OBJECTIVE: Longer-acting pre-exposure prophylaxis (LA-PrEP) products have potential to increase PrEP uptake and continuation. This study sought to elicit preferences for LA-PrEP product and delivery program characteristics among populations disproportionately impacted by HIV to identify factors important to adoption and anticipate potential use challenges. DESIGN: Cross-sectional, online discrete choice experiment. METHODS: We recruited 940 men who have sex with men (MSM), people who inject drugs (PWID), and Black heterosexual men and women (BHMW) with PrEP indications. In a series of 10 tasks, participants chose between two hypothetical LA-PrEP options composed of 5 attributes (product type, side effects, clinic type, appointment duration, cost), or neither (their current HIV prevention method). Analysis used random-parameters logit models. RESULTS: Respondents chose an LA-PrEP method over their current HIV prevention option in 96.8% of tasks. Cost was the most important determinant of LA-PrEP choice for all populations (relative importance [RI] of 10]. Side effects and product type were 1/3 to 1/2 as important as cost (RI 3.5-5.1). MSM and PWID most preferred the 12-month implant followed by semiannual dual injections and least preferred the monthly oral pill and 2-month single injection. BHMW most preferred the monthly pill and semiannual injections and least preferred the 12-month implant and 2-month injection. Clinic type and appointment duration had minimal influence (RI 0.1-2.1). CONCLUSIONS: Results suggest high demand for LA-PrEP among populations with disproportionately high HIV incidence. To facilitate use, programs should offer a range of LA-PrEP products, minimize out-of-pocket costs, and counsel on side effects.

Preexposure prophylaxis (PrEP) is highly effective in preventing HIV infections and is recommended for people without HIV who are at ongoing risk of HIV acquisition. In 2019, the U.S. launched the "Ending the HIV Epidemic in the U.S." initiative, which aims to reduce by 90 % the number of annual new HIV infections. To monitor progress towards this goal, several national indicators have been established, one of which is PrEP coverage. Several ways to monitor PrEP use have been developed, each with its own advantages and disadvantages. We developed a method to estimate PrEP "need" in the U.S. that could be used as a denominator to estimate PrEP coverage. The "population need for PrEP" (PPN) is estimated based on the number of people needed to treat (NNT) with PrEP to prevent an additional HIV infection in subpopulations whose annual HIV incidence is ≥ 1 %. This is done in three steps: 1) calculating NNT for each transmission group using 1 % incidence threshold and clinical trial-and cohort-generated evidence of the degree of PrEP effectiveness in each transmission group, 2) estimating the proportion of new HIV infections in subpopulations with incidence at least 1 % from epidemiologic data, 3) multiplying estimates from steps 1 and 2 with the number of new HIV infections for each transmission group from Surveillance. The estimates for each transmission group are then added together, and the number of current PrEP users is finally added to this estimate to produce PPN. This method is relatively easy to calculate and can provide public health authorities at the national, state, or local level with pragmatic estimates of PrEP "need" among different demographic or transmission groups, which can help with planning, resource allocation, and monitoring progress.

Nonoccupational postexposure prophylaxis (nPEP) for HIV is recommended when a nonoccupational (e.g., sexual, needle, or other) exposure to nonintact skin or mucous membranes that presents a substantial risk for HIV transmission has occurred, and the source has HIV without sustained viral suppression or their viral suppression information is not known. A rapid HIV test (also referred to as point-of-care) or laboratory-based antigen/antibody combination HIV test is recommended before nPEP initiation. Health care professionals should ensure the first dose of nPEP is provided as soon as possible, and ideally within 24 hours, but no later than 72 hours after exposure. The initial nPEP dose should not be delayed due to pending results of any laboratory-based testing, and the recommended length of nPEP course is 28 days. The recommendations in these guidelines update the 2016 nPEP guidelines (CDC. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV - United States, 2016. Atlanta, GA: US Department of Health and Human Services, CDC; 2017). These 2025 nPEP guidelines update recommendations and considerations for use of HIV nPEP in the United States to include newer antiretroviral (ARV) agents, updated nPEP indication considerations, and emerging nPEP implementation strategies. The guidelines also include considerations for testing and nPEP regimens for persons exposed who have received long-acting injectable ARVs in the past. Lastly, testing recommendations for persons who experienced sexual assault were updated to align with the most recent CDC sexually transmitted infection treatment guidelines. These guidelines are divided into two sections: Recommendations and CDC Guidance. The preferred regimens for most adults and adolescents are now bictegravir/emtricitabine/tenofovir alafenamide or dolutegravir plus (tenofovir alafenamide or tenofovir disoproxil fumarate) plus (emtricitabine or lamivudine). However, the regimen can be tailored to the clinical circumstances. Medical follow-up for persons prescribed nPEP also should be tailored to the clinical situation; recommended follow-up includes a visit at 24 hours (remote or in person) with a medical provider, and clinical follow-up 4-6 weeks and 12 weeks after exposure for laboratory testing. Persons initiating nPEP should be informed that pre-exposure prophylaxis for HIV (PrEP) can reduce their risk for acquiring HIV if they will have repeat or continuing exposure to HIV after the end of the nPEP course. Health care professionals should offer PrEP options to persons with ongoing indications for PrEP and create an nPEP-to-PrEP transition plan for persons who accept PrEP.

