Here is the design of a clinical trial:

Official Title: Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti

Included conditions:
- HIV

Study Armgroups:
- {'label': 'Standard-of-care', 'type': 'NO_INTERVENTION', 'description': 'Participants in the standard-of-care arm will receive a standard laboratory-based viral load test at baseline, 3, and 6 months.'}
- {'label': 'Point-of-care', 'type': 'EXPERIMENTAL', 'description': 'Participants in the point-of-care arm will receive a point-of-care viral load test at baseline, 3, and 6 months.', 'interventionNames': ['Diagnostic Test: point-of-care viral load test']}

Interventions:
- {'type': 'DIAGNOSTIC_TEST', 'name': 'point-of-care viral load test', 'description': 'A point-of-care viral load test returns viral load test results within 90 minutes.', 'armGroupLabels': ['Point-of-care']}

Primary Outcomes:
- {'measure': 'The number of steps in the HIV care cascade involved with viral load testing.', 'description': 'The number of steps within the HIV care cascade involved with viral load testing will be measured comparing standard laboratory-based testing to POC testing.', 'timeFrame': '1 day of clinic visit'}

Please estimate the sample size based on the assumption: 
Two-tailed tests, significance level at 5%, power of 80%, and 85% follow-up rate.
Sample size and power calculations
        We calculated the required sample size to address the primary outcome of the study: the proportion of adolescents who receive a VL result within 6 weeks of the month 1 VL test. We calculated the sample size based on a retrospective review of VL results available in the EMR and interviews with providers at GHESKIO and hypothesise the primary outcome will be common. Between July 2016 and December 2016, we observed that 50% of participantsâ VL results were entered into the EMR within 6 weeks of sample collection and confirmed this with providers in the clinic. The method we have chosen for calculation of the sample size is a simple comparison of proportions. We assume two-tailed tests, set a significance level at 5% and power of 80%. For the primary outcome, with a sample size of 124 (62 per arm) we will have 80% power to detect a 20% increase (on the additive scale) in the proportion of patients who receive their VL result within 6 weeks of the month 1 VL test (ie, 70% in the SOC arm vs 90% in the POC arm).
        We also calculated the required sample size to address a secondary outcome of the study: the proportion of adolescents who achieve a VL <1000 copies/ÂµL at 6 months. We anticipate that the secondary outcome will be slightly less common. A cross-sectional retrospective analysis of VL results among adolescents aged 10â24 who had been on ART â¥6 months at the GHESKIO adolescent HIV clinic in 2016 showed 40% were virally suppressed. For the secondary outcome, with the same sample size of 124 (62 per arm), we will have 80% power to detect a 25% increase in the proportion of participants who are virally suppressed at 6 months from the index VL test (ie, 40% in the SOC arm vs 65% in the POC arm). Assuming we will achieve 85% follow-up in both arms, we are enroling a total sample size of 150 (75 per arm).