Feasibility and acceptability of sexually transmitted infection screening during antenatal care of women in Dhaka, Bangladesh.

BACKGROUND: Sexually transmitted infections (STIs) are a major public health concern worldwide. Untreated STIs may have serious sequelae, particularly in pregnant women. The objective of this study was to assess the feasibility and acceptability of screening and treating common STIs in women during pregnancy in Bangladesh. METHODS: Women were enrolled from four maternity clinics/hospitals serving the lower-middle class population in Dhaka, Bangladesh. The participants were interviewed, and vaginal swab samples were collected by clinical staff. Specimens were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis and high-risk Human Papilloma Viruses (HPVs) using GeneXpert (Cepheid, Sunnyvale, California). Women were informed of their test results and were provided treatment for curable infections. A test of cure was performed. RESULTS: Out of 1157 pregnant women approached, 1000 (86.4%) participated. Ninety-one percent women learned of their test results on the same day of testing. Out of the 996 valid results, 7 (0.7%) tested positive for Chlamydia trachomatis and 1 (0.1%) for Trichomonas vaginalis. There were no gonorrhoea cases. Out of the 971 women with valid results for high-risk HPVs, 46 (4.7%) tested positive. CONCLUSIONS: Screening women for STIs during antenatal care was highly feasible and well-accepted in Bangladesh. While the prevalence of common curable STIs was very low, hrHPV infection prevalence was moderately high. Our findings support period monitoring of STIs and continued prevention efforts for cervical cancer in Bangladesh.

Altered Tumor Necrosis Factor Response in Neurologic Postacute SARS-CoV-2 Syndrome.

Neurologic manifestations of postacute sequelae after SARS-CoV-2 infection (neuro-PASC) are common; however, the underlying drivers of those symptoms remain poorly understood. Prior work has postulated that immune dysregulation leads to ongoing neuroinflammation. We aimed to identify the cytokines involved in that immune dysregulation by comparing 37 plasma cytokine profiles among 20 case patients with neuro-PASC to 20 age- and gender-matched controls. Neuro-PASC cases were defined as individuals with self-reported persistent headache, general malaise, and anosmia or ageusia at least 28 days post-SARS-CoV-2 infection. As a sensitivity analysis, we repeated the main analysis among only participants of Hispanic heritage. In total, 40 specimens were tested. Participants were an average of 43.5 years old (interquartile range 30-52), 20 (50.0%) of whom identified as women. Levels of tumor necrosis factor alpha (TNFα) were 0.76 times lower [95% confidence interval (CI) 0.62-0.94] among cases of neuro-PASC compared with controls, as were levels of C-C motif chemokine 19 (CCL19) (0.67; 95% CI 0.50-0.91), C-C motif chemokine 2 (CCL2) (0.72; 95% CI 0.55-0.95), chemokine interferon-gamma inducible protein 10 (CXCL10) (0.63; 95% CI 0.42-0.96), and chemokine interferon-gamma inducible protein 9 (CXCL9) (0.62; 95% CI 0.38-0.99). Restricting analysis of TNF and CCL19 to participants who identified as Hispanic did not alter results. We noted a reduction in TNFα and down-stream chemokines among patients with neuro-PASC, suggesting an overall immune attenuation.

Unique immune and inflammatory cytokine profiles may define long COVID syndrome.

PURPOSE: Long COVID is estimated to occur in 5-10% of individuals after acute SARS-CoV-2 infection. However, the pathophysiology driving the disease process is poorly understood. METHODS: We evaluated urine and plasma inflammatory and immune cytokine profiles in 33 individuals with long COVID compared to 33 who were asymptomatic and recovered, and 34 without prior infection. RESULTS: Mean urinary leukotriene E4 was significantly elevated among individuals with long COVID compared to asymptomatic and recovered individuals (mean difference 774.2 pg/mL; SD 335.7) and individuals without prior SARS-CoV-2 infection (mean difference 503.1 pg/ml; SD 467.7). Plasma chemokine ligand 6 levels were elevated among individuals with long COVID compared to individuals with no prior SARS-CoV-2 infection (mean difference 0.59 units; SD 0.42). We found no significant difference in angiotensin-converting enzyme 2 antibody levels. Plasma tumor necrosis factor receptor-associated factor 2 (TRAF2) levels were reduced among individuals with long COVID compared to individuals who were asymptomatic and recovered (mean difference = 0.6 units, SD 0.46). Similarly, the mean level of Sarcoma Homology 2-B adapter protein 3 was 3.3 units (SD 1.24) among individuals with long COVID, lower than 4.2 units (SD 1.1) among individuals with recovered, asymptomatic COVID. CONCLUSION: Our findings suggest that further studies should be conducted to evaluate the role of leukotriene E4 as a potential biomarker for a diagnostic test. Furthermore, based on reductions in TRAF2, long COVID may be driven in part by impaired TRAF2-dependent immune-mediated inflammation and potentially immune exhaustion.