BACKGROUND: The 2021 update of the CDC clinical guidelines for HIV preexposure prophylaxis (PrEP) recommended both antigen/antibody (Ag/Ab) and RNA testing at PrEP initiation and routine follow-up. We assessed real-world utilization and performance of HIV tests among oral PrEP users. METHODS: An oral PrEP user cohort was constructed using the HealthVerity database that included linked diagnoses, laboratory tests, and prescriptions from December 2018 to August 2023. Data was stratified by guideline pre- (2019-2021) and post-update (2022-2023) periods. For each period, we assessed the agreement between same-day HIV Ag/Ab and RNA results and calculated the false positive rate (FPR) and positive predictive values (PPV) of HIV Ag/Ab and RNA tests compared with adjudicated HIV status. RESULTS: The HIV RNA testing rate for follow-up increased from 16 per 100 person-years (PY) to 123 per 100 PYs after the guideline update. The positivity rate of HIV RNA tests decreased from 1.39% to 0.22%. Overall agreement between Ag/Ab and RNA results remained high. The FPRs of HIV Ag/Ab and RNA testing remained similar, but the PPV of HIV RNA testing for PrEP follow-up decreased from 100% to 67%. We estimated that 8,226 to 9,900 RNA tests would be needed for one HIV diagnosis earlier than would be detected with Ag/Ab testing alone. DISCUSSION: HIV RNA testing did not provide additional value to Ag/Ab testing during routine follow-up of oral PrEP users. Considering the cost and logistical complexity of HIV RNA testing, its use as a routine test during follow-up of oral PrEP users warrants reconsideration.

Objectives. HIV preexposure prophylaxis (PrEP) use has increased since its US Food and Drug Administration approval in 2012. Our objective was to describe trends in PrEP use by US women. Methods. Using national pharmacy and HIV surveillance data, we calculated the PrEP-to-diagnosis ratio (PDR), a measure of PrEP prescriptions each year compared with HIV diagnoses the previous year, for women from 2017 to 2023. We also calculated PDRs in 2023 for the 20 counties with the highest numbers of diagnosed HIV infections among women and reviewed reports of public health activities conducted by recipients of Centers for Disease Control and Prevention HIV prevention funding. Results. The PDR for women was 1.5 in 2017, and it increased to 5.8 by 2023. In the 20 counties with the highest number of diagnosed HIV infections among women, PDRs ranged from 2.2 to 16.9. Counties with the highest PDRs conducted PrEP activities designed for women. Conclusions. PrEP is a highly effective HIV prevention intervention that can empower women to protect their health, but its use has been low. Public health and clinical interventions designed for women can increase their PrEP use and support ending the US HIV epidemic. (Am J Public Health. Published online ahead of print April 24, 2025:e1-e4. https://doi.org/10.2105/AJPH.2025.308056).

INTRODUCTION: The Ending the HIV Epidemic in the U.S. (EHE) initiative was launched by the U.S. Department of Health and Human Services in 2019 with the goal of decreasing new HIV infections 90% by 2030. Increasing the use of HIV preexposure prophylaxis (PrEP) is one of the EHE strategies. We assessed the impact of EHE activities on PrEP use. METHODS: Using IQVIA Real-world longitudinal prescription data and the National HIV Surveillance System data, we calculated jurisdiction-level PrEP to diagnosis ratios (PDRs) in the United States from 2016-2023. We assessed impact of EHE with a difference-in-difference (DID) analysis. RESULTS: The PDR increased from 3.0 to 14.7 in EHE Jurisdictions; from 1.2 to 7.2 in EHE states; and from 2.5 to 13.4 in non-EHE jurisdictions. On average, no additional increase in the PDR was found for EHE counties compared with matched non-EHE counties, (adjusted DID: 0.2, 95% confidence interval [CI]: -1.0∼1.3), or for EHE states (adjusted DID: 0.4, 95% CI: -1.6∼2.4). CONCLUSIONS: Overall PrEP use increased markedly, with some EHE jurisdictions achieving greater increases than non-EHE jurisdictions with similar PDRs in 2019. The uneven increase in PrEP use in EHE jurisdictions underscores the need for jurisdiction-specific PrEP implementation strategies designed for the needs of each community. It also underscores the need for sufficient funding to accomplish EHE goals.

