Here is the design of a clinical trial:

Official Title: Implementation of a Health Information Technology System for Young African American Women Into Community-Based Clinical Sites

Included conditions:
- Preconception Care

Study Armgroups:
- {'label': 'Healthy Start Program 1', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Community Health Center 1', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Healthy Start Program 2', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Community Health Center 2', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Healthy Start Program 3', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Community Health Center 3', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Healthy Start Program 4', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Community Health Center 4', 'description': 'Community Partner with Community Health Center or Federally Qualified Community Health Center designation and services a client population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Healthy Start Program 5', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}
- {'label': 'Healthy Start Program 6', 'description': 'Community Partner with HRSA-funded Healthy Start designation and services a patient population with over 50% identifying African American and/or Black', 'interventionNames': ['Other: Gabby implementation', 'Other: Evaluate the Gabby implementation']}

Interventions:
- {'type': 'OTHER', 'name': 'Gabby implementation', 'description': 'Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings', 'armGroupLabels': ['Community Health Center 1', 'Community Health Center 2', 'Community Health Center 3', 'Community Health Center 4', 'Healthy Start Program 1', 'Healthy Start Program 2', 'Healthy Start Program 3', 'Healthy Start Program 4', 'Healthy Start Program 5', 'Healthy Start Program 6']}
- {'type': 'OTHER', 'name': 'Evaluate the Gabby implementation', 'description': 'Assess implementation outcomes using the Proctor Implementation Outcomes Framework', 'armGroupLabels': ['Community Health Center 1', 'Community Health Center 2', 'Community Health Center 3', 'Community Health Center 4', 'Healthy Start Program 1', 'Healthy Start Program 2', 'Healthy Start Program 3', 'Healthy Start Program 4', 'Healthy Start Program 5', 'Healthy Start Program 6']}

Primary Outcomes:
- {'measure': 'Acceptability of Gabby system by staff', 'description': 'Information about the acceptability of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from acceptability related questions indicate greater acceptability.', 'timeFrame': '6 months'}
- {'measure': 'Feasibility of Gabby system by staff', 'description': 'Information about the feasibility of the Gabby system will be gleaned form qualitative and quantitative data. Virtual interviewers of key staff will be done informed by an interview guide to collect the qualitative data. The quantitative data will be assessed using an investigator developed 33-question Likert scale-based survey. Responses along the 5-point Likert scale will consist of Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), Strongly Agree (5). Higher score from feasibility related questions indicate greater feasibility.', 'timeFrame': '6 months'}

Please estimate the sample size based on the assumption: 
Paired two-sided tests, power of 0.80, significance level of 0.05, intra-class correlation coefficient (ICC) of 0.012, design effect of 1.3, and an anticipated 2/3 of end-users providing outcome data.
Sample size and power calculation
        To assess implementation based on usage and uptake, we will treat the sample size calculated for effectiveness as a convenience sample. Because usage and uptake are being analyzed descriptively with no baseline data and no over-time comparison, it is not appropriate to calculate power for these outcomes.
        To assess effectiveness based on per-end-user stage of change outcomes, our target sample size calculation is based on 12 available sites. Based on our previous RCT of 528 African American/Black women recruited nationally, [19] we expect to see an approximately 7.3% difference in the rate of risks behaviors achieving action or maintenance from 0 to 5.5âmonths, with a common error variance of approximately 28.7%. With paired two-sided tests, at a power of 0.80 and a significance level of 0.05, we would require at least 125 subjects to detect an effect of at least this magnitude. Because end-users are nested within sites, we also must account for within-site clustering. Based on published intra-class correlation coefficient (ICC) data from 61 clinical practices in 8 practice based research networks on risks such as smoking, diet, and exercise, we anticipate an ICC of 0.012 and a design effect of 1.3 [33]. Based on this design effect, we require at least 160 end-users, or 13 end-users per site. If we anticipate only about 2/3 of end-users to provide outcome data (consistent with our previous study), then we must enroll approximately 240 users, or 20 end-users per site, to detect a change in our outcome from 0 to 5.5âmonths.