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BACKGROUND: Assisted partner services (APS) is an effective strategy for testing people with undiagnosed HIV but there is limited information on the relative reach and effectiveness of phone versus in-person contact. METHODS: We analyzed data from 31 facilities in Western Kenya providing APS to female index clients newly HIV-diagnosed, their male partners, and female partners of men newly HIV-diagnosed. APS providers attempted contacting partners using phone first and, if unsuccessful, in-person in the community. Using log-linear mixed models, we estimated relative risks (RR) between phone being the final contact method and partner characteristics and HIV outcomes. RESULTS: From May 2018-March 2020, 2534 female index clients named 7614 male partners, of whom 772 (10.1%) tested positive and named an additional 4956 non-index female partners. Of 11,912 (94.7%) partners reached, 5179 (43.5%) were via phone and 6733 (56.5%) in-person. Of 8076 testing-eligible partners, 99.7% tested and 11.2% first-time tested. Of those tested, 13.1% were newly-diagnosed, of whom 87.0% linked to care. Newly-diagnosed partners were less likely to have been reached by phone vs. in-person (9.8% vs. 15.9%; adjusted RR:0.61, 95%CI:0.53-0.70). Being reached by phone was not significantly associated with testing, first-time testing, or linkage to care. CONCLUSIONS: In an APS program that reached 94% of elicited partners, fewer than half were successfully contacted by phone. A combined phone and in-person approach is likely essential for equitable, effective APS.
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High rates of relationship dissolution among pregnant women living with HIV (PWLHIV) and their male partners might increase mothers' and children's vulnerability to financial hardship and poor health outcomes. This mixed methods analysis identified factors associated with separation between PWLHIV and their male partners. We utilized data from a randomized controlled trial ( www.ClinicalTrials.gov NCT03484533) of 500 PWLHIV attending antenatal care in Uganda and 237 male partners between 2018 and 2020 and followed until 12 months postpartum. Multivariate regression models estimated the impact of relationship factors on the adjusted relative risk of separation during follow up, and we conducted in-depth interviews with 45 women and 45 men enrolled in the trial. Overall, 23% of PWLHIV reported separation during the study period. HIV serodifferent status, financial burdens and gender expectations were sources of relationship conflict. Significant factors associated with separation included unmarried, non-cohabitating, shorter, polygamous relationships, as well as HIV non-disclosure and verbal abuse. Participants discussed potential positive and negative consequences of separation, including impact on their mental health, treatment continuation, financial security, and safety. Addressing relationship dynamics is essential to improve counseling messaging and support PWLHIV who are experiencing relationship conflict.
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Infecções por HIV , Criança , Feminino , Humanos , Masculino , Gravidez , Uganda/epidemiologia , Infecções por HIV/psicologia , Solubilidade , Gestantes/psicologia , Período Pós-Parto , Parceiros Sexuais/psicologia , Transmissão Vertical de Doenças InfecciosasRESUMO
BACKGROUND: There is insufficient evidence to guide ventilatory targets in acute brain injury (ABI). Recent studies have shown associations between mechanical power (MP) and mortality in critical care populations. We aimed to describe MP in ventilated patients with ABI, and evaluate associations between MP and clinical outcomes. METHODS: In this preplanned, secondary analysis of a prospective, multi-center, observational cohort study (ENIO, NCT03400904), we included adult patients with ABI (Glasgow Coma Scale ≤ 12 before intubation) who required mechanical ventilation (MV) ≥ 24 h. Using multivariable log binomial regressions, we separately assessed associations between MP on hospital day (HD)1, HD3, HD7 and clinical outcomes: hospital mortality, need for reintubation, tracheostomy placement, and development of acute respiratory distress syndrome (ARDS). RESULTS: We included 1217 patients (mean age 51.2 years [SD 18.1], 66% male, mean body mass index [BMI] 26.3 [SD 5.18]) hospitalized at 62 intensive care units in 18 countries. Hospital mortality was 11% (n = 139), 44% (n = 536) were extubated by HD7 of which 20% (107/536) required reintubation, 28% (n = 340) underwent tracheostomy placement, and 9% (n = 114) developed ARDS. The median MP on HD1, HD3, and HD7 was 11.9 J/min [IQR 9.2-15.1], 13 J/min [IQR 10-17], and 14 J/min [IQR 11-20], respectively. MP was overall higher in patients with ARDS, especially those with higher ARDS severity. After controlling for same-day pressure of arterial oxygen/fraction of inspired oxygen (P/F ratio), BMI, and neurological severity, MP at HD1, HD3, and HD7 was independently associated with hospital mortality, reintubation and tracheostomy placement. The adjusted relative risk (aRR) was greater at higher MP, and strongest for: mortality on HD1 (compared to the HD1 median MP 11.9 J/min, aRR at 17 J/min was 1.22, 95% CI 1.14-1.30) and HD3 (1.38, 95% CI 1.23-1.53), reintubation on HD1 (1.64; 95% CI 1.57-1.72), and tracheostomy on HD7 (1.53; 95%CI 1.18-1.99). MP was associated with the development of moderate-severe ARDS on HD1 (2.07; 95% CI 1.56-2.78) and HD3 (1.76; 95% CI 1.41-2.22). CONCLUSIONS: Exposure to high MP during the first week of MV is associated with poor clinical outcomes in ABI, independent of P/F ratio and neurological severity. Potential benefits of optimizing ventilator settings to limit MP warrant further investigation.
