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Final Research Plan

Final Research Plan for Sexually Transmitted Infections: Behavioral Counseling

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.

Preface

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.

I. Analytic Framework

Select Text Description below for details.

Abbreviation: STI = sexually transmitted infection.

Text Description.

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).

 

II. Key Questions to be Systematically Reviewed

  1. 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?
    1. Are there population or intervention characteristics that influence the effectiveness of the interventions?
  2. Do behavioral counseling interventions to prevent STIs reduce risky sexual behaviors or increase protective sexual behaviors?
    1. Are there population or intervention characteristics that influence the effectiveness of the interventions?
  3. Are there other positive outcomes besides STI incidence and changes in risky or protective sexual behaviors from behavioral counseling interventions to prevent STIs?
  4. What adverse effects are associated with primary care behavioral counseling interventions to prevent STIs?

III. Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

  1. What is the acceptability of behavioral counseling interventions to reduce risky sexual behaviors and increase protective sexual behaviors?
  2. Are there specific components or active ingredients of behavioral counseling interventions that increase the likelihood that an intervention will improve behavioral or clinical outcomes?

IV. 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). A bridge search will be performed starting from 1 year before the end of the last USPSTF review (i.e., January 2007).

  Inclusion Exclusion
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:
  • Men and women of all ages, of any sexual orientation, including pregnant women
  • Sexually active or not
All KQs:
  • HIV positive (>10% of study population)
  • Current inmates, juvenile offenders, court-involved individuals
  • Psychiatric inpatients
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:

  • Whom targeted: Individual-level identification of being a patient/in need of intervention
  • Who delivered: Usually involves primary care clinicians (family practice, internal medicine, obstetrics-gynecology, pediatrics, or general practitioners), other physicians, nurses, nurse practitioners, physician assistants, or related clinical staff (dietitians, health educators, mental health practitioners, or other counselors) in some direct or indirect way, or is seen as connected to the health care system by the participant
  • How delivered: To individuals or in small groups (15 patients or less)
  • Where delivered: Could be delivered anywhere (including via the Web, interactive technologies, in the home) as long as linked to a health care provider or system
  • Components: Must not include components that cannot be replicated in most health care settings, including environmental components (media messages, signage), or that intervenes on groups in closed (pre-existing) social networks (e.g., worksites, churches) or uses authority figures (e.g., military commanders, workplace supervisors)
  • 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/STIs; circumcision counseling
  • Biomedical HIV/STI prevention interventions (e.g., prophylactic vaccinations, antiretroviral therapy in high-risk individuals) or counseling to increase use
  • Promoting HIV/STI testing
  • Maternal-to-fetal transmission prevention counseling
  • Sexual abuse prevention
  • Cash incentives for behavior change (e.g., condom use)
  • Counseling to increase partner referral/notification only
  • Contraceptive use
  • Complementary and alternative medicine (e.g., hypnosis)
Comparators
  • No intervention (e.g., waitlist)
  • Usual care
  • Minimal intervention (e.g., usual care limited to no more than 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 (testing and self-report)
  • STI-related morbidity and mortality, including: cancer (e.g., liver, oral, cervical, vulvular, vaginal, anal, penile, Kaposi's sarcoma, nonHodgkin's lymphoma), reproductive health problems (e.g., pelvic inflammatory disease, ectopic pregnancy, spontaneous abortion, infertility, epididymitis, prostatitis), maternal problems (e.g., preterm delivery, premature rupture of membranes, puerperal sepsis, postpartum infection), infant problems (e.g., stillbirth, low birth weight, ophthalmia neonatorum [caused by gonorrhea, herpes simplex virus, or chlamydia], pneumonia, neonatal sepsis, congenital HIV, congenital syphilis, acute hepatitis, neurologic damage, congenital abnormalities), AIDS, other (e.g., oral lesions, meningitis, neurosyphilis, chronic liver disease, pelvic pain, genitourinary complaint), or death from any of the aforementioned conditions

KQ 2: Behavioral outcomes

  • Changes in sexual behavior, including risky behaviors (e.g., multiple [new] partners, high-risk partners, unprotected vaginal or anal intercourse, other contact with bodily fluid, sex while intoxicated with alcohol or other substances, sex in exchange for money or drugs)
  • Changes in protective behaviors (e.g., 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])
  • Sexual negotiation skills (trial must also report change in risky or protective behavior listed above or a health outcome)

KQ 3: Other positive outcomes

  • Reduction in unintended pregnancies
  • Others based on target populations (e.g., decrease in substance abuse/misuse among current drug users)

KQ 4: Adverse events

  • Paradoxical increase in STI incidence or risky sexual behaviors or decrease in protective behaviors
  • Care avoidance
  • 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, carrying barrier protection
Intervention setting
  • Primary care settings (e.g., pediatric, obstetrics-gynecology, internal medicine, family practice, family planning, military, adolescent and school-based health clinics)
  • Mental health clinics
  • STI and family planning clinics
  • Virtual (e.g., online counseling)
  • Community/university research laboratories or other nonmedical centers
  • 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 (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)

V. Response to Public Comment

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.

References:
  1. 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.
Current as of: May 2013

Internet Citation: Final Research Plan: Sexually Transmitted Infections: Behavioral Counseling. U.S. Preventive Services Task Force. February 2014.
https://www.uspreventiveservicestaskforce.org/Page/Document/final-research-plan34/sexually-transmitted-infections-behavioral-counseling1

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