Findings from the First Year of a Federally Funded, Direct-to-Consumer HIV Self-Test Distribution Program - United States, March 2023-March 2024.

In September 2022, CDC funded a nationwide program, Together TakeMeHome (TTMH), to expand distribution of HIV self-tests (HIVSTs) directly to consumers by mail through an online ordering portal. To publicize the availability of HIVSTs to priority audiences, particularly those disproportionately affected by HIV, CDC promoted this program through established partnerships and tailored resources from its Let's Stop HIV Together social marketing campaign. The online portal launched March 14, 2023, and through March 13, 2024, distributed 443,813 tests to 219,360 persons. Among 169,623 persons who answered at least one question on a postorder questionnaire, 67.9% of respondents were from priority audiences, 24.1% had never previously received testing for HIV, and 24.8% had not received testing in the past year. Among the subset of participants who initiated a follow-up survey, 88.3% used an HIVST themselves, 27.1% gave away an HIVST, 11.7% accessed additional preventive services, and 1.9% reported a new positive HIVST result. Mailed HIVST distribution can quickly reach large numbers of persons who have never received testing for HIV or have not received testing as often as is recommended. TTMH can help to achieve the goal of diagnosing HIV as early as possible and provides a path to other HIV prevention and care services. Clinicians, community organizations, and public health officials should be aware of HIVST programs, initiate discussions about HIV testing conducted outside their clinics or offices, and initiate follow-up services for persons who report a positive or negative HIVST result.

Decreased Human Immunodeficiency Virus Diagnosis Rates Among Black and Hispanic or Latino Men Who Have Sex With Men in US Jurisdictions Supported by the THRIVE Demonstration Project, 2014-2019.

BACKGROUND: Black and Hispanic/Latino men who have sex with men (MSM) are disproportionately affected by human immunodeficiency virus (HIV). In the Targeted Highly Effective Interventions to Reverse the HIV Epidemic (THRIVE) demonstration project, 7 community collaboratives were developed to provide comprehensive HIV prevention services for these populations. METHODS: We analyzed National HIV Surveillance System data to determine the number of HIV diagnoses for each year from 2014 to 2019 among Black, Hispanic/Latino, and White MSM in 7 THRIVE-eligible Metropolitan Statistical Areas (MSAs) that were awarded funding and 12 THRIVE-eligible MSAs that were not awarded funding. We used generalized linear Poisson regression models to estimate adjusted estimated annual percentage changes (EAPCs) with 95% confidence intervals for HIV diagnosis rates controlling for HIV prevalence, viral suppression, HIV testing rates, preexposure prophylaxis (PrEP) prescription rates, poverty, education, and insurance status. RESULTS: We found larger estimated decreases in HIV diagnosis rates in THRIVE jurisdictions compared with non-THRIVE jurisdictions. The adjusted EAPC among Black MSM was -8.2 (-11.7 to -4.6) in THRIVE MSAs compared with -4.2 (-7.8 to -0.4) in non-THRIVE MSAs. The adjusted EAPC among Hispanic/Latino MSM was -8.6 (-12.2 to -4.8) in THRIVE MSAs compared with -2.6 (-5.1 to -0.1)in non-THRIVE MSAs. The adjusted EAPC among White MSM was -7.6 (-12.0 to -3.1) in THRIVE MSAs compared with 5.9 (1.8-10.1) in non-THRIVE MSAs. CONCLUSIONS: The THRIVE community collaborative model was associated with a decrease in HIV diagnoses among Black and Hispanic/Latino MSM. To achieve the goals of the US Ending the HIV Epidemic initiative, effective interventions aimed to increase PrEP use need to be focused on Black and Hispanic/Latino MSM.

Impact of Coronavirus Disease 2019 (COVID-19) on Human Immunodeficiency Virus (HIV) Pre-exposure Prophylaxis Prescriptions in the United States-A Time-Series Analysis.

