An Evaluation of the Performance, Patient Acceptability and Feasibility of a Point-of-Care HIV-Syphilis Assay in an Urban Emergency Department.

BACKGROUND: Point-of-care (POC) tests for sexually transmitted infections (STIs) permit delivery of results during the patient's emergency department (ED) encounter. We evaluated performance, patient acceptability, and feasibility of a new duplex POC test, Chembio DPP® HIV-Syphilis Assay in an urban ED setting. METHODS: Convenience sampling approach prioritizing those considered at increased risk for an STI and/or with a history of HIV. For the performance evaluation, participants were tested for HIV/syphilis with the Chembio POC assay, and the reference laboratory tests; sensitivity and specificity were determined. For the patient acceptability evaluation, participants completed pre- and post-user surveys. For the feasibility evaluation, ED clinical technicians completed a survey evaluating their perceptions regarding feasibility of use of this POC test. RESULTS: 327 patients were consented and enrolled. The diagnostic sensitivity and specificity of the Chembio POC assay for HIV was 96.5% (95% CI: 90.1%, 99.3%) and 99.6% (95% CI: 97.7%, 100.0%), respectively, and for syphilis was 93.9% (95% CI: 85.0%, 98.3%) and 99.6% (95% CI: 97.9%, 100.0%), respectively. Regarding patient acceptability: 87% trusted the result; and 93% reported they were more likely to seek treatment if they received a positive STI test result in the ED rather than after the ED visit. Regarding feasibility: 90% of the technicians reported they would recommend using the test in EDs. CONCLUSIONS: The Chembio DPP® HIV-Syphilis POC assay had excellent performance characteristics when evaluated in an ED population, as well as high perceived acceptability from patients, and feasibility for ED use from clinical technicians. The test may have utility for HIV-syphilis screening among high-risk ED patients.

A National, County-Level Evaluation of the Association Between COVID-19 and Sexually Transmitted Infections Within the United States in 2020.

BACKGROUND: Shifts in public health infrastructure to respond to one emerging health threat may have unanticipated consequences for preexisting diseases. Previous research evaluating the impact of COVID-19 on sexually transmitted infections (STIs) has been conducted nationally, with little exploration of the impact on a granular geospatial level. This ecological study seeks to quantify the association between COVID-19 cases or deaths and chlamydia, gonorrhea, and syphilis cases for all US counties in 2020. METHODS: Separate, adjusted multivariable quasi-Poisson models with robust standard errors modeled the county-level association between 2020 COVID-19 cases and deaths per 100,000 and 2020 chlamydia, gonorrhea, or syphilis cases per 100,000. Models were adjusted for sociodemographic characteristics. RESULTS: Every 1000 additional COVID-19 cases per 100,000 was associated with a 1.80% increase in the average number of chlamydia cases ( P < 0.001) and a 5.00% increase in the average number of gonorrhea cases ( P < 0.001). Every 1000 additional COVID-19 deaths per 100,000 was associated with a 57.9% increase in the average number gonorrhea cases ( P < 0.001) and a 74.2% decrease in the average number of syphilis cases ( P = 0.004). CONCLUSIONS: Higher rates of COVID-19 cases and deaths were associated with increased rates of some STIs at the US county level. The underlying reasons for these associations could not be established by this study. The emergency response to an emerging threat may have unanticipated influence on preexisting diseases that varies by level of governance.

The National Network of Sexually Transmitted Disease Clinical Prevention Training Centers Turns 40-A Look Back, a Look Ahead.

Since 1979, the National Network of Sexually Transmitted Disease (STD) Clinical Prevention Training Centers (NNPTC) has provided state-of-the-art clinical and laboratory training for STD prevention across the United States. This article provides an overview of the history and activities of the NNPTC from its inception to present day, and emphasizes the important role the network continues to play in maintaining a high-quality STD clinical workforce. Over time, the NNPTC has responded to changing STD epidemiological patterns, technological advances, and increasing private-sector care-seeking for STDs. Its current structure of integrated regional and national training centers allows NNPTC members to provide dynamic, tailored responses to STD training needs across the country.

