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BACKGROUND Few prospective studies have assessed whether antiretroviral therapy (ART) use is associated with changes in sexual risk behavior of human immunodeficiency virus (HIV)-infected persons in known HIV-serodiscordant partnerships. METHODS We conducted a longitudinal analysis of HIV-infected persons with known uninfected partners enrolled in the Partners Pre-Exposure Prophylaxis Study in Kenya and Uganda. Antiretroviral therapy use and self-reported sexual behavior were ascertained every 3 months. We assessed the effect of ART on sexual risk behaviors using zero-inflated negative binomial regression. Primary outcomes were condomless vaginal sex acts, pregnancy incidence and new sexually transmitted infection diagnoses. RESULTS We followed 1817 HIV-infected persons (58% women) for 864 person-years before ART initiation and 771 person-years after ART. Median CD4 and plasma viral load at ART initiation were 277 cells/μL and 4.18 log10 copies/mL. Antiretroviral therapy use was associated with a significant decrease in condomless vaginal sex acts with HIV-uninfected partners (0.65 vs 0.39 per month; rate ratio, 0.64; 95% confidence interval [CI], 0.55-0.75; P < 0.001), but not condomless vaginal sex acts with nonprimary partners (1.30 vs 1.04 per month; rate ratio, 0.94; 95% CI, 0.94-1.20; P = 0.62). Pregnancy incidence was lower after ART (13.2 vs 8.4 per 100 person-years; HR, 0.71; 95% CI, 0.60-0.84; P < 0.001). Incident sexually transmitted infection diagnoses were similar (odds ratio, 1.05; 95% CI, 0.86-1.29; P = 0.63). CONCLUSIONS Substantial risk compensation did not occur after ART initiation among East African HIV-infected persons with known HIV-uninfected partners. These data inform modelling studies of ART for HIV prevention by suggesting that risky sexual behavior did not appear to offset decreased HIV infectiousness in this key population.

Background Herpes simplex virus type-2 (HSV-2) may heighten immune activation and increase human immunodeficiency virus 1 (HIV-1) replication, resulting in greater infectivity and faster HIV-1 disease progression. An 18-week randomized, placebo-controlled crossover trial of 500 mg valacyclovir twice daily in 20 antiretroviral-naive women coinfected with HSV-2 and HIV-1 was conducted and HSV-2 suppression was found to significantly reduce both HSV-2 and HIV-1 viral loads both systemically and the endocervical compartment. Methods To determine the effect of HSV-2 suppression on systemic and genital mucosal inflammation, plasma specimens, and endocervical swabs were collected weekly from volunteers in the trial and cryopreserved. Plasma was assessed for concentrations of 31 cytokines and chemokines; endocervical fluid was eluted from swabs and assayed for 14 cytokines and chemokines. Results Valacyclovir significantly reduced plasma CXCL10 but did not significantly alter other cytokine concentrations in either compartment. Conclusions These data suggest genital tract inflammation in women persists despite HSV-2 suppression, supporting the lack of effect on transmission seen in large scale efficacy trials. Alternative therapies are needed to reduce persistent mucosal inflammation that may enhance transmission of HSV-2 and HIV-1.

BACKGROUND Bacterial vaginosis is associated with sexual activity, but mechanisms for this association are unclear. STUDY DESIGN Cross-sectional analysis of data from women reporting sex with women who provided information on sexual behaviors as part of a study of vaginal bacteria was conducted. Vaginal bacteria were detected by semiquantitative culture. Binomial regression with log-link evaluated associations between detection of bacteria and sexual behaviors reported to occur before enrollment. Linear regression evaluated associations between these behaviors and quantity of bacteria. RESULTS Of the 320 women, 216 (68%) were colonized with H2O2-producing lactobacilli and 142 (44%) with Gardnerella vaginalis. Colonization with G. vaginalis was associated with >20 digital-vaginal sex acts (risk ratio, 2.01; 1.22, 3.29) or >10 toy-vaginal acts in the past 3 months (risk ratio, 1.76; 1.32, 2.36). Quantity of H2O2-producing lactobacilli was 1.3 log lower in colonized women reporting >10 acts of insertive vaginal sex-toy use in the past 3 months (95% confidence interval: -2.04, -0.56), 1.19 log lower with toy-vaginal sex in past 7 days (-1.75, -0.62), and 0.78 log lower in women sharing toys with a partner (-1.25, -0.31). CONCLUSIONS Vaginal insertive use and sharing of sex toys were associated with decreased quantities of H2O2-producing lactobacilli and higher risk of colonization with G. vaginalis.