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Lesões Encefálicas , Síndrome do Desconforto Respiratório , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Extubação , Estudos Prospectivos , Respiração Artificial/efeitos adversos , Cuidados Críticos , Unidades de Terapia Intensiva , Lesões Encefálicas/terapia , Lesões Encefálicas/etiologia , Encéfalo , OxigênioRESUMO
BACKGROUND: Perspectives on COVID-19 risk and the willingness and ability of persons living in refugee settlements to adopt COVID-19 prevention strategies have not been rigorously evaluated. The realities of living conditions in Ugandan refugee settlements may limit the extent to which refugees can uptake strategies to mitigate COVID-19 risk. METHODS: In-depth qualitative interviews were conducted between April 2021 and April 2022 to assess COVID-19 knowledge, risk perception, prevention strategy adoption including COVID-19 vaccination, and COVID-19 impact on living conditions in refugee settlements in Uganda. Interview participants included 28 purposively selected refugees who called into "Dial-COVID", a free telephone COVID-19 information collection and dissemination platform that was advertised in refugee settlements by community health workers. Interviews were analyzed using a combination of deductive and inductive content analysis. Emerging themes were mapped onto the Theoretical Domains Framework to identify domains influencing prevention behavior. Results were synthesized to provide intervention and policy recommendations for risk mitigation in refugee settlements for COVID-19 and future infectious disease outbreaks. RESULTS: The COVID-19 pandemic detrimentally impacted economic and food security as well as social interactions in refugee settlements. Youth were considered especially impacted, and participants reported incidents of child marriage and teenage pregnancy following school closures. Participants displayed general knowledge of COVID-19 and expressed willingness to protect themselves and others from contracting COVID-19. Risk mitigation strategy uptake including COVID-19 vaccination was influenced by COVID-19 knowledge, emotions surrounding COVID-19, the environmental context and resources, personal goals, beliefs about the consequences of (non)adoption, social influences, and behavior reinforcement. Resource constraints, housing conditions, and competing survival needs challenged the adoption of prevention strategies and compliance decreased over time. CONCLUSIONS: Contextual challenges impact the feasibility of COVID-19 risk mitigation strategy uptake in refugee settlements. Pre-existing hardships in this setting were amplified by the COVID-19 pandemic and related lockdowns. Targeted dispelling of myths, alignment of information across communication mediums, supporting survival needs and leveraging of respected role models are strategies that may hold potential to mitigate risk of infectious diseases in this setting. REGISTRATION DETAILS: World Pandemic Research Network - 490,652.