BACKGROUND: People who use long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) can have ambiguous HIV test results if HIV is acquired during its use. The 2021 CDC PrEP guidelines recommend both HIV antigen/antibody (Ag/Ab) and RNA testing at CAB-LA initiation and follow-up. METHODS: We conducted a cohort study using the HealthVerity database to evaluate the utilization of HIV testing among people who use CAB-LA PrEP. We identified and adjudicated HIV Ag/Ab and RNA tests with a positive result, and estimated the incidence of breakthrough HIV infection or long-acting early viral inhibition (LEVI) syndrome. Testing agreement, false positive test rates, and positive predictive value were explored. RESULTS: Among 384 people who use CAB-LA PrEP with both HIV Ag/Ab and RNA testing with a median follow-up time of 4.2 months, we found one discordant pair with Ag/Ab(-) and RNA(+), and one with Ag/Ab(+) and RNA(-). Among four users with a positive Ag/Ab or RNA test, we identified one who acquired HIV before CAB-LA initiation with both Ag/Ab(+) and RNA(+), one likely false RNA(+), one likely false Ag/Ab(+), and one inconclusive Ag/Ab(+) due to insufficient follow-up. We identified no persons with confirmed breakthrough HIV infection or LEVI syndrome, or with RNA testing resulting in an earlier HIV diagnosis compared with Ag/Ab testing alone. INTERPRETATION: The frequency of breakthrough HIV infection or LEVI syndrome in this real-world cohort was low during initial three to seven months of injectable PrEP use. Ongoing assessment of the added value of HIV RNA testing for monitoring during CAB-LA PrEP use is warranted.

OBJECTIVE: The purpose of this study was to characterize age-group specific patterns in the stability of contraceptive use and to evaluate whether factors that are associated with nonuse and sporadic use, compared with stable use, differ by age among women who are at risk for unintended pregnancy. STUDY DESIGN: We used data from the 2006-2010 National Survey of Family Growth to characterize the prevalence of stable and sporadic contraceptive use and nonuse by age over a 1-year period. We used polytomous logistic regression models to assess the odds of contraceptive nonuse and sporadic use vs stable use. Age-stratified models were used to show age-group differences in associated characteristics. RESULTS: Over a 1-year period, stable contraceptive use decreased across age groups from 80% for teens 15-19 years old to 74% for women 20-24 years old, and 70-71% for women 25-34 and 35-44 years old. Contraceptive nonuse increased across age groups from 5% for teens 15-19 years old to 9-20% for older women. By contrast, sporadic use was least common for women 35-44 years old (10% compared with 16-17% for younger women). Among teens 15-19 years old, a history of method discontinuation because of dissatisfaction was associated with nonuse. Among older women, intentions to have children in the future and reported difficulty achieving pregnancy were associated with nonuse and sporadic use. CONCLUSION: Because the stability of contraceptive use and associated factors differ by age, providers may need to consider these differences when talking to women about contraception. To address nonuse, helping teens identify a method that they are comfortable using may be especially important; for older women, discussing the potential for continuing fertility may be more important. To address sporadic use, discussing the benefits of user-independent methods may be helpful, with a particular emphasis on long-acting reversible contraceptives for younger women and teens who are less likely to have completed their desired childbearing and who have tended to rely on methods that are more difficult to use consistently.

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

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.

INTRODUCTION: The HIV/AIDS epidemic has been one of the greatest challenges in global health, significantly affecting women of reproductive potential. Considerable advances in antiretroviral therapy for women living with HIV have contributed to improvements in quality of life, better reproductive and birth outcomes, and a reduced risk of perinatal transmission. AREAS COVERED: Despite the progress made, persistent challenges in access and adherence to antiretroviral drugs may limit their benefits for some women. More pharmacokinetic and safety studies in pregnant and lactating women are urgently needed, as are prospective surveillance systems to evaluate associations between fetal and infant antiretroviral exposures, drug-drug interactions, and pregnancy outcomes. EXPERT OPINION: Multipurpose technologies, such as combined HIV and other STI or unintended pregnancy prevention, and innovative delivery methods, such as the development of long-acting antiretrovirals, have the potential to reduce adherence challenges and enhance quality of life for women with HIV. Parallel advances in drug safety testing and surveillance are needed to ensure the health and safety of women with or at risk for HIV and children at risk for perinatal transmission.