A Silent Epidemic: The Prevalence, Incidence and Persistence of Mycoplasma genitalium Among Young, Asymptomatic High-Risk Women in the United States.

Background: Mycoplasma genitalium can result in pelvic inflammatory disease and adverse pregnancy outcomes. We analyzed data collected from a prospective study of asymptomatic bacterial vaginosis (BV) to determine the natural history of M. genitalium. Methods: Women aged 15-25 years, with asymptomatic BV and ≥2 risk factors for sexually transmitted infection were recruited from 10 sites throughout the United States. Vaginal swab samples were collected at enrollment and through home-based testing every 2 months over 12 months. M. genitalium nucleic acid amplification testing was performed for M. genitalium using transcription-mediated assays (Hologic). The prevalence, incidence, and persistence of M. genitalium, defined as all positive specimens during follow-up, were estimated with 95% confidence intervals (CIs). Adjusted odds ratios (AOR) were calculated using logistic and Poisson regression to evaluate participant characteristics associated with M. genitalium infection. Results: Among 1139 women, 233 were M. genitalium positive, for a prevalence of 20.5% (95% CI, 18.2%-22.9%); 42 of 204 had persistent M. genitalium (20.6%). Among 801 M. genitalium-negative women at baseline, the M. genitalium incidence was 36.6 per 100 person-years (95% CI, 32.4-41.3). Black race (AOR, 1.92; 95% CI, 1.09-3.38), age ≤21 years (1.40; 1.03-1.91), and prior pregnancy (1.36; 1.00-1.85) were associated with prevalent M. genitalium; only black race was associated with incident M. genitalium (P = .03). Conclusions: We identified high rates of prevalent, incident, and persistent M. genitalium infections among young, high-risk women with asymptomatic BV, supporting the need for clinical trials to evaluate the impact of M. genitalium screening on female reproductive health outcomes.

Patterns of point-of-care test use among obstetricians and gynaecologists in the US.

Background Point-of-care tests (POCTs) for reproductive health conditions have existed for decades. Newer POCTs for syphilis, HIV and trichomonas are currently available and easy to use. We surveyed practicing obstetricians and gynaecologists to determine current POCT use and perceived obstacles to use. METHODS: Between June and August 2016, 1000 members of the American College of Obstetricians and Gynecologists were randomly selected and invited to complete a Qualtrics (222 West river Park Drive, Provo, Utah 84604, USA) survey; 600 of these were members of the Collaborative Ambulatory Research Network. Respondents who completed at least 60% of the survey were included in the analysis. RESULTS: Of the 1000 selected members, 749 had valid emails and 288 (38%) of these participated in and completed the survey. Of the respondents, 70% were male with a mean of 18 years in practice. Detection of sexually transmissible infections (STIs) once or twice a week was reported by 30%, whereas 45% reported detecting STIs once or twice a month. POCTs used included pregnancy tests (83%), urine dipstick (83%), wet mount tests (79%) and the vagina pH test (54.8%). Few used Gram stain (5%) and stat rapid plasma regain tests (4%). Relatively newer US Food and Drug Administration-approved POCTs were used less frequently, with 25% of respondents reporting using the Affirm VPIII (Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07471, USA) test use and only 10% using a rapid HIV test. The most common perceived barriers to testing were the amount of reimbursement received for performing the test (61.9%) and the payment coverage from the patient (61.3%). CONCLUSIONS: US obstetricians and gynaecologists rely on laboratory test results and traditional POCTs to diagnosis STIs. Future development and marketing of POCTs should consider not only ease and time of test performance, but also the cost of the tests to the practice and the patient, as well as reimbursement.

Variations in Clinical Presentation of Ocular Syphilis: Case Series Reported From a Growing Epidemic in the United States.

Ocular syphilis, a form of neurosyphilis, has been increasingly diagnosed in the United States. This case series summarizes the course of 6 patients recently diagnosed with ocular syphilis, emphasizing the varied sociodemographic factors and the wide range of symptoms and outcomes that are seen in patients with this disease.

Prevalence and correlates of knowledge of male partner HIV testing and serostatus among African-American women living in high poverty, high HIV prevalence communities (HPTN 064).