BACKGROUND: Uptake of HIV pre-exposure prophylaxis (PrEP) has been increasing in the United States since its FDA approval in 2012; however, the COVID-19 pandemic may have affected this trend. Our objective was to assess the impact of COVID-19 on PrEP prescriptions in the United States. METHODS: We analyzed data from a national pharmacy database from January 2017 through March 2021 to fit an interrupted time-series model that predicted PrEP prescriptions and new PrEP users had the pandemic not occurred. Observed PrEP prescriptions and new users were compared with those predicted by the model. Main outcomes were weekly numbers of PrEP prescriptions and new PrEP users based on a previously developed algorithm. The impact of the COVID-19 pandemic was quantified by computing rate ratios and percentage decreases between the observed and predicted counts during 15/3/2020-31/3/2021. RESULTS: In the absence of the pandemic, our model predicted that there would have been 1 058 162 PrEP prescriptions during 15/3/2020-31/3/2021. We observed 825 239 PrEP prescriptions, a 22.0% reduction (95% CI: 19.1-24.8%) after the emergency declaration. The model predicted 167 720 new PrEP users during the same period; we observed 125 793 new PrEP users, a 25.0% reduction (95% CI: 20.9-28.9%). The COVID-19 impact was greater among younger persons and those with commercial insurance. The impact of the pandemic varied markedly across states. CONCLUSIONS: The COVID-19 pandemic disrupted an increasing trend in PrEP prescriptions in the United States, highlighting the need for innovative interventions to maintain access to HIV-prevention services during similar emergencies.

Incidence of Herpes Simplex Virus Type 2 Infection Among African Women Using Depot Medroxyprogesterone Acetate, a Copper Intrauterine Device, or a Levonorgestrel Implant for Contraception: A Nested Randomized Trial.

BACKGROUND: Globally, women have higher herpes simplex virus type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of intramuscular depot medroxyprogesterone acetate (DMPA-IM). METHODS: Within a randomized trial of the effect of 3 contraceptive methods-DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant-on human immunodeficiency virus (HIV) acquisition, we assessed HSV-2 acquisition. HSV-2 and HIV seronegative women, aged 16-35 years, and seeking effective contraception were followed for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015 to 2018. HSV-2 serologic testing was done at enrollment and final study visits. Intention-to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method. RESULTS: At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI], .65-.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI, .71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI, .89-1.30) for copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55; 95% CI, 2.78-4.48). CONCLUSIONS: In a randomized trial, we found no association between HSV-2 acquisition and use of 3 contraceptive methods. TRIAL REGISTRATION: ClinicalTrials.gov number NCT02550067.

HIV Services and Outcomes During the COVID-19 Pandemic - United States, 2019-2021.

Increasing HIV testing, preexposure prophylaxis (PrEP), and antiretroviral therapy (ART) are pillars of the federal Ending the HIV Epidemic in the U.S. (EHE) initiative, with a goal of decreasing new HIV infections by 90% by 2030.* In response to the COVID-19 pandemic, a national emergency was declared in the United States on March 13, 2020, resulting in the closure of nonessential businesses and most nonemergency health care venues; stay-at-home orders also limited movement within communities (1). As unemployment increased during the pandemic (2), many persons lost employer-sponsored health insurance (3). HIV testing and PrEP prescriptions declined early in the COVID-19 pandemic (4-6); however, the full impact of the pandemic on use of HIV prevention and care services and HIV outcomes is not known. To assess changes in these measures during 2019-2021, quarterly data from two large U.S. commercial laboratories, the IQVIA Real World Data - Longitudinal Prescription Database (IQVIA),† and the National HIV Surveillance System (NHSS)§ were analyzed. During quarter 1 (Q1)¶ 2020, a total of 2,471,614 HIV tests were performed, 190,955 persons were prescribed PrEP, and 8,438 persons received a diagnosis of HIV infection. Decreases were observed during quarter 2 (Q2), with 1,682,578 HIV tests performed (32% decrease), 179,280 persons prescribed PrEP (6% decrease), and 6,228 persons receiving an HIV diagnosis (26% decrease). Partial rebounds were observed during quarter 3 (Q3), with 2,325,554 HIV tests performed, 184,320 persons prescribed PrEP, and 7,905 persons receiving an HIV diagnosis. The proportion of persons linked to HIV care, the number who were prescribed ART, and proportion with a suppressed viral load test (<200 copies of HIV RNA per mL) among those tested were stable during the study period. During public health emergencies, delivery of HIV services outside of traditional clinical settings or that use nonclinical delivery models are needed to facilitate access to HIV testing, ART, and PrEP, as well as to support adherence to ART and PrEP medications.