BACKGROUND AND OBJECTIVES: HIV preexposure prophylaxis (PrEP) is safe, effective, and was approved for adolescents in 2018. Adolescents and young adults make up 20% of HIV diagnoses in the United States. Our objective was to describe trends in adolescents prescribed PrEP during 2018 through 2021 and characteristics of these adolescents and their PrEP providers. METHODS: We identified adolescents aged 13 to 19 years with oral PrEP prescriptions during 2018 through 2021 in a national pharmacy database using a validated algorithm. We assessed trends by calculating the overall percentage change and estimated annual percentage change with 95% confidence intervals. We described characteristics of adolescents and their PrEP providers in 2021. We performed χ2 analyses to assess differences by sex and age group. RESULTS: The number of adolescents prescribed PrEP increased 76.2% from 2018 to 2021 (estimated annual percentage change: 18.0% [95% confidence interval: 16.6-19.5]), despite decreases in 2020. We observed increases among all sex and age groups, with larger increases among older adolescents aged 18 to 19 years. The majority of the 6444 adolescents prescribed PrEP in 2021 were male (82.6%) and aged 18 to 19 years (87.8%). Among 2455 physician PrEP providers, 29.6% were pediatricians, with varying specialty distributions by adolescent age group (P < .001). Among the 217 pediatricians who prescribed PrEP to adolescents aged 13 to 17 years, 67.7% were general pediatricians. CONCLUSIONS: PrEP provision for adolescents has increased, largely among older and male adolescents. The availability of PrEP provides an important opportunity for pediatric providers to take an active role in HIV prevention.

OBJECTIVE: The aim of this study was to understand how vaginal microbiota composition affects antiretroviral concentrations in the setting of hormonal contraception initiation. METHODS: Cervicovaginal fluid (CVF) concentrations of tenofovir, lamivudine, and efavirenz from 73 Malawian women with HIV were compared before and after initiation of depot-medroxyprogesterone acetate (DMPA) or levonorgestrel implant. We evaluated antiretroviral concentrations and vaginal microbiota composition/structure in the context of contraception initiation and predicted genital shedding using multivariable repeated measurements models fit by generalized estimating equations. RESULTS: Mean lamivudine CVF concentrations decreased 37% 1 month after contraception initiation. Subgroup analyses revealed a 41% decrease in women 1 month after initiating levonorgestrel implant, but no significant difference was observed in DMPA group alone. Tenofovir, lamivudine, and efavirenz CVF concentrations were positively correlated with anaerobic bacteria associated with nonoptimal vaginal microbiota. Risk of genital HIV shedding was not significantly associated with tenofovir or lamivudine CVF concentrations [tenofovir relative risk (RR): 0.098, P = 0.75; lamivudine RR: 0.142, P = 0.54]. Lack of association between genital HIV shedding and efavirenz CVF concentrations did not change when adjusting for vaginal microbiota composition and lamivudine/tenofovir CVF concentrations (RR: 1.33, P = 0.531). CONCLUSION: No effect of hormone initiation on genital shedding provides confidence that women with HIV on either DMPA or levonorgestrel implant contraception will not have compromised ART efficacy. The unexpected positive correlation between antiretroviral CVF concentrations and certain bacterial taxa relative abundance requires further work to understand the mechanism and clinical relevance.

