RESUMO
BACKGROUND: Half of new HIV acquisitions in Africa occur in adolescent girls and young women. Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate plus emtricitabine or the monthly dapivirine vaginal ring is efficacious but has lower adherence and effectiveness among adolescent girls and young women. We aimed to assess product adherence, safety, and choice of oral PrEP compared with the dapivirine ring among African adolescent girls and young women. METHODS: MTN-034/REACH was a randomised, open-label, phase 2a crossover trial among HIV-seronegative, non-pregnant adolescent girls and young women aged 16-21 years at four clinical research sites in South Africa, Uganda, and Zimbabwe. Participants were randomly assigned (1:1) to either the dapivirine ring or daily oral PrEP (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) for 6 months, then switched to the other product option for 6 months, followed by a third 6-month period in which participants were given a choice of oral PrEP, the dapivirine ring, or neither. Fixed block randomisation was used, stratified by site. The primary adherence endpoint was use of each product during the randomised periods, with high use defined as tenofovir-diphosphate concentrations greater than or equal to 700 fmol/punch (associated with taking an average of four or more tablets per week in the previous month) and greater than or equal to 4 mg dapivirine released from the returned ring (continuous use for 28 days in the previous month) based on residual drug concentrations. The primary safety endpoint was grade 2 or higher adverse events during each randomised period of 24 weeks of ring and oral PrEP. This trial is registered at ClinicalTrials.gov, NCT03593655. FINDINGS: From Feb 6, 2019 to Sept 9, 2021, 396 adolescent girls and young women were screened, 247 of whom were enrolled and randomly assigned (6 months of the ring followed by 6 months of oral PrEP n=124; 6 months of oral PrEP followed by 6 months of the ring n=123). Median age was 18 years (IQR 17-19). 54 grade 2 or higher product-related adverse events were reported during oral PrEP and five during dapivirine ring use, with no product-related serious adverse events. High adherence was observed in 753 (57%) of the 1316 oral PrEP visits and 806 (57%) of the 1407 dapivirine ring visits. Four women acquired HIV during follow-up. INTERPRETATION: Adherence was moderately high and similar between oral PrEP and the dapivirine ring with favourable safety and tolerability. Oral PrEP and the dapivirine ring are effective, safe, and well tolerated HIV prevention options for adolescent girls and young women who would benefit from a choice of PrEP formulations to meet their needs and preferences. FUNDING: National Institutes of Health.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Humanos , Feminino , Adolescente , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Estudos Cross-Over , Tenofovir/uso terapêutico , Emtricitabina/efeitos adversos , Inibidores da Transcriptase Reversa/efeitos adversos , África do Sul/epidemiologiaRESUMO
INTRODUCTION: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. METHODS: AGYW aged 16-21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP). RESULTS: Of the 247 AGYW enrolled in REACH, 34% were aged 16-17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally. CONCLUSIONS: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Profilaxia Pré-Exposição , Adolescente , Feminino , Humanos , Gravidez , Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Infecções por HIV/tratamento farmacológico , Profilaxia Pré-Exposição/métodos , África do Sul/epidemiologia , Uganda/epidemiologia , Zimbábue/epidemiologia , Adulto JovemRESUMO
OBJECTIVES: To compare the clinical characteristics of Native Hawaiians (NH) and other Pacific Islanders (PI) who are hospitalized with ischemic stroke. DESIGN: Retrospective, cross-sectional analysis of medical records. SETTING: Tertiary, Primary Stroke Center in Honolulu, Hawaii. PATIENTS: Consecutive patients with race/ethnicity identified as NH or PI who were hospitalized for ischemic stroke between January 2006 and December 2012. OUTCOME MEASURES: Age, sex, cardiovascular risk factors, intravenous tissue plasminogen activator (IV-tPA) utilization rate and hospital length of stay. RESULTS: A total of 561 patients (57% NH and 43% PI) were studied. PI were younger (59 ± 13 years vs 62 ± 14 years, P = .002), had higher prevalence of diabetes mellitus (58% vs 41%, P < .0001) and prosthetic valve (6% vs 2%, P = .007), lower prevalence of smoking (14% vs 21%, P = .03), lower HDL cholesterol (38 ± 11 mg/dL vs 41 ± 13 mg/dL, P = .004), and higher discharge diastolic blood pressure (79 ± 15 vs 76 mm Hg ± 14 mm Hg, P = .04) compared to NH. No difference was seen in other cardiovascular risk factors. The IV-tPA utilization rate (5% vs 6%, P = .48) and the hospital length of stay (10 ± 17 days vs 10 ± 49 days, P = .86) were not different between the two groups. CONCLUSION: Native Hawaiians and other Pacific Islanders with ischemic stroke have modestly different age of stroke presentation and burden of risk factors compared to each other. Disaggregating these two racial groups may be important to unmask any potential clinical differences in future studies.