Knowledge of sexual partners' HIV infection can reduce risky sexual behaviors. Yet, there are no published studies to-date examining prevalence and characteristics associated with knowledge among African-American women living in high poverty communities disproportionately affected by HIV. Using the HIV Prevention Trial Network's (HPTN) 064 Study data, multivariable logistic regression was used to examine individual, partner, and partnership-level determinants of women's knowledge (n = 1,768 women). Results showed that women's demographic characteristics alone did not account for the variation in serostatus awareness. Rather, lower knowledge of partner serostatus was associated with having two or more sex partners (OR = 0.49, 95 % CI 0.37-0.65), food insecurity (OR = 0.68, 95 % CI 0.49-0.94), partner age >35 years (OR = 0.68, 95 % CI 0.49-0.94), and partner concurrency (OR = 0.63, 95 % CI 0.49-0.83). Access to financial support (OR = 1.42, 95 % CI 1.05-1.92) and coresidence (OR = 1.43, 95 % CI 1.05-1.95) were associated with higher knowledge of partner serostatus. HIV prevention efforts addressing African-American women's vulnerabilities should employ integrated behavioral, economic, and empowerment approaches.

Patterns of Use and Barriers to STI Point-of-care Tests for Military Obstetrician Gynecologists.

INTRODUCTION: Sexually transmitted infections (STIs) are commonly reported in military populations. Point-of-care tests (POCTs) are commercially available, but their use is variable in the civilian sector. Their use among military providers has not been evaluated. We sought to identify the pattern of use and barriers to using STI POCTs for military obstetrician/gynecologists (OBGYNs). MATERIALS AND METHODS: We adapted a survey of civilian OBGYNs on patterns of use and barriers to STI POCTs for military OBGYNs. We sent an online questionnaire to 479 military OBGYNs via Army, Air Force, and Navy specialty leaders in May 2023. The questionnaire included 14 demographic questions and up to 52 questions regarding availability, use, and barriers to STI POCTs. The USU Institutional Review Board deemed the study exempt from Institutional Review Board review. RESULTS: Of the 479 solicited, 117 participated in the survey (24.4%). Of respondents, 64.1% were women and 79.5% non-Hispanic white. Sexually transmitted infections were detected once to twice weekly by 13.0% of respondents and once or twice monthly by 52.8%. The most available STI-related POCTs were wet mount prep (68.7%), rapid HIV (43.3%), and urine dipstick (38.6%). Gram stain was available for 30.3%, the Affirm VPIII (Becton, Dickinson and Company, Franklin Lakes, NJ) for 24.5%, and stat RPR for 16.3%. Economic barriers to using POCTs included cost of the test from manufacturer/distributor (57.9%) and military funding/stocking decisions (10.3%). The greatest barriers to use were the purchasing of an instrument (60.8%) and the interruption to workflow in clinic (57.8%). CONCLUSIONS: Military OBGYNs rely on several STI-related POCTs. Economic factors and interruption to workflow were cited as the most significant barriers to using POCTs for military OBGYNs. Test cost and impact on workflow should be considered in future development and procurement of POCTs for the Military Health System.

Identification of shared bacterial strains in the vaginal microbiota of related and unrelated reproductive-age mothers and daughters using genome-resolved metagenomics.

It has been suggested that the human microbiome might be vertically transmitted from mother to offspring and that early colonizers may play a critical role in development of the immune system. Studies have shown limited support for the vertical transmission of the intestinal microbiota but the derivation of the vaginal microbiota remains largely unknown. Although the vaginal microbiota of children and reproductive age women differ in composition, the vaginal microbiota could be vertically transmitted. To determine whether there was any support for this hypothesis, we examined the vaginal microbiota of daughter-mother pairs from the Baltimore metropolitan area (ages 14-27, 32-51; n = 39). We assessed whether the daughter's microbiota was similar in composition to their mother's using metataxonomics. Permutation tests revealed that while some pairs did have similar vaginal microbiota, the degree of similarity did not exceed that expected by chance. Genome-resolved metagenomics was used to identify shared bacterial strains in a subset of the families (n = 22). We found a small number of bacterial strains that were shared between mother-daughter pairs but identified more shared strains between individuals from different families, indicating that vaginal bacteria may display biogeographic patterns. Earlier-in-life studies are needed to demonstrate vertical transmission of the vaginal microbiota.