BACKGROUND: A study from Botswana identified an increased risk of neural tube defects (NTDs) in infants of mothers with HIV who were treated with dolutegravir around the time of conception. We aimed to examine associations of dolutegravir use with NTDs and pregnancy loss using large health-care claims databases from the USA, a country with folic acid fortification of food. METHODS: In this cohort study, we analysed health-care claims data, recorded in the Merative MarketScan commercial database (MarketScan data) and Centers for Medicare & Medicaid Services Medicaid database (Medicaid data) from Jan 1, 2008, to Dec 31, 2020. We identified pregnancies with enrolment during their entire duration among women aged 15-49 years and we estimated time of conception. For each pregnancy, we determined HIV status and periconceptional exposure to dolutegravir or other antiretroviral agents. We estimated and compared the incidence rate of NTDs, stillbirths, and pregnancy loss (ie, spontaneous or induced abortions) by type of periconceptional antiretroviral exposure. We calculated adjusted risk ratios of the adverse outcomes using Poisson models adjusting for demographic and clinical factors. FINDINGS: Of 4 489 315 pregnancies in MarketScan data and 14 405 861 pregnancies in Medicaid data that had full enrolment, we identified 69 pregnancies in MarketScan data and 993 pregnancies in Medicaid data that were associated with HIV and periconceptional dolutegravir exposure. For women without HIV, the NTD rate was 4·1 per 10 000 live births (95% CI 3·9-4·3) in MarketScan and 5·7 per 10 000 live births (5·6-5·8) in Medicaid. No NTD cases were found among those with dolutegravir or non- dolutegravir antiretroviral drug exposure in the MarketScan data; only one NTD case was identified among women with dolutegravir, and three among women with non-dolutegravir antiretroviral exposure in Medicaid. After adjusting for covariates, there were no significant differences in risk ratios of NTD between groups with periconceptional dolutegravir or non-dolutegravir antiretroviral exposure and the group without HIV. However, compared with women without HIV, the risk of pregnancy loss was higher among women exposed to antiretroviral therapy: for dolutegravir exposure the adjusted risk ratio was 1·73 (95% CI 1·20-2·49) in MarketScan data and 1·41 (1·30-1·54) in Medicaid data; for non-dolutegravir antiretroviral exposure the adjusted risk ratio was 1·23 (1·10-1·37) in MarketScan data and 1·11 (1·07-1·15) in Medicaid data. INTERPRETATION: We studied the largest US cohort of women with periconceptional or early-pregnancy dolutegravir exposure. Our results do not show an increased risk of NTDs in exposed infants in the USA. Administrative databases can be used, with rigorous methodology, to study correlates of rare outcomes, such as NTDs, and to monitor for adverse pregnancy outcomes in women who receive antiretrovirals. FUNDING: US Centers for Disease Control and Prevention.

In 2012, the Centers for Disease Control and Prevention published a Framework for Elimination of Perinatal Transmission of HIV in the United States in Pediatrics, setting the goals of an incidence of <1 case of perinatal HIV per 100 000 live births, and a perinatal transmission rate of <1%. We used National HIV Surveillance System data to monitor the numbers of perinatally acquired HIV cases among US-born persons and perinatal HIV diagnosis rates per 100 000 live births to approximate incidence. Perinatal HIV transmission rates from 2010 to 2019 were calculated by using estimates of live births to women with an HIV diagnosis from the National Inpatient Sample, Healthcare Cost and Utilization Project. The annual estimated number of live births to women with diagnosed HIV decreased from 4587 in 2010 to 3525 in 2019, and the number of US-born infants with perinatally acquired HIV decreased from 74 in 2010 to 32 in 2019. Annual perinatal HIV diagnosis rates declined from 1.9 to 0.9 per 100 000 live births, and perinatal HIV transmission rates declined from 1.6% to 0.9%. Racial and ethnic disparities in HIV diagnosis rates persisted but declined substantially over the 10-year period. Both diagnosis and transmission rate elimination goals were first achieved in 2019. To maintain the elimination of perinatal HIV, and to eliminate racial disparities, the continued coordinated effort of health care and public health is required. The approach to perinatal HIV elimination is a public health model that can be replicated or expanded to areas beyond HIV.

Pregnancy is a condition of broad interest across many medical and health services research domains, but one not easily identified in healthcare claims data. Our objective was to establish an algorithm to identify pregnant women and their pregnancies in claims data. We identified pregnancy-related diagnosis, procedure, and diagnosis-related group codes, accounting for the transition to International Statistical Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis and procedure codes, in health encounter reporting on 10/1/2015. We selected women in Merative MarketScan commercial databases aged 15-49 years with pregnancy-related claims, and their infants, during 2008-2019. Pregnancies, pregnancy outcomes, and gestational ages were assigned using the constellation of service dates, code types, pregnancy outcomes, and linkage to infant records. We describe pregnancy outcomes and gestational ages, as well as maternal age, census region, and health plan type. In a sensitivity analysis, we compared our algorithm-assigned date of last menstrual period (LMP) to fertility procedure-based LMP (date of procedure + 14 days) among women with embryo transfer or insemination procedures. Among 5,812,699 identified pregnancies, most (77.9%) were livebirths, followed by spontaneous abortions (16.2%); 3,274,353 (72.2%) livebirths could be linked to infants. Most pregnancies were among women 25-34 years (59.1%), living in the South (39.1%) and Midwest (22.4%), with large employer-sponsored insurance (52.0%). Outcome distributions were similar across ICD-9 and ICD-10 eras, with some variation in gestational age distribution observed. Sensitivity analyses supported our algorithm's framework; algorithm- and fertility procedure-derived LMP estimates were within a week of each other (mean difference: -4 days [IQR: -13 to 6 days]; n = 107,870). We have developed an algorithm to identify pregnancies, their gestational age, and outcomes, across ICD-9 and ICD-10 eras using administrative data. This algorithm may be useful to reproductive health researchers investigating a broad range of pregnancy and infant outcomes.

