Please select the eligibility criteria that correspond to the clinical trial below.
Title: Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
Brief Summary: Each year, an estimated 230,000 HIV-infected women in need of services for prevention of mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites are predominantly rural primary health centers (PHCs) where shortages of high-cadre health care providers and insufficient laboratory capacity to perform CD4+ cell count testing have been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing will facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these rural, decentralized sites. A system wherein men are facilitated to accompany their wives to ANC appointments will create an important opportunity to address entrenched gender norms. The investigators therefore propose using community and facility-based measures to encourage male partners to accompany their spouses for ANC. As influential community members, male partners can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT care provided by lower-cadre providers in these resource-constrained settings.

The investigators propose a parallel, cluster randomized trial to evaluate the impact of a family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers. The specific aims of this study are:

1. To evaluate whether implementation of the integrated PMTCT package in primary level antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that the provision of the PMTCT package in intervention clinics will improve PMTCT antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%.
2. To determine whether implementation of the PMTCT package improves postpartum retention of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum retention rates among mother-infant pairs attending intervention sites will be \>20% higher at 6 weeks when compared to mother-infant pairs receiving care in non-intervention sites.
3. Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT intervention compared to the existing standard-of-care referral model. The investigators hypothesize that the proposed intervention will be more cost-effective than the existing model of care.

In addition, two qualitative evaluations will be conducted in order to:

1. Assess client satisfaction with health services, comparing PMTCT services provided by lower level vs. higher level cadre health workers; and
2. Evaluate health care worker satisfaction with the new PMTCT service delivery model.


Options:
A: Inclusion criteria (all of the following):

1. Child is 5-11 years of age (a population in whom a diagnosis of asthma is generally reliable, and in whom exacerbations are common);
2. Child is presenting to the ED, urgent care center, or observation unit at a participating clinical center (Anne and Robert H. Lurie Children's Hospital of Chicago, Sinai Health System's Mount Sinai Hospital, John H. Stroger Jr. Hospital of Cook County Health \& Hospitals System, Rush University Medical Center, University of Chicago Medicine Comer Children's Hospital, and the University of Illinois Hospital \& Health Sciences System);
3. Child is treated with at least 1 dose of an inhaled or nebulized short-acting bronchodilator (quick-relief medication);
4. Child received systemic corticosteroids in the ED OR the caregiver reported at least 1 additional acute care visit for asthma in the previous 6 months (defined as an asthma-related ED visit or urgent care visit, or course of systemic corticosteroids);
5. Child and caregiver approached at least 1 hour after receipt of the first dose of quick-relief medication or systemic corticosteroids, whichever occurred first;
6. Diagnosis of asthma exacerbation by treating clinician;
7. Treating ED clinician indicates the child is likely to be discharged to home; and
8. Caregiver reports that English or Spanish is the preferred language at home.

Exclusion criteria (none of the following):

1. Caregiver declines to provide informed consent, or the child declines to provide assent;
2. Child is admitted to an intensive care unit or transferred to another healthcare facility;
3. Child or another member of the child's primary household is a current or previous participant in the CHICAGO Plan;
4. Child is enrolled in another study involving a health-related intervention;
5. A CHW is already visiting the home as part of another program;
6. Child does not reside in Chicago.
B: Inclusion Criteria:

* Age ≥ 18 years
* Acute HF as a primary cause of hospitalization

  * Hospitalizations for acute HF will be determined by local clinician-investigators but should include the following:
  * Symptoms (eg, dyspnea, fatigue), signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the hospitalization and
  * Treatments aimed at acute HF (eg, intravenous diuretics, vasodilators, or inotropes)
* LVEF ≤ 40% based on last local measurement using echocardiography, multigated acquisition scan, computed tomography (CT) scanning, magnetic resonance imaging, or ventricular angiography
* Planned discharge to home or other supported care facility where patients are individually responsible for medication management

Exclusion Criteria:

* Prior heart transplant or current/planned left ventricular assistance device
* Chronic kidney disease requiring dialysis
* Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
* Unable to participate in longitudinal follow-up, such as plans to move outside the US in the following year
C: Inclusion Criteria:

1. HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status;
2. HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery.

Exclusion Criteria:

HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC.
D: Patient Eligibility Criteria

Inclusion Criteria:

* Patients over 18 years old, diagnosed with ischemic stroke (including transient ischemic attack) with symptoms lasting up to 24 hours.

Exclusion Criteria:

* Patients with signs of hemorrhagic stroke, expansive lesions, central nervous system infections, and those coming from institutions that did not provide institutional approval form signed by the patients' guardians.

Cluster Eligibility Criteria

Inclusion Criteria:

* Hospitals with a emergency department, with available tomography, neurologist and alteplase

Exclusion Criteria:

* Hospitals that don't provide Institutional Authorization Form

Answer: C