BACKGROUND: Understanding protection against SARS-CoV-2 infection by vaccine and hybrid immunity is important for informing public health strategies as new variants emerge. METHODS: We analyzed data from three cohort studies spanning September 1, 2022-July 31, 2023, to estimate COVID-19 vaccine effectiveness (VE) against SARS-CoV-2 infection and symptomatic COVID-19 among adults with and without prior infection in the United States. Participants collected weekly nasal swabs, irrespective of symptoms, annual blood draws, and completed periodic surveys, which included vaccination status and prior infection history. Swabs were tested molecularly for SARS-CoV-2. VE was estimated using Cox proportional hazards models for the hazard ratios of infections, adjusting for covariates. VE was calculated considering prior infection and recency of vaccination. RESULTS: Among 3,344 adults, adjusted VE of bivalent vaccine against infection was 37.2% (95% CI: 12.3-55.7%) within 7-59 days of vaccination and 21.1% (95% CI: -0.5-37.1%) within 60-179 days of vaccination compared to participants who were unvaccinated/received an original monovalent vaccine dose ≥180 days prior. Overall, adjusted VE of bivalent vaccine against infection, in conjunction with prior infection, was 62.2% (95% CI: 46.0-74.5%) within 7-179 days of vaccination and 39.4% (95% CI: 12.5-61.6%) ≥180 days compared to naïve participants who were unvaccinated/received a monovalent vaccine dose ≥180 days prior. CONCLUSIONS: Adults with both prior infection and recent vaccination had high protection against infection and symptomatic illness. Recent vaccination alone provided moderate protection.

OBJECTIVE: To understand SARS-CoV-2 transmission in early care and education (ECE) settings, we implemented a Test to Stay (TTS) strategy, which allowed children and staff who were close contacts to COVID-19 to remain in person if they agreed to test twice after exposure. We describe SARS-CoV-2 transmission, testing preferences, and the number of in-person days saved among participating ECE facilities. METHODS: From March 21 through May 27, 2022, 32 ECE facilities in Illinois implemented TTS. Unvaccinated children and staff who were not up to date with COVID-19 vaccination could participate if exposed to COVID-19. Participants received 2 tests within 7 days after exposure and were given the option to test at home or at the ECE facility. RESULTS: During the study period, 331 TTS participants were exposed to index cases (defined as people attending the ECE facility with a positive SARS-CoV-2 test result during the infectious period); 14 participants tested positive, resulting in a secondary attack rate of 4.2%. No tertiary cases (defined as a person with a positive SARS-CoV-2 test result within 10 days after exposure to a secondary case) occurred in the ECE facilities. Most participants (366 of 383; 95.6%) chose to test at home. Remaining in-person after an exposure to COVID-19 saved approximately 1915 in-person days among children and staff and approximately 1870 parent workdays. CONCLUSION: SARS-CoV-2 transmission rates were low in ECE facilities during the study period. Serial testing after COVID-19 exposure among children and staff at ECE facilities is a valuable strategy to allow children to remain in person and parents to avoid missing workdays.

Internet-recruited gay, bisexual, and other men who have sex with men (MSM) were offered HIV self-tests (HIVSTs) after completing baseline, 3-, 6-, and 9-month follow-up surveys. The surveys asked about the use and distribution of these HIVSTs. Among 995 who reported on their distribution of HIVSTs, 667 (67.0%) distributed HIVSTs to their social network associates (SNAs), which resulted in 34 newly identified HIV infections among 2301 SNAs (1.5%). The main reasons participants reported not distributing HIVSTs included: wanting to use the HIVSTs themselves (74.9%); thinking that their SNAs would get angry or upset if offered HIVSTs (12.5%); or not knowing that they could give the HIVSTs away (11.3%). Self-testing programs can provide multiple HIVSTs and encourage the distribution of HIVST by MSM to their SNAs to increase awareness of HIV status among persons disproportionately affected by HIV.