We developed an ad hoc method to estimate the number of excess deaths among persons with HIV (PWH) during the COVID-19 pandemic in the United States. Using this method, we estimated approximately 1,448 excess deaths from COVID-19 among PWH in 2020 in the United States. We also developed an Excel workbook for use as a tool to quickly assess excess deaths among PWH in settings with limited surveillance data.

Important questions remain on how hormonal contraceptives alter the local immune environment and the microbiota in the female genital tract and how such effects may impact susceptibility to HIV infection. We leveraged samples from a previously conducted clinical trial of Malawian women with (n = 73) and without (n = 24) HIV infection randomized to depot medroxyprogesterone acetate (DMPA) or the levonogestrel implant in equal numbers within each group and determined the effects of these hormonal contraceptives (HCs) on the vaginal immune milieu and the composition of the vaginal microbiota. Longitudinal data for soluble immune mediators, measured by multiplex bead arrays and enzyme-linked immunosorbent assays (ELISAs), and vaginal microbiota, assessed by 16S rRNA gene amplicon, were collected prior to and over a period of 180 days post-HC initiation. DMPA and levonogestrel had only minimal effects on the vaginal immune milieu and microbiota. In women with HIV, with the caveat of a small sample size, there was an association between the median log(10) change in the interleukin-12 (IL-12)/IL-10 ratio in vaginal fluid at day 180 post-HC compared to baseline when these women were classified as having a community state type (CST) IV vaginal microbiota and were randomized to DMPA. Long-lasting alterations in soluble immune markers or shifts in microbiota composition were not observed. Furthermore, women with HIV did not exhibit increased viral shedding in the genital tract after HC initiation. Consistent with the results of the ECHO (Evidence for Contraceptive Options and HIV Outcomes) trial, our data imply that the progestin-based HC DMPA and levonorgestrel are associated with minimal risk for women with HIV. (This study has been registered at ClinicalTrials.gov under registration no. NCT02103660). IMPORTANCE The results of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial, the first large randomized controlled clinical trial comparing the HIV acquisition risk of women receiving DMPA, the levonorgestrel (LNG) implant, or the copper intrauterine device (IUD), did not reveal an increased risk of HIV acquisition for women on any of these three contraceptives. Our study results confirm that the two different progestin-based hormonal contraceptives DMPA and levonogestrel will not increase the risk for HIV infection. Furthermore, DMPA and levonogestrel have only minimal effects on the immune milieu and the microbiota in the vaginal tract, attesting to the safety of these hormonal contraceptives.

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.

PURPOSE: Mobile technology allows delivery of sexual and reproductive health (SRH) information directly to youth. We tested the efficacy of Crush, a mobile application aimed at improving sexual health by promoting the use of SRH services and contraception among female adolescents. METHODS: We recruited 1,210 women aged 14-18years through social media advertising and randomized them into a Crush intervention group and a control group that received a wellness app. At 3 and 6months post randomization, we compared changes from baseline in behaviors, attitudes, self-efficacy, perceived social norms, birth control knowledge, perceived control and use intentions, and SRH service utilization. Odds ratios were estimated with multivariable logistic regression and adjusted for baseline outcome, age, race/ethnicity, mother's education, and sexual experience. RESULTS: There was no difference in accessing SRH services according to study group. Three months post baseline, Crush users had higher odds (p < .05) than control participants of reporting confidence in accessing SRH services (adjusted odds ratio [aOR]= 1.6, 95% confidence interval [CI]: 1.1-2.3) and of believing that it is a good thing to use birth control consistently (aOR= 2.3, 95% CI: 1.4-3.8). Six months after baseline, Crush users had higher odds than control participants of reporting they can control whether birth control is used every time they have sex (aOR= 1.8, 95% CI: 1.2-2.6) and perceiving they would get pregnant if they did not use birth control (aOR: 1.5, 95% CI: 1.1-2.2). Impacts on other behavioral constructs were also found. DISCUSSION: Crush was associated with improvements in knowledge, attitudes, and self-efficacy related to key SRH behaviors and may be a strategy to deliver SRH education to adolescent women. Studies including larger numbers of sexually active adolescents are needed to demonstrate behavioral impacts.