Antibiotic Multidrug Resistance of Escherichia coli Causing Device- and Procedure-related Infections in the United States Reported to the National Healthcare Safety Network, 2013-2017.

BACKGROUND: Escherichia coli is one of the most common causes of healthcare-associated infections (HAIs); multidrug resistance reduces available options for antibiotic treatment. We examined factors associated with the spread of multidrug-resistant E. coli phenotypes responsible for device- and procedure-related HAIs from acute care hospitals, long-term acute care hospitals, and inpatient rehabilitation facilities, using isolate and antimicrobial susceptibility data reported to the National Healthcare Safety Network during 2013-2017. METHODS: We used multivariable logistic regression to examine associations between co-resistant phenotypes, patient and healthcare facility characteristics, and time. We also examined the geographic distribution of co-resistant phenotypes each year by state and by hospital referral region to identify hot spots. RESULTS: A total of 96 672 E. coli isolates were included. Patient median age was 62 years, and 60% were female; more than half (54%) were reported from catheter-associated urinary tract infections. From 2013 to 2017, 35% of the isolates were nonsusceptible to fluoroquinolones (FQs), 17% to extended-spectrum cephalosporins (ESCs), and 13% to both ESCs and FQs. The proportion of isolates co-resistant to ESCs and FQs was higher in 2017 (14%) than in 2013 (11%) (P < .0001); overall prevalence and increases were heterogeneously distributed across healthcare referral regions. Co-resistance to FQs and ESCs was independently associated with male sex, central line-associated bloodstream infections, long-term acute care hospitals, and the 2016-2017 (vs 2013-2014) reporting period. CONCLUSIONS: Multidrug resistance among E. coli causing device- and procedure-related HAIs has increased in the United States. FQ and ESC co-resistant strains appear to be spreading heterogeneously across hospital referral regions.

Motivations to use hormonal contraceptive methods and condoms among HIV-positive and negative women randomized to a progestin contraceptive in Malawi: a qualitative study.

BACKGROUND: Although many countries have been promoting hormonal contraceptives to prevent unintended pregnancy and condom use to prevent HIV transmission, little is known about how women targeted by these messages have interpreted and internalized them. We describe HIV-positive and negative women's understanding of the benefits of contraception and condoms and their motivations to use them. METHODS: This is a qualitative sub-study from a clinical trial evaluating the effects of progestin contraception on HIV-positive and negative women aged 18-45 years randomly assigned to depot medroxyprogesterone acetate (DMPA) injection or levonorgestrel (LNG) implant. We purposively recruited 41 women to participate in in-depth interviews (IDIs) and focus group discussions (FGDs) after randomization into the main study. We conducted a total of 30 IDIs and 6 FGDs comprised of 4-7 women (N = 32). All women were counselled about potential risks for HIV acquisition/transmission with progestin-only contraception, drug-drug interactions between the implant and efavirenz-based ART, and the need to use condoms with their assigned contraceptive to help prevent pregnancy and HIV acquisition and transmission. RESULTS: All women understood that HIV is transmitted through unprotected sex and that HIV transmission can be prevented through condom use but not DMPA injection or LNG implant use. Nearly all HIV-positive women knew or suspected that their partners were also HIV-positive and were most interested in using condoms to prevent infection with a drug-resistant HIV strain to keep their HIV viral load low. Almost all reported that their partners agreed to condom use, but few used them consistently. Most women believed that condoms were effective at preventing both HIV and pregnancy if used consistently. Nearly all women considered contraception and condom use as important in preventing unintended pregnancy and HIV because partner disclosure of HIV status is low. CONCLUSION: Our results showed that both HIV-positive and negative women understood modes of HIV transmission and prevention and were aware that hormonal contraceptives are only effective for preventing pregnancy and not HIV. Although both HIV-negative and positive women were motivated to use condoms to prevent both HIV acquisition and infection with other HIV strains respectively, they all faced challenges from their partners in using condoms consistently.

