Implementing post-trial access plans for HIV prevention research

Journal of Medical Ethics
Amy PaulJeremy Sugarman

Abstract

Ethics guidance increasingly recognises that researchers and sponsors have obligations to consider provisions for post-trial access (PTA) to interventions that are found to be beneficial in research. Yet, there is little information regarding whether and how such plans can actually be implemented. Understanding practical experiences of developing and implementing these plans is critical to both optimising their implementation and informing conceptual work related to PTA. This viewpoint is informed by experiences with developing and implementing PTA plans for six large-scale multicentre HIV prevention trials supported by the HIV Prevention Trials Network. These experiences suggest that planning and implementing PTA often involve challenges of planning under uncertainty and confronting practical barriers to accessing healthcare systems. Even in relatively favourable circumstances where a tested intervention medication is approved and available in the local healthcare system, system-level barriers can threaten the viability of PTA plans. The aggregate experience across these HIV prevention trials suggests that simply referring participants to local healthcare systems for PTA will not necessarily result in continued access to benef...Continue Reading

References

Jul 18, 2009·American Journal of Public Health·Seema ShahChristine Grady
Nov 30, 2010·Journal of Medical Ethics·Stuart Rennie, Jeremy Sugarman
Aug 24, 2012·Journal of Medical Ethics·Sonia M Dainesi, Moises Goldbaum
Oct 16, 2013·Clinical Trials : Journal of the Society for Clinical Trials·Jeremy SugarmanDavid Metzger
Feb 28, 2014·Journal of Empirical Research on Human Research Ethics : JERHRE·Catherine M Slack
Jul 22, 2015·Developing World Bioethics·Bridget Haire, Christopher Jordens
Sep 24, 2015·Journal of Medical Ethics·Kathryn Therese MngadiLeila Mansoor
Jan 21, 2016·Health Care for Women International·Eleanor Krassen Covan
Dec 7, 2016·JAMA : the Journal of the American Medical Association·Johannes J M van Delden, Rieke van der Graaf

❮ Previous
Next ❯

Citations

Aug 31, 2018·International Journal of STD & AIDS·Isdora OderoDeborah A Gust
Mar 5, 2020·Journal of Bioethical Inquiry·Jessica PaceWendy Lipworth
May 15, 2020·Journal of the International AIDS Society·Brandon J Brown, Jeremy Sugarman

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.