Lack of association of herpes simplex virus type 2 seropositivity with the progression of HIV infection in the HERS cohort.

Many studies have chronicled the "epidemiologic synergy" between human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV-2). HIV adversely affects the natural history of HSV-2 and results in more frequent and severe HSV-2 reactivation. Few longitudinal studies, however, have examined whether HSV-2 is associated with increased HIV plasma viral loads or decreased CD4 counts. The authors estimated the effect of HSV-2 seropositivity on HIV RNA viral load and on CD4 count over time among 777 HIV-seropositive US women not receiving suppressive HSV-2 therapy in the HIV Epidemiology Research Study (1993-2000). Linear mixed models were used to assess the effect of HSV-2 on log HIV viral load and CD4 count/mm(3) prior to widespread initiation of highly active antiretroviral therapy. Coinfection with HSV-2 was not associated with HIV RNA plasma viral loads during study follow-up. There was a statistically significant association between HSV-2 seropositivity and CD4 count over time, but this difference was small and counterintuitive at an increase of 8 cells/mm(3) (95% confidence interval: 2, 14) per year among HSV-2-seropositive women compared with HSV-2-seronegative women. These data do not support a clinically meaningful effect of baseline HSV-2 seropositivity on the trajectories of HIV plasma viral loads or CD4 counts.

Treatment of syphilis in HIV-infected subjects: a systematic review of the literature.

BACKGROUND: The optimal antimicrobial regimen to treat syphilis in HIV-infected subjects remains controversial. OBJECTIVE: To systematically assess the literature for studies evaluating syphilis treatment regimens in this population. METHODS: Two reviewers independently assessed studies published between 1980 and June 2008 in electronic databases, trial registries and bibliographies (with no language restrictions) for content and quality. Studies that included 10 or more people, with documented HIV status, type and duration of syphilis treatment and at least 6 months of follow-up were included. The primary outcome was syphilis serological or clinical failure stratified by syphilis stage. RESULTS: Of 1380 unique citations, 23 studies (22 published papers and 1 conference abstract) were included in the systematic review. Owing to the significant heterogeneity among studies, pooled summary statistics could not be generated. The range of probabilities for serological failure with 2.4 million units (MU) of intramuscular benzathine penicillin G (BPG) was 6.9% (95% CI 2.6% to 14.4%) to 22.4% (11.7% to 36.6%); that of 7.2 MU of BPG in late latent syphilis was 19.4% (11.9% to 28.9%) to 31.1% (22.3% to 40.9%) and failure estimates with 18-24 MU of aqueous penicillin for the treatment of neurosyphilis were 27.3% (6.0% to 61.0%) to 27.8% (14.2% to 45.2%). CONCLUSIONS: The optimal antimicrobial regimen to treat syphilis in HIV-infected subjects is unknown; guideline recommendations in this population are based on little objective data.

Discordance between spermatozoa detection and self-reported semen exposure.

An analysis of data from a prospective study of 1257 high-risk women revealed 7 predictors of discordance between self-reported lack of recent exposure to semen and detection of spermatozoa on Gram stain, suggesting that inaccuracies in the reporting of sexual behaviors cannot be assumed to be distributed randomly.

Bacterial vaginosis and the natural history of human papillomavirus.

OBJECTIVE: To evaluate associations between common vaginal infections and human papillomavirus (HPV). STUDY DESIGN: Data from up to 15 visits on 756 HIV-infected women and 380 high-risk HIV-uninfected women enrolled in the HIV Epidemiology Research Study (HERS) were evaluated for associations of bacterial vaginosis, trichomoniasis, and vaginal Candida colonization with prevalent HPV, incident HPV, and clearance of HPV in multivariate analysis. RESULTS: Bacterial vaginosis (BV) was associated with increased odds for prevalent (aOR = 1.14, 95% CI: 1.04, 1.26) and incident (aOR = 1.24, 95% CI: 1.04, 1.47) HPV and with delayed clearance of infection (aHR = 0.84, 95% CI: 0.72, 0.97). Whereas BV at the preceding or current visit was associated with incident HPV, in an alternate model for the outcome of incident BV, HPV at the current, but not preceding, visit was associated with incident BV. CONCLUSION: These findings underscore the importance of prevention and successful treatment of bacterial vaginosis.