BACKGROUND: To determine whether Positive Health Check, a highly tailored video doctor intervention, can improve viral suppression and retention in care. SETTING: Four clinics that deliver HIV primary care. METHODS: A hybrid type 1 effectiveness-implementation randomized trial design was used to test study hypotheses. Participants (N = 799) who were not virally suppressed, were new to care, or had fallen out of care were randomly assigned to receive Positive Health Check or the standard of care alone. The primary endpoint was viral load suppression, and the secondary endpoint was retention in care, both assessed at 12 months, using an intention-to-treat approach. A priori subgroup analyses based on sex assigned at birth and race were examined as well. RESULTS: There were no statistically significant differences between Positive Health Check (N = 397) and standard of care (N = 402) for either endpoint. However, statistically significant group differences were identified from a priori subgroup analyses. Male participants receiving Positive Health Check were more likely to achieve suppression at 12 months than male participants receiving standard of care adjusted risk ratio [aRR] [95% confidence interval (CI)] = 1.14 (1.00 to 1.29), P = 0.046}. For retention in care, there was a statistically significant lower risk for a 6-month visit gap in the Positive Health Check arm for the youngest participants, 18-29 years old [aRR (95% CI) = 0.55 (0.33 to 0.92), P = 0.024] and the oldest participants, 60-81 years old [aRR (95% CI) = 0.49 (0.30 to 0.81), P = 0.006]. CONCLUSIONS: Positive Health Check may help male participants with HIV achieve viral suppression, and younger and older patients consistently attend HIV care. REGISTRY NAME: Positive Health Check Evaluation Trial. Trial ID: 1U18PS004967-01. URL: https://clinicaltrials.gov/ct2/show/NCT03292913.

To assess whether pressuring others to use HIV self-tests is prevalent among US men who have sex with men (MSM), we analyzed data from a randomized controlled trial of HIV self-testing. Among 752 online-recruited MSM who received HIV self-tests and responded to a 12-month survey, 8.5% (60/709) reported pressuring someone to use an HIV self-test: 29 pressured a friend, 28 pressured a sexual partner, and 1 pressured a family member. Conversely, 2.1% (15/715) reported being pressured to self-test: 12 by a sexual partner and 3 by a friend. No physical harm was reported. HIV prevention programs that use HIV self-tests to reach populations at risk for HIV may be reassured by our findings because, despite reports of pressure to use HIV self-tests, no physical abuse was reported between sex partners. These programs should, however, include messages emphasizing the voluntary use of HIV self-tests and be prepared to address concerns of persons who have been pressured to use HIV self-tests. This trial is registered at www.clinicaltrials.gov (NCT02067039) and the date of registration is February 5, 2014.

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.

We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (>/= 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (>/= 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.

Importance: Undiagnosed HIV infection results in delayed access to treatment and increased transmission. Self-tests for HIV may increase awareness of infection among men who have sex with men (MSM). Objective: To evaluate the effect of providing HIV self-tests on frequency of testing, diagnoses of HIV infection, and sexual risk behaviors. Design, Setting, and Participants: This 12-month longitudinal, 2-group randomized clinical trial recruited MSM through online banner advertisements from March through August 2015. Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses. Participants completed quarterly online surveys. Telephone call notes and laboratory test results were included in the analysis, which was completed from August 2017 through December 2018. Interventions: All participants had access to online web-based HIV testing resources and telephone counseling on request. Participants were randomized in a 1:1 ratio to the control group or a self-testing (ST) group, which received 4 HIV self-tests after completing the baseline survey with the option to replenish self-tests after completing quarterly surveys. At study completion, all participants were offered 2 self-tests and 1 dried blood spot collection kit. Main Outcomes and Measures: Primary outcomes were HIV testing frequency (tested >/=3 times during the trial) and number of newly identified HIV infections among participants in both groups and social network members who used the study HIV self-tests. Secondary outcomes included sex behaviors (eg, anal sex, serosorting). Results: Of 2665 participants, the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment. Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys. More ST participants reported testing 3 or more times during the trial than control participants (777 of 1014 [76.6%] vs 215 of 977 [22.0%]; P < .01). The cumulative number of newly identified infections during the trial was twice as high in the ST participants as the control participants (25 of 1325 [1.9%] vs 11 of 1340 [0.8%]; P = .02), with the largest difference in HIV infections identified in the first 3 months (12 of 1325 [0.9%] vs 2 of 1340 [0.1%]; P < .01). The ST participants reported 34 newly identified infections among social network members who used the self-tests. Conclusions and Relevance: Distribution of HIV self-tests provides a worthwhile mechanism to increase awareness of HIV infection and prevent transmission among MSM. Trial Registration: ClinicalTrials.gov identifier: NCT02067039.