Background: To determine whether the 2gether intervention increases use of a dual protection (DP; concurrent prevention of pregnancy and sexually transmitted infections [STIs]) strategy and decreases pregnancy and STIs among young African American females, who disproportionately experience these outcomes. Materials and Methods: We conducted a randomized clinical trial comparing the 2gether intervention to standard of care (SOC). Participants were self-identified African American females aged 14-19 years who were sexually active with a male partner in the past 6 months. Participants were followed for 12 months; 685 were included in the analytic sample. The primary biologic outcome was time to any incident biologic event (chlamydia, gonorrhea, trichomonas infections, or pregnancy). The primary behavioral outcomes were use of and adherence to a DP strategy. Results: 2gether intervention participants had a decreased hazard of chlamydia, gonorrhea, trichomonas infections, or pregnancy during follow-up, hazard ratio=0.73 (95% confidence interval [CI] 0.58-0.92), and were more likely to report use of condoms plus contraception, generally, adjusted risk ratio (aRR)=1.61 (95% CI 1.15-2.26) and condoms plus an implant or intrauterine device (IUD), specifically, aRR=2.11 (95% CI 1.35-3.29) in the prior 3 months compared with those receiving SOC. 2gether participants were also more likely to report use of condoms plus an implant or IUD at last sex and consistently over the prior 3 months. Conclusions: 2gether was efficacious in increasing use of condoms with contraception and decreasing pregnancy or selected STIs in our participants. Implementation of this intervention in clinical settings serving young people with high rates of pregnancy and STIs may be beneficial. ClinicalTrials.gov, No. NCT02291224 (https://clinicaltrials.gov/ct2/show/NCT02291224term=2gether&draw=2&rank=5).

As of October 21, 2022, a total of 27,884 monkeypox cases (confirmed and probable) have been reported in the United States.(§) Gay, bisexual, and other men who have sex with men have constituted a majority of cases, and persons with HIV infection and those from racial and ethnic minority groups have been disproportionately affected (1,2). During previous monkeypox outbreaks, severe manifestations of disease and poor outcomes have been reported among persons with HIV infection, particularly those with AIDS (3-5). This report summarizes findings from CDC clinical consultations provided for 57 patients aged ≥18 years who were hospitalized with severe manifestations of monkeypox(¶) during August 10-October 10, 2022, and highlights three clinically representative cases. Overall, 47 (82%) patients had HIV infection, four (9%) of whom were receiving antiretroviral therapy (ART) before monkeypox diagnosis. Most patients were male (95%) and 68% were non-Hispanic Black (Black). Overall, 17 (30%) patients received intensive care unit (ICU)-level care, and 12 (21%) have died. As of this report, monkeypox was a cause of death or contributing factor in five of these deaths; six deaths remain under investigation to determine whether monkeypox was a causal or contributing factor; and in one death, monkeypox was not a cause or contributing factor.** Health care providers and public health professionals should be aware that severe morbidity and mortality associated with monkeypox have been observed during the current outbreak in the United States (6,7), particularly among highly immunocompromised persons. Providers should test all sexually active patients with suspected monkeypox for HIV at the time of monkeypox testing unless a patient is already known to have HIV infection. Providers should consider early commencement and extended duration of monkeypox-directed therapy(††) in highly immunocompromised patients with suspected or laboratory-diagnosed monkeypox.(§§) Engaging all persons with HIV in sustained care remains a critical public health priority.

Chronic hepatitis B virus (HBV) infection and HIV infection are diseases of great public health importance. Tenofovir disoproxil fumarate (TDF), a nucleotide analog reverse transcriptase inhibitor, is effective for the treatment of both HIV and HBV.1,2 However, information on the bone safety of TDF during pregnancy, a time with increased demands on bone metabolism, has not been systematically assessed. | We conducted a phase II randomized controlled trial (RCT) in Guangxi Zhuang Autonomous Region of the People’s Republic of China, to evaluate the bone mineral density (BMD) effects of TDF on women and their infants. Effects of TDF on bone health of infants have been reported elsewhere3; this report presents our findings on the effects of TDF on maternal BMD.

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.