Assessment of human papillomavirus vaccination rates of adolescents in California, 2018-2019.

Accurate documentation of state-level human papillomavirus (HPV) vaccination is required for public health planning and to inform corrective actions. To examine the representativeness of the California Immunization Registry, we compared the National Immunization Survey (NIS)-Teen, commercial HMOs in California, Medi-Cal, and California Immunization Registry data for HPV vaccine series completion. Our objectives were to evaluate the vaccine registries, compare and report their completeness, and make recommendations on how to improve and use these studies. Vaccination values were extrapolated for all adolescents aged 13 to 17 years from 2018 to 2019 from NIS-Teen, adolescents aged 13 years from 2018 to 2019 reported in the California Immunization Registry, and adolescents aged 13 years for 2018 for commercial HMOs and Medi-Cal. HPV series completion among 13-year-olds in 2018 for commercial HMOs was 50 %, Medi-Cal was 45 %, and the California Immunization Registry was 28 %, with NIS-Teen rates for 13 to 17-year-olds at 50 % in 2018 and 54 % in 2019. Both rural and urban geographic regions were found to have low completion rates of the HPV series, with trends ranging from 13 % to 45 %. The California Immunization Registry's lower HPV vaccine series completion among 13-year-olds compared to the other reporting sources is most likely due differences in reporting and data collection. Importantly, this data will serve as a comparator for future, similar studies of various sources of HPV vaccination rates following the passing of Bill-1797, which will mandate immunization reporting starting in January 2023.

Impact of aetiological screening of sexually transmitted infections during pregnancy on pregnancy outcomes in South Africa.

BACKGROUND: Sexually transmitted infections (STIs) during pregnancy may increase the risk of adverse pregnancy outcomes. STI syndromic management is standard of care in South Africa but has its limitations. We evaluated the impact of diagnosing and treating curable STIs during pregnancy on adverse pregnancy and birth outcomes. METHODS: We combined data from two prospective studies of pregnant women attending public sector antenatal care (ANC) clinics in Tshwane District and Cape Town, South Africa. Pregnant women were enrolled, tested and treated for STIs. We evaluated the association between any STI at the first ANC visit and a composite adverse pregnancy outcome (miscarriage, stillbirth, preterm birth, early neonatal death, or low birthweight) using modified Poisson regression models, stratifying by HIV infection and adjusting for maternal characteristics. RESULTS: Among 619 women, 61% (n = 380) were from Tshwane District and 39% (n = 239) from Cape Town; 79% (n = 486) were women living with HIV. The prevalence of any STI was 37% (n = 228); C. trachomatis, 26% (n = 158), T. vaginalis, 18% (n = 120) and N. gonorrhoeae, 6% (n = 40). There were 93% (n = 574) singleton live births, 5% (n = 29) miscarriages and 2% (n = 16) stillbirths. Among the live births, there were 1% (n = 3) neonatal deaths, 7% (n = 35) low birthweight in full-term babies and 10% (n = 62) preterm delivery. There were 24% (n = 146) for the composite adverse pregnancy outcome. Overall, any STI diagnosis and treatment at first ANC visit was not associated with adverse outcomes in women living with HIV (adjusted relative risk (aRR); 1.43, 95% CI: 0.95-2.16) or women without HIV (aRR; 2.11, 95% CI: 0.89-5.01). However, C. trachomatis (aRR; 1.57, 95% CI: 1.04-2.39) and N. gonorrhoeae (aRR; 1.69, 95% CI: 1.09-3.08), were each independently associated with the composite adverse outcome in women living with HIV. CONCLUSION: Treated STIs at the first ANC visit were not associated with adverse pregnancy outcome overall. In women living with HIV, C. trachomatis or N. gonorrhoeae at first ANC were each independently associated with adverse pregnancy outcome. Our results highlights complex interactions between the timing of STI detection and treatment, HIV infection and pregnancy outcomes, which warrants further investigation.

Estimated prevalence of human papillomavirus among Nigerian women: A systematic review and meta-analysis.