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COVID-19 , Refugiados , Adolescente , Criança , Humanos , COVID-19/prevenção & controle , Refugiados/psicologia , Uganda/epidemiologia , Vacinas contra COVID-19 , Pandemias/prevenção & controle , Controle de Doenças Transmissíveis , VacinaçãoRESUMO
BACKGROUND: HIV assisted partner services (aPS), or provider notification and testing for sexual and injecting partners of people diagnosed with HIV, is shown to be safe, effective, and cost-effective and was scaled up within the national HIV testing services (HTS) program in Kenya in 2016. We estimated the costs of integrating aPS into routine HTS within an ongoing aPS scale-up project in western Kenya. METHODS: We conducted microcosting using the payer perspective in 14 facilities offering aPS. Although aPS was offered to both males and females testing HIV-positive (index clients), we only collected data on female index clients and their male sex partners (MSP). We used activity-based costing to identify key aPS activities, inputs, resources, and estimated financial and economic costs of goods and services. We analyzed costs by start-up (August 2018), and recurrent costs one-year after aPS implementation (Kisumu: August 2019; Homa Bay: January 2020) and conducted time-and-motion observations of aPS activities. We estimated the incremental costs of aPS, average cost per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy, cost shares, and costs disaggregated by facility. RESULTS: Overall, the number of MSPs traced, tested, testing HIV-positive, and on antiretroviral therapy was 1027, 869, 370, and 272 respectively. Average unit costs per MSP traced, tested, testing HIV-positive, and on antiretroviral therapy were $34.54, $42.50, $108.71 and $152.28, respectively, which varied by county and facility client volume. The weighted average incremental cost of integrating aPS was $7,485.97 per facility per year, with recurrent costs accounting for approximately 90% of costs. The largest cost drivers were personnel (49%) and transport (13%). Providers spent approximately 25% of the HTS visit obtaining MSP contact information (HIV-negative clients: 13 out of 54 min; HIV-positive clients: 20 out of 96 min), while the median time spent per MSP traced on phone and in-person was 6 min and 2.5 hours, respectively. CONCLUSION: Average facility costs will increase when integrating aPS to HTS with incremental costs largely driven by personnel and transport. Strategies to efficiently utilize healthcare personnel will be critical for effective, affordable, and sustainable aPS.
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Baías , Infecções por HIV , Análise Custo-Benefício , Feminino , Infecções por HIV/diagnóstico , Teste de HIV , Humanos , Quênia/epidemiologia , Masculino , Parceiros SexuaisRESUMO
BACKGROUND: Assisted partner service (APS) is effective for increasing HIV testing services (HTS) uptake among sexual partners of people diagnosed with HIV with rare social harm. The acceptability of APS to HTS providers is important for the quality and effectiveness of APS delivery. Within a larger ongoing implementation science study of APS in western Kenya, we qualitatively evaluated the provider acceptability of APS. METHODS: From May-June 2020, we conducted virtual, semi-structured in-depth interviews with 14 HTS providers recruited from 8 of 31 study health facilities in Homa Bay and Kisumu counties. Participants were selected using criteria-based purposive sampling to maximize variation on patient volume (assessed by the number of index clients tested for HIV) and APS performance (assessed by sexual partners elicitation and enrollment). Interviews inquired providers' experiences providing APS including challenges and facilitators and the impact of contextual factors. Data were analyzed using an inductive approach. RESULTS: Overall, HTS providers found APS acceptable. It was consistently reported that doing APS was a continuous process rather than a one-day job, which required building rapport and persistent efforts. Benefits of APS including efficiency in HIV case finding, expanded testing coverage in men, and increased HIV status awareness and linkage to care motivated the providers. Provider referral was perceived advantageous in terms of independent contact with partners on behalf of index clients and efficiency in partner tracing. Challenges of providing APS included protecting clients' confidentiality, difficulty obtaining partners' accurate contact information, logistic barriers of tracing, and clients' refusal due to fear of being judged for multiple sexual partners, fear of breach of confidentiality, and HIV stigma. Building rapport with clients, communicating with patience and nonjudgmental attitude and assuring confidentiality were examples of facilitators. Working in rural areas and bigger facilities, training, supportive supervision, and community awareness of APS promoted APS delivery while low salaries, lack of equipment, and high workload undermined it. CONCLUSIONS: HTS providers found APS acceptable. Delivering APS as a process was the key to success. Future scale-up of APS could consider encouraging provider referral instead of the other APS methods to improve efficiency and reduce potential harm to clients.