BACKGROUND: Persons with human immunodeficiency virus (HIV) who get and keep a suppressed viral load are unlikely to transmit HIV. Simple, practical interventions to help achieve HIV viral suppression that are easy and inexpensive to administer in clinical settings are needed. We evaluated whether a brief video containing HIV-related health messages targeted to all patients in the waiting room improved treatment initiation, medication adherence, and retention in care. METHODS AND FINDINGS: In a quasi-experimental trial all patients (N = 2,023) attending two HIV clinics from June 2016 to March 2017 were exposed to a theory-based, 29-minute video depicting persons overcoming barriers to starting treatment, taking medication as prescribed, and keeping medical appointments. New prescriptions at index visit, HIV viral load test results, and dates of return visits were collected through review of medical records for all patients during the 10 months that the video was shown. Those data were compared with the same variables collected for all patients (N = 1,979) visiting the clinics during the prior 10 months (August 2015 to May 2016). Among patients exposed to the video, there was an overall 10.4 percentage point increase in patients prescribed treatment (60.3% to 70.7%, p< 0.01). Additionally, there was an overall 6.0 percentage point improvement in viral suppression (56.7% to 62.7%, p< 0.01), however mixed results between sites was observed. There was not a significant change in rates of return visits (77.5% to 78.8%). A study limitation is that, due to the lack of randomization, the findings may be subject to bias and secular trends. CONCLUSIONS: Showing a brief treatment-focused video in HIV clinic waiting rooms can be effective at improving treatment initiation and may help patients achieve viral suppression. This feasible, low resource-reliant video intervention may be appropriate for adoption by other clinics treating persons with HIV. TRIAL REGISTRATION: http://www.ClinicalTrials.gov (NCT03508310).

BACKGROUND: For HIV-infected pregnant and breastfeeding women, antiretroviral therapy (ART) is known to reduce the mother's risk of passing the infection to her child. However, concerns remain about possible associations between various components of different ART regimens and adverse fetal and infant outcomes. As part of a clinical trial in western Kenya for the prevention of mother-to-child transmission (PMTCT) of HIV, pregnant women received one of two different ART regimens. METHODS: The original PMTCT study conducted in Kenya enrolled 522 HIV-infected, ART-naive pregnant women. These women were assigned to receive an ART regimen that included either nevirapine, a nonnucleoside reverse transcriptase inhibitor (NNRTI), or nelfinavir, a protease inhibitor. This substudy involves 384 women from the original study who had baseline CD4 counts at least 250 cells/mul, and compares the risks of adverse fetal and infant outcomes between the two ART regimens. RESULTS: There were 386 live births (including multiples) and 7 (1.8%) stillbirths. Among live births, there were 67 preterm deliveries, 37 low-birth weight infants, and 14 infant deaths by 6 months. There were no statistically significant differences between the two ART regimens for any of the reported adverse outcomes. CONCLUSION: Although these data do not show significant differences between the NNRTI-based or protease inhibitor-based regimens in serious adverse fetal and infant outcomes, more studies need to be done and careful vigilance is needed to ensure infant safety.

In the United States, an estimated 67% of new HIV diagnoses are among men who have sex with men (MSM), however 25% of HIV-positive MSM in the 2014 National HIV Behavioral Surveillance Survey were unaware of their infection. HIV self-testing (HIVST) with rapid diagnostic tests (RDTs) may facilitate access to HIV testing. We evaluated the ability of 22 MSM to conduct two HIV RDTs (OraQuick (R) In-Home HIV Test and a home-use prototype of Sure Check (R) HIV 1/2 Assay), interpret sample images of test results, and collect a dried blood spot (DBS) specimen. While some participants did not follow every direction, most participants were able to conduct HIVST and correctly interpret their results. Interpretation of panels of RDT images was especially difficult when the "control" line was missing, and 27% of DBS cards produced were rated as of bad quality. Modifications to the DBS instructions were necessary prior to evaluating the performance of these tests in real-world settings.

