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Research on interventions to prevent HIV and other sexually transmitted infections (STIs) is heavily influenced by participant reporting of sexual behavior, despite uncertainty about its validity. Exclusive reliance on participant self-report often is based, overtly or by implication, on 4 assumptions: (1) no feasible alternatives exist; (2) misreporting can be minimized to levels that can be disregarded; (3) misreporting tends to underreport sensitive behaviors; and (4) misreporting tends to be nondifferential with respect to the groups being compared. The objective of this review are to evaluate these assumptions, including a review of studies using semen biomarkers to evaluate the validity of self-reported data, and to make recommendations for applying biological markers of semen exposure detectable in women to further strengthen research on HIV/STI prevention. Increasing evidence shows that semen biomarkers provide an important means of assessing and augmenting the validity of studies on HIV/STI prevention. Additional biomarkers are needed to assess male exposure to vaginal sex and both male and female exposure to anal sex. Methods and study designs that incorporate biomarkers into studies collecting self-reported behavioral data should be considered where possible.

Background: The effectiveness of counseling messages to avoid unprotected sex during short-term treatment for curable sexually transmitted infections is unknown., Methods: We randomized 300 female STI clinic patients 18 years or older with cervicitis and/or vaginal discharge in Kingston, Jamaica, in 2010 to 2011, to 1 of 2 counseling messages for their course of syndromic treatment: abstinence only or abstinence backed up by condom use. At a follow-up visit 6 days afterward, we collected vaginal swabs to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure, and administered a questionnaire assessing sexual behavior., Results: No differences were found in the proportions of women testing positive for PSA at follow-up in the abstinence-plus-condom group (11.9%) and abstinence-only group (8.4%) (risk difference, 3.5; 95% confidence interval, -3.5 to 10.5). There also was no significant difference in reporting of unprotected sex between groups. Reporting a history of condom use before enrollment significantly modified the effect of counseling arm on PSA positivity (P = 0.03). Among those reporting recent condom use, 10.3% in the abstinence-only arm and 4.8% in the abstinence-plus-condom arm tested positive for PSA. Conversely, among those not reporting recent condom use, 6.5% in the abstinence-only arm and 17.3% in the abstinence-plus-condom arm had PSA detected., Conclusions: We found no evidence to support the superiority of either counseling message. Post hoc analyses suggest that women with recent condom experience may benefit significantly more from abstinence-plus-condom messages, whereas women without such experience may benefit significantly more from abstinence-only messages. Providers should weigh individual condom use history when determining the most appropriate counseling message.

The prevalence of condom use at last intercourse, estimated from questions added to a national survey, was estimated to be 20.2%. Use of condom was significantly higher for sex outside ongoing relationships and among those with 2 or more past-year sex partners and its use increased slightly but significantly from 1996 to 2008.

Background: It has not been well established whether common indices of male condom failure are valid predictors of biologically meaningful exposure during condom use., Methods: To address this gap, the authors compared self-reported condom malfunctions (i.e., breakage and slippage) and incorrect condom practices to 2 following objective measures of failure: prostate-specific antigen (PSA) detected in vaginal swabs collected after condom use and structural integrity of used condoms. The study, conducted in 2000-2001, evaluated 635 male condoms used by 77 women attending an outpatient, reproductive-health clinic in Birmingham, AL., Results: Women reported breakage or slippage for 7.9% of condoms; 3.5% of postcoital swabs had moderate or high levels of PSA; and laboratory testing of used condoms revealed breaks (1.1%) and leaks (2.0%). Self-reported breakage and slippage was associated with moderate/high PSA concentrations in postcoital swabs only when the malfunctions were not accompanied by reports of corrective actions to reduce exposure (adjusted odds ratio [aOR], 6.9; 95% confidence interval [CI], 1.8-26.2). Defects observed in postcoital laboratory testing were related to PSA detection (aOR, 8.0; 95% CI, 1.5-42.6). Incorrect practices defined on the condom label were frequent, but not all types were associated with semen exposure. Furthermore, other practices not currently label-defined were associated with semen exposure: touching the tip of the penis with his hands (aOR, 6.2; 95% CI, 2.3-17.0) or with her hands (aOR, 2.8; 95% CI, 1.1-72) before donning the condom., Conclusions: Used correctly, male condoms afforded good protection based on objective measures of failure.