Association between semen exposure and incident bacterial vaginosis.

OBJECTIVE. To identify correlates of incident bacterial vaginosis (BV) diagnosed with Nugent scoring among high-risk women. STUDY DESIGN. We conducted both cohort and case-crossover analyses, stratified by HIV infection status, based on 871 HIV-infected and 439 HIV-uninfected participants in the HIV Epidemiology Research Study, conducted in 4 US sites in 1993-2000. RESULTS. BV incidence was 21% and 19% among HIV-infected and -uninfected women, respectively. Fewer correlates of BV were found with case-crossover than with cohort design. Reporting frequent coitus (regardless of consistency of condom use) was correlated with BV in cohort analyses but not in case-crossover analyses. The sole correlate of BV in both types of analyses was the detection of spermatozoa on Gram stain, which is a marker of semen exposure. CONCLUSION. The inconsistent association between condom use and BV in prior studies could be from reporting bias. We found evidence of a relationship between semen exposure and incident BV.

Building Partnerships and Stakeholder Relationships for HIV Prevention: Longitudinal Cohort Study Focuses on Community Engagement.

BACKGROUND: African American women bear disproportionate human immunodeficiency virus (HIV) burden in the United States, yet are often underrepresented in clinical research. Community engagement may decrease research mistrust and increase participation. We describe strategies used to engage community partners and female participants in a multisite HIV incidence study, HIV Prevention Trials Network (HPTN) 064. OBJECTIVES: HPTN 064 assessed HIV incidence among women in 10 geographic areas chosen for both high prevalence of HIV and poverty. METHODS: Women were recruited using venue-based sampling and followed for six to 12 months. Recruitment and engagement approaches aligned with the National Institutes of Health (NIH) Director's Council of Public Representatives (COPR) Community Engagement Framework's. RESULTS: Results showed engagement activities increased rapport and established new partnerships with community stakeholders. Study sites engaged 56 community organizations with 2,099 women enrolled in 14 months. Final retention was 94%. CONCLUSIONS: The COPR model maximized inclusiveness and participation of African American women impacted by HIV, supported recruitment and retention, and was the cornerstone of community engagement.

Lumbar puncture in HIV-infected patients with syphilis and no neurologic symptoms.

BACKGROUND: The decision to perform lumbar puncture in patients with asymptomatic human immunodeficiency virus (HIV) infection and syphilis is controversial. The Centers for Disease Control and Prevention recommend certain criteria that warrant lumbar puncture. Here, we assess the performance of these criteria for detecting asymptomatic neurosyphilis (ANS). METHODS: Eligible subjects consisted of all patients with concurrent HIV infection and syphilis in a prospective clinical cohort who had no neurologic symptoms at the time of lumbar puncture. We retrospectively applied different stratification criteria to calculate the performance of lumbar puncture in detecting ANS: (1) lumbar puncture in patients with late latent syphilis or syphilis of an unknown duration, regardless of the CD4 cell count or rapid plasma reagin titer; (2) lumbar puncture if the CD4 cell count was 350 cells/mL and/or the rapid plasma reagin titer was 1:32, regardless of the syphilis stage; and (3) lumbar puncture in the context of serologic nonresponse to syphilis therapy. RESULTS: Two hundred two of 231 patients with syphilis did not have neurologic symptoms. Immediate lumbar puncture was performed for 46 patients, and 10 cases (22%) of ANS were detected. With use of the first criterion, 2 (14%) of 10 cases of ANS in patients with early-stage syphilis would have been missed (sensitivity, 80% [95% confidence interval [CI], 44%-97%]; specificity, 23% (95% confidence interval [CI], 11.4%-40.2%) [corrected] Criterion 2 would not have missed any cases of ANS (sensitivity, 100% [95% CI, 70%-100%]; specificity, 13.2% (95% CI, 4.4%-29.1%) [corrected] but would have required that a lumbar puncture be performed for 88% of patients. Performance of lumbar puncture performed in 13 cases based on serologic nonresponse to syphilis therapy yielded 4 cases (31%) of ANS. CONCLUSIONS: In patients with concurrent HIV infection and syphilis, the use of criteria based on rapid plasma reagin titer and CD4 cell count, instead of stage-based criteria, improved the ability to identify ANS.

