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:

* Suspected pulmonary TB.
* Ability and willingness of candidate or legal guardian/representative to provide informed consent.
* Men and women age equal to or greater than 18 years.

Exclusion Criteria:

* Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
C: Inclusion Criteria:

* Adult PLHIV (≥18 years), irrespective of their CD4 count and antiretroviral therapy (ART) status, at risk of having pulmonary and/or extra-pulmonary TB
* Inpatients: irrespective of TB symptoms
* Outpatients: at least one of the symptoms suggestive of TB (as defined by WHO\*)
* written informed consent
* willingness to have a trial follow-up visit at 2-3 and 6 months after enrolment (e.g. not planning to relocate)

Exclusion Criteria:

* Current anti-TB treatment \*
* Any anti-TB treatment within 60 days prior to enrolment
* Any isoniazid preventive therapy within 6 months prior to enrolment \* Patients starting anti-TB treatment at the time of enrolment will not be excluded from the trial provided that all trial specimens are collected before starting the 3rd dose of treatment.
D: 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.

Answer: D