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Infecções por HIV , Infecções por HIV/diagnóstico , Infecções por HIV/terapia , Teste de HIV , Humanos , Quênia , Masculino , Parceiros Sexuais , Estigma SocialRESUMO
OBJECTIVE: To assess the risk of hematoma expansion in patients with acute intracranial hemorrhage (ICH) requiring therapeutic anticoagulation for the treatment of venous thromboembolism. METHODS: We retrospectively reviewed all patients at our institution between 2014 and 2019 who were therapeutically anticoagulated for venous thromboembolism within 4 weeks after ICH. We included subtypes of traumatic ICH and spontaneous intraparenchymal hemorrhage. Our main outcome was the incidence of hematoma expansion within 14 days from initiating therapeutic anticoagulation. Hematoma expansion was defined as (1) radiographically proven expansion leading to cessation of therapeutic anticoagulation or (2) death due to hematoma expansion. Secondary outcomes included mortality due to hematoma expansion and characteristics associated with hematoma expansion. RESULTS: Fifty patients met inclusion criteria (mean age: 54 years, 80% male, 76% Caucasian); 24% had undergone a neurosurgical procedure prior to therapeutic anticoagulation. Median time from ICH to therapeutic anticoagulation initiation was 9.5 days (IQR 4-17), 40% received therapeutic anticoagulation in <7 days after ICH. Six patients (12%) developed hematoma expansion, of whom two (4%) died. While not statistically significant, patients with hematoma expansion tended to be older (57.8 vs. 53.5 years), were anticoagulated sooner (4 vs. 10 days), presented with lower GCS (50% vs. 39% with GCS <8), higher hematoma volume (50% vs. 42% >30 cc), and higher SDH diameter (16 mm vs. 8.35 mm). There was a trend towards greater risk of hematoma expansion for patients undergoing endoscopic ICH evacuation (16% vs. 2%, p = 0.09); patients with hematoma expansion were more likely to present with hydrocephalus (67% vs. 16%, p = 0.02). CONCLUSIONS: Our study is among the first to explore characteristics associated with hematoma expansion in patients undergoing therapeutic anticoagulation after acute ICH. Larger studies in different ICH subtypes are needed to identify determinants of hematoma expansion in this high-acuity population.
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Tromboembolia Venosa , Anticoagulantes/efeitos adversos , Hemorragia Cerebral/tratamento farmacológico , Feminino , Hematoma , Humanos , Hemorragias Intracranianas/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tromboembolia Venosa/induzido quimicamente , Tromboembolia Venosa/tratamento farmacológicoRESUMO
BACKGROUND: Assessing the impact of coronavirus disease 2019 (COVID-19) on intensive care unit (ICU) providers' perceptions of resource availability and evaluating the factors associated with emotional distress/burnout can inform interventions to promote provider well-being. METHODS: Between 23 April and 7 May 2020, we electronically administered a survey to physicians, nurses, respiratory therapists (RTs), and advanced practice providers (APPs) caring for COVID-19 patients in the United States. We conducted a multivariate regression to assess associations between concerns, a reported lack of resources, and 3 outcomes: a primary outcome of emotional distress/burnout and 2 secondary outcomes of (1) fear that the hospital is unable to keep providers safe; and (2) concern about transmitting COVID-19 to their families/communities. RESULTS: We included 1651 respondents from all 50 states: 47% were nurses, 25% physicians, 17% RTs, and 11% APPs. Shortages of intensivists and ICU nurses were reported by 12% and 28% of providers, respectively. The largest supply restrictions reported were for powered air purifying respirators (56% reporting restricted availability). Provider concerns included worries about transmitting COVID-19 to their families/communities (66%), emotional distress/burnout (58%), and insufficient personal protective equipment (PPE; 40%). After adjustment, emotional distress/burnout was significantly associated with insufficient PPE access (adjusted relative risk [aRR], 1.43; 95% confidence interval [CI], 1.32-1.55), stigma from community (aRR, 1.32; 95% CI, 1.24-1.41), and poor communication with supervisors (aRR, 1.13; 95% CI, 1.06-1.21). Insufficient PPE access was the strongest predictor of feeling that the hospital is unable to keep providers safe and worries about transmitting infection to their families/communities. CONCLUSIONS: Addressing insufficient PPE access, poor communication from supervisors, and community stigma may improve provider mental well-being during the COVID-19 pandemic.
