Please select the eligibility criteria that correspond to the clinical trial below.
Title: Saving Lives With Better Gestational Age Estimation: Improving the Accuracy of Recall and Reporting of the Date of Last Menstrual Period (LMP) in Rural Bangladesh
Brief Summary: Background (brief):

1. Burden: Bangladesh has a high maternal (194 per 100,000 live births) and newborn mortality (28 per 1000 live births). In 2010, prematurity represented \~14% of all births and directly and indirectly contributed to 45% of all neonatal deaths. Gestational age (GA) is a key determinant of newborn survival and long-term impairment. Accurate estimation of GA facilitates timely provision of essential interventions to improve maternal and newborn outcomes.
2. Knowledge gap: Last menstrual period (LMP) is a simple, low-cost self reported information, recommended by the World Health Organization for estimating gestational age but has issues of recall mainly among poorer, less educated women and women with irregular menstruation, undiagnosed abortion, and spotting during early pregnancy. Several studies have noted that about 20-50% of women cannot accurately recall the date of LMP.
3. Relevance: The goal of this study is to improve maternal and newborn outcomes by increasing the accuracy of gestational age estimation, using menstrual based dating, that is vital for providing timely and necessary obstetric and newborn care interventions. The study will determine the efficacy of three community based interventions using e-platform targeted to improve the recall and reporting of the date of last menstrual period in a rural resource poor setting. The innovative e-platform based interventions, if successful, can provide substantial evidence to scale-up in a low resource setting where e-Health and m-Health initiatives are proliferating with active support from all sectors in policy and implementation.

Hypothesis :

1. Implementation of conventional and e-platform based interventions will lead to a 30% improvement in recall of the date of the LMP in adolescent girls and married women in rural Bangladesh.
2. Intervention triggered improvement in LMP date recall among pregnant women in rural Bangladesh will improve the accuracy in GA estimation.

Objectives: The main objectives of the study are to:

1. Determine whether a set of conventional and e-platform based interventions improve recall of the date of the LMP in adolescent girls and married women in rural Bangladesh.
2. Determine whether intervention triggered improvement in LMP date recall in rural Bangladesh improves the accuracy in GA estimation or not

Methods: A 4- parallel arm, superiority, community based cluster randomized controlled trial comparing three conventional and e-platform based interventions is proposed to improve recall of GA with a control arm. The trial will be conducted among adolescent girls and recently married women (within past two years) with no children or a single child in Mirzapur sub-district of Bangladesh.The interventions include (i) education and calendar for recording date of LMP (ii) education and SMS based system for recording dates of LMP and reminders using mobile phone (normal) (iii) education and smart-phone based application for recording dates of LMP with an inbuilt reminder system.

Outcome measures/variables: The trial has two primary outcomes, (i) improvement in the recall of LMP date among enrolled participants in the three different intervention compared to control arm and (ii) increased accuracy of LMP-based gestational age measurement, as compared to USG, following the intervention.


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:

* Caregiver of infant aged 6-8 months at time of enrollment
* Self-reported resident of one of the study villages; where the definition of a resident is defined by caregiver
* Willing to sign informed consent for the study

Exclusion Criteria:

* Child of enrolled caregiver has already received one dose of measles vaccine, not including any supplemental measles vaccines
* Caregiver plans to move away in the next 6 months
C: Inclusion Criteria:

For Adolescent girls:

1. Permanent resident of the study area (Adolescents who are usual residents of the households and living or intend to live in the area for 6 or more months)
2. Aged between 15-17 years at the time of recruitment
3. Parent or legal guardian is present at the time of recruitment and is willing to give assent for the adolescent's participation

For Recently married women:

1. Permanent resident of the study area (Recently married women who are usual residents of the households living or intend to live in the area for 6 or more months)
2. Married within the past two years with no children or a single child

Exclusion Criteria:

For Adolescent girls:

1. Married at the time of recruitment
2. Parent or the legal guardian is mentally/physically unable to give assent

For Recently married women:

1. Pregnant or exclusively breastfeeding at the time of recruitment
D: Inclusion Criteria:

Mother-child (or caregiver-child) units with child \<2 years of age OR Pregnant women

Exclusion Criteria:

Family does not have cell-phone OR cannot provide informed consent

Answer: C