HPV prevalence in Nigeria has been challenging to quantify given regional population heterogeneity and differences in diagnostic methodology. We conducted a systematic review and meta-analysis of 17 studies, each of which summarized HPV prevalence in women residing in six geopolitical zones of Nigeria. The estimated pooled prevalence (effect size) of HPV in Nigeria was 32% (CI: 23-41%). HPV prevalence was 29% (CI: 20-39%) among studies that detected HPV by genotype. HPV prevalence among studies that used serologic detection was 38% (CI: 12-65%). When stratified by region, a study in the South East (SE) geopolitical zone reported the highest prevalence of 71% (CI: 61-80%) while a study in the South South (SS) geopolitical zone reported the lowest prevalence of 4.9% (CI: 3-9%). HPV prevalence in Nigeria was high. Heterogeneity between study regions and differing HPV detection methods both contribute to variation in estimates. Using pooled estimates serves to inform future strategies for epidemiologic surveillance and future design of HPV and cervical cancer prevention initiatives.

Evaluation of the INDICAID COVID-19 Rapid Antigen Test in Symptomatic Populations and Asymptomatic Community Testing.

As the COVID-19 pandemic progresses, there is an increasing need for rapid, accessible assays for SARS-CoV-2 detection. We present a clinical evaluation and real-world implementation of the INDICAID COVID-19 rapid antigen test (INDICAID rapid test). A multisite clinical evaluation of the INDICAID rapid test using prospectively collected nasal (bilateral anterior) swab samples from symptomatic subjects was performed. The INDICAID rapid test demonstrated a positive percent agreement (PPA) and negative percent agreement (NPA) of 85.3% (95% confidence interval [95% CI], 75.6% to 91.6%) and 94.9% (95% CI, 91.6% to 96.9%), respectively, compared to laboratory-based reverse transcriptase PCR (RT-PCR) using nasal specimens. The INDICAID rapid test was then implemented at COVID-19 outbreak screening centers in Hong Kong as part of a testing algorithm (termed "dual-track") to screen asymptomatic individuals for prioritization for confirmatory RT-PCR testing. In one approach, preliminary positive INDICAID rapid test results triggered expedited processing for laboratory-based RT-PCR, reducing the average time to confirmatory result from 10.85 h to 7.0 h. In a second approach, preliminary positive results triggered subsequent testing with an onsite rapid RT-PCR, reducing the average time to confirmatory result to 0.84 h. In 22,994 asymptomatic patients, the INDICAID rapid test demonstrated a PPA of 84.2% (95% CI, 69.6% to 92.6%) and an NPA of 99.9% (95% CI, 99.9% to 100%) compared to laboratory-based RT-PCR using combined nasal/oropharyngeal specimens. The INDICAID rapid test has excellent performance compared to laboratory-based RT-PCR testing and, when used in tandem with RT-PCR, reduces the time to confirmatory positive result. IMPORTANCE Laboratory-based RT-PCR, the current gold standard for COVID-19 testing, can require a turnaround time of 24 to 48 h from sample collection to result. The delayed time to result limits the effectiveness of centralized RT-PCR testing to reduce transmission and stem potential outbreaks. To address this, we conducted a thorough evaluation of the INDICAID COVID-19 rapid antigen test, a 20-minute rapid antigen test, in both symptomatic and asymptomatic populations. The INDICAID rapid test demonstrated high sensitivity and specificity with RT-PCR as the comparator method. A dual-track testing algorithm was also evaluated utilizing the INDICAID rapid test to screen for preliminary positive patients, whose samples were then prioritized for RT-PCR testing. The dual-track method demonstrated significant improvements in expediting the reporting of positive RT-PCR test results compared to standard RT-PCR testing without prioritization, offering an improved strategy for community testing and controlling SARS-CoV-2 outbreaks.

Decline in Frequency of Newborn Male Circumcision After Change in Medicaid Coverage Status in Selected States in the United States.