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COVID-19 , Pandemias , Cuidados Críticos , Humanos , Percepção , SARS-CoV-2 , Inquéritos e Questionários , Estados UnidosRESUMO
HIV testing and counselling is the first crucial step for linkage to HIV treatment and prevention. However, despite high HIV burden in sub-Saharan Africa, testing coverage is low, particularly among young adults and men. Community-based HIV testing and counselling (testing outside of health facilities) has the potential to reduce coverage gaps, but the relative impact of different modalities is not well assessed. We conducted a systematic review of HIV testing modalities, characterizing community (home, mobile, index, key populations, campaign, workplace and self-testing) and facility approaches by population reached, HIV positivity, CD4 count at diagnosis and linkage. Of 2,520 abstracts screened, 126 met eligibility criteria. Community HIV testing and counselling had high coverage and uptake and identified HIV-positive people at higher CD4 counts than facility testing. Mobile HIV testing reached the highest proportion of men of all modalities examined (50%, 95% confidence interval (CI) = 47-54%) and home with self-testing reached the highest proportion of young adults (66%, 95% CI = 65-67%). Few studies evaluated HIV testing for key populations (commercial sex workers and men who have sex with men), but these interventions yielded high HIV positivity (38%, 95% CI = 19-62%) combined with the highest proportion of first-time testers (78%, 95% CI = 63-88%), indicating service gaps. Community testing with facilitated linkage (for example, counsellor follow-up to support linkage) achieved high linkage to care (95%, 95% CI = 87-98%) and antiretroviral initiation (75%, 95% CI = 68-82%). Expanding home and mobile testing, self-testing and outreach to key populations with facilitated linkage can increase the proportion of men, young adults and high-risk individuals linked to HIV treatment and prevention, and decrease HIV burden.
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Testes Diagnósticos de Rotina/estatística & dados numéricos , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Necessidades e Demandas de Serviços de Saúde , África Subsaariana , Contagem de Linfócito CD4 , Testes Diagnósticos de Rotina/economia , Infecções por HIV/economia , Infecções por HIV/virologia , Necessidades e Demandas de Serviços de Saúde/economia , Humanos , Distribuição por Sexo , Carga Viral/efeitos dos fármacosRESUMO
OBJECTIVE: To synthesize reported long-term outcomes in patients undergoing tracheostomy after severe acute brain injury (SABI). METHODS: We systematically searched PubMed, EMBASE, and Cochrane Library for studies in English, German, and Spanish between 1990 and 2019, reporting outcomes in patients with SABI who underwent tracheostomy. We adhered to the preferred reporting items for systematic reviews and meta-analyses guidelines and the meta-analyses of observational studies in epidemiology guidelines. We excluded studies reporting on less than 10 patients, mixed populations with other neurological diseases, or studies assessing highly select subgroups defined by age or procedures. Data were extracted independently by two investigators. Results were pooled using random effects modeling. The primary outcome was long-term functional outcome (mRS or GOS) at 6-12 months. Secondary outcomes included hospital and long-term mortality, decannulation rates, and discharge home rates. RESULTS: Of 1405 studies identified, 61 underwent full manuscript review and 19 studies comprising 35,362 patients from 10 countries were included in the meta-analysis. The primary outcome was available from five studies with 451 patients. At 6-12 months, about one-third of patients (30%; 95% confidence interval [CI] 17-48) achieved independence, and about one-third survived in a dependent state (36%, 95% CI 28-46%). The pooled short-term mortality for 19,048 patients was 12%, (95% CI 9-17%) with no significant difference between stroke (10%) and TBI patients (13%), and the pooled long-term mortality was 21% (95% CI 11-36). Decannulation occurred in 79% (95% CI 51-93%) of survivors. Heterogeneity was high for most outcome assessments (I2 > 75%). CONCLUSIONS: Our findings suggest that about one in three patients with SABI who undergo tracheostomy may eventually achieve independence. Future research is needed to understand the reasons for the heterogeneity between studies and to identify those patients with promising outcomes as well as factors influencing outcome.
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Lesões Encefálicas , Acidente Vascular Cerebral , Humanos , Avaliação de Resultados em Cuidados de Saúde , TraqueostomiaAssuntos
Lesões Encefálicas , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Lesões Encefálicas/fisiopatologia , Adulto , Condução de Veículo , IdosoRESUMO
BACKGROUND: Home-based human immunodeficiency virus (HIV) testing and education has increased HIV test uptake and access to health services among men. We studied how a home-based antenatal intervention influenced male partner utilization of clinic-based HIV and sexually transmitted infection (STI) services, linkage to HIV care and medical circumcision. METHODS: We conducted a secondary analysis within a randomized controlled trial of pregnant women attending antenatal care in Kenya. Women and their male partners received either a home-based couple intervention or an invitation letter for clinic-based couple HIV testing. The home-based intervention included education on STI symptoms, STI and HIV treatment and male circumcision for HIV prevention. Male self-reported outcomes were compared using relative risks at 6 months postpartum. RESULTS: Among 525 women, we reached 487 (93%) of their male partners; 247 men in the intervention arm and 240 men in the control arm. Men who received the intervention were more likely to report an STI consultation (n = 47 vs. 16; relative risk, 1.59; 95% confidence interval, 1.33-1.89). Among 23 men with newly diagnosed HIV, linkage to HIV care was reported by 4 of 15 in the intervention (3 men had missing linkage data) and 3 of 5 men in the control arms (relative risk, 0.66; 95% confidence interval, 0.34-1.29). Although the intervention identified 3 times more men with new HIV infection, the study lacked power to find significant differences in linkage to HIV care. Few eligible men sought medical circumcision (4 of 72 intervention and 2 of 88 control). CONCLUSIONS: Home-based couple education and testing increased STI consultations among male partners of pregnant women, but appeared insufficient to overcome the barriers involved in linkage to HIV care and medical circumcision.
