Evidence Summary

Sexually Transmitted Infections: Behavioral Counseling

August 18, 2020

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.

By Jillian T. Henderson, PhD, MPH; Caitlyn A. Senger, MPH; Michelle Henninger, PhD; Sarah I. Bean, MPH; Nadia Redmond, MSPH; Elizabeth A. O’Connor, PhD

The information in this article is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This article is intended as a reference and not as a substitute for clinical judgment.

This article may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

This article was published online in JAMA on August 18, 2020 (JAMA. 2020;324(7):682-699. doi:10.1001/jama.2020.10371).

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Importance: Increasing rates of preventable sexually transmitted infections (STIs) in the US pose substantial burdens to health and well-being.

Objective: To update evidence for the US Preventive Services Task Force (USPSTF) on effectiveness of behavioral counseling interventions for preventing STIs.

Data Sources: Studies from the previous USPSTF review (2014); literature published January 2013 through May 31, 2019, in MEDLINE, PubMed (for publisher-supplied records only), PsycINFO, and Cochrane Central Register of Controlled Trials. Ongoing surveillance through May 22, 2020.

Study Selection: Good- and fair-quality randomized and nonrandomized controlled intervention studies of behavioral counseling interventions for adolescents and adults conducted in primary care settings were included. Studies with active comparators only or limited to individuals requiring specialist care for STI risk-related comorbidities were excluded.

Data Extraction and Synthesis: Dual risk of bias assessment, with inconsistent ratings adjudicated by a third team member. Study data were abstracted into prespecified forms. Pooled odds ratios (ORs) were estimated using the DerSimonian and Laird method or the restricted maximum likelihood method with Knapp-Hartung adjustment.

Main Outcomes and Measures: Differences in STI diagnoses, self-reported condom use, and self-reported unprotected sex at 3 months or more after baseline.

Results: The review included 37 randomized trials and 2 nonrandomized controlled intervention studies (N = 65,888; 13 good-quality, 26 fair-quality) recruited from primary care settings in the US. Study populations were composed predominantly of heterosexual adolescents and young adults (12 to 25 years), females, and racial and ethnic minorities at increased risk for STIs. Nineteen trials (n = 52,072) reported STI diagnoses as outcomes (3 to 17 months’ follow-up); intervention was associated with reduced STI incidence (OR, 0.66 [95% CI, 0.54-0.81; I2 = 74%]). Absolute differences in STI acquisition between groups varied widely depending on baseline population STI risk and intervention effectiveness, ranging from 19% fewer to 4% more people acquiring STI. Thirty-four trials (n = 21,417) reported behavioral change outcomes. Interventions were associated with self-reported behavioral change (eg, increased condom use) that reduce STI risk (OR, 1.31 [95% CI, 1.10-1.56; I2 = 40%, n = 5253). There was limited evidence on persistence of intervention effects beyond 1 year. No harms were identified in 7 studies (n = 3458) reporting adverse outcomes.

Conclusions and Relevance: Behavioral counseling interventions for individuals seeking primary health care were associated with reduced incidence of STIs. Group or individual counseling sessions lasting more than 2 hours were associated with larger reductions in STI incidence, and interventions of shorter duration also were associated with STI prevention, although evidence was limited on whether the STI reductions associated with these interventions persisted beyond 1 year.

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In 2008 the Centers for Disease Control and Prevention estimated that more than 20 million sexually transmitted infections (STIs) occur each year in the US.1 Surveillance data since then, and especially from 2014 to 2018, indicate substantial increases in the incidence of most STIs,2 including syphilis and gonorrhea, that were previously rare or declining.3 STI incidence is highest among adolescents and young adults.1 For example, 61% of the 1.1 million cases of chlamydia reported in 2018 in the US were among individuals aged 15 to 24 years.3 The high rates of STI in the US contribute to chronic disease, cancer, infertility, adverse birth outcomes, and mortality, posing a substantial burden to population health.3 Reported disparities in STI rates by region of the country, age, race, ethnicity, and sexual orientation are attributed to structural and social conditions, sexual behavior, and unequal access to health care, education, and public health programs.4,5

Primary care clinicians have an important role in primary and secondary prevention of STIs. In addition to providing recommended STI screening and treatments, primary care clinicians can identify patients at increased risk for STIs by obtaining comprehensive sexual histories.2,6 In 2014 the US Preventive Services Task Force (USPSTF) recommended intensive behavioral counseling for all sexually active adolescents and for adults at an increased risk for sexually transmitted infections (B recommendation).7,8 The current review of the evidence on behavioral counseling interventions for STI prevention was conducted to inform a USPSTF update to its current recommendation.

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Scope of Review

An analytic framework was developed with 3 key questions (KQs) (Figure 1) that examined the effectiveness of behavioral counseling interventions in reducing STIs, related morbidity and mortality, or other health outcomes (KQ1); decreasing risky sexual behaviors or increasing protective behaviors (KQ2); and potential harms of behavioral counseling interventions (KQ3). Additional methodological details are publicly available in the full evidence report.10

Data Sources and Searches

To identify studies published since the previous review,8 literature searches were conducted from January 2013 through May 31, 2019, in MEDLINE, PubMed (for publisher-supplied records only), PsycINFO, and the Cochrane Central Register of Controlled Trials (eMethods in the Supplement). Additional studies were located by reviewing reference lists of other systematic reviews and through suggestions from experts. Ongoing surveillance was conducted after May 2019 through May 22, 2020, to identify newly published studies that might affect the findings of the review. This was accomplished through article alerts and targeted searches of journals with a high impact factor and journals relevant to the topic. The last surveillance on May 22, 2020, identified no new studies.

Study Selection

Two reviewers independently evaluated articles from the previous review in addition to citations and full-text articles from the literature searches against prespecified inclusion criteria (Figure 2). Given changes to the medical and social context of STI risk and prevention, studies from the previous review published more than 20 years ago (years 1999 or earlier) were not included. For all KQs, included studies were required to target sexual behavior change to prevent STIs. Studies among adults and adolescents, including those who were pregnant, were included. Studies that included people living with HIV were not excluded unless the study population and intervention was focused solely on HIV-positive populations. Studies that focused solely on behavior change to prevent unintended pregnancy or change behaviors such as drug and alcohol use associated with risky sexual behavior were not included. Additionally, studies limited to populations requiring complex, specialized interventions outside the scope of primary care to address their specific STI risk (eg, HIV-serodiscordant couples, commercial sex workers) were not included in the review. Randomized clinical trials (RCTs) and nonrandomized controlled intervention studies involving behavioral counseling to prevent or reduce STIs were included. Trials that assessed effectiveness of circumcision for HIV prevention, STI testing only, biomedical prevention interventions, or those conducted within closed or preexisting social networks were not included.