Assuntos
Disparidades nos Níveis de Saúde , Havaiano Nativo ou Outro Ilhéu do Pacífico/estatística & dados numéricos , Acidente Vascular Cerebral/etnologia , Fatores Etários , Idoso , Estudos Transversais , Feminino , Fibrinolíticos/uso terapêutico , Havaí/etnologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Ilhas do Pacífico/etnologia , Estudos Retrospectivos , Fatores Sexuais , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Ativador de Plasminogênio Tecidual/uso terapêuticoRESUMO
BACKGROUND: Little is known about rates of incident pregnancy among HIV-positive women initiating highly active antiretroviral therapy (HAART). METHODS: We conducted a retrospective clinical cohort study among therapy-naïve women ages 18-45 initiating HAART between 1 April 2004 and 30 September 2009 at an adult HAART clinic in Johannesburg, South Africa. We used Poisson regression to characterize rates and rate ratios of pregnancy. RESULTS: We evaluated 5,996 women who experienced 727 pregnancies during 14,095 person-years at risk. The overall rate of pregnancy was 5.2 per 100 person-years (95% confidence limits [CL] 4.8, 5.5). By six years, cumulative incidence of first pregnancy was 22.9% (95% CL 20.6%, 25.4%); among women ages 18-25 at HAART initiation, cumulative incidence was 52.2% (95% CL 35.0%, 71.8%). The strongest predictor of incidence of pregnancy was age, with women 18-25 having 13.2 times the rate of pregnancy of women ages 40-45 in adjusted analysis. CD4 counts below 100 and worse adherence to HAART were associated with lower rates of incident pregnancy. CONCLUSIONS: Women experience high rates of incident pregnancy after HAART initiation. Understanding which women are most likely to experience pregnancy will help planning and future efforts to understand the implications of pregnancy for response to HAART.
Assuntos
Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Taxa de Gravidez , Adolescente , Adulto , Distribuição por Idade , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Análise de Regressão , Estudos Retrospectivos , África do Sul , Adulto JovemRESUMO
BACKGROUND: Native Hawaiians and other Pacific Islanders (NHOPI) have high prevalence of overweight status, obesity, and hypertension, as well as high rates of asthma and cancer mortality. Some barriers to health care delivery for this population are a physician shortage in Hawai'i and a geographical maldistribution of actively practicing physicians. This study examines the distribution of NHOPI physicians compared to the NHOPI population in Hawai'i through Geographical Information System choropleth mapping. METHODS: The maps and results were gathered and constructed from Census Tract data from the US Department of Commerce, the Census Bureau, the Physician Workforce Assessment, and the 'Ahahui o na Kauka reports. RESULTS: With the exception of East Honolulu, all areas of Hawai'i show drastic disparities in the ratio of NHOPI physicians to NHOPI populations as compared to the ratio of total physicians to the total population. DISCUSSION: Given the NHOPI physician shortage and their geographical maldistribution, this study underscores the importance of increasing the number of NHOPI medical school applicants, graduates, residents, and physicians in permanent active practices in rural areas and the neighbor islands. Current institutional and academic programs, such as the John A. Burns School of Medicine, Imi Ho'ola, and the Native Hawaiian Center of Excellence, are contributing to resolving some of the health disparities and should consider expanding their efforts.