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Infecções por HIV/prevenção & controle , Educação em Saúde/métodos , Parceiros Sexuais , Infecções Sexualmente Transmissíveis/prevenção & controle , Sífilis/prevenção & controle , Adulto , Circuncisão Masculina , Feminino , HIV/efeitos dos fármacos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Infecções por HIV/transmissão , Educação em Saúde/estatística & dados numéricos , Humanos , Quênia/epidemiologia , Masculino , Gravidez , Gestantes/educação , Cuidado Pré-Natal , Prevalência , Infecções Sexualmente Transmissíveis/microbiologia , Infecções Sexualmente Transmissíveis/virologia , Sífilis/tratamento farmacológico , Sífilis/epidemiologia , Sífilis/transmissãoRESUMO
BACKGROUND: Many clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa. METHODS: We used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation. RESULTS: Among 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment. CONCLUSIONS: This busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same-day diagnosis for all patients screened for TB. Further research on implementing POC testing efficiently into care pathways is required to make these promising assays a success.
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Instituições de Assistência Ambulatorial/estatística & dados numéricos , Testes Imediatos/estatística & dados numéricos , Infecções Sexualmente Transmissíveis/diagnóstico , Assistência Ambulatorial/estatística & dados numéricos , Atitude do Pessoal de Saúde , Diagnóstico Precoce , Eficiência , Infecções por HIV/diagnóstico , Humanos , Encaminhamento e Consulta , África do Sul , Tempo para o Tratamento/estatística & dados numéricos , Tuberculose/diagnósticoRESUMO
BACKGROUND: Herpes zoster (HZ) is caused by varicella-zoster virus ( VZV ) reactivation. In the United States, Zoster vaccine (ZOSTAVAX) is indicated for HZ prevention in patients ≥50 years. AIMS: To evaluate the immunogenicity, safety, and tolerability of ZOSTAVAX in healthy Indian subjects, to support its registration in India. METHODS: This open-label, single-arm study was conducted at 10 sites in India. Healthy Indians (≥50 years) received a single ZOSTAVAX dose. Immunogenicity was assessed by VZV-specific antibody titer using gpELISA assay. VZV-specific antibody geometric mean titers (GMT; Day 1 pre-vaccination, Week 6 post-vaccination) and geometric mean fold-rise (GMFR; Week 6 post-vaccination) were assessed. Safety was evaluated by the incidence of adverse events (AEs) and serious adverse events (SAEs) within 42 days of vaccination. Two-sided 95% confidence intervals (CIs) were evaluated using t-distribution with natural log-transformed values. RESULTS: Of the 250 subjects (mean age, 58.6 years) enrolled and vaccinated, 244 subjects completed the 6-week follow-up. Overall, subjects in the per-protocol population had GMT of 149.8 gpELISA units/mL (n=250; 95% CI: 132.6, 169.2) at Day 1 pre-vaccination, and 410.8 gpELISA units/mL (n=243; 95% CI: 373.0, 452.6) at Week 6 post-vaccination. GMFR of VZV-specific antibody from Day 1 pre-vaccination to Week 6 post-vaccination was 2.8 (95% CI: 2.5, 3.1). Overall, 67 subjects (26.8%) experienced AEs, with 48 (19.2%) reporting injection-site AEs and 38 (15.2%) reporting non-injection-site AEs. SAE-abdominal pain and bronchitis-was reported in one (0.4%) patient each. There was one death, which was unrelated to the vaccine. LIMITATIONS: Since ZOSTAVAX introduces a new live attenuated virus, clinical reactivation of ZOSTAVAX virus and wild-type VZV will need to be differentiated. CONCLUSIONS: In healthy Indians ≥50 years, ZOSTAVAX was well tolerated and resulted in expected VZV-specific antibody titer levels at 6 weeks post-vaccination.
