Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Provider Workload While Preserving Patient Safety: A 2-Way Texting Intervention in Zimbabwe's Voluntary Medical Male Circumcision Program
Brief Summary: Voluntary medical male circumcision (VMMC) in sub-Saharan Africa is safe: the average rate of moderate and severe adverse events (AEs) at the country level is 0.8%, corresponding to 99% of men healing without incident. To reach the global target of 20 million by 2018, VMMC productivity needs to double in countries already plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care (MoHCC) and performed over 120,000 VMMCs. Current VMMC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. Over 95% adhere to multiple follow-up visits within 14 days of VMMC. ZAZIC's program has an overall AE rate of 0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews for VMMC clients without complications. High mobile phone ownership, severe healthcare worker shortages, and rapid VMMC scale up make ZAZIC's VMMC program an ideal setting to test a mobile health (mHealth) intervention to reduce provider workload while safeguarding patient safety. Through an un-blinded, prospective, randomized, control trial (RCT) in high-volume facilities providing VMMC, ZAZIC will implement an interactive, two-way texting (2wT) intervention to identify men healing without complication, allowing them to decline routine in-person follow up visits. 2wT will simultaneously identify men with any sign of an adverse event, encouraging rapid in-person follow-up when an AE is suspected on any day, reducing unnecessary visits while maintaining quality care. We aim to 1) determine if 2wT can safely reduce VMMC follow-up visits; 2) estimate the cost savings associated with 2wT over routine VMMC follow-up; and 3) assess the acceptability and feasibility of 2wT for further scale-up. It is expected that this intervention with be as safe as routine care while providing distinct advantages in terms of efficiency, costs, and reduced healthcare worker burden. This approach is innovative as it focuses on using a low-cost mHealth intervention to reduce provider workload without deterioration in quality care. The success of this intervention could lead to adoption of this intervention at the national level, increasing efficiency of VMMC scale up and reducing burdens on providers and patients


Options:
A: contraceptive continuation (6 months)
B: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (4-months post-encouragement)
C: Average number of missed pills per cycle (3 months)
D: Cumulative adverse event (AE) rate (moderate or severe) (≤ Day 14 for each participant with analysis completed in year 1.); Mean number of in-person visits (Before 42 day visit for each participant with analysis completed in year 1.); 2wT costs (The costing data collection will be completed by April 2018 at the completion of all study participant follow-up. Analysis will conclude in year 1); 2WT acceptability (The acceptability activities will be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.); 2WT feasibility (The feasibility activities be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.)

Answer: D