Bacterial vaginosis (BV) recurs frequently after metronidazole treatment. This randomized, single-masked clinical trial evaluated the efficacy of topical application of 62% ethyl alcohol in emollient gel (gel) to the penis by male partners of women diagnosed with BV for preventing post-treatment BV recurrence.Among 587 Kenyan women presenting with vulvovaginal symptoms, 236 had BV (vaginal Gram stain Nugent score=7), of whom 223 (94.3%) agreed, along with their partners, to be randomized: 115 to the intervention and 108 to the control arm. In the intervention arm, male partners agreed to apply gel each morning, and before and after sexual intercourse. All couples received counseling, condoms, and syndromic treatment of sexually transmitted infection symptoms. Follow-up visits were scheduled 1 week, 1 month, and 2 months postenrollment, with vaginal Gram stains at every visit and culture for H2O2-producing lactobacilli at the 2-month visit. The primary outcome was time to diagnosis of BV during follow-up.In the primary intent-to-treat analysis, diagnosis of BV was significantly more frequent in the intervention arm (hazard ratio: 1.44, 95% confidence interval: 1.01–2.04). After adjustment for baseline covariates, the hazard ratio was 1.39 (95% confidence interval: 0.98–1.99). At the 2-month visit, prevalences of any vaginal lactobacilli or of H2O2-producing lactobacilli did not differ appreciably in the 2 study arms (P = 0.81 and 0.32, respectively).Daily use of the 62% ethyl alcohol gel by men before and after sex significantly increased persistence or early recurrence of BV in their partners through 2 months after metronidazole treatment. However, no difference was observed in prevalences of vaginal lactobacilli within this same period.

Background: Expedited partner therapy (EPT) has been shown to reduce the risk of persistent or recurrent gonorrhea and chlamydial infection in heterosexuals, and to increase the proportion of sex partners receiving treatment. The objective of this analysis was to evaluate the consistency of EPT’s effect across sociodemographic and behavioral subgroups. Methods: Subset analyses from a randomized controlled trial compared EPT to standard partner referral (SPR) in sociodemographic and behaviorally defined subgroups. Outcomes included persistent or recurrent infection in study participants and participants’ report that their partners received treatment. Results: Reinfection risk was lower among EPT recipients than nonrecipients in 21 of 22 subgroups, with relative risks (RRs) varying from 0.4 to 0.94. Compared to persons receiving SPR, persons receiving EPT were more likely to report that their partners were very likely to have been treated in 33 of 34 subgroups (RRs range, 1.03–1.36). Although EPT reduced the risk of persistent or recurrent infection somewhat more in men (RR, 0.56; 95% CI, 0.3–1.08) than in women (RR, 0.81; 95% CI, 0.61– 1.07) and more in persons with gonorrhea (RR, 0.32; 95% CI, 0.13– 0.78) than those with chlamydial infection (RR, 0.82; 95% CI, 0.63–1.07), the RR of partners being treated associated with EPT was similar in men (RR, 1.21; 95% CI, 1.05–1.39) and women (RR, 1.18; 95% CI, 1.10 –1.27), and also in persons with gonorrhea (RR, 1.33; 95% CI, 0.80 –2.23) and chlamydial infection (RR, 1.33; 95% CI, 1.07–1.66). Conclusions: In this study, EPT is shown to be superior to SPR across a wide spectrum of sociodemographic and behaviorally defined subgroups. E xpedited partner therapy (EPT), the practice of treating the sex partners of people with curable sexually transmitted infections (STI) without requiring the partner to first undergo medical evaluation, improves partner notification outcomes for gonorrhea and chlamydial infection. 1,2 This conclusion is supported by 3 randomized controlled trials (RCTs) 3–5 and 2 observational studies. 6,7 Recent guidelines, both from the Centers for Disease Control and Prevention and from several US state departments of health, have suggested that EPT should play a role in the management of heterosexuals with these infections. 1,8 –10 In 2005, we reported results of a RCT comparing EPT to standard partner referral with an offer of assistance notifying partners (SPR) in heterosexuals with gonorrhea or chlamydial infection. 4 The trial found that EPT significantly reduced participants’ risk of persistent or recurrent infections and increased the proportion of participants’ partners perceived to have received treatment. However, we did not assess the impact of EPT in sociodemographically or behaviorally defined subgroups in our original report, nor has this been reported in other EPT trials. To evaluate the effect of EPT across population subgroups, we conducted an exploratory analysis of data from our randomized trial to estimate EPT efficacy in sociodemographic and behavioral subgroups. In addition, we used statistical regression tree analysis to identify subgroups of persons at high risk for not ensuring their partners’ treatment even if provided with EPT.