Background: Prostate-specific antigen (PSA) is a valid biomarker of semen exposure in women and has been used to assess reliability of self-reported sexual behavior as well as serve as a proxy measure for condom efficacy. Quantitative PSA tests are expensive and require specialized equipment. A simple, rapid, and inexpensive test for PSA would facilitate semen biomarker evaluation in a variety of research settings. This study evaluated the performance of a rapid PSA test compared with a quantitative assay to identify semen in vaginal swab specimens., Methods: We tested 581 vaginal swabs collected from 492 women participating in 2 separate research studies in Bangladesh and Zimbabwe. PSA in vaginal secretions was detected using the quantitative IMx (Abbott Laboratories) assay and the ABAcard p30 (Abacus Diagnostics) rapid immunochromatographic strip test., Results: The ABAcard test was 100% sensitive (95% confidence interval [CI], 98%-100%) and 96% specific (95% CI, 93%-97%) compared with the quantitative test in detecting >1.0 ng PSA/mL vaginal swab eluate. Rapid PSA results were semiquantitative and correlated well with PSA concentrations (kappa = 0.88; 95% CI, 0.85-0.90)., Conclusion: Rapid PSA detection requires no instrumentation and can be performed easily and economically. Having rapid PSA results available immediately following interview provides opportunities to explore discrepancies between the objective marker of recent semen exposure and self-reported behaviors.

Objectives: To estimate the incidence of herpes simplex type 2 virus (HSV-2) infection, to identify risk factors for its acquisition, and to assess the protective effect of condoms., Study Design: Prospective study of 293 HSV-2 seronegative women, aged 18 to 35 years, attending a sexually transmitted disease clinic in Alabama from 1992 to 1995., Results: Incidence of HSV-2 infection was 20.5 per 100 woman-years [95% confidence interval (CI), 13.1-30.5]. Young women (18-20 years) had a significantly higher risk of incident HSV-2 infection [adjusted hazard ratio (HR), 2.8; 95% CI, 1.3-6.4] than older women. Women diagnosed with prevalent or incident bacterial vaginosis had a higher incidence of HSV-2 infection than those who were not so diagnosed (adjusted HR, 2.4; 95% CI, 1.1-5.6). No significant protective effect was observed for consistent (100%) condom use without breakage and slippage against HSV-2 acquisition (adjusted HR, 0.8; 95% CI, 0.2-2.3)., Conclusion: Acquisition of HSV-2 infection among study participants was higher than previous estimates for adult female sexually transmitted disease clinic attendees, and no protective effect for condoms was demonstrated. The high incidence of HSV-2 infection with its potential for adverse health consequences emphasizes the need for better prevention strategies.

Objectives/goal: To compare self-reported condom use problems and objectively determined semen exposure in 2 populations., Study Design: Two randomized crossover trials in the United States and Brazil compared the failure rates of the female condom (FC) and male condom (MC). Participants used both condom types, completed condom-specific questionnaires to report problems, and collected precoital and postcoital samples of vaginal fluid. Prostate-specific antigen (PSA) was detected by immunoassay., Results: Problems with condom use were reported less frequently in the Brazilian study (rate difference: FC = 24%, P <0.0001, MC = 5%, P = 0.003). By contrast, the PSA detection rates were similar for both the FC and the MC (rate difference: FC = 2%, MC = 1%, not significant). These results suggest that the PSA detection rate was similar in the 2 study groups and that self-reported problems may be a less reliable measure of condom failure., Conclusions: Use of biomarkers of condom failure like PSA may help to strengthen the validity of studies promoting behavior change for the prevention of sexually transmitted diseases.

Background: Studies of condom use to reduce risk of most sexually transmitted infection provide inconsistent results. This inconsistency is often attributed to methodologic limitations yet has not been assessed systematically., Objectives: The objectives of this study were to review studies of condom use and risk of gonorrhea and chlamydia, and to evaluate the importance of 4 key design and measurement factors on condom effectiveness estimates., Design: We reviewed studies published 1966-2004 to assess risk reduction for gonorrhea and/or chlamydia associated with male condom use., Results: Of 45 studies identified, most found reduced risk of infection associated with condom use. All studies reviewed had methodologic limitations: only 28 (62%) distinguished consistent from inconsistent use; 2 (4%) reported on correct use or use problems; 13 (29%) distinguished incident from prevalent infection; and one (2%) included a population with documented exposure to infection. Eight of 10 studies with 2 or more of these attributes reported statistically significant protective effects for condom use versus 15 of 35 studies with zero or one attribute (80% vs. 43%, P = 0.04)., Conclusions: Condom use was associated with reduced risk of gonorrhea and chlamydia in men and women in most studies, despite methodologic limitations that likely underestimate condom effectiveness. Epidemiologic studies that better address these factors are needed to provide more accurate assessment of condom effectiveness.

