Final Research Plan
Sexually Transmitted Infections: Behavioral Counseling
May 15, 2013
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.
Behavioral Counseling to Prevent Sexually Transmitted Infections
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 Report forms the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from January 29 until February 25, 2013 at 5:00 p.m., ET.
Abbreviation: STI = sexually transmitted infection.
This figure is the analytic framework that depicts the four Key Questions (KQs) to be addressed by the systematic review. The figure illustrates how behavioral counseling interventions to reduce sexually transmitted infections (STIs) may result in reduced incidence of STIs and related morbidity and mortality (KQ 1) in men and women of all ages of any sexual orientation, including pregnant women. It also depicts how these interventions may also reduce risky behaviors and increase protective behaviors (KQ 2). The systematic review will also address whether these interventions have any other positive outcomes (KQ 3) or potential harms (KQ 4).
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Is there direct evidence that behavioral counseling interventions to reduce risky sexual behaviors and increase protective sexual behaviors reduce sexually transmitted infection (STI) incidence and/or related morbidity and mortality?
- Are there population or intervention characteristics that influence the effectiveness of the interventions?
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Do behavioral counseling interventions to prevent STIs reduce risky sexual behaviors or increase protective sexual behaviors?
- Are there population or intervention characteristics that influence the effectiveness of the interventions?
- Are there other positive outcomes besides STI incidence and changes in risky or protective sexual behaviors from behavioral counseling interventions to prevent STIs?
- What adverse effects are associated with primary care behavioral counseling interventions to prevent STIs?
Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What is the acceptability of behavioral counseling interventions to reduce risky sexual behaviors and increase protective sexual behaviors?
- Are there specific components or active ingredients of behavioral counseling interventions that increase the likelihood that an intervention will improve behavioral or clinical outcomes?
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). A bridge search will be performed starting from 1 year before the end of the last USPSTF review (i.e., January 2007).
Inclusion | Exclusion | |
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Aim | Targeting sexual behavior change to prevent HIV/STIs (may also target additional behaviors) | Only targeting sexual behavior change to prevent unintended pregnancy or another behavior associated with risky sexual behavior (e.g., alcohol misuse, drug abuse) |
Condition | An STI is any infection that is transmitted through sexual contact (i.e., oral, vaginal, or anal)1 | Other methods by which bloodborne STIs can be acquired (e.g., maternal-to-fetal transmission, blood transfusions, inadvertent needle sticks, sharing needles or injection equipment with a potentially infected person) |
Population |
All KQs:
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All KQs:
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Interventions |
Primary care conducted, feasible*, or referable intervention involving behavioral counseling to prevent or reduce STI/HIV (i.e., 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
Interventions may include, but are not limited to: individual-, family-, couple-, or group-based counseling (e.g., motivational interviewing, cognitive behavioral counseling), abstinence contracts with provider, virtual- or technology-based interventions (e.g., text messages), HIV counseling and testing, case management, and skills training * Criteria for feasibility:
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Comparators |
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Active intervention (i.e., comparative effectiveness) |
Outcomes |
KQ 1: Health outcomes
KQ 2: Behavioral outcomes
KQ 3: Other positive outcomes
KQ 4: Adverse events
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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, carrying barrier protection |
Intervention setting |
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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 (not search date) | Published after 1987 (1988 to present; post-HIV/AIDS era) | Published in 1987 or earlier |
Country | Any country with a Human Development Index of “Very High”: Andorra, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brunei Darussalam, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United States | Countries with a Human Development Index below “Very High” |
Language | English only | Non-English publications |
Study quality | Fair or good | Poor (e.g., <60% retention overall) |
The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from January 29 to February 25, 2013. The USPSTF received comments suggesting that reduction in health care utilization not be included as a beneficial outcome of STI prevention counseling; this outcome was removed from the inclusion criteria. One contextual question was modified to broadly address acceptability of interventions rather than just acceptability of interventions by adolescent patients and their parents. Additional comments addressed data abstraction and analysis or potentially important contextual issues or discussion points. These comments did not warrant changes to the Research Plan but will be considered in the preparation of the evidence review and report.
- Workowski KA, Berman S; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59(RR-12):1-110.