Please select the eligibility criteria that correspond to the clinical trial below.
Title: Reducing Alcohol Exposed Pregnancy Risk
Brief Summary: The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.


Options:
A: Primary study participants for intervention evaluation are rural young men (n=1500) and their wives (n=1500). Inclusion and exclusion criteria for these men are as follows:

INCLUSION CRITERIA

* Age 18-30 years and Fluent in Marathi
* Willing to Have Wife Included in the Study
* Residing in the village for the past 2 years and residing with wife in village for past 3 months

EXCLUSION CRITERIA

* Sterile or Wife is Sterile
* Cognitive Impairment (husband or wife)
* Intend to move in next 18 months
B: Inclusion criteria:

* Sexually active females 16 to 24 years of age who present to a University of Texas Medical Branch (UTMB) clinic and request to initiate oral contraception for birth control.

Exclusion criteria:

* Women who are currently pregnant or breastfeeding.
* Women who wish to become pregnant within the next 12 months.
* Women who have a medical contraindication to use of estrogen (e.g., thromboembolic disease, acute liver disease, breast cancer, genital cancer, or undiagnosed genital bleeding).
* Women wishing to initiate use of a contraceptive method that is not oral, such as transdermal (the patch) or injectable (DMPA) methods, or the vaginal ring.
* Current and previous users of oral contraceptives.
C: Inclusion Criteria:

* ages 18-44
* fertile
* can provide informed consent
* had vaginal intercourse with a man in the past 3 months
* uses ineffective or no contraception
* speaks and reads English
* reports drinking more than seven standard drinks per week on average or more than one binge drinking episode (more than 3 standard drinks on one occasion) during the past 3 months
* if opioid dependent with recent use, is enrolled in opiate agonist treatment
* planning to remain available for the follow-up period

Exclusion Criteria:

* pregnancy
* cognitive disorders including mental retardation, dementia, or active -psychosis that could impair ability to understand the intervention material or give informed consent
* current Major Depressive Disorder that could diminish responsiveness to interventions focused on promoting change
* currently opioid dependent with active use and not engaged in opiate agonist treatment
* concurrently participating in another behavioral intervention study during the study period targeting drinking or contraception efficacy that could interfere with or augment the intervention in the EARLY project.
D: Inclusion Criteria:

* Mexican American,
* 14 - 45 years old,
* English Speaking,
* non-viral sexually transmitted infection

Exclusion Criteria:

* Non-English speaking,
* viral sexually transmitted infection

Answer: C