Objective: The objective of this study was to compare 2 interventions promoting condoms and vaginal microbicides to prevent sexually transmitted disease (STD)., Study: Women (N = 427) attending an STD clinic were randomly assigned to 2 clinician-delivered interventions and followed up monthly to assess condom/microbicide use and incidence of gonorrhea, chlamydia, and syphilis., Results: During follow up, condom use rates were 69% (enhanced) and 49% (basic) and microbicide use rates were 44% and 29%, respectively. STD rates did not significantly differ between intervention groups. Perfect condom use (regardless of intervention arm) was associated with a 3-fold decrease in STD rates (relative risk [RR], 0.3; 95% confidence interval [CI], 0.1-0.8). Using a vaginal microbicide during > or =50% of the acts of intercourse was associated with reduced STD rates (RR, 0.5; 95% CI, 0.3-1.0) across intervention groups and condom use categories., Conclusions: The enhanced intervention increased use of condoms and vaginal microbicide; however, STD rates did not decrease because a protective effect was seen only among perfect barrier users, and the enhanced intervention only modestly increased perfect use.

Objectives: This study assessed whether participant baseline characteristics modified the effects of a skill-based intervention promoting condom use., Study: The randomized, controlled trial enrolled 427 women from a sexually transmitted disease clinic in Birmingham, Alabama. The main outcome measures: consistent (100%) and problem-free (correct, no breakage or slippage) condom use were verified by sexual diary self-report and contraceptive product counts., Results: The enhanced intervention group had a 60% higher consistent condom use rate compared to the basic group (risk ratio [RR], 1.6; 95% confidence interval [CI], 1.4-1.8). There was no statistically significant difference between groups in relationship to problem-free, consistent use (RR, 1.0; 95% CI, 0.9-1.1). A binomial regression analysis identified the following factors as significant modifiers of intervention effectiveness on consistent condom use: intention to use condoms next time, early-age sexual debut, marital status combined with place of intercourse, and substance use before sex., Conclusions: The results suggest that participant baseline characteristics can be modifiers of intervention effectiveness.

Objective: The objective of this study was to study the frequency and determinants of breakage and slippage during female and male condom use., Goal: The goal of this study was to determine condom breakage and slippage rate., Study: We conducted a 6-month prospective follow-up study of women attending 2 sexually transmitted disease clinics. Breakage and slippage rates were computed. Logistic regression was used to evaluate baseline characteristics and time-dependent behaviors., Results: A total of 869 women used condoms in 20,148 acts of intercourse. Breakage was less common for female condoms (0.1%; 95% confidence interval [CI], 0.05-0.21) than for male condoms (3.1%; 95% CI, 2.80-3.42). Slippage was more common for female condoms (5.6%; 95% CI, 5.10-6.13) than for male condoms (1.1%; 95% CI, 0.90-1.28). Rates significantly decreased with use and increased with number of previous failures. From first use to >15 uses, combined failure rate fell from 20% to 1.2% for female condoms (P < 0.0001) and 9% to 2.3% for male condoms (P < 0.01)., Conclusions: Both condoms may provide good protection against sexually transmitted diseases. Experience determines success with either condom.

Background: Chlamydia trachomatis infection rates in Alabama increased dramatically from 1996 to 1998, due in part to expanded screening. Detection of prevalent infection through increased testing could mask timely detection of the impact of screening programs on community prevalence., Goal: The goal of the study was to evaluate the temporal trend in prevalence among women aged 15 to 34 years attending reproductive healthcare clinics in Birmingham, Alabama., Study Design: Between 1995 and 1998, systematic screening of the first 60 women presenting each month to each of six participating clinics was performed with urine-based testing for chlamydia., Results: In contrast to the 218% increase in chlamydia prevalence detected through passive surveillance, during the study period surveillance in sentinel sites revealed that first-visit chlamydia prevalence declined from 12.8% to 8.6%., Conclusions: Sentinel site surveillance served as a valuable adjunct to passive surveillance for determining the true trend of chlamydia prevalence during the hyperendemic phase of a local epidemic.

Background: Previous research has identified factors associated with condom use. However, less information exists on the impact that a history of sexually transmitted disease (STD) has on condom use., Goal: To identify factors associated with self-reported male condom use that relate to a history of STD., Study Design: Women attending STD clinics completed a survey that assessed sexual behavior, STD history, and psychosocial characteristics. Binomial regression was used to estimate the association between these factors and condom use., Results: Of the 12 factors included in the regression model, 11 were significant for all women. When the analysis was stratified by STD history, high condom use self-efficacy, high convenience of condom use, and high frequency of condom use requests were significantly associated with increased condom use among women with or without a history of STD. Factors such as greater perceived condom use norms, higher perceived level of risk, and greater need for condom use in long-term relationships were significantly associated with increased condom use among women with a history of STD. Factors such as shorter duration of a relationship, less violence in the relationship, and lifetime drug use were associated with increased condom use among women with no history of STD., Conclusions: The pattern of psychosocial factors determining condom use is modified by a positive history of STD. These findings suggest that a history of STD could be an important factor in targeting condom use interventions.