OBJECTIVES: Male circumcision is linked to a reduction in the risk of HIV infection, sexually transmitted infections, penile inflammatory skin disorders, cancers, urinary tract infections, and other complications. We examined the extent to which the change in circumcision recommendation by the American Academy of Pediatrics in 1999 and Medicaid coverage status in states affected the total number of procedures performed. METHODS: We used data from the Nationwide Inpatient Sample for 1998-2011 collected annually by the Healthcare Cost and Utilization Project. We examined data on all male births in the United States with Medicaid and private health insurance. We then categorized births into 4 groups: (1) births with newborn male circumcision procedure, (2) births with Medicaid or private health insurance, (3) births that occurred in states where Medicaid coverage for newborn male circumcision was removed, and (4) births that occurred before or after the policy change. We used multivariable logistic regression to estimate the adjusted odds of newborn male circumcision. RESULTS: In the 10 states where a change in Medicaid policy occurred, circumcision frequency had a mean percentage-point decrease of 21.4% among Medicaid beneficiaries and 3.2% among private health insurance beneficiaries from before to after the policy change. In states where coverage was maintained, the change in circumcision frequency was negligible for Medicaid and private health insurance beneficiaries. These changes resulted in an estimated 163 456 potential circumcisions not performed. CONCLUSION: Decreases in newborn male circumcision frequency correlated with the Medicaid policy change for the procedure. Efforts should be made to reduce barriers for cost-effective preventive procedures that promote health, such as newborn male circumcision.

Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments.

CONTEXT.­: Sexually transmitted infections (STIs) are among the most common communicable diseases globally and are associated with significant morbidity and mortality worldwide. Point-of-care tests have the potential to revolutionize the prevention and control of STIs by enabling rapid diagnosis and early treatment of infections, thus interrupting transmission and preventing the sequelae of untreated infections. Currently, there are several point-of-care (POC) tests available for the diagnosis of Treponema pallidum, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections, although these tests differ with regard to their performance, turnaround time, and cost. OBJECTIVE.­: To provide an updated review of the POC tests available and under development for the diagnosis of T pallidum, C trachomatis, N gonorrhoeae, and T vaginalis infections, to discuss the context for which these tests might be used, and to highlight future directions for test development. DATA SOURCES.­: We reviewed the literature pertaining to the recent development and performance evaluations of POC tests for the diagnosis of syphilis, chlamydia, gonorrhea, and trichomonas. CONCLUSIONS.­: Recently, there has been rapid development of new POC tests for STIs. Although there are inexpensive, rapid, and accurate POC tests available for syphilis, there are few such tests available for the diagnosis of chlamydia, gonorrhea, or trichomonas, and currently none with the ability to detect antimicrobial resistance in N gonorrhoeae. Research evaluating implementation strategies for the currently available tests and the development of additional POC tests that are rapid, accurate, and affordable are urgently needed to address the rising number of STIs worldwide.

Association Between Human Papillomavirus Vaccination School-Entry Requirements and Vaccination Initiation.

Importance: Human papillomavirus (HPV) vaccination coverage is suboptimal in the US. The association between HPV vaccination requirements for school entry and HPV vaccination coverage remains to be studied. Objective: To examine the association between HPV vaccination school-entry requirements and vaccination initiation in jurisdictions with such vaccination policies (ie, Virginia, the District of Columbia, and Rhode Island) compared with other regions of the US, as determined by the National Center for Chronic Disease Prevention and Health Promotion. Design, Setting, and Participants: In a population-based, cross-sectional study, 2017 data from the National Immunization Survey-Teen database were used to determine HPV vaccination initiation. Data from 2008 to 2017 were then examined to assess the association between HPV vaccination school-entry policies and vaccination initiation. Data were obtained for adolescents aged 13 to 17 years in the US with health care professional-reported HPV vaccination histories (cross-sectional study, n = 4784; pre-post policy comparisons, n = 42 431). This study was conducted from May 1, 2019, to March 31, 2020. Exposures: State-level HPV vaccination school-entry requirements from 2008 to 2017. Main Outcomes and Measures: Health care professional-confirmed HPV vaccination initiation. Results: The 2017 cross-sectional study included 4784 adolescents aged 13 to 17 years (2228 [46.6%] girls; 2556 [53.4%] boys; mean [SD] age, 15.0 [1.4] years; interquartile range, 14-16 years). Compared with nonpolicy jurisdictions within the same region, Rhode Island and the District of Columbia, which have HPV immunization school-entry requirements, had higher levels of HPV vaccination initiation (Rhode Island: adjusted odds ratio [aOR], 4.34; 95% CI, 2.16-10.00; District of Columbia: aOR, 2.35; 95% CI, 1.39-4.19). However, compared with regional nonpolicy states, Virginia's HPV vaccination initiation did not differ significantly (aOR, 1.01; 95% CI, 0.72-1.42). The 2008-2017 pre-post policy comparisons involved 42 431 adolescents aged 13-17 years (22 362 [52.7%] girls; 20 069 [47.3%] boys; mean [SD] age, 15.0 [1.4] years; interquartile range, 14-16 years). Postpolicy levels of HPV vaccination initiation in girls was significantly higher in Rhode Island (aOR, 3.12; 95% CI, 1.92-5.07) than prepolicy values. Similar changes were noted for postpolicy HPV vaccination initiation in boys in the District of Columbia (aOR, 6.36; 95% CI, 4.27-9.46) and Rhode Island (aOR, 5.84; 95% CI, 3.92-8.69) compared with prepolicy measures. With respect to regional nonpolicy states during the same period, both girls and boys in Rhode Island and boys in the District of Columbia experienced larger increases in HPV vaccination initiation. For example, in Rhode Island, boys aged 16 to 17 years had 7.32 (95% CI, 3.56-15.06) times the change in pre-post policy HPV vaccination initiation, while girls aged 16 to 17 years had 1.28 (95% CI, 0.60-2.73) times the change. In the District of Columbia, boys had 6.36 (95% CI, 4.27-9.46) times the change in pre-post policy HPV vaccination initiation. Conclusions and Relevance: The findings of this study suggest that HPV vaccination school-entry requirements are associated with increases in vaccination initiation. Expanding such policies may increase HPV vaccination in the US.