Women's perspectives on relationship dynamics with their partners and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use.

Background: Limited information exists about relationship dynamics and their role in HIV acquisition, HIV disclosure, hormonal contraceptive uptake, and condom use among women in Malawi.Methods: Ninety-seven women aged 18-45 years were randomly assigned to initiate the depot medroxyprogesterone acetate injectable or levonorgestrel implant from May 2014 to April 2015 in Lilongwe, Malawi. Women were recruited after randomisation to participate in semi-structured interviews about HIV and family planning using purposive sampling. Interviews were thematically analysed using within and between group comparisons.Results: We conducted individual interviews and/or focus group discussions with 41 women: 30 (73%) women living with HIV and 11 (27%) women not living with HIV. Most women living with HIV who participated in in-depth interviews disclosed their status to their partners, and most partners agreed to get HIV tested only after disclosure. Nearly all women said their partners agreed to use condoms, but few used them consistently. Nearly all women believed their current and former partners had outside partners. Most women living with HIV who participated in in-depth interviews believed their current or other serious partners were the source of their infection. Some women thought their partner's infidelity was due to their partner's disinterest in sex with them during menstrual/ breakthrough bleeding. Some women included their partners in contraceptive decision-making when the partner was supportive.Discussion: Relationship dynamics affected decision-making for contraceptive and condom use, as well as serodisclosure for the women living with HIV in the study. All women reported challenges with consistent condom use with their male partners, although contraceptive use was generally more acceptable. Women included their partners in their decision-making concerning contraceptive use when they were supportive.

Maternal and Infant Bone Mineral Density 1 Year After Delivery in a Randomized, Controlled Trial of Maternal Tenofovir Disoproxil Fumarate to Prevent Mother-to-child Transmission of Hepatitis B Virus.

In a randomized, double-blind, placebo-controlled trial of tenofovir disoproxil fumarate (TDF) use from 28 weeks gestational age to 2 months postpartum to prevent mother-to-child transmission of hepatitis B virus, there was no significant effect of maternal TDF use on maternal or infant bone mineral density 1 year after delivery/birth. Clinical Trials Registration. NCT01745822.

Prescription of Antibacterial Drugs for HIV-Exposed, Uninfected Infants, Malawi, 2004-2010.

Antimicrobial drug resistance is a serious health hazard driven by overuse. Administration of antimicrobial drugs to HIV-exposed, uninfected infants, a population that is growing and at high risk for infection, is poorly studied. We therefore analyzed factors associated with antibacterial drug administration to HIV-exposed, uninfected infants during their first year of life. Our study population was 2,152 HIV-exposed, uninfected infants enrolled in the Breastfeeding, Antiretrovirals and Nutrition study in Lilongwe, Malawi, during 2004-2010. All infants were breastfed through 28 weeks of age. Antibacterial drugs were prescribed frequently (to 80% of infants), and most (67%) of the 5,329 prescriptions were for respiratory indications. Most commonly prescribed were penicillins (43%) and sulfonamides (23%). Factors associated with lower hazard for antibacterial drug prescription included receipt of cotrimoxazole preventive therapy, receipt of antiretroviral drugs, and increased age. Thus, cotrimoxazole preventive therapy may lead to fewer prescriptions for antibacterial drugs for these infants.

Vital Signs: Epidemiology and Recent Trends in Methicillin-Resistant and in Methicillin-Susceptible Staphylococcus aureus Bloodstream Infections - United States.

