Please select the eligibility criteria that correspond to the clinical trial below.
Title: CCTG 595: A Multicenter, Randomized Study of Text Messaging to Improve Adherence to PrEP in Risky MSM
Brief Summary: CCTG 595 is a controlled, open-label, two-arm, randomized (1:1) clinical demonstration project to determine if the use of a text-message based adherence intervention (iTAB) improves retention and adherence to PrEP compared to standard of care (SoC) PrEP delivery.


Options:
A: Inclusion Criteria:

* HIV+ women starting ART
* Willing to be contacted by mobile phone
* Speaks English or Hindi or Kannada
* Screens positive for depressive symptoms or psychosocial risk factors
* Able to provide informed consent

Exclusion Criteria:

* Unable to participate in study visits
* Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate
B: Inclusion Criteria:

* Man or transgender M to F who has sex with men.
* Age 18 years or older.
* Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following:

  * Has at least one HIV infected sexual partner for ≥4 weeks.
  * No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last 3 months.
  * No condom use during anal sex with ≥1 male partner and STI diagnosis during the last 3 months.
* Negative for HIV infection by rapid HIV test and confirmed negative by NAT or other sensitive method such as antibody- antigen test.
* Acceptable laboratory values in the past 30 days:

  * Calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula (eCcr (male) in mL/min = \[(140 - age in years) x (lean body weight in kg)\] / (72 x serum creatinine in mg/dL)
  * Alanine aminotransferase (ALT) and/ or aspartate aminotransferase (AST) \< 3 x upper limit of normal (ULN)
  * Hemoglobin \> 9 g/dL
  * Absolute neutrophil count \> 750/ mm3
  * Platelets \> 75,000/ mm3

Exclusion Criteria:

* Unable to give informed consent.
* Active hepatitis B (positive hepatitis B surface antigen (HBSAg) or HBSAg negative/ HB core antibody positive/ HBV PCR positive).
* Has substantial medical condition, that in the opinion of the investigator would preclude participation, as defined by

  * cardiovascular condition that may lead to an increased risk of complication if placed on study drugs.
  * gastrointestinal condition that would impair absorption of study drugs.
  * neurological or psychiatric condition that would significantly impair the ability to adhere to PrEP.
  * calculated GFR \< 60 mL/min.
  * alcohol or drug abuse or dependence that would significantly impair the ability to adhere to PrEP (only for those with severe impairment).
  * other medical condition that would unacceptably increase the risk of harm from study drug or significantly impair the ability to adhere to PrEP.
* Suspected sensitivity or allergy to the study drug or any of its components.
* Currently using an essential product or medication that interacts with the study drug such as the following:

  * ART (including nucleoside analogs, non-nucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents)
  * Agents with known nephrotoxic potential:

    * aminoglycoside antibiotics (including gentamicin)
    * IV amphotericin B
    * cidofovir
    * cisplatin
    * foscarnet
    * IV pentamidine
    * IV vancomycin
    * oral or IV gancyclovir
    * other agents with significant nephrotoxic potential
  * Drugs that slow renal excretion

    * Probenecid
  * Immune system modulators

    * Systemic chemotherapeutic agents (i.e. cancer treatment medications)
    * Ongoing systemic corticosteroids (with the exception of short courses of tapering steroid doses for asthma or other self- limited condition).
    * Interleukin-2 (IL-2)
    * Interferon (alpha, beta, or gamma)
  * Other agent known to have a significant interaction with TDF or FTC
  * Proteinuria 2+ or greater by urine dipstick
  * Signs or symptoms suggestive of acute HIV infection
  * Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
C: Inclusion Criteria:

* Aged 18-24 years
* Own a personal mobile phone
* Not using the pill, implant, injection, intrauterine device or patch
* Live in the West Bank

Exclusion Criteria:

* Cannot read Arabic
D: Inclusion Criteria (for treated and control subjects):

* female
* aged 14-24
* secondary school student at day school

Exclusion Criteria (for treated and control subjects):

* male
* secondary school student at boarding school

Inclusion criteria (for spillover subjects):

* aged 14-24
* secondary school student at day school

Exclusion Criteria (for spillover subjects):

- secondary school student at boarding school

Answer: B