OBJECTIVE: Using published, nationally representative estimates, we calculated the total number of perinatally HIV-exposed and -infected infants born during 1978-2010, the number of perinatal HIV cases prevented by interventions designed for the prevention of mother-to-child transmission (PMTCT), and the number of infants exposed to antiretroviral drugs during the prenatal and intrapartum periods. DESIGN: We calculated the number of infants exposed to antiretroviral drugs since 1994, and the number of cases of mother-to-child HIV transmission prevented from 1994-2010 using published data. We generated confidence limits for our estimates by performing a simulation study. METHODS: Data were obtained from published, nationally-representative estimates from CDC. Model parameters included the annual numbers of HIV-infected pregnant women, the annual numbers of perinatally-infected infants, the annual proportions of infants exposed to antiretroviral drugs during the prenatal and intrapartum period, and the estimated mother-to-child transmission (MTCT) rate in the absence of preventive interventions. For the simulation study, model parameters were assigned distributions and we performed 1,000,000 repetitions. RESULTS: Between 1978 and 2010, an estimated 186,157 (95% CI: 185,312-187,003) HIV-exposed infants and approximately 21,003 (95% CI: 20.179-21,288) infected infants were born in the United States. Between 1994 and 2010, an estimated 124,342 (95% CI: 123,651-125,034) HIV-exposed infants were born in the U.S., and approximately 6,083 (95% CI: 5,931-6,236) infants were perinatally infected with HIV. During this same period about 100,207 (95% CI: 99,374-101,028) infants were prenatally exposed to antiretroviral drugs. As a result of PMTCT interventions, an estimated 21,956 (95% CI: 20,191-23,759) MTCT HIV cases have been prevented in the US since 1994. CONCLUSION: Though continued vigilance is needed to eliminate mother-to-child HIV transmission, PMTCT interventions have prevented nearly 22,000 cases of perinatal HIV transmission in the United States since 1994.

BACKGROUND: Patients in sexually transmitted disease (STD) clinic waiting rooms represent a potential audience for delivering health messages via video-based interventions. A controlled trial at 3 sites found that patients exposed to one intervention, Safe in the City, had a significantly lower incidence of STDs compared with patients in the control condition. An evaluation of the intervention's cost could help determine whether such interventions are programmatically viable. MATERIALS AND METHODS: The cost of producing the Safe in the City intervention was estimated using study records, including logs, calendars, and contract invoices. Production costs were divided by the 1650 digital video kits initially fabricated to get an estimated cost per digital video. Clinic costs for showing the video in waiting rooms included staff time costs for equipment operation and hardware depreciation and were estimated for the 21-month study observation period retrospectively. RESULTS: The intervention cost an estimated $416,966 to develop, equaling $253 per digital video disk produced. Per-site costs to show the video intervention were estimated to be $2699 during the randomized trial. CONCLUSIONS: The cost of producing and implementing Safe in the City intervention suggests that similar interventions could potentially be produced and made available to end users at a price that would both cover production costs and be low enough that the end users could afford them.

OBJECTIVE: To identify factors associated with repeat pregnancy subsequent to an index pregnancy among women living with HIV (WLWH) in western Kenya who were enrolled in a 24-month phase-II clinical trial of triple-ART prophylaxis for prevention of mother-to-child transmission, and to contextualize social and cultural influences on WLWH's reproductive decision making. METHODS: A mixed-methods approach was used to examine repeat pregnancy within a 24 month period after birth. Counselor-administered questionnaires were collected from 500 WLWH. Forty women (22 with a repeat pregnancy; 18 with no repeat pregnancy) were purposively selected for a qualitative interview (QI). Simple and multiple logistic regression analyses were performed for quantitative data. Thematic coding and saliency analysis were undertaken for qualitative data. RESULTS: Eighty-eight (17.6%) women had a repeat pregnancy. Median maternal age was 23 years (range 15-43 years) and median gestational age at enrollment was 34 weeks. In multiple logistic regression analyses, living in the same compound with a husband (adjusted odds ratio (AOR): 2.33; 95% confidence interval (CI): 1.14, 4.75) was associated with increased odds of repeat pregnancy (p ≤ 0.05). Being in the 30-43 age group (AOR: 0.25; 95% CI: 0.07, 0.87), having talked to a partner about family planning (FP) use (AOR: 0.53; 95% CI: 0.29, 0.98), and prior usage of FP (AOR: 0.45; 95% CI: 0.25, 0.82) were associated with a decrease in odds of repeat pregnancy. QI findings centered on concerns about modern contraception methods (side effects and views that they 'ruined the womb') and a desire to have the right number of children. Religious leaders, family, and the broader community were viewed as reinforcing cultural expectations for married women to have children. Repeat pregnancy was commonly attributed to contraception failure or to lack of knowledge about post-delivery fertility. CONCLUSIONS: In addition to cultural context, reproductive health programs for WLWH may need to address issues related to living circumstances and the possibility that reproductive-decision making may extend beyond the woman and her partner.

