Final Research Plan
Sexually Transmitted Infections: Behavioral Counseling
May 01, 2025
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.
Abbreviations: STI=sexually transmitted infection; QoL=quality of life.
- Do behavioral counseling interventions that aim to decrease risky or increase protective sexual behaviors, or both, reduce sexually transmitted infections (STIs) or related morbidity and mortality?
- Do behavioral counseling interventions decrease risky or increase protective sexual behaviors that can reduce the risk of STIs?
- What potential harms are associated with behavioral counseling interventions to reduce STI infections?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What clinical risk assessment tools or guidance can be used to help primary care clinicians identify individuals at higher risk for STIs?
- What social, structural, and health system factors in the United States contribute to variation in STI risk, and how can they be addressed to improve sexual health outcomes?
- Are there STI behavioral counseling interventions or modalities that have been developed to address the needs and concerns of populations with disproportionately higher rates of STIs?
To the extent possible, we will describe the participant characteristics and major intervention components of included studies. Data on population characteristics will be used to explore the degree to which the findings are broadly representative of the U.S. population, with respect to age, sex, race, ethnicity, socioeconomic status, geographic region, and other factors. We will also analyze results stratified by relevant population and intervention characteristics when possible.
The proposed 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 Review. Criteria are overarching as well as specific to each of the key questions.
| Category | 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., 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, chlamydia, gonorrhea, syphilis, mpox, and trichomoniasis | Infections acquired through non-sexual 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, including those who are pregnant Persons who are sexually active Persons who have not yet become sexually active |
Studies conducted exclusively in populations requiring specialized healthcare or interventions to address STI and other health risks (e.g., HIV-positive individuals, commercial sex workers, persons who inject drugs) |
| Interventions | Interventions involving behavioral counseling to help individuals reduce their risk of STI (i.e., 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 health and risk reduction or risk avoidance, which can feasibly be implemented in or referred from primary care. Interventions may include, but are not limited to:
|
Trials within closed pre-existing social networks (e.g., worksite or church programs) or within schools Social marketing (e.g., media campaigns) Trials focused exclusively on biomedical prevention interventions (e.g., HPV vaccination, doxy PEP, PrEP for HIV) STI testing only Counseling to increase partner referral/notification only |
| Comparators | 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 focused 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):
KQ 2 (Behavioral outcomes):
KQ 3 (Harms):
|
Self-reported measures of infection, attitude, knowledge, ability, or self-efficacy, including:
|
| Setting | Conducted in or recruited from primary care settings, including:
|
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 post-baseline | <3 months post-baseline |
| Publication date | Published after 1999 (2000 to present) | Published in or before 1999 |
| Country | Studies conducted in countries categorized as “Very High” on the 2023/2024 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) |
Abbreviations: AIDS = acquired immunodeficiency syndrome; doxy PEP = doxycycline post-exposure prophylaxis; HIV = human immunodeficiency virus; HSV = herpes simplex virus; KQ = key question; PrEP = pre-exposure prophylaxis; STI = sexually transmitted infection; USPSTF = U.S. Preventive Services Task Force.
The draft Research Plan was posted for public comment on the USPSTF website from January 16, 2025, to February 12, 2025. The USPSTF did not change the review scope in response to public comments but made minor additions and wording changes to improve the clarity and specificity of the research approach.