Background and Objectives: Mechanical failure may reduce the efficacy of condoms. Little is known about frequency and determinants of condom failure in groups at high risk of sexually transmitted diseases (STD)., Goal: To measure condom breakage and slippage rates and evaluate potential determinants of failure among women attending a public STD clinic., Study Design: Women attending an STD clinic participated in a 6-month prospective study of barrier contraception for the prevention of STD. They completed sexual diaries that were reviewed at monthly follow-up visits. No data were collected from the male partners. Baseline characteristics of the participants and time-dependent behaviors were evaluated as potential determinants of condom failure., Results: Of 21,852 condoms used by 892 women, 500 broke during intercourse (2.3%) and 290 slipped (1.3%). Breakage was more common among young, black, single nulliparae who engaged in high-risk behavior. Slippage was more common among married women with children. Failure rates decreased with condom use, with coital frequency, and with use of spermicides., Conclusion: User characteristics and experience are determinants of breakage and slippage, which are often regarded only as the effect of product design flaws. Attention to modifiable determinants of failure may improve user counseling and product labeling.

Background: Infections by herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2) are common in the United States. Herpes simplex virus type 2 is transmitted sexually, and the prevalence of antibodies to HSV-2 has increased in recent years., Goals of This Study: The objective of the present study was to estimate the seroprevalence of HSV-1 and HSV-2 antibodies among women attending a sexually transmitted disease (STD) clinic and to evaluate factors associated with HSV-1 and HSV-2 seropositivity., Study Design: The report describes a cross-sectional study conducted at an STD clinic. This study included 1,103 women between the ages of 18 and 35. Eighty-nine percent of the subjects were African Americans. The remaining subjects were white., Results: The overall prevalence of HSV-1 and HSV-2 antibodies among study subjects was 72% and 64%, respectively. Both HSV-1 and HSV-2 seropositivity were related directly to age and were higher among African Americans than whites. The prevalence of HSV-2 antibodies also increased with the number of lifetime sexual partners, an early age at first coitus, a history of syphilis, and the absence of HSV-1 antibodies. Drug use and recent use of barrier contraception were unrelated to either HSV-1 or HSV-2., Comment: Despite efforts by the public health community to prevent AIDS by promoting safe sexual practices, the prevalence of HSV-2 seropositivity has increased in recent years. Increased numbers of partners and an early age at first coitus are important correlates of HSV-2 infection. Public health interventions to prevent HSV-2 infection should target teenagers. Women of reproductive age attending STD clinics may also comprise an important target for interventions to prevent perinatal herpes.

Background and Objectives: The AIDS epidemic has brought barrier contraceptives to the forefront of public health research. A comprehensive evaluation of the efficacy of barrier contraceptive use in preventing sexually transmitted diseases (STDs), including AIDS, is necessary to inform both potential users and public health policy makers. This study was undertaken to evaluate the efficacy of condoms and vaginal spermicide products, used alone or in combination, in preventing gonorrhea and chlamydia among women attending an STD clinic., Goal of This Study: To describe the general characteristics of the study group and its follow-up experience., Study Design: Women who met the eligibility criteria were invited to participate. The initial visit included an interview, a behavioral intervention promoting barrier methods, a physical examination, and instructions to complete a sexual diary. Participants received free barrier contraceptives and returned for six monthly follow-up visits. DESIGN RESULTS: Participants (n = 1,122) were low income, single (74%) black (89%) women with a median age of 24. The behavioral intervention led to the use of barrier protection in more than 70% of reported acts of vaginal intercourse. Barriers were used consistently (100% of sexual acts) during 51% of the months of follow-up. A total of 148 cases of gonorrhea (28 per 1,000 months) and 122 cases of chlamydia infection (23 cases per 1,000 months) were diagnosed during follow-up., Conclusion: This study represents a practical solution to a complex set of design considerations. The study protocol was successful in promoting consistent and proper use of barrier methods.

Background and Objectives: Epidemiologic studies of chlamydial infections may often miss factors associated with the acquisition of infection., Goal: To evaluate factors associated with risk for initial and recurrent Chlamydia trachomatis infections., Study Design: A retrospective study of patients attending a sexually transmitted disease clinic and, within this retrospective cohort, a nested case-control study., Results: Among initial-negative subjects the crude incidence rate was 11.5 per 1,000 months of follow-up. Among initial-positive subjects, the crude incidence rate was 28 per 1,000 months of follow-up (RR = 1.8, 95% CI: 1.4-2.2). The increase in risk of infection associated with prior infection was independent of age. In the case-control study, a reduced risk of recurrent infection was associated with tubal ligation, hormonal contraception, and barrier contraception., Conclusions: As well as targeting sexually active adolescents, prevention programs should recommend repeat testing for all women with prior chlamydial infection, irrespective of age. Furthermore, issues related to personal control of health may modify risk for infection.