The Application of Cytokine Expression Assays to Differentiate Active From Previously Treated Syphilis.

To investigate the role of serum cytokine assays to distinguish between active from treated syphilis among serofast patients, we recruited individuals into a prospective cohort study. Participants underwent routine syphilis screening. We selected specimens from a majority cohort of serofast participants with treated and active syphilis. We analyzed specimens with a 62-cytokine multiplex bead-based enzyme-linked immunosorbent assay. Cytokines, brain-derived neurotrophic factor and tumor necrosis factor ß, were most predictive. We built a decision tree that was 82.4% accurate, 100% (95% confidence interval, 82%-100%) sensitive, and 45% (18%-75%) specific. Our decision tree differentiated between serum specimens from serofast participants with treated syphilis versus active syphilis.

Safety and Effectiveness of Same-Day Chlamydia trachomatis and Neisseria gonorrhoeae Screening and Treatment Among Gay, Bisexual, Transgender, and Homeless Youth in Los Angeles, California, and New Orleans, Louisiana.

BACKGROUND: Gay, bisexual, transgender, and homeless youth are at risk of sexually transmitted infections. As part of an adolescent human immunodeficiency virus prevention study, we provided same-day Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment. We aimed to evaluate the feasibility and effectiveness of same-day CT and NG treatment on the proportion of participants receiving timely treatment. METHODS: We recruited adolescents with high sexual risk behaviors aged 12 to 24 years from homeless shelters, lesbian, gay, bisexual, and transgender organizations, and community health centers in Los Angeles, California, and New Orleans, Louisiana from May 2017 to June 2019. Initially, participants were offered point-of-care pharyngeal, rectal, and urethral/vaginal CT and NG testing and referral to another clinic for treatment. After March 2018 in Los Angeles and November 2018 in New Orleans, we provided same-day treatment (and partner treatment packs) for study participants. We measured the proportion of participants who received same-day treatment and the median time to treatment. We collected frequency of partner treatment and any reported adverse treatment-related events. RESULTS: The proportion of participants receiving same-day CT and NG treatment increased from 3.6% (5/140) to 21.1% (20/95; Δ17.5%; 95% confidence interval, 9.2%-26.9%) after implementation of same-day testing and treatment. The median time to treatment decreased from 18.5 to 3 days. Overall, 36 participants took a total of 48 partner treatment packs. There were no reported treatment-related adverse events. CONCLUSIONS: Providing sexually transmitted infection treatment to adolescents at the same visit as testing is feasible and safe, and can increase the proportion of individuals receiving timely treatment.

Excess Cancer Cases and Medical Costs Due to Suboptimal Human Papillomavirus Vaccination Coverage in California.