Studies were required to have outcomes assessed at 3 months’ postbaseline or longer and be conducted in or recruited from general primary care settings and other preventive care outpatient settings, including family planning clinics, STI clinics, school-based health clinics, and behavioral/mental health clinics. Studies were limited to those conducted in countries categorized as “very high” on the Human Development Index (2016) published by the United Nations Development Programme.11 Included studies were limited to those published in English and deemed good or fair quality based on USPSTF quality rating standards.9

Data Extraction and Quality Assessment

Two reviewers applied USPSTF design-specific criteria9 to assess the methodological quality of all eligible studies, and each study was assigned a quality rating of “good,” “fair,” or “poor.” Discordant quality ratings were resolved by discussion or by a third reviewer and adjudicated as needed. Studies rated as poor quality were excluded from the review. Good-quality RCTs were those that met all or nearly all the prespecified quality criteria. Fair-quality studies did not meet all criteria but did not have serious threats to their internal validity related to design, execution, or reporting. Intervention studies rated as poor quality generally had several important limitations, including at least 1of the following risks of bias: very high attrition (defined as >40%); differential attrition between intervention groups (defined as >20%); lack of baseline comparability between groups without adjustment; or problematic issues in trial conduct, analysis, or reporting of results. One reviewer extracted data from all included studies rated as fair- or good-quality directly into evidence tables, and a second reviewer checked the data for accuracy.

Data Synthesis and Analysis

Data were synthesized separately for each KQ, and tables were created to describe study results for all included outcomes, with stratification by intervention and study population characteristics. Narrative summary and summary tables were used to describe important features of the included evidence, including study design and setting, interval validity, and important characteristics about patients and interventions. Based on a priori plans to evaluate differences in intervention effects by age, 2 sets of data tables were prepared—1 set for studies focused on adolescent and young adult populations and the second for those on adult populations. Age categories represented broad age spans of included populations. To examine age effects, within-study age-specific subgroup analyses were extracted when available, regardless of the subgroup comparison methods.

Meta-analyses of STI incidence, condom use, and unprotected intercourse were conducted. The DerSimonian and Laird model was used for pooling odd ratios (ORs) of STI incidence. Adjusted study-reported ORs were used if reported, and ORs were calculated based on the reported proportion of participants with an STI in each group if adjusted differences were not reported or results were presented in a format that could not be combined for meta-analysis of ORs (eg, hazard ratios). A funnel plot was created and an Egger test was conducted to explore small-study effects, which can be related to publication bias.12 Additionally, meta-regression and subgroup analyses were conducted to explore factors associated with effect size. Because fewer than 10 trials could be included in these analyses and statistical heterogeneity was fairly high (I2 = 50% and higher), restricted maximum likelihood models were run with the Knapp-Hartung correction for small samples, because the DerSimonian and Laird method tends to underestimate the width of the 95% CI when the number of studies is small or statistical heterogeneity is high.13 Several factors were examined as potential effect modifiers, including but not limited to recruitment setting (eg, STI clinic vs other settings), participant characteristics (eg, whether the study was limited to adolescents or young adults, whether the study was limited to male or female participants only), amount of intervention contact time (eg, length and number of sessions), modality (eg, in-person individual or group counseling), administrator (eg, licensed health professional), and study design features (eg, type of control). Analyses to assess the sensitivity of pooled effects to individual studies or types of studies—for example, those unique in terms of reported STI outcomes or study design—were conducted when potential outliers were identified.

For KQ1, STI outcomes based on laboratory-confirmed clinical tests, conducted as part of the study, recorded in the medical records of study participants, and/or found in public health surveillance registries were analyzed. A few studies reported incidence of a specific STI, while others considered intervention effects on the diagnosis of any STI. For meta-analysis, these outcomes were combined. The follow-up periods ranged from 6 to 24 months; when several time points were reported, those closest to 12 months were included in the meta-analysis. For KQ2, condom use outcomes were reported using a variety of measures. A pooled analysis of dichotomous condom use measures was conducted, with selection based on any of the following in order of preference: consistent condom use (variably defined), condom use at last intercourse, any condom use,and condom used at first intercourse with new partners. Female condom use was included for this outcome and was reported in 1 trial.14

Stata version 15.1 (StataCorp LP) was used for all analyses. All significance testing was 2-sided, and results were considered statistically significant at P < 0.05.

The strength of evidence was rated for each KQ based on consistency (similarity of effect direction and size), precision (degree of certainty around an estimate), reporting bias (potential for bias related to publication, selective outcome reporting, or selective analysis reporting), and study quality (ie, study limitations).

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Two reviewers evaluated 4649 citations and 273 full-text articles against inclusion criteria, and 39 studies (62 articles)14-75 met inclusion criteria for this systematic review (Figure 2). Twenty-two studies (20 RCTs;14,17-20,23-25,28,30-32,36,38,45-47,49,50,53 2 nonrandomized controlled intervention studies42,51) were carried forward from the previous USPSTF report, and 17 new RCTs15,16,55,58-61,66-75 were identified for inclusion (Table 1, Table 2, Table 3, Table 4). The newly available studies included 4 conducted among adolescents,58,67,72,74 5 conducted among a mix of adolescents and young adults,59,61,68,71,75 and 1 focused solely on young adults.55 The remaining 7 enrolled mostly adults and spanned a wider age range.15,16,60,66,69,70,73 Among the studies of adults and mixed-age populations, the mean age of participants was younger than 30 years in most studies, and none reported a mean age of 40 years or older. Thus, among studies that included adults, young adults (ie, aged 18-25 years) were most often recruited. Of the 39 included studies, 35 (90%) tested intervention effectiveness among individuals at an increased risk for an STI, including some participants with a recent STI diagnosis. Characteristics used to identify trial participants at increased risk for acquiring an STI included demographic characteristics associated with higher prevalence of STI in the US (eg, aged 15 to 24 years, African American race, Hispanic ethnicity), self-reported sexual and behavioral factors associated with STI risk (eg, men who have sex with men [MSM], multiple partners, unprotected intercourse), and personal health history (eg, recent STI or visit to STI clinic).

Most interventions were conducted in the following health care settings: general primary care, obstetrics and gynecology, STI clinics, women’s health clinics, adolescent medicine, and family planning clinics. Nine studies20,31,47,49,51,55,60,71,75 included a low–contact time intervention group (<30 minutes), 1315-17,24,28,36,38,42,45,46,61,68,69 included a moderate–contact time intervention group (30-120 minutes), and more than half (21/39 [54%])14,17-20,23,25,30-32,50,53,58,59,66-68,70,72-74 tested a high–contact time intervention group (>2 hours). The most common therapeutic approach in the included interventions was motivational interviewing,76,77 which was used in 11 studies;16,19,20,23,36,46,69,72,74,75 another 7 studies used cognitive behavioral therapy approaches.17,30,50,53,68,72,73,78 Group counseling was the most common intervention component and was used in 25 intervention groups. Group counseling was frequently paired with other treatment components, such as individual counseling, videos, video games, or telephone contact. In most studies of group counseling, participants were of the same gender. Fourteen of the intervention groups primarily involved mobile-phone text or computer interventions, and all but 2 of these involved low or moderate contact times ranging from 5 to 90 minutes.15,16,19,45,55,60,61,67,69,71,74,75

Benefits on Health Outcomes

Key Question 1. Do behavioral counseling interventions that aim to decrease risky sexual behaviors or increase protective behaviors, or both, reduce sexually transmitted infections (STIs) or related morbidity and mortality?
Key Question 1a. Does the effectiveness of behavioral counseling interventions differ for subpopulations (eg, defined by age, STI history, sexual orientation, gender, pregnancy status)?
Key Question 1b. Does the effectiveness of behavioral counseling interventions differ by intervention characteristics (eg, intensity or mode)?