Black women are disproportionately affected by the U.S. human immunodeficiency virus (HIV) epidemic. Preexposure prophylaxis (PrEP) is a safe and effective intervention for HIV prevention. Increased PrEP implementation is a pillar of the U.S. Department of Health and Human Services' Ending the HIV Epidemic in the U.S. initiative. However, PrEP has been used by a smaller proportion of women with PrEP indications compared with men. The goals of the Ending the HIV Epidemic in the U.S. initiative can be achieved only by increasing PrEP use among Black women. Obstetricians and gynecologists are uniquely poised to provide PrEP services for women. We describe the need for community-to-clinic models to overcome the barriers to PrEP use by Black women and a roadmap for clinician and community organization collaboration to increase access to and use of PrEP by Black women.

OBJECTIVE: To access disruption in healthcare services for HIV treatment by national emergency in response to the coronavirus disease 2019 (COVID-19) pandemic in the United States. DESIGN: Time-series analysis. METHODS: We analyzed the IQVIA Real World Data-Longitudinal Prescriptions Database and calculated time trends in the weekly number of persons with active antiretroviral (ARV) prescriptions for HIV treatment, and of persons who obtained ARV prescriptions during January 2017-March 2021. We used interrupted time-series models to estimate the impact of the COVID-19 pandemic on antiretroviral therapy (ART) use between March 2020 and March 2021. RESULTS: We found that the weekly number of persons with active ARV prescriptions decreased by an average 2.5% (95% confidence interval [CI]: -3.8% to -1.1%), compared to predicted use, during March 2020 through March 2021. The weekly number of persons who obtained ARV prescriptions decreased 4.5% (95% CI: -6.0% to -3.0%), compared to the predicted number. Men, persons aged ≤34 years, privately insured persons, and persons in medication assistance programs had greater decreases than other groups. CONCLUSIONS: We demonstrated a decrease in the number of persons with active ARV prescriptions during the first year of the COVID-19 pandemic and the number did not return to levels expected in the absence of the pandemic. Disruptions in HIV care and decreased ART may lead to lower levels of viral suppression and immunologic control, and increased HIV transmission in the community.

BACKGROUND: HIV-1 vaccine efforts are primarily directed towards eliciting neutralizing antibodies (nAbs). However, vaccine trials and mother to child natural history cohort investigations indicate that antibody-dependent cellular cytotoxicity (ADCC), not nAbs, correlate with prevention. The ADCC characteristics associated with lack of HIV-1 acquisition remain unclear. METHODS: Here we examine ADCC and nAb properties in pre-transmission plasma from HIV-1 exposed infants and from the corresponding transmitting and non-transmitting mothers' breast milk and plasma. Breadth and potency (BP) is assessed against a panel of heterologous, non-maternal, variants. ADCC and neutralization sensitivity is estimated for the strains present in the infected mothers. RESULTS: Infants that eventually acquire HIV-1 and those that remain uninfected have similar pre-transmission ADCC BP. The viruses circulating in the transmitting and the non-transmitting mothers also have similar ADCC susceptibility. Infants with a combination of higher pre-transmission ADCC BP and exposure to more ADCC susceptible strains are less likely to acquire HIV-1. In contrast, higher pre-existing infant neutralization BP and greater maternal virus neutralization sensitivity does not associate with transmission. Infants have higher ADCC BP closer to birth and in the presence of high plasma IgG relative to IgA levels. Mothers with potent humoral responses against their autologous viruses harbor more ADCC sensitive strains. CONCLUSION: ADCC sensitivity of the exposure variants along with preexisting ADCC BP influence mother to child HIV-1 transmission during breastfeeding. Vaccination strategies that enhance ADCC responses are likely not sufficient to prevent HIV-1 transmission because strains present in chronically infected individuals can have low ADCC susceptibility. TRIAL REGISTRATION: NCT00164736 for BAN study.

Vaccines are safe and effective in protecting individuals and populations against infectious diseases. New vaccines are evaluated by a long-standing, rigorous, and transparent process through the US Food and Drug Administration and the Centers for Disease Control and Prevention (CDC), by which safety and efficacy data are reviewed before authorization and recommendation.

BACKGROUND: Uptake of HIV preexposure 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 the COVID-19 pandemic 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 percent decreases between the observed and predicted counts during 3/15/2020 - 3/31/2021. RESULTS: In the absence of the pandemic, our model predicted that there would have been 1,058,162 PrEP prescriptions during 3/15/2020 - 3/31/2021. 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. CONCLUSION: 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.

BACKGROUND: Globally, women have higher herpes simplex 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 three contraceptive methods - DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant - on 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 2015-2018. 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. FINDINGS: 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] 0.65-0.97) for DMPA-IM compared with copper IUD, 0.86 (95% CI 0.71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI 0.89-1.30) 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). INTERPRETATION: In a randomized trial, we found no association between HSV-2 acquisition and use of three contraceptive methods.