Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Smoking Cessation Intervention During Pregnancy in Argentina and Uruguay
Brief Summary: Argentina and Uruguay are among the countries with the highest proportion of pregnant women who smoke. The implementation of an effective smoking cessation intervention would have a significant impact on the health of mothers and children. The "5 A's" (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide. However, it is under used in Argentina and Uruguay. We will conduct a two-arm, parallel cluster randomized controlled trial of an implementation intervention in 20 prenatal clinics in Argentina and Uruguay. Our primary hypothesis is that the intervention is feasible in prenatal clinics in Argentina and Uruguay and will increase the frequency of women receiving tobacco use cessation counseling during pregnancy. Our secondary hypothesis is that the intervention will decrease the frequency of women who smoke by the end of their pregnancies. Prenatal clinics will be randomly allocated to either an intervention or a control group after a baseline data collection period. Midwife facilitators in the ten intervention clinics will be identified and trained to deliver the "5 A's" to pregnant women and will then disseminate and implement the program. The ten clinics in the control group will continue with their standard in-service activities. A follow-up data collection will be conducted immediately after delivery. The intervention will be tailored by formative research to be readily applicable to local prenatal care services at busy maternity hospitals, as well as to be acceptable to local pregnant women and health providers. The study will be conducted in 48 months.


Options:
A: Arm Label: Implementation of intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Training in smoking cessation counseling | Arm Label: No implementation of the intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Training in smoking cessation counseling; Assigned to Arm(s): Implementation of intervention
B: Arm Label: 1 - CBT Counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Motivational interviewing for smoking cessation, Behavioral: Cognitive behaviors therapy | Arm Label: 2 - Counseling + NRT; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational interviewing for smoking cessation, Drug: CBT + NRT | Intervention Type: BEHAVIORAL; Name: Motivational interviewing for smoking cessation; Assigned to Arm(s): 1 - CBT Counseling, 2 - Counseling + NRT | Intervention Type: BEHAVIORAL; Name: Cognitive behaviors therapy; Assigned to Arm(s): 1 - CBT Counseling | Intervention Type: DRUG; Name: CBT + NRT; Assigned to Arm(s): 2 - Counseling + NRT
C: Intervention Type: BEHAVIORAL; Name: Smoking cessation counseling delivered by telephone; Assigned to Arm(s): N/A
D: Arm Label: Standard support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support | Arm Label: Proactive telephone support; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support | Arm Label: Standard support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Reactive (standard) telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Arm Label: Proactive support & offer NRT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Proactive telephone support, Drug: Offer of voucher for cost-free Nicotine Replacement Therapy | Intervention Type: BEHAVIORAL; Name: Proactive telephone support; Assigned to Arm(s): Proactive support & offer NRT, Proactive telephone support | Intervention Type: BEHAVIORAL; Name: Reactive (standard) telephone support; Assigned to Arm(s): Standard support, Standard support & offer NRT | Intervention Type: DRUG; Name: Offer of voucher for cost-free Nicotine Replacement Therapy; Assigned to Arm(s): Proactive support & offer NRT, Standard support & offer NRT

Answer: A