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Vacina contra Herpes Zoster , Herpes Zoster , Adulto , Anticorpos Antivirais , Herpesvirus Humano 3 , Humanos , Índia , Pessoa de Meia-IdadeRESUMO
Monica Sharma and colleagues discuss evidence-based approaches to improving HIV services for men in sub-Saharan Africa.
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Redes Comunitárias/organização & administração , Procedimentos Clínicos , Identidade de Gênero , Infecções por HIV/terapia , Participação do Paciente , África Subsaariana , Antirretrovirais/uso terapêutico , Aconselhamento/métodos , Aconselhamento/organização & administração , Procedimentos Clínicos/organização & administração , Procedimentos Clínicos/normas , Feminino , Infecções por HIV/epidemiologia , HIV-1 , Homossexualidade Masculina/estatística & dados numéricos , Humanos , Masculino , Saúde do Homem , Participação do Paciente/métodos , Parceiros Sexuais , Planejamento EstratégicoRESUMO
Mathematical models of cervical cancer have been widely used to evaluate the comparative effectiveness and cost-effectiveness of preventive strategies. Major advances in the understanding of cervical carcinogenesis motivate the creation of a new disease paradigm in such models. To keep pace with the most recent evidence, we updated a previously developed microsimulation model of human papillomavirus (HPV) infection and cervical cancer to reflect 1) a shift towards health states based on HPV rather than poorly reproducible histological diagnoses and 2) HPV clearance and progression to precancer as a function of infection duration and genotype, as derived from the control arm of the Costa Rica Vaccine Trial (2004-2010). The model was calibrated leveraging empirical data from the New Mexico Surveillance, Epidemiology, and End Results Registry (1980-1999) and a state-of-the-art cervical cancer screening registry in New Mexico (2007-2009). The calibrated model had good correspondence with data on genotype- and age-specific HPV prevalence, genotype frequency in precancer and cancer, and age-specific cancer incidence. We present this model in response to a call for new natural history models of cervical cancer intended for decision analysis and economic evaluation at a time when global cervical cancer prevention policy continues to evolve and evidence of the long-term health effects of cervical interventions remains critical.
Assuntos
Alphapapillomavirus/genética , Simulação por Computador , Modelos Biológicos , Infecções por Papillomavirus/complicações , Displasia do Colo do Útero/virologia , Neoplasias do Colo do Útero/virologia , Adolescente , Adulto , Idoso , Feminino , Humanos , Pessoa de Meia-Idade , Método de Monte Carlo , New Mexico/epidemiologia , Infecções por Papillomavirus/epidemiologia , Neoplasias do Colo do Útero/epidemiologia , Neoplasias do Colo do Útero/prevenção & controle , Adulto Jovem , Displasia do Colo do Útero/epidemiologia , Displasia do Colo do Útero/prevenção & controleRESUMO
OBJECTIVE: AIDS Drug Assistance Programs (ADAPs) are state-administered programs that pay for medical care and medication for people living with HIV (PLWH) in the United States. In October 2021, the federal policy requiring that clients recertify for the program every 6 months was repealed, giving states the authority to set their own recertification policies. However, little data exist on the costs and health effects of alternative recertification schedules. We assessed the cost of changing the legacy 6-month recertification to a 12-month schedule in Washington State to inform policy decisions on recertification. METHODS: We used a Markov model to simulate the population of PLWH in Washington State who are eligible or enrolled in ADAP. We obtained model inputs and validation data from the Washington State Ryan White database. We estimated the cost of 12-month and 6-month criteria over a 5-year time horizon. Model outputs included annual program costs, population sizes, and number of people virally suppressed, by scenario. RESULTS: Under a continuation of the legacy 6-month recertification criteria, the annual cost of Washington ADAP would be $37 663 000 (95% CI, $34 570 000-$41 686 000) during the next 5 years, with a per-client cost of $7966 (95% CI, $7478-$8494). Under 12-month criteria, the annual cost would be $40 217 000 (95% CI, $36 243 000-$44 401 000) and the per-client cost would be $7543 (95% CI, $7084-$8042). Under the 12-month scenario, 245 more people will have been virally suppressed by the end of 2025. CONCLUSIONS: Switching to a less frequent recertification process may improve health outcomes at a modest increase in cost in Washington State.
