Moving to Another World: Understanding the Impact of Clinical Trial Closure on Research Participants Living With HIV in Uganda

J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e96-e108. doi: 10.1097/JNC.0000000000000057.

Abstract

Despite an increasing need for clinical trials involving people living with HIV (PLWH), little is known about how PLWH experience trial closure, particularly in low-income countries, where the majority of trials take place. We sought to explore the impact of trial closure on PLWH in Uganda. This was an interpretive, grounded theory study using in-depth interviews, conducted between October 2014 and August 2015. Adult participants (N = 23) from 3 trials were included. The findings indicated that trial closure was represented as "moving to another world" and was an emotional transition, linked to a loss of quality care in the research environment, the need to find alternative health facilities, fear of experiencing unwanted side effects, a desire to receive trial feedback, and difficulties linking to posttrial care. We concluded that PLWH leaving trials in a resource-limited setting required holistic care to facilitate their transition back to "usual care."

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Clinical Trials as Topic*
  • Continuity of Patient Care*
  • Female
  • HIV Infections / drug therapy
  • HIV Infections / psychology*
  • Humans
  • Interviews as Topic
  • Male
  • Qualitative Research
  • Research Subjects / psychology*
  • Uganda