Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
Brief Summary: This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.


Options:
A: Inclusion Criteria:

* The patient is willing to provide specimens (urine, blood, stool, respiratory tract specimens and swabs)
* The patient is clinically suspected of having TB (Two WHO TB symptoms for HIV negative patients and one WHO TB symptom if HIV positive)

Exclusion Criteria:

* The patient is under the age of 18 years old
* The patient declines consent
* The patient has too few clinical symptoms for TB
B: Inclusion Criteria:

-

Program Implementation:

Inclusion criteria:

* Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
* Ability to produce sputum
* Verbal consent of parent or guardian if \< 18 years old

Operations Research:

Inclusion criteria

* Adults (18 years and older)
* TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)
* Ability to provide a sputum sample
* Willing to provide written informed consent
* Willing to undergo full clinical evaluation
* Willing to undergo a CXR
C: Inclusion Criteria:

* Men and women of ≥18 years of age
* Presence of cough, fever, night sweats or weight loss
* Ability and willingness to give written informed consent
* Documentation of positive HIV status (test conducted at GHESKIO)
* Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".

Exclusion Criteria:

* Any use of ART in the past
* Treatment for TB in the year prior to screening visit
* Pregnancy or breastfeeding at the screening visit
* Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
* Score of \<3 for any of the 7 questions on the ART readiness survey
* Planning to transfer care to another clinic during the study period
* Symptoms consistent with WHO stage 4 neurologic disease (cryptococcal meningitis, TB meningitis; central nervous system toxoplasmosis; HIV encephalopathy; progressive multifocal leukoencephalopathy)
* Severe illness, classified as one of the WHO "danger signs" of temperature \>39 degrees Celsius, pulse \>120 beats/minutes, respiratory rate \>30, or inability to walk unaided.
D: Inclusion Criteria:

* • Age 18 years or above;

  * Symptoms suggesting pulmonary TB, i.e. persistent cough (generally ≥3 weeks or as per local definition of TB suspect), and at least one of the following:

    * Previously received \>1 month of treatment for a prior TB episode or
    * Failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
    * Had close contact with a known drug-resistant TB case or
    * Newly diagnosed with MDR-TB within the last 30 days or
    * Previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen

Patients meeting the above criteria will be screened by Xpert MTB/RIF or Xpert MTB/RIF Ultra. TB patients meeting the following criteria will be included in the study:

* A clear Mtb-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Xpert MTB/RIF Ultra
* Provision of informed consent;
* Production of an adequate quantity (\>3mL) of sputum

Exclusion Criteria:

* Participants will be excluded from the study if informed consent is not provided.

Answer: C