No studies reported intervention effects on STI morbidity or mortality, but 21 included studies16,17,20,23-25,30-32,36,38,42,45,46,50,51,53,60,61,69,75 (n = 59,328) reported on the effectiveness of behavioral interventions for preventing STI, nearly all were conducted among populations at increased risk (20/21 [95%]), and 19 reported measures that could be combined for meta-analysis. These interventions were significantly associated with a lower incidence of STI at follow-up, most often reported at 6 to 12 months, with an overall pooled OR of 0.66 (95% CI, 0.54-0.81; I2 = 74%; n = 52,072) (Figure 3). Only 4 studies16,36,38,69 reported higher absolute STI rates in the control condition, but the rates were not significantly different from rates in the intervention groups. STI incidence rates were highly variable across studies; control group rates ranged from 0% to 50%, while intervention group rates ranged from 0% to 37%. Statistical heterogeneity was substantial, and there was also considerable clinical heterogeneity, particularly in terms of populations and intervention characteristics. Planned subgroup comparisons were conducted to examine sources of heterogeneity (described below). A sensitivity analysis excluding a study of bacterial vaginosis prevention among lesbian and bisexual women did not change the overall result (pooled OR, 0.65 [95% CI, 0.52-0.80]; I2 = 75.3%; 18 studies).

Rigorous tests of intervention effectiveness for different subpopulations within trials were not reported. One trial51 reported several prespecified exploratory subgroup comparisons but did not test for interactions or account for multiple comparisons, while other trials presented post hoc exploratory subgroup comparisons67 or secondary analyses on a subset of trial participants.25 Instead, most of the included evidence focused exclusively on a specific subpopulation defined by sex, age, sexual history, pregnancy status, and racial/ethnic identity. Some subpopulations were not well-represented in the body of evidence; for example, only 2 included studies32,69 recruited participants for interventions occurring during pregnancy. Many of the interventions designed for specific subpopulations were found to be effective, such as those for African American and Latina adolescents, adult minority women, and mixed-gender populations making visits to STI clinics. Trials among men, adolescent boys, MSM, and average risk populations were not well-represented in the body of evidence. Based on meta-regression tests for subgroup effects for STI prevention, larger effect sizes were associated with studies conducted among adolescents (P = 0.002), high-contact interventions (more than 2 hours compared with 2 hours or less) (P = 0.02), or group counseling sessions (P = 0.02). Overall, subgroup comparisons tended to include few studies in at least 1 category, and confounding of study population and intervention characteristics limited conclusions about which specific factors were responsible for intervention effectiveness.

Benefits on Behavioral Outcomes

Key Question 2. Do behavioral counseling interventions decrease risky sexual behaviors or increase protective behaviors that can reduce the risk of STIs?
Key Question 2a. Does the effectiveness of behavioral counseling interventions differ for subpopulations (eg, defined by age, STI history, sexual orientation, gender, pregnancy status)?
Key Question 2b. Does the effectiveness of behavioral counseling interventions differ by intervention characteristics (eg, intensity or mode)?

In total, 34 studies (n = 21,471) contributed evidence on the effectiveness of behavioral counseling interventions in changing a variety of sexual risk and protective behaviors. Like the studies reporting STI outcomes, most of included evidence (30/34 [88%]) was from studies of people at increased risk for STI. Follow-up time in the studies reporting behavioral outcomes ranged from 3 to 14 months (mode, 12 months), and for the few studies reporting extended follow-up beyond 1 year, effects tended to diminish. Statistical heterogeneity was modest, but clinical heterogeneity was high because of the diverse populations and intervention approaches. Behavioral outcomes were not consistently reported, and measures were variable.

Eighteen14,15,17,18,24,25,31,32,45-47,49,55,58,61,68,70,74 studies reported on the effectiveness of behavioral interventions for condom use. Of these, 13 studies14,17,24,25,31,45,47,49,55,58,61,70,74 (n = 5253) reported dichotomous condom-use outcomes with measures that were pooled for meta-analysis (Table 5). The pooled result across these studies suggested that the intervention was associated with a higher odds of condom use (OR, 1.31 [95% CI, 1.10-1.56]; I2 = 40%) (Table 5).The percentage reporting condom use varied depending on the measure reported (eg, condom use at last sex, consistent condom use). Absolute differences between groups ranged from –7% to 27%. Eight17,24,25,31,32,45,46,61 of the studies reporting condom use outcomes also reported STI incidence, and the direction and statistical significance of effects were internally consistent; studies with higher levels of reported behavioral changes found greater reductions in STI diagnoses.

Twenty-one studies (n = 13,665) reported a measure of unprotected intercourse. Of these, 14 studies (n = 9183)15,16,19,20,24,25,30-32,38,58,67,70,73 reported the number of times participants engaged in unprotected sexual intercourse or intercourse without a condom over various time frames, with different degrees of specificity regarding the type of partner or sexual intercourse act. When combined to estimate an overall association, there was a small but statistically significant difference between groups. Fewer unprotected intercourse occasions were reported among those assigned to the intervention conditions (pooled mean difference, –0.94 [95% CI, –1.40 to –0.48]; I2 = 16%) (Table 5).

Other behavioral outcomes, such as the number of sexual partners and sexual abstinence, were reported by fewer studies and tended to be consistent with effects seen for other reported outcomes. Only 1 trial tested an intervention aimed at reducing future STI risk before the onset of sexual activity. The moderate–contact-time trial (Families Talking Together) enrolled male and female Hispanic or African American adolescents and their mothers at the time of a pediatric care visit and supported parental communication and education about sexual health.28 At 9 months of follow-up, a lower proportion of adolescents in the intervention group reported ever having had sexual intercourse compared with the control group (6.8% vs 22.2%, P < 0.05 as reported in primary study).

Evidence on potential subpopulation differences available from within-trial comparisons was limited for the same reasons described above for STI outcomes. Comparisons of effect differences at the study level were not conducted for self-reported behavioral outcomes due to inconsistency in the outcome measures and the relatively small numbers of studies available for subgroup meta-regression analysis

Harms

Key Question 3. What potential harms are associated with behavioral counseling interventions to reduce STI infections?

Few studies reported potential adverse consequences related to the STI-prevention behavioral interventions that were evaluated, and no evidence of statistically significant intervention harms was identified. Seven trials (n = 3458) reported potentially adverse consequences that might theoretically arise from the behavioral interventions evaluated.17,25,32,45,61,66,75 A study conducted among adolescents and young adults that involved a text-messaging intervention reported 3 driver-caused road traffic crashes related to texting: 2 in the intervention group and 1 in the control group. The study was too small to permit estimation of the difference with any precision, and it was unclear whether the texting associated with the accidents was study related. No other studies relying on text-messaging interventions reported adverse events related to driving and texting.

