Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2019 Mar;22(3):e25260.
doi: 10.1002/jia2.25260.

Going off antiretroviral treatment in a closely monitored HIV "cure" trial: longitudinal assessments of acutely diagnosed trial participants and decliners

Gail E Henderson  1 , Margaret Waltz  1 , Karen Meagher  2 , R Jean Cadigan  1 , Thidarat Jupimai  3 , Sinéad Isaacson  1 , Nuchanart Q Ormsby  1 , Donn J Colby  4 , Eugène Kroon  4 , Nittaya Phanuphak  4 , Jintanat Ananworanich  4   5   6 , Holly L Peay  7
Affiliations
Clinical Trial

Going off antiretroviral treatment in a closely monitored HIV "cure" trial: longitudinal assessments of acutely diagnosed trial participants and decliners

Gail E Henderson et al. J Int AIDS Soc. 2019 Mar.

Abstract

Introduction: The South East Asia Research Collaboration in HIV (SEARCH) RV411 clinical trial in Thailand was a systematic investigation of analytic treatment interruption (ATI) in individuals diagnosed and treated since Fiebig stage I acute HIV infection. Here, we explore decision-making processes and perceptions of trial participation in a phase I trial that raised important ethical considerations, to identify potential areas of improvement in this relatively new field of HIV research. Similar considerations apply to other HIV phase I trials, especially those involving ATI, making this trial a model to identify challenges and opportunities in promoting informed choice.

Methods: Using longitudinal semi-structured interviews and a validated questionnaire, we examined how decisions to join or decline the trial were made, whether there was evidence of decisional conflict, and reactions to the trial outcomes. We also explored contrasting views and experiences in this small trial cohort. We report analyses of data from these questionnaires and interviews, conducted from February through December of 2016 with the 14 SEARCH cohort participants who either joined (n = 8) or declined (n = 6) participation in RV411.

Results: The eight participants and six decliners had low overall decisional conflict, which remained low over time. Decision making was more difficult for decliners than participants, at least initially. While all interviewees described being satisfied with their decisions, our study identified important negative consequences for a few individuals, including seroconversion, negative experiences with optional procedures and disappointment due to rapid viral rebound.

Conclusions: Although our results reflect the experiences of a small group invited to join this trial, our overall finding of low decisional conflict even while some individuals reported negative experiences provides lessons for clinical trial investigators. We developed points-to-consider in helping participants make informed choices, to support participants during the trial and to support decliners in their decisions.

Keywords: HIV clinical trials; analytic treatment interruption; informed consent; phase I clinical trials; qualitative research; research ethics.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Decisional conflict scores for participants and decliners.
See this image and copyright information in PMC

References

    1. De Souza MS, Phanuphak N, Pinyakorn S, Trichavaroj R, Pattanachaiwit S, Chomchey N, et al. Impact of nucleic acid testing relative to antigen/antibody combination immunoassay on the detection of acute HIV infection. AIDS. 2015;29(7):793–800. - PubMed
    1. Peay HL, Henderson GE. What motivates participation in HIV cure trials? A call for real‐time assessment to improve informed consent. J Virus Erad. 2015;1(1):51. - PMC - PubMed
    1. Henderson GE, Peay HL, Kroon E, Cadigan RJ, Meagher K, Jupimai T, et al. Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment. J Med Ethics. 2018;44:270–6. - PMC - PubMed
    1. Colby DJ, Trautmann L, Pinyakorn S, Leyre L, Pagliuzza A, Kroon E, et al. Rapid HIV RNA rebound after antiretroviral treatment interruption in persons durably suppressed in Fiebig I acute HIV infection. Nat Med. 2018;24(7):923–6. - PMC - PubMed
    1. Fiebig EW, Wright DJ, Rawal BD, Garrett PE, Schumacher RT, Peddada L, et al. Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS. 2003;17(13):1871–9. - PubMed

Publication types

Substances