OBJECTIVES: This cross-sectional study examined African American and Hispanic women's (N = 1,509) self-reports of unwanted forced sex and its association with behavioral and mental health outcomes after the event. METHODS: Twenty percent of the women had experienced forced sex (1st occurrence at age 15 years or younger for 10%, 1st occurrence at older than 15 years of age for 10%). RESULTS: Regardless of when forced sex 1st occurred, women were more likely to have engaged in unprotected vaginal and anal sex, to have had multiple unprotected sex partners, to have sexually transmitted infections, to have reported binge drinking and illicit drug use, and to exhibit distress and have received mental health counseling. CONCLUSIONS: Forced sex may have wide-ranging behavioral and mental health consequences years later.

BACKGROUND: The number of strategies to prevent HIV transmission has increased following trials evaluating antiretroviral therapy (ART), preexposure prophylaxis (PrEP) and male circumcision. Serodiscordant couples need guidance on the effects of these strategies alone, and in combination with each other, on HIV transmission. METHODS: We estimated the sexual risk of HIV transmission over 1-year and 10-year periods among male-male and male-female serodiscordant couples. We assumed the following reductions in transmission: 80% from consistent condom use; 54% from circumcision in the negative male partner of a heterosexual couple; 73% from circumcision in the negative partner of a male-male couple; 71% from PrEP in heterosexual couples; 44% from PrEP in male-male couples; and 96% from ART use by the HIV-infected partner. FINDINGS: For couples using any single prevention strategy, a substantial cumulative risk of HIV transmission remained. For a male-female couple using only condoms, estimated risk over 10 years was 11%; for a male-male couple using only condoms, estimated risk was 76%. ART use by the HIV-infected partner was the most effective single strategy in reducing risk; among male-male couples, adding consistent condom use was necessary to keep the 10-year risk below 10%. CONCLUSION: Focusing on 1-year and longer term transmission probabilities gives couples a better understanding of risk than those illustrated by data for a single sexual act. Long-term transmission probabilities to the negative partner in serodiscordant couples can be high, though these can be substantially reduced with the strategic use of preventive methods, especially those that include ART.

BACKGROUND: Effective HIV prevention programs rely on accurate estimates of the per-act risk of HIV acquisition from sexual and parenteral exposures. We updated the previous risk estimates of HIV acquisition from parenteral, vertical, and sexual exposures, and assessed the modifying effects of factors including condom use, male circumcision, and antiretroviral therapy. METHODS: We conducted literature searches to identify new studies reporting data regarding per-act HIV transmission risk and modifying factors. Of the 7339 abstracts potentially related to per-act HIV transmission risk, 3 meta-analyses provided pooled per-act transmission risk probabilities and 2 studies provided data on modifying factors. Of the 8119 abstracts related to modifying factors, 15 relevant articles, including 3 meta-analyses, were included. We used fixed-effects inverse-variance models on the logarithmic scale to obtain updated estimates of certain transmission risks using data from primary studies, and employed Poisson regression to calculate relative risks with exact 95% confidence intervals for certain modifying factors. RESULTS: Risk of HIV transmission was greatest for blood transfusion, followed by vertical exposure, sexual exposures, and other parenteral exposures. Sexual exposure risks ranged from low for oral sex to 138 infections per 10 000 exposures for receptive anal intercourse. Estimated risks of HIV acquisition from sexual exposure were attenuated by 99.2% with the dual use of condoms and antiretroviral treatment of the HIV-infected partner. CONCLUSION: The risk of HIV acquisition varied widely, and the estimates for receptive anal intercourse increased compared with previous estimates. The risk associated with sexual intercourse was reduced most substantially by the combined use of condoms and antiretroviral treatment of HIV-infected partners.

