductive health (e.g., pelvic inflammatory disease, ectopic pregnancy, spontaneous abortion, infertility, epididymitis, prostatitis), maternal health (e.g., preterm delivery, premature rupture of membranes, puerperal sepsis, postpartum infection), and infant health (e.g., stillbirth, low birth weight, ophthalmia neonatorum [caused by gonorrhea, HSV type 1 and 2, or chlamydia], pneumonia, neonatal sepsis, congenital HIV, congenital syphilis, acute hepatitis, neurologic damage, congenital abnormalities)
  • Chronic conditions (e.g., AIDS, neurosyphilis, chronic liver disease) and other STI complications (e.g., oral lesions, meningitis, pelvic pain, genitourinary complaints)
  • Unintended pregnancy
  • Mental health
  • Quality of life

KQ 2 (behavioral outcomes):

  • Changes in STI risk behaviors (e.g., multiple [new] sexual partners, sexual partners with high STI risk, unprotected vaginal or anal intercourse, other contact with bodily fluids, 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, decreased contact with bodily fluids [use of condoms, other barrier methods, 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)
  • Stigma
Self-reported measures of attitude, knowledge, ability, or self-efficacy (e.g., knowledge of HIV/STI risk and transmission, knowledge of protective behaviors, perception of HIV/STI risk in self or partners, regretted intercourse, participation in AIDS-related community activities, perceived powerlessness), sexual negotiation skills, scheduling a health care appointment or discussing its importance with family, intention to use protective barriers, or carrying barrier protection
  • Conducted in or recruited from primary care; health care system
  • Primary care clinics; STI and family planning clinics, prenatal clinics; military health clinics; obstetrics-gynecology clinics; school health 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 (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 1987 (1988 to present; post-HIV/AIDS era) Published in or before 1987
Country Studies conducted in countries categorized as “Very High” on the 2016 Human Development Index (as defined by the United Nations Development Programme) Countries with a Human Development Index other than “Very High”
Language English only Non-English publications
Study quality Fair or good-quality studies Poor-quality studies (according to design-specific USPSTF criteria)
Current as of: April 2018

Internet Citation: Draft Research Plan: Sexually Transmitted Infections: Behavioral Counseling. U.S. Preventive Services Task Force. April 2018.

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