Assuntos
Infecções por HIV , Humanos , Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Síndrome da Imunodeficiência Adquirida/economia , Fármacos Anti-HIV/economia , Fármacos Anti-HIV/uso terapêutico , Custos e Análise de Custo , Infecções por HIV/tratamento farmacológico , Infecções por HIV/economia , Cadeias de Markov , Assistência Médica/organização & administração , WashingtonRESUMO
Background: Assisted partner services (APS) is a recommended public health approach to promote HIV testing for sexual partners of individuals diagnosed with HIV. We evaluated the cost and cost-effectiveness of integrating oral HIV self-testing (HIVST) into existing APS programs. Methods: Within the APS-HIVST study conducted in western Kenya (2021-2022), we conducted micro-costing, time-and-motion, and provider surveys to determine incremental HIVST distribution cost (2022 USD). Using a decision tree model, we estimated the incremental cost per new diagnosis (ICND) for HIVST incorporated into APS, compared to APS with provider-delivered testing only. Scenario, parameter and probabilistic sensitivity analyses were conducted to explore influential assumptions. Results: The cost per HIVST distributed within APS was USD 8.97, largest component costs were testing supplies (38%) and personnel (30%). Under conditions of a facility-based testing uptake of <91%, or HIVST utilization rates of <27%, HIVST integration into APS is potentially cost-effective. At a willing-to-pay threshold of USD 1000, the net monetary benefit was sensitive to the effectiveness of HIVST in increasing testing rates, phone call rates, HIVST sensitivity, HIV prevalence, cost of HIVST, space allocation at facilities, and personnel time during facility-based testing. In a best-case scenario, the HIVST option was cheaper by USD 3037 and diagnosed 11 more cases (ICND = 265.82). Conclusions: Implementers and policy makers should ensure that HIVST programs are implemented under conditions that guarantee efficiency by focusing on facilities with low uptake for provider-delivered facility-based testing, while deliberately targeting HIVST utilization among the few likely to benefit from remote testing. Additional measures should focus on minimizing costs relating to personnel and testing supplies.
RESUMO
Introduction: Women living with human immunodeficiency virus (WLHIV) face elevated risks of human papillomavirus (HPV) acquisition and cervical cancer (CC). Coverage of CC screening and treatment remains low in low-and-middle-income settings, reflecting resource challenges and loss to follow-up with current strategies. We estimated the health and economic impact of alternative scalable CC screening strategies in KwaZulu-Natal, South Africa, a region with high burden of CC and HIV. Methods: We parameterized a dynamic compartmental model of HPV and HIV transmission and CC natural history to KwaZulu-Natal. Over 100 years, we simulated the status quo of a multi-visit screening and treatment strategy with cytology and colposcopy triage (South African standard of care) and six single-visit comparator scenarios with varying: 1) screening strategy (HPV DNA testing alone, with genotyping, or with automated visual evaluation triage, a new high-performance technology), 2) screening frequency (once-per-lifetime for all women, or repeated every 5 years for WLHIV and twice for women without HIV), and 3) loss to follow-up for treatment. Using the Ministry of Health perspective, we estimated costs associated with HPV vaccination, screening, and pre-cancer, CC, and HIV treatment. We quantified CC cases, deaths, and disability-adjusted life-years (DALYs) averted for each scenario. We discounted costs (2022 US dollars) and outcomes at 3% annually and calculated incremental cost-effectiveness ratios (ICERs). Results: We projected 69,294 new CC cases and 43,950 CC-related deaths in the status quo scenario. HPV DNA testing achieved the greatest improvement in health outcomes, averting 9.4% of cases and 9.0% of deaths with one-time screening and 37.1% and 35.1%, respectively, with repeat screening. Compared to the cost of the status quo ($12.79 billion), repeat screening using HPV DNA genotyping had the greatest increase in costs. Repeat screening with HPV DNA testing was the most effective strategy below the willingness to pay threshold (ICER: $3,194/DALY averted). One-time screening with HPV DNA testing was also an efficient strategy (ICER: $1,398/DALY averted). Conclusions: Repeat single-visit screening with HPV DNA testing was the optimal strategy simulated. Single-visit strategies with increased frequency for WLHIV may be cost-effective in KwaZulu-Natal and similar settings with high HIV and HPV prevalence.