Here is the design of a clinical trial:

Official Title: IPrEP: A Combination HIV Prevention Strategy for Young Women at Risk for HIV in Kisumu, Kenya IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya

Included conditions:
- HIV

Study Armgroups:
- {'label': 'PrEP+', 'type': 'EXPERIMENTAL', 'description': 'PrEP+ is an experimental pre-exposure prophylaxis (PrEP)-focused prevention strategy providing daily oral tenofovir/emtricitabine (TDF/FTC) in combination with two adherence self-management interventions: (1) real-time feedback from point-of-care urine drug-level assay, (2) HIV self-testing and (3) 2-way text message reminders in addition to standard of care HIV risk-reduction counseling among male clients (MC) of female sex workers in Kisumu, Kenya.', 'interventionNames': ['Device: UrSure Rapid Urine Tenofovir Test', 'Device: OraQuick Rapid HIV Self-test kit', 'Drug: Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]', 'Behavioral: 2-way text message reminders', 'Behavioral: HIV risk-reduction counseling']}

Interventions:
- {'type': 'DEVICE', 'name': 'UrSure Rapid Urine Tenofovir Test', 'description': 'A point of care urine immunoassay to measure PrEP drug levels for adherence in participant urine samples over the preceding seven days will be done at all follow-up visits. At enrollment, study staff will explain the use of this experimental measurement of PrEP drug level in urine samples. Participants will receive results of the test at the same study visit during which it is performed.', 'armGroupLabels': ['PrEP+']}
- {'type': 'DEVICE', 'name': 'OraQuick Rapid HIV Self-test kit', 'description': 'Participants will be provided with HIV self-testing kits to use at their discretion and, in case of multi-month dispensing, prior to start of new bottle of PrEP medication, in between study visits. HIV self-testing kits will be provided to confirm their HIV-negative status and make a connection between PrEP use and protection against HIV. Participants will receive detailed, interactive training on HIVST with pictorial elements, including instructions to contact study staff immediately in event of a reactive test for confirmation as per Kenya guidelines.', 'armGroupLabels': ['PrEP+']}
- {'type': 'DRUG', 'name': 'Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]', 'description': 'Information will be provided regarding dosing of PrEP medications, importance of daily adherence, importance of frequent HIV testing, and signs and symptoms of drug toxicity, acute HIV infection and STIs. An initial one-month supply (30 pills) of FTC/TDF will be given to all PrEP study participants. At the one-month study assessment, a two-month supply of daily oral FTC/TDF will be given to each participant, after HIV testing, assessment for acute HIV infection and review of side effects and adherence, following national guidelines and procedures for PrEP services. At Month 3 assessment, a three-month supply of oral FTC/TDF will be given.', 'armGroupLabels': ['PrEP+']}
- {'type': 'BEHAVIORAL', 'name': '2-way text message reminders', 'description': 'All participants will receive weekly SMS visit reminders to support PrEP adherence. Participants will be asked at study enrollment for a primary contact telephone number and an alternate number for contact. Participants without cell phones will be provided an inexpensive cell phone (although cell phone ownership is very high in Kenya). Participants will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, use of HIV self-test kit, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is "Remember to look after yourself today, See you tomorrow." Participants will be requested to respond to the message with any questions, concerns or messages that they have for the study staff.', 'armGroupLabels': ['PrEP+']}
- {'type': 'BEHAVIORAL', 'name': 'HIV risk-reduction counseling', 'description': 'All study participants will be provided with brief interactive counseling at each study visit, tailored to the results of their urine assay.', 'armGroupLabels': ['PrEP+']}

Primary Outcomes:
- {'measure': 'PrEP adherence', 'description': 'Percentage of participants with plasma tenofovir concentration of \\>40 ng/mL (consistent with daily adherence)', 'timeFrame': '6-month visit'}

Please estimate the sample size based on the assumption: 
Design Effect of 2.40, significance level not explicitly stated, power not explicitly stated, assuming loss-to-follow-up of 10%.
Sample size justification
          The study sample size was determined to be 120 MCs based on feasibility concerns for conducting a convenience sample of this population. An estimate of the precision of the 95% CI of our primary outcome of 6-month adherence (described below) was obtained using the methodology applied by Cornfield and assuming a Design Effect of 2.40 A Design Effect is a simple number that estimates how much less efficient a non-random sample is compared with a simple random sample; a Design Effect of 2 implies that a non-random sample would need twice the number of individuals as a simple random sample to obtain the same-precision estimates .41
          With 120 participants enrolled, and treating those lost to follow-up as ânot adherentâ (as in the primary analysis), this sample size will result in a reasonably precise estimate of adherence at 6âmonths. For example, assuming 70% adherence at 6âmonths, our powered 95%âCI will be 58.4%â81.6%% (11.6% precision). Similarly, conducting a âcomplete caseâ analysis (as in the secondary analysis) restricted to those with complete outcome ascertainment and assuming loss-to-follow-up of 10%, our powered 95%âCI will be marginally wider at 57.8%â82.2% (12.2% precision).41 With 120 participants, our precision will be similar across a range of measured adherence proportions at 6 months (table 2).
          
            Table 2
            
              Width of 95%âCI for estimating adherence at 6 months, assuming a sample size of 120 and a design effect of 2
            
            
              
                
                  Proportion adherent at 6âmonths (%)
                  LCL (%)
                  UCL (%)
                  Precision(1/2 width of 95%âCI) (%)
                
              
              
                
                  30
                  18.4
                  41.6
                  11.6
                
                
                  40
                  27.6
                  52.4
                  12.4
                
                
                  50
                  37.3
                  62.7
                  12.7
                
                
                  60
                  47.6
                  72.4
                  12.4
                
                
                  70
                  58.4
                  81.6
                  11.6
                
                
                  80
                  69.9
                  90.1
                  10.1
                
                
                  90
                  82.4
                  97.6
                  7.6
                
              
            
            
              
                LCL, Lower Confidence Limit; UCL, Upper Confidence Limit.
              
            
          
          Quantitative data analysis will be conducted using SAS V.9.4 (Cary, North Carolina, USA). An overview of primary and secondary outcomes and their definitions follows.