Please select the eligibility criteria that correspond to the clinical trial below.
Title: Mixed-Methods Approach to Evaluate a mHealth Intervention to Increase Adherence to Triage of HPV+ Women Who Have Performed Self-collection
Brief Summary: Background: Cervical cancer is one of the leading causes of cancer death among women worldwide, with more than 85% of cases occurring in low- and middle-income countries. Human papillomavirus (HPV) screening allows for self-collection with the potential to increase coverage, but still requires triage to identify which HPV+ women need diagnostic and treatment procedures. However, achieving high levels of triage adherence can be challenging, especially among socially vulnerable women. The ATICA protocol (Application of Communication and Information Technologies to Self-Collection, for its initials in Spanish), aimed at evaluating the implementation strategy and the effectiveness of a multi-component mobile health (mHealth) intervention to increase adherence to triage among women with HPV+ self-collected tests. Methods: Researchers will use an effectiveness-implementation hybrid type I trial with a mixed-methods evaluation approach. A cluster randomized trial design including 200 community health workers (CHWs) will evaluate whether the mHealth intervention increases adherence to triage among HPV+ women who self-collected at home during a CHW visit within 120 days after a positive result. The intervention includes an initial mobile phone text message (SMS) alert and subsequent reminders sent to HPV+ women. For those who do not adhere to triage within 60 days of a positive HPV test, an email and SMS will be sent to the CHWs to promote contact with these women during home visits. Reserchers will use the Consolidated Framework for Implementation Research (CFIR) as an organizing and analytic framework to evaluate the implementation of the intervention while also drawing on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM). Researchers will conduct a self-administered, semi-structured survey of CHWs, semi-structured interviews with local health authorities, and a survey of HPV+ women.


Options:
A: Inclusion Criteria:

In the Randomized Controlled Trial we will recruit a minimum of 4000 women, aged 30 and older living in the province of Jujuy, Argentina.

Inclusion criteria are:

1. Having performed self-collection of HPV-testing.
2. Mentally competent to understand the consent form.
3. Able to communicate with study staff.
4. Being able to provide a mobile phone telephone number.

Exclusion Criteria:

* Current pregnancy.
* Women with Mental disability.
B: Inclusion Criteria:

* Pregnant; at least 28 weeks gestation
* HIV negative
* Daily access to a mobile phone
* Planning to stay in area for 6 months postpartum
* Able to read/write or has trusted person to help

Exclusion Criteria:

* Does not meet above criteria
C: Inclusion Criteria:

* Pregnant women age 18 to 40 years
* Singleton birth (e.g. no twins or triplets)
* Prenatal intention to breastfeed
* Have a mobile phone capable of receiving SMS text messages and phone calls
* Know how to send a text message
* ≥4th grade literacy level

Exclusion Criteria:

* Non-fluent in English
* Known fetal anomaly
* Infant delivery \<37 weeks
* \>3 days in neonatal intensive care unit (NICU)
* Medical history: pre-pregnancy BMI \>50, history of thyroid disorders, failed one hour and three hour glucola test or if they ever needed oral hypoglycemic, hypertension (HTN) before/during pregnancy, postpartum hemorrhage
* Medically contraindicated for breastfeeding (provider's judgment)
* Women who will breastfeed but not from their own breast (e.g. buy breast milk on the Internet/milk bank)
* Women who are hesitant about answering a series of text messages regularly
* Women who are unable to be contacted by SMS text message or are unwilling to provide their contact number
* Women with neurologic, anatomic, or cognitive disorders that are unable to consent and/or answer text messages
D: Inclusion Criteria:

* Have a confirmed pregnancy,
* English speaking,
* 18-55 years of age,
* Are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation,
* Have a cellular phone that is capable of receiving text messages, and be willing to pay for any related fees for testing.
* Willing and able to commit to the visit schedule

Exclusion Criteria:

* Gestational age \> 35 weeks at quit date
* If subjects are in the pre-contemplative or contemplative stages of change or have already received 30 minute pharmacy education targeted for the quit date in this pregnancy.

Answer: A