Quality of life is used increasingly as a primary and secondary endpoint of clinical investigations of new therapies. Quality of life information may be especially useful for the assessment of cancer treatments, where increases in survival may be accompanied by detrimental side effects. The recognition of the importance of quality of life has led to the recent proliferation of cancer specific quality of life instruments. As more is understood about the heterogeneity of patient populations, however, we must assess how culturally defined factors may impact patient quality of life and its assessment. Quality of life instruments are diverse, ranging from those focusing on objective measures of functionality to those assessing subjective measures of patient preferences for their current health state. These instruments have been developed for use in the general population and for disease-specific populations. Assessment of the appropriateness of potential quality of life instruments in specific clinical settings, in addition to understanding the cultural diversity of the clinical population being studied, will guide the researcher in the choice of an appropriate quality of life instrument for cancer clinical trials.
BackgroundYoung men who have sex with men are disproportionately impacted by the HIV epidemic in the United States. Few rigorously tested HIV prevention interventions have been developed for young men who have sex with men; previous interventions have primarily focused on in-person programming, with high variability in fidelity. With nearly all young men who have sex with men going online daily, eHealth approaches to prevention may successfully bridge research and practice. Keep It Up! is an eHealth HIV Prevention program for young men who have sex with men. Previous research has demonstrated its effectiveness in reducing sexually transmitted infections and condomless anal sex and efficiency in delivering HIV prevention education. Aim 1 is to compare two strategies for implementing KIU—implementation in community-based organizations and a centralized direct-to-consumer recruitment arm. Aim 2 is to examine adoption characteristics which explain variability in implementation success. Our exploratory aim will develop recommendations and materials for sustainment of KIU after completion of the trial.MethodsThis is a Type III Hybrid Effectiveness-Implementation cluster randomized trial. Using estimates of young men who have sex with men per county in the United States, we identified 113 counties for our sample frame. Using an iterative process, we selected 66 counties to randomize 2:1 to our two strategies in Aim 1. The RE-AIM model for implementation science will be used to drive our outcome measurements in reach, effectiveness, implementation variability, and cost. Outcome measures will be collected from community-based organization staff participants, young men who have sex with men participants, and the technology provider. Our second aim will use mixed-methods research mapped onto the domains of the consolidated framework for implementation research. DiscussionThe trial has launched and is ongoing. This study is among the first to use a cluster randomized trial design in HIV implementation science. In comparing the community-based organization and direct to consumer models for recruitment and ongoing participant engagement, we are examining two strategies which have shown effectiveness in delivering health and technology interventions in the past, but with little base knowledge on their comparative advantages and disadvantages in implementation. The results of the trial will further understanding of the implementation of eHealth prevention interventions.Trial RegistrationNCT03896776, clinicaltrials.gov, 1 April 2019
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