For epidemiologic surveillance of HIV infection in the United States, until this year, the staging system for adults (published in 2008) had been separate from the classification system for children (published in 1994).1,2 To design a single staging system for both adults and children based primarily on absolute CD4 T-lymphocyte counts, we retained the age-specific CD4 count thresholds used to define the boundaries between stages 1, 2, and 3 (called “immunologic categories” rather than “stages” in the 1994 classification for children). Values greater than or equal to the upper threshold indicate stage 1, values less than the upper threshold but greater than or equal to the lower threshold indicate stage 2, and values less than the lower threshold indicate stage 3 (AIDS). For children aged <1 year, the lower and upper CD4 count thresholds are 750 and 1500 (cells/μL); for children aged 1 to <6 years, they are 500 and 1000; for children aged 6 to <13 and for adults and adolescents aged 13 or older, they are 200 and 500. | Those staging/classification systems used both the absolute CD4 count and the CD4 percentage of total lymphocytes to classify cases into stages; if the CD4 count and the CD4 percentage indicated different stages, the more advanced of the 2 stages was selected. If one of these measurements was not available, the classification was based solely on the other measurement. The lower and upper CD4 percentage thresholds in those staging/classification systems were 15% and 25% for all 3 age groups of children, and 14% and 29% for adults and adolescents.1,2 In developing an updated staging system, we reassessed the relationship between the CD4 counts and the CD4 percentages and selected the mean CD4 percentage corresponding to each CD4 count threshold.

The purpose of this study was to estimate prenatal human immunodeficiency virus (HIV) screening rates prior to and on admission to labor and delivery (L&D) and to examine factors associated with HIV screening, including hospital policies, with a comparison of HIV and hepatitis B prenatal screening practices and hospital policies. In March 2006, a survey of hospitals (n = 190) and review of paired maternal and infant medical records (n = 4,762) were conducted in 50 US states, DC, and Puerto Rico. Data from the survey and medical record review were analyzed using SAS software v9.2 (SAS Institute, Cary, NC). HIV testing before delivery occurred among 3,438 women (73.9 %); African American and Hispanic women were more likely to be tested than white women [aOR 2.22, 95 % CI (1.6-3.1) and aOR 1.55, 95 % CI (1.1-2.2), respectively]. Among women without previous HIV testing, 138 (16.6 %) were tested after admission to labor and delivery. Policies to test women with undocumented HIV status in at delivery were present in 65 (36.3 %) hospitals. HIV testing after admission to L&D was more likely in hospitals with policies to test women with undocumented HIV status [aOR 5.91, 95 % CI (2.0-17.8)]. Overall, policies and screening practices for HIV were consistently less prevalent than those for hepatitis B. Many women are not being routinely screened for HIV before or at delivery. Women with unknown HIV status were more likely to be tested in L&D in hospitals with testing policies.

BACKGROUND: Few studies have evaluated the risk of nevirapine (NVP)-associated hepatotoxicity among HIV-infected pregnant women with a CD4 count ≥250 cells/mm(3). METHODS: We enrolled HIV-infected pregnant Kenyan women who initiated triple antiretroviral therapy (ART) at 34 weeks gestation. We compared the rates of severe hepatotoxicity (grades 3-4 hepatotoxicity) and rash-associated hepatotoxicity (rash with ≥grade 2 hepatotoxicity) with NVP and nelfinavir (NFV), respectively. RESULTS: We initiated triple ART in 522 pregnant women; severe hepatotoxicity and rash-associated hepatotoxicity occurred in 14 (3%) and 9 (2%) women, respectively. Women who initiated NVP had higher rates of severe hepatotoxicity (5% vs 1%; P = .03) and rash-associated hepatotoxicity (4% vs 0%; P = .003) when compared with NFV. Among women who initiated NVP (n = 254), a baseline CD4 count ≥250 cells/mm(3) was not associated with severe hepatotoxicity (5% vs 3%; P = .52) or rash-associated hepatotoxicity (4% vs 3%; P = .69). CONCLUSION: Nevirapine use but not CD4 count ≥250 cells/mm(3) was associated with hepatotoxicity.

We used Centers for Disease Control and Prevention HIV Counseling and Testing System data from 2007 to determine the percentage and characteristics of persons newly identified as HIV-positive in US correctional facilities. The newly identified HIV positivity was 0.7%, and 30% of detainees newly identified with HIV were categorized as having low-risk heterosexual contact or no acknowledged risk. Correctional facilities should provide detainees with routine opt-out HIV testing, unless the prevalence of previously undiagnosed HIV infection has been documented to be less than 0.1%. (Am J Public Health. Published online ahead of print March 8, 2012: e1-e4. doi:10.2105/AJPH.2011.300614).