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This evidence report reviewed studies on behavioral counseling interventions to prevent STIs; the evidence is summarized by KQ in Table 6. An individual’s risk of acquiring an STI is influenced by many factors, including their sexual practices; relationship dynamics (eg, power and communication); skills, ability, and willingness to engage in health protective behaviors; and the prevalence of untreated STI in their social networks and community. For those at increased risk, behavioral counseling interventions provided in or referred from primary care settings can be effective in changing sexual risk and protective behaviors, lowering the risk of STI diagnosis for up to 1 year.

The randomized trials included in this review recruited participants at increased risk based on their reported sexual risk behaviors, history of STIs, and sociodemographic risk factors, including age and race/ethnicity. Most trials were focused on the prevention of STIs from heterosexual intercourse, with a few exceptions.36,67,73 Increasing the use of male condoms during sex and reducing unprotected sexual intercourse was a primary aim of most interventions. Group and individual counseling provided by trained facilitators or health professionals were commonly included components of interventions, tending to involve more than 2 hours of contact time over the course of several weeks or months. Counseling interventions involving more than 2 hours of contact time may be associated with larger reductions in diagnosed STI at follow-up, although confounding of intervention and population characteristics limited conclusions that could be drawn about differences in effectiveness. Other reviews that have focused on different settings, study designs, and populations in evaluating STI behavioral counseling interventions have reported beneficial effects in a comparable range.79-81

Compared with the 2014 USPSTF review,8 this review included 17 new studies15,16,55,58-61,66-75 and broadly supports the previous conclusions.82 Of the 17 additional studies contributing evidence to this update, just 5 reported STI diagnosis outcomes.16,60,61,69,75 Three of these 5 studies were low– or moderate–contact time interventions using tailored computer-based75 or text messages61 delivered to male and female adolescent and young adult populations or, in the case of a small trial in Great Britain (Men’s Safer Sex), a 10-minute website visit intervention for adult men.60 The previous USPSTF review called for the development and testing of less time-intensive and media-based interventions that might be applicable to broader populations. It is encouraging that there were new studies evaluating low– and moderate–contact time interventions available for the current review. Effect sizes of the newly added low- and moderate-contact interventions were comparable in size to effects seen in high-contact trials and contributed to the overall estimate of the effectiveness of behavioral interventions for STI prevention. Overall, however, the evidence on STI prevention in this review was primarily from previously included trials,23-25,30,31,42,50,51,53 and most of these were high–contact time interventions focused on narrowly defined populations at increased risk for STIs.

Many studies reported outcomes at 12 or more months of followup, including several that reported statistically significant differences at 6 months that were no longer observed at 12 months. Thus, for studies reporting shorter follow-up times, it is possible that observed effects would have diminished with longer observation. The sustainability of the intervention effects observed in this review is unclear. Establishing new sexual habits and skills may have lasting effects or may require reinforcement to have continued health benefits. A comparative effectiveness study that was not included in this review, but that tested an adaptation of an included intervention,25 found that ongoing telephone reinforcement was effective for maintaining STI prevention benefits for African American adolescents receiving the HORIZONS intervention.83,84

The review was designed to identify evidence for interventions that can be feasibly implemented in or referred from US-based primary care health care settings. A broader body of evidence on STI prevention programs in the US and globally provides evidence on prevention strategies beyond this context. For example, evidence on interventions evaluated among people identified through social groups or institutions was not reviewed (eg, schools, churches, worksites), so an effective intervention with Latino MSM that recruited individuals from social settings such as bars or dance clubs and involving recruitment of friends was not included.85 Thus, the absence of studies for some important populations at increased risk for STI in this review does not necessarily mean there are no effective interventions available. Other resources, such as the Community Guide of the Community Preventive Services Task Force,86 provide reviews on effective community-based STI prevention programs.

Clinician risk assessments are necessary when ascertaining the eligibility of patients at increased risk of STIs for behavioral counseling interventions, yet few of the included studies incorporated risk assessment by primary care clinicians into the study design. Tests of interventions among populations of patients identified using defined STI risk assessment procedures could strengthen the applicability of evidence to primary care populations. Given that there may be considerable variation in sexual history–taking practices in primary care, the implementation of behavioral counseling interventions for populations at increased risk will likely require greater attention to this aspect of clinician training and health care delivery. There also remains a need for research on lower-intensity behavioral interventions that could be applied in primary care settings serving patients across a range of levels of STI risk. Pragmatic studies in health systems could provide important evidence on intervening in the context of routine primary care, especially when patients screen positive for an STI or report sexual risk behaviors such as multiple concurrent partners and unprotected intercourse.

One included trial was implemented in a pediatric health care setting and found to be effective for delaying self-reported initiation of sexual intercourse. The Families Talking Together intervention enrolled mother-child dyads and was designed for African American and Hispanic youth before they became sexually active.28 A trial replicating these results among a larger sample of Hispanic, African American, and mixed-race youth published in May 2020 was identified in ongoing surveillance of the literature and provides additional evidence that the intervention was effective for reducing self-reported behavioral risk factors for STI (ie, time to sexual debut, condom use).87 The included literature primarily evaluated intervention effectiveness within narrowly defined population groups (such as African American women or adolescent girls), and it is unknown whether the reported effect estimates would also be observed for the interventions if adapted to other populations. Most studies primarily included heterosexual participants at increased STI risk. Several groups that can experience increased risk for STIs were underrepresented in the evidence, however, including older adults, gay boys and men, and transgender populations. There also were only 2 studies in this review conducted among pregnant women, despite the clinical importance of preventing vertical transmission of STIs and complications that can be associated with STIs during delivery. Recent reports of a steep increase in mortality from congenital syphilis heighten the urgency of identifying pregnant individuals at increased risk and providing effective preventive interventions, as well as STI screening and treatment during pregnancy.3 Notably, none of the effectiveness trials eligible for this review enrolled sexual partner dyads despite the recognized role of interpersonal communication and relationship factors in STI risk.88,89

Limitations

This review has several limitations. First, studies that assessed the comparative effectiveness of different types of behavioral counseling interventions were not included because the topic scope was informed by the USPSTF Procedure Manual.9 Accordingly, the review was designed to support a recommendation based on intervention efficacy, and several studies were excluded because they did not include a usual-care or no-intervention control condition. Some excluded studies focused on high-risk populations not well-represented in the included body of evidence, such as African American boys and men,90,91 MSM,92-96 bisexual Black men,97,98 transgender women,99 and homeless young adults.100 In addition, relatively few of the included studies were replications or adaptations of effective interventions.42

Second, this review focused on interventions evaluated in the past 20 years, more than one-third of which were published prior to 2010. Changes in sexual risk behaviors and risks during this period may have implications for the applicability of the body of evidence. The development of effective treatments and a prophylactic agent for HIV infection may have shifted population risk perceptions. In addition, the emergence of social networking and dating app platforms has altered the landscape that defines sexual networks and sexual practices.101 Since adolescents and young adults have the highest rates of STI, research is needed to develop interventions addressing the current sexual, social, and interpersonal contexts that emerging adolescents and young adults will navigate.