The effect of highly active antiretroviral therapy on human papillomavirus clearance and cervical cytology.

OBJECTIVE: To examine the association of highly active antiretroviral therapy (HAART) with human papillomavirus (HPV) clearance and progression or regression of cervical cytological abnormalities in women with human immunodeficiency virus (HIV). METHODS: Five hundred thirty-seven women with HIV participating in the HIV Epidemiology Research Study, an observational, multisite cohort study, were evaluated semiannually from 1996 to 2000. Cervical Pap tests were collected for cervical cytology. Testing for HPV was conducted by polymerase chain reaction. Cox proportional hazard models were used to calculate hazard ratios and 95% confidence intervals (CIs). Number needed to treat (NNT) at 2 years was calculated for HAART. RESULTS: Among women with cervical squamous intraepithelial lesions, HAART was associated with an increased likelihood of HPV clearance (hazard ratio 4.5, 95% CI 1.2-16.3, NNT 22.4). Use of HAART was not associated with an increased likelihood of HPV clearance among women with normal cervical cytology (hazard ratio 1.7, 95% CI 0.9-3.1, NNT 6.5) or atypical squamous cells of undetermined significance cytology (hazard ratio 1.0, 95% CI 0.4-2.5, NNT 174.0). Use of HAART was not significantly associated with an increased likelihood of cervical cytologic regression (hazard ratio 1.3, 95% CI 1.0-1.7, NNT 10.9) or cervical cytologic progression (hazard ratio 0.7, 95% CI 0.6-1.0, NNT 12.8). CONCLUSION: Among women with preexisting abnormal cervical cytology, HAART was associated with enhanced HPV clearance but not with Pap test regression. Close monitoring of women with HIV for cervical cytologic abnormalities, regardless of HAART treatment status, is warranted. LEVEL OF EVIDENCE: II.

Antiretroviral therapy is associated with reduced serologic failure rates for syphilis among HIV-infected patients.

BACKGROUND: Syphilis and human immunodeficiency virus (HIV) frequently coexist in patients, but the effects of immunosuppression on the course of syphilis are unknown. Our goal was to determine whether the degree of HIV-mediated immunosuppression and the use of highly active antiretroviral therapy impact syphilis serologic responses. METHODS: We assessed all cases of syphilis with positive serologic test results from 1990 through 2006 in a prospective, observational clinical cohort of HIV-infected patients. We defined seroreversion as the loss of reactivity in a patient who previously had a serologic test result positive for syphilis. We defined serologic failure as the lack of a 4-fold decrease in rapid plasma reagin titers 270-365 days after therapy or a 4-fold increase in titers > or =30 days after therapy. We used Cox proportional hazards models with statistical adjustments for multiple failure instances. RESULTS: One hundred eighty subjects experienced 231 cases of syphilis. The median follow-up time was 5.3 years. A total of 71 episodes of serologic failure were documented. A CD4 cell count of <200 cells/mL at the time of syphilis diagnosis was associated with an increased risk of serologic failure (adjusted hazard ratio, 2.48; 95% confidence interval, 1.26-4.88). The receipt of highly active antiretroviral therapy was associated with a 60% reduction in the rate of serologic failure (adjusted hazard ratio, 0.40; 95% confidence interval, 0.21-0.75), independent of concomitant CD4 cell response. Rapid plasma reagin seroreversion was infrequent (16.1%) and inconsistent, and it was more likely to occur among patients who received macrolides. CONCLUSION: The use of highly active antiretroviral therapy to reverse immunosuppression and the routine use of macrolides for the prevention of opportunistic infections may reduce syphilis serologic failure rates among HIV-infected patients who have syphilis.

