Please select the eligibility criteria that correspond to the clinical trial below.
Title: Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
Brief Summary: This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+. The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) . The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care. The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.


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:

* women who attend antenatal care clinic and have intention to deliver at the study hospital.
* Thai race
* participant or husband or relatives is an owner of mobile phone with social networking application

Exclusion Criteria:

* participant is known by other one in different study arm (contamination)
* cannot be assess on wel-being about privacy, delivery failure and misinterpretation of media via social network after complete study
C: Inclusion Criteria:

* HIV positive (diagnosed within the last 12 months prior to study/patient contact)
* Has access to a mobile phone
* Willing to receive and respond to text messages and calls from clinic and study staff (all arms)
* Willing to communicate and meet with PN (PN arm)
* Willing to meet with study staff for survey at study start, 6 months, and 12 months (all arms)
* regard study clinic area as the regular clinic for accessing healthcare

Exclusion Criteria:

* First tested positive over 12 months prior to recruitment
* Under the age of 18
* Unable to give informed consent
* Unable to read basic English and with no one to read study sms to participant
* Principally accesses care through a clinic not in the study
* Planning to permanently move away from the area served by the clinic within next 6 months (following enrollment)
D: Inclusion Criteria:

* Age 18 years or older,
* HIV-infected pregnant women and their HIV-exposed infants pairs,
* attends the antenatal care (ANC) clinic at one of the study sites.

Exclusion Criteria:

* Less than 18 years of age,
* HIV-infected women not currently pregnant,
* not HIV-infected at the time of the first ANC visit.

Answer: D