Third, a variety of measures of condom use were reported across the trials, limiting estimation of pooled effects for behavioral outcomes. STI prevention generally requires consistent condom use, but many of the studies evaluated reported condom use only at last sex or whether condoms were ever used. Furthermore, behavioral outcomes were self-reported and subject to recall bias, Hawthorne effects, and social desirability bias.79,102,103 Nevertheless, in studies reporting the incidence of diagnosed STIs, results for behavioral measures were generally consistent in the degree and direction of effects.

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Behavioral counseling interventions for individuals seeking primary health care were associated with reduced incidence of STIs. Group or individual counseling sessions lasting more than 2 hours were associated with larger reductions in STI incidence, and interventions of shorter duration also were associated with STI prevention, although evidence was limited on whether the STI reductions associated with these interventions persisted beyond 1 year.

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Source: This article was first published online in the Journal of the American Medical Association on August 18, 2020 (JAMA. 2020;324(7):682-699. doi:10.1001/jama.2020.10371).

Conflict of Interest Disclosures: None reported.

Funding/Support: This research was funded under contract HHSA-290-2015-000017-I, Task Order No. 5, from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services.

Role of the Funder/Sponsor: Investigators worked with USPSTF members and AHRQ staff to develop the scope, analytic framework, and key questions for this review. AHRQ had no role in study selection, quality assessment, or synthesis. AHRQ staff provided project oversight, reviewed the report to ensure that the analysis met methodological standards, and distributed the draft for peer review. Otherwise, AHRQ had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript findings.

Additional Information: A draft version of this evidence report underwent external peer review from 4 content experts (Errol Lamont Fields, MD, PhD, Johns Hopkins University School of Medicine; Marie Harvey, DrPH, MPH, Oregon State University; Ralph DiClemente, PhD, New York University; Michelle Ybarra, PhD, MPH, Johns Hopkins University School of Medicine); and 3 federal partners: the Centers for Disease Control and Prevention, US Food and Drug Association, and National Institutes of Health. Comments were presented to the USPSTF during its deliberation of the evidence and were considered in preparing the final evidence review.

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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 or increase protective behaviors, or both, reduce sexually transmitted infections (STI) and/or morbidity and mortality (Key Question 1). Additionally, the figure illustrates how behavioral counseling interventions lead to decreased risky sexual behaviors or increased protective behaviors that can reduce the risk of STI (Key Question 2) and any related harms associated with these interventions (Key Question 3).

Evidence reviews for the US Preventive Services Task Force (USPSTF) use an analytic framework to visually display the key questions that the review will address to allow the USPSTF to evaluate the effectiveness and safety of a preventive service. The questions are depicted by linkages that relate interventions and outcomes. A dashed line indicates a health outcome that immediately follows an intermediate outcome. See the USPSTF Procedure Manual9 for interpretation of the analytical framework.

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This figure is a flow chart that summarizes the search and selection of articles in the review. There were 4,583 citations identified through literature databases. An additional 4 citations were identified from outside sources such as reference lists and suggestions from peer reviewers, and 62 citations were from the 2014 USPSTF Behavioral Counseling to Prevent Sexually Transmitted Infections review. After duplicates were removed, 4,649 unique citations were screened at the title/abstract stage. The full text of 273 citations were examined for inclusion for one or more of the Key Questions. The following number of studies were included for Key Question 1 (k=21), Key Question 2 (k=34), Key Question 3 (k=7). Reasons for excluding the other articles are available in Appendix D.

KQ indicates key question.
a Relevance: Study aim not relevant. Design: Not a randomized clinical trial or controlled clinical trial. Not primary data: eg, editorials, narrative reviews. Setting: Excluded on the basis of setting alone (eg, emergency departments, research laboratories, school classrooms, worksites, inpatient/residential departments). Population: limited to populations requiring specialized health care or interventions to address sexually transmitted infection (STI) health risks. Intervention: Not linked to health care (eg, STI testing only, sexual abuse prevention, cash and reward-based incentives, preexposure prophylaxis, or vaccine only). Comparator: Control group received active intervention. Outcomes: No relevant outcomes or self-reported STI. Poor quality: Study was poor quality. Country: Not a country with a very high Human Development Index ranking.
b Included studies may appear in more than 1 key question.

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Figure 3 depicts the studies included in the evidence review, organized by age group and risk for sexually transmitted infection, as well as the intervention contact times and Key Question 1 outcome (STI).

Dashed line indicates the overall measure of effect. Confidence intervals were estimated with the DerSimonian and Laird method. NR indicates not reported.
a Total intervention contact time categorized as high (>120 minutes), moderate (30 to 120 minutes), and low (<30 minutes).
b Study participants ranged in age from 12 to 19 years.
c Study participants ranged in age from 12 to 25 years or study included adolescents and adults with population mean age younger than 25 years.
d Study participants ranged in age from 18 to 25 years only or study enrolled adults of all ages with population mean age younger than 25 years.
e Study participants 18 years and older or enrolled broad age-range population with mean age older than 25 years.

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Source Study quality Country, recruitment setting No. randomized, population
description
Intervention name (description) Mean age (range), y Female, % Race/ethnicity, % Sexual and STI history, %
Bai et al,72 2018 Good US; primary care clinic, community-based health clinic 187 Adolescents aged 13-18 y with depressive symptoms Healthy Teens (ten 60-min in-person sessions) 16.1
(13-18)
57.0 White: 8.6
Black: 11.3
Hispanic: 73.1
Other: 7.0
NR
Champion and Collins,23 2012 Fair US; community-based health clinic 559 African and Mexican American adolescent women, aged 14 to 18 y, history of abuse or STI Project SAFE (two 3-4–h group counseling sessions, 2 or more individual counseling sessions, 3-5 optional support group sessions) 16.5
(14-18)
100 Black: 16.4
Hispanic: 83.6
Sexual abuse history: 58.9
Mean lifetime No. of male partners: 7.2
Lifetime STIb: ≈100
DiClemente et al,25 2004 Good US; community-based health clinic 522 African American adolescent girls, aged 14-18 y, reported vaginal intercourse in past 6 mo HORIZONS (four 4-h group counseling sessions) 16.0
(14-18)
100 Black: 100 History of nonconsensual sex: 13.9
Baseline Chlamydia trochomatis: 17.4
Baseline gonorrhea: 5.2
Baseline trichomoniasis: 12.6
Guilamo-Ramos et al,28 2011 Fair US; community-based health clinic 264 Mother-child dyads, African American or Latino/a adolescents aged 11-14 y, resident mother attending child's health care visit Mother received one 30-min individual counseling session + program manual + 2 telephone calls 12.9 (NR) 52.3 Black: 15.5
Hispanic: 84.5
Sexually active: 6.4
Jemmott et al,30 2005 Good US; hospital- based adolescent medicine clinic 682 Sexually experienced African American and Latina adolescent women aged 12-19 y Intervention 1: one 250-min group counseling session, skills-based