INTRODUCTION: Staphylococcus aureus is one of the most common pathogens in health care facilities and in the community, and can cause invasive infections, sepsis, and death. Despite progress in preventing methicillin-resistant S. aureus (MRSA) infections in health care settings, assessment of the problem in both health care and community settings is needed. Further, the epidemiology of methicillin-susceptible S. aureus (MSSA) infections is not well described at the national level. METHODS: Data from the Emerging Infections Program (EIP) MRSA population surveillance (2005-2016) and from the Premier and Cerner Electronic Health Record databases (2012-2017) were analyzed to describe trends in incidence of hospital-onset and community-onset MRSA and MSSA bloodstream infections and to estimate the overall incidence of S. aureus bloodstream infections in the United States and associated in-hospital mortality. RESULTS: In 2017, an estimated 119,247 S. aureus bloodstream infections with 19,832 associated deaths occurred. During 2005-2012 rates of hospital-onset MRSA bloodstream infection decreased by 17.1% annually, but the decline slowed during 2013-2016. Community-onset MRSA declined less markedly (6.9% annually during 2005-2016), mostly related to declines in health care-associated infections. Hospital-onset MSSA has not significantly changed (p = 0.11), and community-onset MSSA infections have slightly increased (3.9% per year, p<0.0001) from 2012 to 2017. CONCLUSIONS AND IMPLICATIONS FOR PUBLIC HEALTH PRACTICE: Despite reductions in incidence of MRSA bloodstream infections since 2005, S. aureus infections account for significant morbidity and mortality in the United States. To reduce the incidence of these infections further, health care facilities should take steps to fully implement CDC recommendations for prevention of device- and procedure-associated infections and for interruption of transmission. New and novel prevention strategies are also needed.

Trends in Oral and Injectable HIV Preexposure Prophylaxis Prescriptions in the US, 2013-2023.

This study examines the prescribing trends of 3 oral preexposure prophylaxis medications and a long-acting injectable option from 2013 to 2023.

Examining the contraceptive decisions of young, HIV-infected women: A qualitative study.

This study qualitatively examined factors that influenced contraceptive choices in a sample of young, HIV-infected women. Individual qualitative interviews were conducted among 30 vertically and horizontally HIV-infected women (n = 26 African American) from the ages of 14 to 24 years (Mean age = 20.9 years). We recruited sample groups with the following characteristics: (a) current contraceptive/condom use with ≥1 child (n = 11); (b) current contraceptive/condom use with no children (n = 12); and (c) no current contraceptive/condom use with no children (n = 7). A semi-structured interview guide was used to ask participants about factors influencing past and current contraceptive choices. Individual interviews were digitally recorded and transcribed verbatim; analyses to identify core themes were informed by the Grounded Theoretical approach. Young, HIV-infected women did not identify their HIV serostatus or disease-related concerns as influential in their contraceptive decisions. However, they reported that recommendations from health-care providers and input from family and friends influenced their contraceptive choices. They also considered a particular method's advantages (e.g., menstrual cycle improvements) and disadvantages (e.g., increased pill burden) when selecting a method. Findings suggested that HIV-infected young women's contraceptive decisions were influenced by factors other than those related to their infection.

Contribution of Maternal Antiretroviral Therapy and Breastfeeding to 24-Month Survival in Human Immunodeficiency Virus-Exposed Uninfected Children: An Individual Pooled Analysis of African and Asian Studies.

Background: Human immunodeficiency virus (HIV)-infected pregnant women increasingly receive antiretroviral therapy (ART) to prevent mother-to-child transmission (PMTCT). Studies suggest HIV-exposed uninfected (HEU) children face higher mortality than HIV-unexposed children, but most evidence relates to the pre-ART era, breastfeeding of limited duration, and considerable maternal mortality. Maternal ART and prolonged breastfeeding while on ART may improve survival, although this has not been reliably quantified. Methods: Individual data on 19 219 HEU children from 21 PMTCT trials/cohorts undertaken from 1995 to 2015 in Africa and Asia were pooled to estimate the association between 24-month mortality and maternal/infant factors, using random-effects Cox proportional hazards models. Adjusted attributable fractions of risks computed using the predict function in the R package "frailtypack" were used to estimate the relative contribution of risk factors to overall mortality. Results: Cumulative incidence of death was 5.5% (95% confidence interval, 5.1-5.9) by age 24 months. Low birth weight (LBW <2500 g, adjusted hazard ratio (aHR, 2.9), no breastfeeding (aHR, 2.5), and maternal death (aHR, 11.1) were significantly associated with increased mortality. Maternal ART (aHR, 0.5) was significantly associated with lower mortality. At the population level, LBW accounted for 16.2% of 24-month mortality, never breastfeeding for 10.8%, mother not receiving ART for 45.6%, and maternal death for 4.3%; combined, these factors explained 63.6% of deaths by age 24 months. Conclusions: Survival of HEU children could be substantially improved if public health practices provided all HIV-infected mothers with ART and supported optimal infant feeding and care for LBW neonates.