BACKGROUND: Three cases of pediatric HIV transmission attributed to the feeding practice of premasticating food for children have been reported. The degree of risk that premastication poses for pediatric HIV transmission and the prevalence of this behavior among HIV-infected caregivers is unknown. METHODS: During December 2009-February 2010, we conducted a case-control investigation of late-diagnosed HIV infection in children at six HIV clinics, using in-person and telephone interviews. A cross-sectional investigation of premastication was conducted in concert with this case-control investigation. RESULTS: We compared 11 case-patients to 35 HIV-exposed controls of similar age. Sixteen (35%) of 46 children were fed premasticated food, 10 (22%) by an HIV-infected caregiver. Twenty-seven percent of case-patients received premasticated food from an HIV-infected caregiver compared to 20% of controls (odds ratio = 1.5; 95% confidence interval = 0.3 - 7.1). In the cross-sectional investigation, 48 (31%) of 154 primary caregivers of children aged ≥6 months reported the children received premasticated food from themselves or someone else. The prevalence of premastication decreased with increasing caregiver age, and had been used to feed children aged 1-36 months. CONCLUSIONS: Premastication, a potential route of HIV transmission to children, was a common practice of caregivers. Public health officials and healthcare providers should educate the public about the potential risk of disease transmission via premastication.

PURPOSE: We examined sexual risk behaviors and unrecognized HIV infection among heterosexually active African-American and Hispanic women. METHODS: Women not previously diagnosed with HIV infection were recruited in rural counties in North Carolina (African American) and Alabama (African American), and an urban county in southern Florida (Hispanic) using multiple methods. They completed a computer-administered questionnaire and were tested for HIV infection. RESULTS: Between October 2008 and September 2009, 1,527 women (1,013 African American and 514 Hispanic) enrolled in the study. Median age was 35 years (range, 18-59), 33% were married or living as married, 50% had an annual household income of $12,000 or less, and 56% were employed full or part time. Two women (0.13%) tested positive for HIV. In the past 12 months, 19% had been diagnosed with a sexually transmitted infection (other than HIV), 87% engaged in unprotected vaginal intercourse (UVI), and 26% engaged in unprotected anal intercourse (UAI). In multivariate analysis, UAI was significantly (p < .05) more likely among those who reported ever being pregnant, binge drinking in the past 30 days, ever exchanging sex for things needed or wanted, engaging in UVI, or being of Hispanic ethnicity. UAI was also more likely to occur with partners with whom women had a current or past relationship as opposed to casual partners. CONCLUSION: A high percentage of our sample of heterosexually active women of color had recently engaged in sexual risk behaviors, particularly UAI. More research is needed to elucidate the interpersonal dynamics that may promote this high-risk behavior. Educational messages that explicitly address the risks of heterosexual anal intercourse need to be developed for heterosexually active women and their male partners.

BACKGROUND: Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention. METHODS AND FINDINGS: HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34-36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ≥500 cells/mm(3) were 8.4% (95% confidence interval [CI] 5.8%-12.0%) and 4.1% (1.8%-8.8%), respectively (p = 0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ≥10,000 copies/ml were 3.0% (1.1%-7.8%) and 8.7% (6.1%-12.3%), respectively (p = 0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%-19.4%). CONCLUSIONS: This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These findings are consistent with those from other trials using maternal triple-antiretroviral regimens during breastfeeding in comparable settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT00146380 Please see later in the article for the Editors' Summary.

BACKGROUND: Early mortality rates after initiating antiretroviral therapy (ART) are high in sub-Saharan Africa. We examined whether serum chemistries at ART initiation predicted mortality among HIV-infected women. METHODS: From May 2005-January 2007, we enrolled women initiating ART in a prospective cohort study in Zambia and Kenya. We used Cox proportional hazards models to identify risk factors associated with mortality. RESULTS: Among 661 HIV-infected women, 53 (8%) died during the first year of ART, and tuberculosis was the most common cause of death (32%). Women were more likely to die if they were both hyponatremic (sodium < 135 mmol/L) and hypochloremic (chloride < 95 mmol/L) (37% vs. 6%) or hypoalbuminemic (albumin < 34 g/L, 13% vs. 4%) when initiating ART. A body mass index < 18 kg/m2 (adjusted hazard ratio [aHR] 5.3, 95% confidence interval [CI] 2.6-10.6) and hyponatremia with hypochloremia (aHR 4.5, 95% CI 2.2-9.4) were associated with one-year mortality after adjusting for country, CD4 cell count, WHO clinical stage, hemoglobin, and albumin. Among women with a CD4 cell count >50 cells/microL, hypoalbuminemia was also a significant predictor of mortality (aHR = 3.7, 95% CI 1.4 - 9.8) CONCLUSIONS: Baseline hyponatremia with hypochloremia and hypoalbuminemia predicted mortality in the first year of initiating ART, and these abnormalities might reflect opportunistic infections (e.g., tuberculosis) or advanced HIV disease. Assessment of serum sodium, chloride, and albumin can identify HIV-infected patients at highest risk for mortality who may benefit from more intensive medical management during the first year of ART.