Intervention 2: one 250-min group counseling session, information-based

15.5
(12-19)
100 Black: 67.9
Hispanic: 32.1
Unprotected sex in past 3 mo: 52.0
Multiple sex partners in past 3 mo: 16.0
Baseline STI: 21.6
Morrison-Beedy et al,58 2013 Good US; school health clinic, community-based health clinic, hospital-based adolescent medicine clinic, general community 639 Adolescent females aged 15-19 y, majority low-income African American HIPTeens (four 120-min information-motivation behavioral group counseling sessions + two 90-min group counseling sessions) 16.4
(15-19)
100 White: 8.0
Black: 73.0
Hispanic: 16.0
Other: 20.0
Sex in past 3 mo: 100
Mean age of first sex: 14.4 y
Redding et al,74 2015 Good US; family planning clinic, community-based health clinic 828 Adolescent females Step by Step (four 25-min computer sessions followed by individual counseling) 16.4
(14-17)
100 White: 7.8
Black: 83.9
Asian: 0.8
Alaska Native/Native American: 1.5
Hispanic: 7.8
Had vaginal or anal sex: 95.9
Mean total No. of sex partners: 5.0
Baseline syphilis: 1.7
Baseline gonorrhea: 10.4
Baseline Chlamydia trochomatis: 20.6
Ybarra et al,67 2017 Good US; advertisements or media 302 Adolescent cisgender males aged 14-18 y, identify as gay, bisexual, or queer Guy2Guy (text messages 5-10 times/d for five consecutive wk + text messages for 1 wk) NR (14-18) 0 White: 67.1
Black: 14.8
Other: 18.0
Ever had sex: 70.0

Abbreviations: NR, not reported; STI, sexually transmitted infection.
a All studies were randomized clinical trials.
b Participants recruited based on history of STI or abuse.

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Source Study quality Country, recruitment setting No. randomized, population
description
Intervention name (description) Mean age (range), y Female, % Race/ethnicity, % Sexual and STI history, %
Berenson and Rahman,17
2012
Fair US; prenatal or OB/GYN 1155 Sexually active women, aged 16-24 y, not pregnant, seeking oral contraception Intervention 1: one 45 min, individual, clinic-based counseling session +>6 telephone calls

Intervention 2: one 45 min, individual, clinic-based counseling session

19.9
(16-24)
100 White: 24.8
Black: 18.6
Hispanic: 54.2
Other: 2.3
Mean sex partners in past 12 mo: 1.6
Lifetime STI: 26.1
Costa et al,68 2017 Fair Portugal; family planning clinic 177 Women 16 to 26 y of age at high risk for STI Intervention 1: six 120-min group counseling sessions

Intervention 2: two 15-min individual counseling sessions, informational

20.0
(16-26)
100 White: 93.8 NR
Free et al,61 2016 Fair UK; STI clinic, university health clinic 200 People aged 16-24 y, diagnosed with STI or reporting >1 partner in past year and condomless sex 49 to 63 text messages tailored to participant characteristics (gender, STI) 20.5
(16-24)
70.0 White: 57.0
Black: 26.5
Asian: 1.0
Other: 15.5
>2 sex partners in past 12 mo: 92.5
Baseline STI: 44.5
Kershaw et al,32 2009 Fair US; prenatal or OB/GYN 712 Pregnant adolescent and young women without serious medical problems, aged 14 to 25 y Centering Pregnancy Plus (ten 120-min group counseling sessions) 20.4
(14-25)
100 White: 6.0
Black: 80.0
Hispanic: 13.0
Other: 1.0
NR
Peipert et al,45 2008 Fair US; primary care clinic, family planning clinic, prenatal or OB/GYN, advertisements or media 542 Sexually active adolescent and young women aged 13-24 y and women aged 25-35 y at “high risk”
for STI or unintended pregnancy; desire to avoid pregnancy in next 2 y
Three 30-min individually tailored web-based sessions 22.0
(13-35)
100 White: 45.0
Black: 26.0
Hispanic: 17.0
Other: 12.0
>11 lifetime sex partners: 28.0
>2 sex partners in past 1 mo: 15.0
Forced sex in past 12 mo: 10.0
Lifetime STI: 47.0
Sanci et al,59 2015 Fair Australia; primary care clinic 901 Healthy youth aged 14-24 y Clinicians received 9 h of training +2 practice visits NR (14-24) 75.7 75.7 NR NR
Shafii et al,75 2019 Fair US; STI clinic, advertisements or media 272 Adolescents and young adults aged 14-24 y with a history of risky sexual behavior e-KISS (1 computer-based tailored feedback session) 21.0
(15-24)
64.7 White: 37.4
Black: 34.1
Asian: 10.0
Alaska Native/Native American: 2.2
Hispanic: 7.0
Other: 9.3
Any oral sex given in past 2 mo: 75.0
Any receptive oral sex in past 2 mo: 80.9
Any anal sex (given or received) in past 2 mo: 14.7
Median (range) No. of vaginal sex partners in past 12 mo: 3 (1-120)
Lifetime sex while drunk or high: 83.5
Lifetime exchange drugs or money for sex: 7.8
Lifetime STI: 53.3
Baseline gonorrhea: 2.6
Baseline Chlamydia trochomatis: 11.8
Shain et al,50 2004 Fair US; STI clinic 775 Mexican-American and African American women aged 15-45 y, STI diagnosis Intervention 1: one individual counseling session + three 3-h group counseling sessions + option to attend five 90-min group counseling sessions

Intervention 2: one individual counseling session + three 3-h group counseling sessions

21.0
(15-45)
100 Black: 23.2
Hispanic: 76.8
>1 sex partner in past 3 mo: 25.7
Baseline STI: 100
Baseline Chlamydia
trochomatis
: 77.8
Baseline syphilis: 4.6
Whiteley et al,71 2018 Fair US; general community 60 Sexually active adolescents and young adults aged 15-24 y Eight emails containing 19 links to internet content 18.6
(15-24)
38.0 Black: 52.0
Hispanic: 36.0
NR

Abbreviations: e-KISS, electronic-KIOSK Intervention for Safer Sex; NR, not reported; OB/GYN, obstetrics/gynecology; STI, sexually transmitted infection.
a All studies were randomized clinical trials except Sanci et al59 (cluster RCT).

