| 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-fetal transmission, blood transfusions, inadvertent needle sticks, sharing needles or injection equipment with a potentially infected person) |
| Population |
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HIV-positive (>10% of study population) Current inmates, juvenile offenders, court-involved individuals Psychiatric inpatients
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| Interventions | Primary care conducted, feasible,* or referable intervention involving behavioral counseling to prevent or reduce HIV/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
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) Where delivered: could be delivered anywhere (including via the Web, interactive technology, 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 (preexisting) social networks (e.g., worksites, churches) or uses authority figures (e.g., military commanders, workplace supervisors)
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Trials within closed preexisting 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 or notification only Contraceptive use Complementary and alternative medicine (e.g., hypnosis)
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| Comparators |
No intervention (e.g., waitlist) Usual care Minimal intervention (e.g., usual care limited to ≤15 min 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 |
KQ1: Health outcomesSTI incidence (testing and self-report) STI-related morbidity and mortality, including: cancer (e.g., liver, oral, cervical, vulvular, vaginal, anal, penile, Kaposi's sarcoma, non-Hodgkin'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 these conditions
KQ 2: Behavioral outcomesChanges 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 outcomesReduction in unintended pregnancy Others based on target populations (e.g., decrease in substance abuse/misuse among current drug users)
KQ 4: Adverse events | 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 |
| 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)
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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
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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 or before 1987 |
| Country | Countries with a Human Development Index of “Very High” | 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) |