Prevalence, Magnitude, and Correlates of HIV-1 Genital Shedding in Women on Antiretroviral Therapy.

Background: Genital human immunodeficiency virus (HIV) RNA shedding can continue despite HIV being undetectable in blood, and can be associated with transmission. Methods: We included African women on antiretroviral therapy (ART). Linear and generalized linear mixed models were used to compare the magnitude and prevalence of genital shedding, respectively, by time since ART initiation. Multivariable logistic regression with generalized estimating equations was used to assess predictors of genital shedding among women with undetectable plasma viral load (VL). Results: Among 1114 women, 5.8% of visits with undetectable plasma VL and 23.6% of visits with detectable VL had genital shedding. The proportion of visits with genital shedding decreased with time since ART initiation but the magnitude of shedding remained unchanged when plasma VL was undetectable (P = .032). Prevalence of shedding did not vary by time since ART initiation when plasma VL was detectable (P = .195), though the magnitude of shedding significantly increased (P = .04). Predictors of genital shedding were HIV disease stage, antiretroviral regimen, and genital ulcers or cervical tenderness. Discussion: In addition to ART, reducing immune activation through prevention and treatment of HIV-related conditions and genital tract infections may decrease the risk of HIV-1 shedding and potential transmission.

Co-trimoxazole Prophylaxis, Asymptomatic Malaria Parasitemia, and Infectious Morbidity in Human Immunodeficiency Virus-Exposed, Uninfected Infants in Malawi: The BAN Study.

Background: Human immunodeficiency virus (HIV)-exposed infants are disproportionately at risk of morbidity and mortality compared with their HIV-unexposed counterparts. The role of co-trimoxazole preventive therapy (CPT) in reducing leading causes of infectious morbidity is unclear. Methods: We used data from the Breastfeeding, Antiretrovirals and Nutrition (BAN) clinical trial (conducted 2004-2010, Malawi) to assess the association of (1) CPT and (2) asymptomatic malaria parasitemia with respiratory and diarrheal morbidity in infants. In June 2006, all HIV-exposed infants in BAN began receiving CPT (240 mg) from 6 to 36 weeks of age, or until weaning occurred and HIV infection was ruled out. All HIV-exposed, uninfected infants (HEIs) at 8 weeks of age (n = 1984) were included when CPT was the exposure. A subset of HEIs (n = 471) were tested for malarial parasitemia using dried blood spots from 12, 24, and 36 weeks of age. Cox proportional hazards models for recurrent gap-time data were used to examine the association of time-varying exposures on morbidity. Results: CPT was associated with a 36% reduction in respiratory morbidity (hazard ratio [HR], 0.64 [95% confidence interval {CI}, .60-.69]) and a 41% reduction in diarrheal morbidity (HR, 0.59 [95% CI, .54-.65]). Having asymptomatic malaria parasitemia was associated with a 40% increase in respiratory morbidity (HR, 1.40 [95% CI, 1.13-1.74]) and a 50% increase in diarrheal morbidity (HR, 1.50 [95% CI, 1.09-2.06]), after adjusting for CPT. Conclusions: CPT may have an important role to play in reducing the leading global causes of morbidity and mortality in the growing population of HEIs in malaria-endemic resource-limited settings.

