Please select the eligibility criteria that correspond to the clinical trial below.
Title: Rapid Initiation of Antiretroviral Therapy to Promote Early HIV/AIDS Treatment in South Africa (RapIT Study)
Brief Summary: One of the most serious challenges facing antiretroviral therapy (ART) programs for HIV/AIDS in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to care of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require approximately four clinic visits over a period of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and tuberculosis (TB) diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation under South African guidelines (lab tests, physical exam, education) to take place on the day the patient presents for an HIV test.

This study is a randomized strategy evaluation of the feasibility, effectiveness, and cost-effectiveness of rapid ART initiation. Outpatient, non-pregnant, HIV-positive adults who come to a South African clinic for an HIV test, consent to study participation, and are eligible for ART will be randomized 1:1 to rapid ART initiation or to standard care. Those who are assigned to rapid ART initiation will have the possibility of receiving their first dose of ARVs as early as the same day, while those who are assigned to standard care will follow the clinic's usual procedures for starting ART. Rapid ART initiation for HIV-positive pregnant women, which has recently become the standard of care in South Africa, will also be assessed in a programmatic evaluation conducted alongside the randomized evaluation, with a retrospective comparison group. The primary study outcome for non-pregnant adults will be remaining alive, in care and virally suppressed 10 months after having a positive HIV test at the study site or making a first HIV-related visit. The primary study outcome for pregnant women will be adherence to ART until delivery. The cost effectiveness of the rapid initiation strategy will be assessed as the cost per patient achieving the primary outcome for each population.


Options:
A: Inclusion Criteria:

* Age 18 or over
* Positive HIV test result
* CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry
* Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid)
* Naive to ART
* TB treatment started less than one week prior enrolment
* Negative gonadotrophin pregnancy test (blood) for women of childbearing potential (i.e. not surgically sterile or less than 2 years menopause)
* Agreement from female candidates who are participating in sexual activity that could lead to pregnancy while receiving and for 6 weeks after stopping efavirenz to use two reliable methods of contraception, one of which including condom.

Exclusion Criteria:

* Suspected TB with negative AFB
* Pregnant or breastfeeding women
* Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value)
* Unable and/or unlikely to comprehend and/or be adherent to the protocol
* Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial
B: Inclusion Criteria:

* 18 years of age or older
* Testing HIV positive at the largest-volume HIV point of testing (other than prevention of mother-to-child transmission or tuberculosis) at SU with written proof of test result
* Agreeing to be referred to the HIV care services associated with the SU
* Agreeing to provide locator information
* Agreeing to adhere to study procedures, including a baseline interview, interviews 1 and 12 months after study enrollment, and extraction of data from the HIV care and treatment electronic database
* Able to provide informed consent

Exclusion Criteria:

* Being pregnant at study enrollment
* Planning on leaving the community where they currently reside in the next 12 months
* Enrolled in HIV care in the past 6 months at any clinic
* Initiated ART (for any duration) in the past 6 months at any clinic
* Currently on ART
* Does not speak or understand Portuguese or Xitswa/Matswa
C: Inclusion Criteria:

* HIV-infected
* Received pre- and post-test counseling at the GHESKIO Centers
* CD4 count between 200 and 350 cells/mm3
* World Health Organization (WHO) Stage I, II, or III HIV disease
* Willing to use acceptable forms of contraception

Exclusion Criteria:

* WHO Stage IV HIV disease (AIDS)
* 7 or more days of cumulative ART prior to study entry OR on ART at time of study entry
* Active TB, if diagnostic work-up for TB is incomplete OR if decision to treat TB has not been made. More information on this criterion can be found in the protocol.
* Recurrent active TB OR history of interrupted or incomplete TB therapy. More information on this criterion can be found in the protocol.
* Has not been evaluated for latent TB and decision to treat latent TB with isoniazid has not been made. More information on this criterion can be found in the protocol.
* Requires ART in the next 3 months, in the opinion of the investigator
* Other serious medical illness requiring chronic maintenance therapy (e.g., hypertension, diabetes) UNLESS the individual has completed at least 14 days of therapy prior to study enrollment AND is clinically stable
* Any psychological condition (e.g., severe depression, schizophrenia) that, in the opinion of the investigator, may interfere with the study
* Any social condition (e.g., pending emigration, pending incarceration) that, in the opinion of the investigator, may interfere with the study
* Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
* Current inflammation of the pancreas
* Allergy/sensitivity to any of study drugs or their formulations
* Requires certain medications
* Enrolled in another therapeutic or interventional clinical trial
* Pregnant or breastfeeding
D: Inclusion Criteria:

* Adult patients (\>18 years)
* Tested HIV-positive at study site's outpatient testing service or antenatal clinic on day of study enrollment or previously tested HIV-positive but making first visit to study site for HIV-related care or antenatal care for the current pregnancy
* Eligible for antiretroviral therapy under prevailing South African guidelines

Exclusion Criteria:

* Currently or previously on ART (three-drug combination; previous PMTCT regimen exposure for an earlier pregnancy is not an exclusion criterion)
* Stated intention to seek further HIV or antenatal care at another site, not at the study site
* Not physically or emotionally able to participate in the study, in the opinion of the investigators
* Not willing or able to provide written informed consent to participate in the study
* Previously screened for the same study

Answer: D