Bacterial vaginosis (BV) is the most prevalent vaginal infection in reproductive age women, and has been consistently associated with adverse outcomes related to the upper genital tract, and with increased risk of HIV acquisition.1–3 Of 3739 women enrolled between 2001 and 2004 in a nationally representative sample of the US civilian noninstitutionalized population, almost 1 in 3 (29.2%; 95% CI, 27.2–31.3) had BV by Gram stain of vaginal fluid.4,5 Microbiologically, BV is characterized by depletion of hydrogen peroxide-producing lactobacilli that characterize normal vaginal flora, with profound overgrowth of anaerobic bacteria.6 However, the cause of BV remains elusive, and various studies have reported a diversity of risks for this common condition, including demographic (black race), hormonal (no hormonal contraception), and sexual behavioral (unprotected sex with men, sex with women, anal sex) characteristics.6,7 For unknown reasons, women who have sex with women have a high prevalence of BV (25%–52%).4,8 In a pilot study, we previously reported risks for prevalent BV in this population, which included higher lifetime number of female sex partners, shared use of a vaginally inserted sex toy, and oral-anal sex with a female partner. We also found that women with BV were highly likely to have sex partners who also had BV. While these findings supported the general concept that BV may be sexually transmitted in this group of women, more complete assessment of recent sexual risk was needed. With this objective, we assessed risks for BV at the enrollment visit in lesbian and bisexual women enrolled in a prospective study of vaginal flora. In addition to measuring the contribution of previously recognized risk factors for BV, including race, smoking, and douching, we used comprehensive computer-assisted self-interview (CASI) to assess behavioral risks. CASI has been shown to yield significantly higher rates of disclosure for same-sex behavior and undesirable social behaviors when compared directly with self-administered questionnaires.9–12 CASI provides other benefits, including standardized delivery of survey content, eliminating variation in interviewer or day, and computer-controlled branching, automated consistency, and range checking.

Objective The objective of this study was to determine why different criteria for response to treatment of bacterial vaginosis (BV) led to markedly different conclusions about treatment efficacy in a randomized trial comparing metronidazole gel versus metronidazole/nystatin ovules. Study We compared the impact of two treatment regimens on individual components of Amsel and Nugent criteria at follow-up visits 14, 42, and 104 days after initiating treatment. Results Compared with gel, ovules more effectively eliminated amines, clue cells, and Gardnerella, Prevotella, or Mobiluncus morphotypes from vaginal fluid, thus achieving cure based on "usual" criteria (absence of BV by Amsel or Nugent criteria), but did not more effectively restore Lactobacillus morphotypes or lower vaginal pH, thus not meeting Federal Drug Administration (FDA) criteria for cure. Conclusion Because early vaginal recolonization by lactobacilli was poor after both gel and ovules, FDA draft criteria for cure missed marked differences in treatment efficacies against Gardnerella, clue cells, and amines. Cure defined more "usually" may give more useful information.

Bacterial vaginosis (BV) is a common cause of vaginitis and, for unknown reasons, is common in lesbian and bisexual women. We defined risks for prevalent BV in lesbian and bisexual women with attention to detailed sexual risk history.Women 16 to 35 years reporting sex withor = 1 woman in prior year underwent computer-assisted self-interview with extensive sexual and medical history. BV was defined by Amsel criteria, and associations with subject characteristics were estimated by Poisson regression and generalized estimating equation to adjust for potential coenrollment of current sexual partners.Of 335 participants (median age, 25 years; 22% nonwhite race), 6% reported douching, 24% sex with men, and 91% any sex in the prior 3 months. 96 (29%) had BV, 40% of whom reported corresponding symptoms. BV was associated with reporting a partner with BV (39% vs. 12%; multivariate relative risk [MRR], 4.53 [2.59 -7.93]), vaginal lubricant use (59% vs. 21%; MRR, 1.86 [0.94 -3.68]), or sharing vaginal sex toys in prior 3 months (33% vs. 21%; MRR, 1.70 [0.96 -3.01]). No association was seen for age, race, smoking, hormone use, douching, vaginal, anal or oral sex, or numbers of new partners. Lubricant use and shared vaginal toys were correlated (Spearman 0.29).BV is associated with practices that efficiently transmit vaginal fluid and with use of vaginal lubricant; since these are correlated, assessing independent effects will require further analysis. More research is required to understand relationships between role of transmission of BV-associated bacteria and vaginal lubricant on BV pathogenesis.