Here is the design of a clinical trial:

Official Title: Project Someleze: A Randomized Trial of ImpACT+, a Coping Intervention to Improve Clinical and Mental Health Outcomes Among HIV-infected Women With Sexual Trauma in South Africa

Included conditions:
- HIV
- Trauma Exposure

Study Armgroups:
- {'label': 'Improving AIDS Care after Trauma+', 'type': 'EXPERIMENTAL', 'description': 'ImpACT+ (Improving AIDS Care after Trauma+), is an individual-level coping intervention to address traumatic stress and HIV care engagement among South African women with sexual trauma histories. The ImpACT+ individual sessions will focus on coping skills and care engagement during an early critical period, while maintenance check-ins will serve to reinforce positive change and support the ongoing implementation of skills as new challenges arise.', 'interventionNames': ['Behavioral: Improving AIDS Care After Trauma +']}
- {'label': 'Adapted Problem-Solving Therapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Participants randomly assigned to the control condition will receive a brief adapted version of problem-solving therapy (PST), based on Problem Management Plus, a component of the World Health Organization (WHO) Mental Health Gap Action Programme (mhGAP). PST is a psychoeducational treatment focused on managing the negative effects of stressful life events. PST has been found to be effective for a range of problems, such as depression, and is recommended for implementation in low-resource settings.', 'interventionNames': ['Behavioral: Adapted Problem-Solving Therapy']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Improving AIDS Care After Trauma +', 'description': 'ImpACT+ integrates skills for HIV treatment adherence and coping with trauma, tailored to the South African context. This includes exploration of values informing care engagement, recognizing the synergistic stress of sexual trauma and HIV, understanding the contribution of stressors to maladaptive coping, and developing adaptive methods for coping as alternatives to avoidance. ImpACT+ will be delivered in private spaces at the primary care clinic and will consist of 6 individual sessions followed by 6 maintenance check-ins. Individual sessions focus on coping, adherence, and care engagement during an early critical period, while maintenance check-ins reinforce positive change and support ongoing implementation of skills. Evidence supports a 6-session format in low-resource settings. Individual sessions will begin within 2 weeks after the baseline survey and be completed by the 4-month assessment. Maintenance check-ins will begin following the 4-month assessment.', 'armGroupLabels': ['Improving AIDS Care after Trauma+']}
- {'type': 'BEHAVIORAL', 'name': 'Adapted Problem-Solving Therapy', 'description': 'Participants will receive three weekly individual sessions of adapted PST. The goal of PST is to identify problems that interfere with daily activities and address them through problem-orientation work. We anticipate stressors will include (a) relationship difficulties, including family stress, (b) financial stress and unemployment, (c) general impact of HIV infection, and (d) overall chronic stress. Thus, PST may indirectly address stressors that may impact care engagement, but will not address the intersection of HIV and trauma specifically.', 'armGroupLabels': ['Adapted Problem-Solving Therapy']}

Primary Outcomes:
- {'measure': 'Viral suppression/viral load', 'description': 'HIV-1 RNA viral load (COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0, Roche). Viral suppression defined as \\<50 copies/ml. Continuous measures of viral load, modeled using a log10 transformation.', 'timeFrame': 'Up to 12 months'}

Please estimate the sample size based on the assumption: 
80% power, two-tailed alpha level of 0.05, 80% retention rate
Sample size {14}
          Our enrollment target is 350, which will allow detection of intervention effects on viral suppression at 12-month follow-up. Based on data from our preliminary studies [66] and corroborated by national estimates [32], we expect that 57% of women who are newly initiating ART and randomized to the PST condition will be virally suppressed at the 12-month follow-up. With 350 women randomized equally to both conditions, we will have 80% power with a two-tailed alpha level of 0.05 to detect differences between a proportion of 57% in the PST condition and 73% in the ImpACTâ+âcondition. This power calculation assumes we will retain 80% of participants over the study period. In the pilot, we were able to successfully retain 80% of all participants (83.3% of newly initiating participants) for the duration of the study [45].