OBJECTIVE: The aim of the study was to determine risk factors for developing severe hepatotoxicity (grade 3 or 4 hepatotoxicity) and rash-associated hepatotoxicity (rash with ≥grade 2 hepatotoxicity) among women initiating nevirapine-based antiretroviral therapy (ART). METHODS: The Non-Nucleoside Reverse Transcriptase Inhibitor Response Study was a prospective cohort study carried out in Zambia, Thailand and Kenya. Between May 2005 and January 2007, we enrolled antiretroviral-naive HIV-infected women initiating nevirapine-based ART. At enrolment and at weeks 2, 4, 8, 16 and 24, participants had serum alanine transferase (ALT) and aspartate transaminase (AST) measured and were evaluated clinically for hepatitis and rash. RESULTS: Nevirapine-based ART was initiated in 820 women and baseline ALT or AST results were abnormal (≥grade 1) in 113 (14%) women. After initiating nevirapine-based ART, severe hepatotoxicity occurred in 41 (5%) women and rash-associated hepatotoxicity occurred in 27 (3%) women. In a multivariate logistic regression model, severe hepatotoxicity and rash-associated hepatotoxicity were both associated with baseline abnormal (≥grade 1) ALT or AST results, but not with a baseline CD4 cell count ≥250 cells/muL. Three participants (0.4%) died with symptoms suggestive of fatal hepatotoxicity; all three women had baseline CD4 count <100 cells/muL and were receiving anti-tuberculosis therapy. CONCLUSION: Among women taking nevirapine-based ART, severe hepatotoxicity and rash-associated hepatotoxicity were predicted by abnormal baseline ALT or AST results, but not by a CD4 count ≥250 cells/muL. In resource-limited settings where transaminase testing is available, testing should focus on early time-points and on women with abnormal baseline ALT or AST results.

BACKGROUND: Intrapartum and neonatal single-dose nevirapine (NVP) reduces the risk of mother-to-child HIV transmission but also induces viral resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs. This drug resistance largely fades over time. We hypothesized that women with a prior single-dose NVP exposure would have no more than a 10% higher cumulative prevalence of failure of their NNRTI-containing antiretroviral therapy (ART) over the first 48 wk of therapy than would women without a prior exposure. METHODS AND FINDINGS: We enrolled 355 NVP-exposed and 523 NVP-unexposed women at two sites in Zambia, one site in Kenya, and two sites in Thailand into a prospective, non-inferiority cohort study and followed them for 48 wk on ART. Those who died, discontinued NNRTI-containing ART, or had a plasma viral load >or=400 copies/ml at either the 24 wk or 48 wk study visits and confirmed on repeat testing were characterized as having failed therapy. Overall, 114 of 355 NVP-exposed women (32.1%) and 132 of 523 NVP-unexposed women (25.2%) met criteria for treatment failure. The difference in failure rates between the exposure groups was 6.9% (95% confidence interval [CI] 0.8%-13.0%). The failure rates of women stratified by our predefined exposure interval categories were as follows: 47 of 116 women in whom less than 6 mo elapsed between exposure and starting ART failed therapy (40%; p<0.001 compared to unexposed women); 25 of 67 women in whom 7-12 mo elapsed between exposure and starting ART failed therapy (37%; p = 0.04 compared to unexposed women); and 42 of 172 women in whom more than 12 mo elapsed between exposure and starting ART failed therapy (24%; p = 0.82 compared to unexposed women). Locally weighted regression analysis also indicated a clear inverse relationship between virologic failure and the exposure interval. CONCLUSIONS: Prior exposure to single-dose NVP was associated with an increased risk of treatment failure; however, this risk seems largely confined to women with a more recent exposure. Women requiring ART within 12 mo of NVP exposure should not be prescribed an NNRTI-containing regimen as first-line therapy.