Prevalence and risk factors associated with STIs among women initiating contraceptive implants in Kingston, Jamaica.

BACKGROUND: There is limited information on rates of STIs in Jamaica due to syndromic management and limited aetiological surveillance. We examined the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) and characteristics associated with STIs among sexually active women who participated in a randomised trial of a progestin implant initiation in Jamaica (the Sino-Implant Study (SIS)). METHODS: SIS was a randomised trial conducted in Kingston, Jamaica, from 2012 to 2014 to evaluate whether initiation of the Sino-Implant (II) led to more unprotected sex among women ages 18-44 years. Data collected included self-reported demographic, sexual behaviour information; and vaginal swabs collected at baseline, 1-month and 3-month follow-up visits for a biomarker of recent semen exposure (prostate-specific antigen (PSA)) and for STIs. We examined associations between STIs and PSA, demographics, sexual behaviour and insertion of an implant, with a repeated-measures analysis using generalised estimating equations (SAS Institute, V.9.3). RESULTS: Remnant vaginal swabs from 254 of 414 study participants were tested for STIs. At baseline, 29% of participants tested for STIs (n=247) had laboratory-confirmed CT, 5% NG, 23% TV and 45% any STI. In a repeated-measures analysis adjusted for study arm (immediate vs delayed implant insertion), those with PSA detected did not have an increased prevalence of any STI (prevalence ratio (PR)=1.04 (95% CI 0.89 to 1.21)), whereas prevalence decreased for each 1-year increase in age (PR=0.98 (95% CI 0.97 to 0.99)). Immediate implant insertion was not associated with increases in any STI in subsequent visits (PR=1.09 (95% CI 0.94 to 1.27)). CONCLUSIONS: Although the prevalence of laboratory-confirmed STIs was high, the immediate initiation of a contraceptive implant was not associated with higher STI prevalence rates over 3 months. TRIAL REGISTRATION NUMBER: NCT01684358.

Trends in contraceptive use according to HIV status among privately insured women in the United States.

BACKGROUND: There is limited information on the patterns and trends of contraceptive use among women living with HIV, compared with noninfected women in the United States. Further, little is known about whether antiretroviral therapy correlates with contraceptive use. Such information is needed to help identify potential gaps in care and to enhance unintended pregnancy prevention efforts. OBJECTIVE: We sought to compare contraceptive method use among HIV-infected and noninfected privately insured women in the United States, and to evaluate the association between antiretroviral therapy use and contraceptive method use. STUDY DESIGN: We used a large US nationwide health care claims database to identify girls and women ages 15-44 years with prescription drug coverage. We used diagnosis, procedure, and National Drug Codes to assess female sterilization and reversible prescription contraception use in 2008 and 2014 among women continuously enrolled in the database during 2003 through 2008 or 2009 through 2014, respectively. Women with no codes were classified as using no method; these may have included women using nonprescription methods, such as condoms. We calculated prevalence of contraceptive use by HIV infection status, and by use of antiretroviral therapy among those with HIV. We used multivariable polytomous logistic regression to calculate unadjusted and adjusted odds ratios and 95% confidence intervals for female sterilization, long-acting reversible contraception, and short-acting hormonal contraception compared to no method. RESULTS: While contraceptive use increased among HIV-infected and noninfected women from 2008 through 2014, in both years, a lower proportion of HIV-infected women used prescription contraceptive methods (2008: 17.5%; 2014: 28.9%, compared with noninfected women (2008: 28.8%; 2014: 39.8%, P < .001 for both). Controlling for demographics, chronic medical conditions, pregnancy history, and cohort year, HIV-infected women compared to HIV-noninfected women had lower odds of using long-acting reversible contraception (adjusted odds ratio, 0.67; 95% confidence interval, 0.52-0.86 compared to no method) or short-acting hormonal contraception method (adjusted odds ratio, 0.59; 95% confidence interval, 0.50-0.70 compared to no method). In 2014, HIV-infected women using antiretroviral therapy were significantly more likely to use no method (76.8% vs 64.1%), and significantly less likely to use short-acting hormonal contraception (11.0% vs 22.7%) compared to HIV-infected women not using antiretroviral therapy. Those receiving antiretroviral therapy had lower odds of using short-acting hormonal contraception compared to no method (adjusted odds ratio, 0.45; 95% confidence interval, 0.32-0.63). There was no significant difference in female sterilization by HIV status or antiretroviral therapy use. CONCLUSION: Despite the safety of reversible contraceptives for women with HIV, use of prescription contraception continues to be lower among privately insured HIV-infected women compared to noninfected women, particularly among those receiving antiretroviral therapy.