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Source Study quality Country, recruitment setting No. randomized, population
description
Intervention name (description) Mean age (range), y Female, % Race/ethnicity, % Sexual and STI history, %
Ehrhardt et al,14 2002 Good US; women’s health clinic 360 Sexually active women, aged 18 to 30 y Intervention 1: eight 2-h group counseling sessions

Intervention 2: four 2-h group counseling sessions

22.3
(18-30)
100 Black: 72.5
Hispanic: 16.9
Other: 10.6
>2 current male partners 23.4
STI past 3 mo: 16.9
Lifetime STI: 58.3
Lewis et al,55 2019 Fair US; advertisements or media, general community 402 Sexually active young adults aged 18-25 y, report drinking alcohol Intervention 1: one 5-min computer web-based personalized feedback session

Intervention 2: one 5-min computer web-based integrated personalized feedback session

22.4
(18-25)
54.0 White: 68.0
Black: 11.0
Asian: 8.0
Alaska
Native/Native
American: 1.0
Hispanic: 14.0
Other: 12.0
NR
Metsch et al,38 2013 Good US; STI clinic 5012 Adults aged ≥18 y One 30-min individual counseling session + HIV testing NR (NR) 34.0 White: 31.8
Black: 41.9
Hispanic: 15.3
Other: 11.1
Predicted mean number unprotected sex acts in past 6 mo: 23.2
Predicted mean number of sex partners in past 6 mo: 4.6
Baseline STI: 44.3
Baseline HIV: 1.1
Proude et al,47 2004 Fair Australia; primary care clinic 312 Young adults aged 18-25 y One 15-min physician counseling session + informational resource pamphlets, 2 condoms, lubricant NR
(18-25)
71.0 NR Ever had sexual partner: 78
Scholes et al,49 2003 Fair US; primary care clinic 1210 Sexually active women aged 18-24 y, not sexually monogamous, at risk for HIV/AIDS 2 tailored print mailings 21.0
(18-25)
100 White: 69.0
Black: 19.0
Other: 12.0
>2 sex partners in past 12 mo: 56.5
Lifetime STI: 27.0
Wingood et al,53 2013 Good US; primary care clinic 848 African American women aged 18-29 y Two 4-h group counseling sessions 22.0
(18-29)
100 Black: 100 Baseline STI: 17.0
Baseline CT: 10.4

Abbreviations: NR, not reported; STI, sexually transmitted infection.
a All studies were randomized clinical trials

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Source Study quality Country, recruitment setting No. randomized, population
description
Intervention name (description) Mean age (range), y Female, % Race/ethnicity, % Sexual and STI history, %
Bailey et al,60 2016 Good UK; STI clinic 176 Men aged ≥16 y Men’s Safer Sex (one 10-min website visit) 29.4 (≥16) 0 White: 69.2
Black: 14.5
Asian: 7.5
Other: 8.2
Baseline STI: 3.4
Berkman et al,18 2007 Good US; behavioral health clinic 149 Men aged 18 to 59 y, psychiatric outpatients with severe mental illness diagnosis and history of psychosis e-SexG (thirteen 60-min group counseling sessions) 38.6
(18-56)
0 White: 11.0
Black: 54.0
Hispanic: 28.0
Other: 7.0
NR
Billings et al,15 2015 Fair US; community-based health clinic 83 African American women, aged 18-50 y, at high risk for STI Safe Sistah (1 computer-based educational session) 35.1
(18-50
100 Black: 100 >1 sexual partner in past 2 mo: 34.5
Carey et al,19 2004 Fair US; community-based health clinic 268 Women and men, aged ≥18 y, psychiatric outpatients with alcohol or drug use in the past year Ten group counseling sessions 36.5 (≥18) 54.0 White: 67.0
Black: 21.0
Other: 12.0
Lifetime STI: 38.0
Carey et al,20 2010 Fair US; STI clinic 1483 Women and men, aged ≥18 y, sexual risk behavior in past 3 mo, willing to be tested for HIV Intervention 1: one 15-min individual counseling session + 4-h intensive motivational, behavioral, skills workshop

Intervention 2: one 15-min individual
counseling session + 4-h intensive informational workshop

Intervention 3: one 15-min individual counseling session

Intervention 4: one 15-min informational video + 4-h intensive informational workshop

Intervention 5: one 15-min informational video + 4 h intensive motivational, behavioral, skills workshop

29.2 (≥18) 46.4 White: 24.3
Black: 63.9
Hispanic: 8.7
Other: 11.9
Lifetime history of sex trade: 22.0
Age at first intercourse <13 y: 18.0
Baseline STI: 18.1
Carey et al,16 2015 Fair US; STI clinic 1010 Men and women aged ≥16 y, sexual risk behavior in past 3 mo Intervention 1: one 22-min video + sexual health questionnaire

Intervention 2: one 22-min video + general health questionnaire

Intervention 3: one 22-min video + sexual health questionnaire

28.5 (NR) 44.0 White: 19.0
Black: 69.0
Hispanic: 8.0
Other: 13.0
>1 concurrent sexual partners in past 3 mo: 47.0
Jemmott et al,31 2007 Good US; women’s health clinic 564 Sexually experienced African American women, aged 18-45 y Sister-to-Sister (one 200-min group counseling session, skills-based; one 200-min group counseling session, information-based; one 20-min individual counseling session,
skills-based; one individual, 20-min counseling session, information-based)
27.2
(18-45)
100 Black: 100 Baseline STI: 20.3
Marrazzo et al,36 2011 Fair US; advertisements or media 89 WSW aged 16-30 y, positive bacterial vaginosis diagnosis,
reported sex with woman in past 60 d
One 30-min individual counseling session 25.4
(16-30)
100 Black: 8.0 >1 female sex partner: 24.7
Baseline bacterial vaginosis: 100
Mittal et al,66 2017 Fair US; community-based health clinic, women’s health clinic, community agencies 55 Women aged ≥18 y, history of intimate partner violence SUPPORT (three 135-min individual counseling sessions + five 135-min group counseling session 34.5
(18-49)
100 White: 33.0
Black: 51.0
Other: 16.0
Median No. of lifetime sex partners: 19.0
Mean episodes unprotected sex in past 3 mo: 21.0 (SD, 27.2)
Neumann et al,42 2011 Fair US; STI clinic 3365 Adults aged ≥18 y VOICES/VOCES (one 45-min group counseling session) 29.3
(18-71)
51.5 White: 0.8
Black: 40.1
Hispanic: 50.9
Other: 8.2
Baseline STI: 22.2
O’Cleirigh et al,73 2019 Fair US; community-based health clinic, advertisements or media 43 Adult MSM with a history of childhood sexual abuse HIV/STI counseling and testing + 10 in-person therapy sessions 39.2 0 White: 62.8
Black: 25.6
Hispanic: 7.0
Other: 4.7
NR
Peragallo Montano et al,70 2019 Fair US; community-based health clinic, advertisements or media, community agencies 320 Refugee and immigrant Hispanic women (>95% born outside US) aged 18-50 y with any recent sexual activity SEPA (three 2.5-h sessions) 35.5
(18-50)
100 Hispanic: 10 Any sexual activity in past 3 mo: 100
Petersen et al,46 2007 Fair US; primary care clinic 764 Women aged 16-44 y at risk of unintended pregnancy WRAP (1 individual counseling session + follow-up telephone call or visit) NR (16-44 100 White: 62.0
Black: 27.0
Other: 10.0
Sex in past 30 d: 70.0
Tzilos Wernette et al,69 2018 Fair US; prenatal or OB/GYN 50 Pregnant women at risk for STI/HIV and alcohol/drug use One 60-min computer session + one 15-min booster session 24.4 100 White: 30.0
Black: 26.0
Alaska
Native/Native
American: 4.0
Hispanic: 32.0
Other: 40.0
NR
Warner et al,51 2008 Good US; STI clinic 40,282 Individuals making visits to STI clinics Safe in the City (one 23-min video + educational pamphlets and condoms) NR (NR) 30.0 Black: 18.5
Hispanic: 25.0
White: 46.0
Other: 11.0
Baseline STI: 15.5