Doxycycline compared with benzathine penicillin for the treatment of early syphilis.

BACKGROUND: Doxycycline is the preferred recommended second-line agent for the treatment of syphilis, although efficacy data from controlled trials are lacking. We compared the serological responses of patients with early syphilis treated with doxycycline with the responses of patients treated with benzathine penicillin G (BPG). METHODS: All patients who received a diagnosis of early syphilis attending 2 public sexually transmitted disease clinics in Baltimore, Maryland, who were treated with doxycycline (100 mg orally, twice daily for 14 days) between October 1993 and June 2000 were eligible. Patients treated with BPG (a single dose of 2.4 million units intramuscularly) were selected as the control group. Inclusion criteria included a clinician-recorded diagnosis of primary, secondary, or early latent syphilis with reactive serological test results at the time of diagnosis and at least 1 follow-up serological test titer. Serological failure was defined as lack of a 4-fold drop in rapid plasma reagin titer 270-400 days after treatment, or a 4-fold increase in titer 30-400 days after therapy. RESULTS: During the study period, 1558 patients were treated for early syphilis, and 87 received doxycycline. Of those treated with doxycycline, 34 met the inclusion criteria. Seventy-three patients from a randomly selected group of 200 age-matched individuals treated with BPG met the inclusion criteria. There were 4 patients with serological failure in the BPG group (5.5%; 95% confidence interval [CI], 1.6%-13.8%) and 0 patients with serological failure in the doxycycline group (0%; 95% CI, 0%-10.3%; P=.2). The median times to successful serological responses for patients in the doxycycline and BPG groups were 106 days (95% CI, 75-149 days) and 137 days (95% CI, 111-172 days), respectively (P=.6). CONCLUSION: Doxycycline appears to be an effective agent for the treatment of early syphilis.

Bacterial pneumonia, HIV therapy, and disease progression among HIV-infected women in the HIV epidemiologic research (HER) study.

BACKGROUND: To determine the rate and predictors of community-acquired bacterial pneumonia and its effect on human immunodeficiency virus (HIV) disease progression in HIV-infected women, we performed a multiple-site, prospective study of HIV-infected women in 4 cities in the United States. METHODS: During the period of 1993-2000, we observed 885 HIV-infected and 425 HIV-uninfected women with a history of injection drug use or high-risk sexual behavior. Participants underwent semiannual interviews, and CD4+ lymphocyte count and viral load were assessed in HIV-infected subjects. Data regarding episodes of bacterial pneumonia were ascertained from medical record reviews. RESULTS: The rate of bacterial pneumonia among 885 HIV-infected women was 8.5 cases per 100 person-years, compared with 0.7 cases per 100 person-years in 425 HIV-uninfected women (P < .001). In analyses limited to follow-up after 1 January 1996, highly active antiretroviral therapy (HAART) and trimethoprim-sulfamethoxazole (TMP-SMX) use were associated with a decreased risk of bacterial pneumonia. Among women who had used TMP-SMX for 12 months, each month of HAART decreased bacterial pneumonia risk by 8% (adjusted hazard ratio [HR(adj)], 0.92; 95% confidence interval [CI], 0.89-0.95). Increments of 50 CD4+ cells/mm3 decreased the risk (HR(adj), 0.88; 95% CI, 0.84-0.93), and smoking doubled the risk (HR(adj), 2.12; 95% CI, 1.26-3.55). Bacterial pneumonia increased mortality risk (HR(adj), 5.02; 95% CI, 2.12-11.87), with adjustment for CD4+ lymphocyte count and duration of HAART and TMP-SMX use. CONCLUSIONS: High rates of bacterial pneumonia persist among HIV-infected women. Although HAART and TMP-SMX treatment decreased the risk, bacterial pneumonia was associated with an accelerated progression to death. Interventions that improve HAART utilization and promote smoking cessation among HIV-infected women are warranted.