Effect of Postnatal HIV Treatment on Clinical Mastitis and Breast Inflammation in HIV-Infected Breast-feeding Women.

BACKGROUND: The relationship between mastitis and antiretroviral therapy among HIV-positive, breast-feeding women is unclear. METHODS: In the Breastfeeding, Antiretrovirals, and Nutrition (BAN) study, conducted in Lilongwe, Malawi, 2369 mother-infant pairs were randomized to a nutritional supplement group and to one of three treatment groups: maternal antiretroviral therapy (ART), infant nevirapine (NVP) or standard of care for 24 weeks of exclusive breast-feeding and 4 weeks of weaning. Among 1472 HIV-infected women who delivered live infants between 2004 and 2007, we estimated cumulative incidence functions and sub-distribution hazard ratios (HR) of mastitis or breast inflammation comparing women in maternal ART (n = 487) or infant nevirapine (n = 492) groups to the standard of care (n = 493). Nutritional supplement groups (743 took, 729 did not) were also compared. RESULTS: Through 28-weeks post-partum, 102 of 1472 women experienced at least one occurrence of mastitis or breast inflammation. The 28-week risk was higher for maternal ART (risk difference (RD) 4.5, 95% confidence interval (CI) 0.9, 8.1) and infant NVP (RD 3.6, 95% CI 0.3, 6.9) compared to standard of care. The hazard of late-appearing mastitis or breast inflammation (from week 5-28) was also higher for maternal ART (HR 6.7, 95% CI 2.0, 22.6) and infant NVP (HR 5.1, 95% CI 1.5, 17. 5) compared to the standard of care. CONCLUSIONS: Mastitis or breast inflammation while breast-feeding is a possible side effect for women taking prophylactic ART and women whose infants take NVP, warranting additional research in the context of postnatal HIV transmission.

Full-Term Small-for-Gestational-Age Newborns in the U.S.: Characteristics, Trends, and Morbidity.

Objectives The magnitude, characteristics, and morbidity of term (≥37 weeks gestation) newborns that are small-for-gestational-age (SGA) in the U.S. are underexplored. We sought to examine characteristics and trends for SGA-coded term newborns in the U.S. Methods Data were obtained from the Nationwide Inpatient Sample, a nationally representative database of hospital stays in the U.S. from 2002 to 2011. Term, singleton newborns with SGA codes were identified and examined over the study period. Demographic characteristics were compared for term newborns according to presence of SGA codes using χ2 tests. Odds ratios (OR) were calculated to compare morbidities between the two groups, adjusting for relevant demographic and clinical variables. Results In 2011, 15 per 1000 term newborns in the U.S. were coded as SGA, a 29.9 % increase since 2002. Compared with other term newborns, SGA term newborns were significantly (p < 0.05) more likely to be female, receive public insurance, and reside in lower income zip codes. Comorbidities, including perinatal complications, metabolic disorders, central nervous system diseases, infection, and neonatal abstinence syndrome were more common among SGA-coded term newborns. These newborns also had higher odds of in-hospital death (OR = 3.0 95 % confidence interval: 2.0, 4.4), longer mean length of stay (3.7 vs. 2.3 days, p < 0.001), and higher mean hospital charges ($12,621 vs. $5012, p < 0.001). Conclusions for practice Term newborns coded as SGA have higher morbidity, mortality, and incur higher hospital charges than other term newborns. More research is needed to understand causes of SGA so its incidence and effects can be reduced.