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Regulatory Issues In Electronic Health Records For Adolescent Hiv Research: Strategies And Lessons Learned, Sara Ali Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y. Outlaw, Sylvie Naar Feb 2024

Regulatory Issues In Electronic Health Records For Adolescent Hiv Research: Strategies And Lessons Learned, Sara Ali Shaw Green, Sung-Jae Lee, Samantha Chahin, Meardith Pooler-Burgess, Monique Green-Jones, Sitaji Gurung, Angulique Y. Outlaw, Sylvie Naar

Publications and Research

Background: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.

Objective: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS …


Low Risk Of Attrition Among Adults On Antiretroviral Therapy In The Rwandan National Program: A Retrospective Cohort Analysis Of 6, 12, And 18 Month Outcomes, Harriet Nuwagaba-Biribonwoha, Aleksandra Jakubowski, Veronicah Mudisha, Paulin Basinga, Anita Asiimwe, Denis Nash, Batya Elul Aug 2014

Low Risk Of Attrition Among Adults On Antiretroviral Therapy In The Rwandan National Program: A Retrospective Cohort Analysis Of 6, 12, And 18 Month Outcomes, Harriet Nuwagaba-Biribonwoha, Aleksandra Jakubowski, Veronicah Mudisha, Paulin Basinga, Anita Asiimwe, Denis Nash, Batya Elul

Publications and Research

Background
We report levels and determinants of attrition in Rwanda, one of the few African countries with universal ART access.

Methods
We analyzed data abstracted from health facility records of a nationally representative sample of adults [≥18 years] who initiated ART 6, 12, and 18 months prior to data collection; and collected facility characteristics with a health facility assessment questionnaire. Weighted proportions and rates of attrition [loss to follow-up or death] were calculated, and patient- and health facility-level factors associated with attrition examined using Cox proportional hazard models.

Results
1678 adults initiated ART 6, 12 and 18 months prior to …