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CHARISMA Expansion Study

RTI International · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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hiv-preventionna
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA)-to reduce social harms (SHs) and intimate partner violence (IPV), increase healthy relationship dynamics and oral PrEP (pre-exposure prophylaxis) TDF/FTC (tenofovir disoproxil fumarate/emtricitabine), hereafter called PrEP, adherence among enrolled women. This study is an expansion of the CHARISMA intervention pilot study which was appended to the Microbicide Trials Network (MTN)-025 HOPE (HIV Open Label Prevention Extension) study. CHARISMA is defined by the use of a tool, called the CHARISMA HEAlthy Relationship Assessment Tool (HEART) used in combination with three counselling modules: * Module A: General Partner Communication and Relationship Skills * Module B: Partner Disclosure and Communication around PrEP Use * Module C: Responding to Intimate Partner Violence and Safety Planning
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