Abbreviations: e-SexG, Enhanced Sex, Games, and Videotape; MSM, men who have sex with men; NR, not reported; OB/GYN, obstetrics/gynecology; SEPA, Salud, Educacion, Prevencion y Autocuidado; STI, sexually transmitted infection; SUPPORT, Supporting Positive and Healthy Relationships; VOICES/VOCES, Video Opportunities for Innovative Condom Education and Safer Sex; WRAP,Women's Reproductive Assessment Program; WSW, women who have sex with women.
a All studies were randomized clinical trials except Neumann et al42 (nonrandomized controlled intervention study) and Warner et al51 (nonrandomized controlled intervention studies).
b Four studies did not exclude adolescents but primarily recruited adults, and the mean age in the study populations was older than 25 years.

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Outcome Total No. Type of outcome
measure
Pooled effect estimate
(95% CI)a
No.b I2, % τ2 Effect rangec
Studies Participants Studies Participants
Condom use 18 9205 Dichotomous (eg, consistent, at last sex) OR, 1.31 (1.10 to 1.56) 13 5253 39.9 0 0.54 to 5.08
Continuous (eg, proportion of sexual intercourse with condom use) MD, 10.75 (1.01 to 20.50) 7 2920 79.2 79.4 −8.42 to 27.88
SMD, 0.34 (0.06 to 0.63) 7 1914d 78.9 0.1 −0.24 to 0.73
Unprotected intercourse 21 13,665 Continuous (eg, No. of unprotected sex acts/ episodes per d) SMD, −0.11 (−0.19 to −0.03) 14 9183 58.8 0 −0.71 to .25
MD, −0.94 (−1.40 to −0.48) 14 9183 16.4 0.1 −11.90 to 4.50

Abbreviations: IQR, interquartile range; MD, mean difference between groups; OR, odds ratio; SMD, standardized mean difference (Hedges g).
a Effect estimate based on restricted maximum likelihood model with the Knapp-Hartung adjustment for small samples (<10). Remaining effects based on DerSimonian and Laird method.
b Number of trials and number of participants do not add up to the total number reporting any outcome because some trials did not provide data to calculate the effect for either dichotomous or continuous score.
c Range of effects for all study groups and time points, ie, not limited to records in the meta-analysis.
d MD and SMD analyses have same number of studies but differed by 1 study because of available statistical measures. Thus, the total number of participants in the analysis differed.

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No. of studies/study designs
(No. of observations)
Summary of findings Consistency and precision Other limitations Strength of evidence Applicability
KQ1: Effectiveness of behavioral counseling interventions for reducing STI
21 (19 RCTs, 2 controlled intervention studies [n = 59,328]) Behavioral interventions delivered to individuals at increased risk for STI were associated with reduced STI risk [pooled OR, 0.66 [95% CI, 0.54 to 0.81]; I2 = 74.1%; 19 studies, n = 52,072]

Substantial statistical heterogeneity could not be attributed to specific factors, since the most effective interventions generally shared similar characteristics; larger preventive effects tended to be observed for interventions that included group counseling sessions, involved high contact times (>120 min), and focused on adolescent girls at increased risk

Reasonably consistent

Reasonably precise

Seven trials assessed as good quality with low risk of bias, and remainder deemed of fair quality owing to modest risk of bias associated mainly with modest loss to follow-up and incomplete outcome ascertainment

Statistical heterogeneity could not be readily explained by any independent factor, as there was considerable overlap in the features of effective interventions (eg, group counseling, higher contact times, age group, sex/gender of participant

Moderate for benefit Most trials conducted in the US among populations at increased risk for STI

Increased-risk populations defined by STI clinic attendance or history (highest risk), sexual risk behaviors, or demographic characteristics

Most studies focused on specific subpopulations defined by race/ethnicity, sexual orientation, age, gender, pregnancy, or other factors

Eleven studies (52%) were limited to girls or women; 2 studies were limited to men

KQ2: Effectiveness of behavioral counseling interventions for reducing sexual risk behaviors
34 RCTs (n = 21,417) Among 18 studies reporting a variety of condom use measures and 21 studies reporting unprotected intercourse, there was evidence of intervention effectiveness

Intervention was associated with increased odds of reported condom use for dichotomous measures (pooled OR,1.3 [95% CI, 1.10 to 1.56];  I2 = 39.9%; 13 studies, n = 5253) and a decrease in reported unprotected intercourse measured as counts (pooled MD, −0.94 [95% CI, −1.40 to −0.48]; I2 = 16.4%; 14 studies, n = 9183)

Studies reporting STI and behavioral outcomes were internally consistent, suggesting reductions in sexual risk behaviors contributed to lower STI incidence

One study of adolescents (mostly not yet sexually active) found reduced reports of vaginal sex associated with the intervention

Reasonably consistent

Imprecise due to variability in reported measures and effect sizes across measures

Measures of behavioral outcomes were heterogeneous and
inconsistently reported, limiting the ability to quantitatively summarize intervention effects on sexual risk behaviors

Self-reported behavioral outcomes are subject to respondent recall and social desirability bias, which can lead to overestimation of intervention effects

Low for benefit Most trials were conducted in the US among populations at increased risk for STI.

Increased risk populations were defined by STI clinic attendance or history (highest risk), sexual risk behaviors, or demographic characteristics

Most studies focused on specific subpopulations defined by race/ethnicity, sexual orientation, age, gender, pregnancy, or other factors

KQ3: Harms of behavioral counseling interventions
7 RCTs (n = 3458) No evidence of harms in the few studies reporting adverse events or possible harms related to unintended pregnancy risk or mental health

One study reported car crashes associated with text messages to evaluate this potential adverse effect of the intervention, but numbers were too small for inference

Imprecise

Consistency NA

Very limited reporting of potential adverse effects of behavioral counseling intervention to prevent STI Insufficient Most trials conducted in the US among populations at increased risk for STI

Increased-risk populations defined by STI clinic attendance or history (highest risk), sexual risk behaviors, or demographic characteristics

Most studies focused on specific subpopulations defined by race/ethnicity, sexual orientation, age, gender, pregnancy, or other factors

Abbreviations: KQ, key question; MD, mean difference; NA, not applicable; OR, odds ratio; RCT, randomized clinical trial; STI, sexually transmitted infection.

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