Please select the eligibility criteria that correspond to the clinical trial below.
Title: Do Smartphones Increase Linkage to and Retention in Care in Newly Diagnosed HIV-positive Patients in Johannesburg, South Africa: A Multisite Randomised Controlled Trial
Brief Summary: This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.


Options:
A: 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.
B: Inclusion Criteria:

* Received menstrual regulation services using Manual Vacuum Aspiration (MVA) or Medical Abortion (MA)
* Have a personal mobile telephone
* Agree to receive messages on mobile about family planning
* Provide informed consent for participation

Exclusion Criteria:

* Received anaesthesia for their MVA procedure
* Intend to become pregnant within the next six months
* Intend to use, or for partner to use, a permanent method of contraception (i.e. sterilisation) within the next six months
C: Inclusion Criteria:

* Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
* Access to an Android smartphone with data
* Willing to pay the (very small) cost to access their laboratory result
* Age - 18 years and older
* Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
* Can read English or Zulu
* Ability and willingness to sign informed consent

Exclusion Criteria:

* Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
* Refusal to participate
D: Inclusion Criteria:

All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have

* agreed to participate in the study
* indicated their mobile phone number
* sufficient knowledge of German language.

If one partner is refusing to participate, the other person may be admitted as an individual.

Exclusion Criteria:

* denial of participation
* non-existent smartphone
* insufficient knowledge of German language

Answer: C