BACKGROUND: Human papillomavirus (HPV) vaccination coverage continues to be at low to moderate levels throughout the United States. HPV infection is linked to multiple types of cancers resulting in high economic and health burden. We aimed to estimate the excess number of cancer cases and associated medical costs due to current HPV vaccination coverage for a 20-year-old birth cohort in California. METHODS: We estimated the lifetime number of cancer cases caused by vaccine-preventable strains of HPV for a cohort of 20 year-olds in California. We then estimated the excess number of cancer cases in that cohort which would occur due to 2017 HPV vaccination coverage compared with an optimal coverage of 99.5%. By multiplying those excess cases by the average cost of treatment, we determined the excess cost due to current HPV vaccination coverage. RESULTS: With current vaccination coverage in California, the 20-year-old cohort is at risk for an excess 1352 cancer cases that could be prevented with a projected optimal vaccination coverage of 99.5%. The excess cost of treatment for those cancer cases would be US $52.2 million. Male oropharyngeal cancer accounts for the greatest projected cost burden US $21.3 million followed by cervical cancer US $16.1 million. CONCLUSIONS: Increased HPV vaccination coverage in California is needed to reduce economic and health burdens associated with cancers caused by HPV infection.

Enhancing the Control of Syphilis Among Men Who Have Sex With Men by Focusing on Acute Infectious Primary Syphilis and Core Transmission Groups.

The syphilis epidemic among men who have sex with men (MSM) has been increasing steadily. Many syphilis control programs focus on assuring treatment of all persons diagnosed with early syphilis without prioritizing acute primary syphilis or specific subgroups. Acute primary syphilis is highly infectious and contributes to a high proportion of new cases. Surveillance data show that among MSM with incident syphilis (primary or secondary) only about 35% are identified in the primary stage, indicating that most primary cases are missed and untreated. Patients with primary syphilis and large numbers of sex partners may play a major role in maintaining syphilis transmission. Considering those issues, sexually transmitted disease (STD) programs should consider increasing their focus on primary syphilis by assigning primary cases the highest priority, expanding client and clinician health education, and increasing the detection of primary syphilis through increased serologic screening frequency among high-risk MSM. Furthermore, syphilis control programs should implement steps to identify asymptomatic high-probable occult primary cases based on low titer (≤1:8) and recent seroconversion. Finally, to address core transmission groups, programs should implement periodic risk assessment to identify persons with a high number of sex partners and offer these individuals risk-reduction counseling, case management, and selective syphilis preexposure or postexposure doxycycline chemoprophylaxis. Although reprioritizing prevention efforts might be challenging, the Centers for Disease Control and Prevention, community advocacy groups, university STD research centers, and national STD prevention training centers can assist by providing support for consensus discussions and direction in developing operational guidance, some of which may be best delivered through STD and human immunodeficiency virus program partnerships.

Performance of a Dual Human Immunodeficiency Virus/Syphilis Rapid Test Compared With Conventional Serological Testing for Syphilis and Human Immunodeficiency Virus in a Laboratory Setting: Results From the Zimbabwe STI Etiology Study.

BACKGROUND: Dual human immunodeficiency virus (HIV)/syphilis rapid, point-of-care testing may enhance syphilis screening among high-risk populations, increase case finding, reduce time to treatment, and prevent complications. We assessed the laboratory-based performance of a rapid dual HIV/syphilis test using serum collected from patients enrolled in the Zimbabwe Sexually Transmitted Infections (STI) Etiology study. METHODS: Blood specimens were collected from patients presenting with STI syndromes in 6, predominantly urban STI clinics in different regions of Zimbabwe. All specimens were tested at a central research laboratory using the Standard Diagnostics Bioline HIV/Syphilis Duo test. The treponemal syphilis component of the dual rapid test was compared with the Treponema pallidum hemagglutination assay (TPHA) as a gold standard comparator, both alone or in combination with a nontreponemal test, the rapid plasma reagin test. The HIV component of the dual test was compared with a combination of HIV rapid tests conducted at the research laboratory following the Zimbabwe national HIV testing algorithm. RESULTS: Of 600 men and women enrolled in the study, 436 consented to serological syphilis and HIV testing and had specimens successfully tested by all assays. The treponemal component of the dual test had a sensitivity of 66.2% (95% confidence interval [CI], 55.2%-77.2%) and a specificity of 96.4% (95% CI, 94.5%-98.3%) when compared with TPHA; the sensitivity increased to 91.7% (95% CI, 82.6%-99.9%) when both TPHA and rapid plasma reagin were positive. The HIV component of the dual test had a sensitivity of 99.4% (95% CI, 98.4%-99.9%) and a specificity of 100% (95% CI, 99.9%-100%) when compared with the HIV testing algorithm. CONCLUSIONS: Laboratory performance of the SD Bioline HIV/Syphilis Duo test was high for the HIV component of the test. Sensitivity of the treponemal component was lower than reported from most laboratory-based evaluations in the literature. However, sensitivity of the test increased substantially among patients more likely to have active syphilis for which results of both standard treponemal and nontreponemal tests were positive.