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<p>HIV remission (or cure) clinical trials require potential participants to understand trial-related risks, approaches to minimize risks, potential benefits, procedures, and participation alternatives to make an informed decision. Decision aids (DAs) support preference-sensitive decisions. We report on the development and evaluation of a DA called Decision Partner, designed to support informed consent. We used an iterative, mixed-methods approach to develop and test Decision Partner. We conducted research and engagement activities among people living with HIV (PLWHIV), advocates, researchers, trialists, and clinicians which resulted in a product reflective of information required for informed choice. Among 20 PLWHIV, 90% rated that Decision Partner would be useful for decision-making. Decision conflict significantly decreased after using Decision Partner (37.3 to 16.8, <i>p</i> =.007) and knowledge significantly increased from pre to-post(<i>z</i> = -3.11, <i>p</i> &lt;.01). Our findings indicated that Decision Partner holds promise to augment the informed consent process, in HIV remission trials.</p>

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Development and Evaluation of Decision Partner: A Decision Aid for HIV Remission Clinical Trial Participation

  • 期刊论文

  • 发表日期：

    2025年6月10日

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  • Rebecca R. Moultrie,
  • Gail Henderson,
  • Sarah Nelson Potter,
  • Emily Cheves,
  • Kristine J. Kuczynski,
  • Dean Jackman,
  • Stuart Rennie,
  • Cynthia Gay,
  • Chelsea Gieck,
  • Yujiemi Chisholm,
  • Holly L. Peay

摘要

HIV remission (or cure) clinical trials require potential participants to understand trial-related risks, approaches to minimize risks, potential benefits, procedures, and participation alternatives to make an informed decision. Decision aids (DAs) support preference-sensitive decisions. We report on the development and evaluation of a DA called Decision Partner, designed to support informed consent. We used an iterative, mixed-methods approach to develop and test Decision Partner. We conducted research and engagement activities among people living with HIV (PLWHIV), advocates, researchers, trialists, and clinicians which resulted in a product reflective of information required for informed choice. Among 20 PLWHIV, 90% rated that Decision Partner would be useful for decision-making. Decision conflict significantly decreased after using Decision Partner (37.3 to 16.8, p =.007) and knowledge significantly increased from pre to-post(z = -3.11, p <.01). Our findings indicated that Decision Partner holds promise to augment the informed consent process, in HIV remission trials.