Establishing a continuum of care between HIV prevention trials and public healthcare systems: The MIRA Standard of Care program

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 beneficial interventions for trial participants. Serious commitments to PTA will require additional efforts to learn from future approaches, measuring the success of PTA plans with dedicated follow-up and further developing normative guidance to help research stakeholders navigate the complex practical challenges of realising PTA.

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Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

Trials ◽

10.1186/s13063-021-05754-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Maurine D. Miner ◽

Linda-Gail Bekker ◽

Tamara Kredo ◽

Niresh Bhagwandin ◽

Lawrence Corey ◽

...

Keyword(s):

Clinical Trials ◽

Hiv Prevention ◽

South African ◽

Medical Research Council ◽

Standard Of Care ◽

Hiv Vaccine ◽

Middle Income ◽

Hiv Vaccine Trials ◽

Vaccine Trials ◽

Prevention Trials

AbstractA cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.

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Standard of care for social harms in HIV prevention trials: A South African perspective

Developing World Bioethics ◽

10.1111/dewb.12255 ◽

2019 ◽

Vol 20 (4) ◽

pp. 194-199

Author(s):

Takshita Sookan ◽

Ganzamungu Zihindula ◽

Douglas Wassenaar

Keyword(s):

Hiv Prevention ◽

South African ◽

Standard Of Care ◽

African Perspective ◽

Prevention Trials

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Choosing Appropriate Interventions and Defining Locally Achievable Standard of Care for HIV Prevention Trials in Africa: A Multidisciplinary Approach

AIDS Research and Human Retroviruses ◽

10.1089/aid.2014.5205.abstract ◽

2014 ◽

Vol 30 (S1) ◽

pp. A108-A109

Author(s):

Susan Allen ◽

William Kilembe ◽

Mubiana Inambao ◽

Bellington Vwalika ◽

Shabir Lakhi ◽

...

Keyword(s):

Hiv Prevention ◽

Multidisciplinary Approach ◽

Standard Of Care ◽

Prevention Trials

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Meeting Report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

10.14293/111.000/000010.v1 ◽

2020 ◽

Author(s):

Maurine Miner ◽

Linda-Gail Bekker ◽

Tamara Kredo ◽

Niresh Bhagwandin ◽

Lawrence Corey ◽

...

Keyword(s):

Hiv Prevention ◽

Medical Research ◽

South African ◽

Medical Research Council ◽

Standard Of Care ◽

Hiv Vaccine ◽

Hiv Vaccine Trials ◽

Treatment And Prevention ◽

Vaccine Trials ◽

Prevention Trials

Introduction: The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to standard of care (SoC) in HIV prevention clinical trials, both for treatment and prevention of disease. Policymakers, regulators, ethicists, experts in the law (as it pertains to medical research), researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. Discussion: Summit participants discussed how and when to include new modalities of HIV treatment and prevention into existing clinical practice guidelines, and by extension in clinical trial protocols. Participants involved in the execution of care and the scale-up of new interventions, in particular, the roll out of pre-exposure prophylaxis (PrEP), presented the opportunities for and challenges to scaling up interventions, and their experience with demonstration projects of PrEP. Advocates and community members propagated the need to make interventions that could avert HIV infection available as soon as possible. Experts in evidence-based guideline development discussed the nuances in evaluating evidence for policy and the mechanisms for getting medicines on the Essential Medicines List in South Africa. Given the variability in clinical trial efficacy of PrEP amongst different populations, scientists and statisticians discussed the various biological, virological and immunological reasons for this heterogeneity. Conclusions: Input was given as to the impact of introducing PrEP in other HIV prevention trials, and the considerations for the design of both antiretroviral (ARV)-based and non-ARV based HIV prevention trials. The meeting recommended supporting access to PrEP in HIV prevention trials by 1) developing PrEP access plans for HIV vaccine trials; 2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism; and 3) support the safety monitoring of PrEP.

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Occupational health risks for doctors in contemporary public healthcare systems (review)

Health Risk Analysis ◽

10.21668/health.risk/2020.2.20 ◽

2020 ◽

pp. 185-192

Author(s):

I.L. Krom ◽

Keyword(s):

Occupational Health ◽

Health Risks ◽

Healthcare Systems ◽

Public Healthcare

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Mental Health, Social Influences, and HIV Pre-exposure Prophylaxis (PrEP) Utilization Among Men and Transgender Individuals Screening for HIV Prevention Trials

AIDS and Behavior ◽

10.1007/s10461-020-03004-y ◽

2020 ◽

Author(s):

Sarah M. Wood ◽

Knashawn H. Morales ◽

David Metzger ◽

Annet Davis ◽

Danielle Fiore ◽

...

Keyword(s):

Mental Health ◽

Hiv Prevention ◽

Social Influences ◽

Prevention Trials ◽

Exposure Prophylaxis

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Comparing models of delivery for cancer genetics services among patients receiving primary care who meet criteria for genetic evaluation in two healthcare systems: BRIDGE randomized controlled trial

BMC Health Services Research ◽

10.1186/s12913-021-06489-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Kimberly A. Kaphingst ◽

Wendy Kohlmann ◽

Rachelle Lorenz Chambers ◽

Melody S. Goodman ◽

Richard Bradshaw ◽

...

Keyword(s):

Primary Care ◽

Genetic Counseling ◽

Cancer Susceptibility ◽

Cancer Genetics ◽

Controlled Trial ◽

Standard Of Care ◽

Healthcare Systems ◽

Genetic Services ◽

Inherited Cancer ◽

Services Delivery

Abstract Background Advances in genetics and sequencing technologies are enabling the identification of more individuals with inherited cancer susceptibility who could benefit from tailored screening and prevention recommendations. While cancer family history information is used in primary care settings to identify unaffected patients who could benefit from a cancer genetics evaluation, this information is underutilized. System-level population health management strategies are needed to assist health care systems in identifying patients who may benefit from genetic services. In addition, because of the limited number of trained genetics specialists and increasing patient volume, the development of innovative and sustainable approaches to delivering cancer genetic services is essential. Methods We are conducting a randomized controlled trial, entitled Broadening the Reach, Impact, and Delivery of Genetic Services (BRIDGE), to address these needs. The trial is comparing uptake of genetic counseling, uptake of genetic testing, and patient adherence to management recommendations for automated, patient-directed versus enhanced standard of care cancer genetics services delivery models. An algorithm-based system that utilizes structured cancer family history data available in the electronic health record (EHR) is used to identify unaffected patients who receive primary care at the study sites and meet current guidelines for cancer genetic testing. We are enrolling eligible patients at two healthcare systems (University of Utah Health and New York University Langone Health) through outreach to a randomly selected sample of 2780 eligible patients in the two sites, with 1:1 randomization to the genetic services delivery arms within sites. Study outcomes are assessed through genetics clinic records, EHR, and two follow-up questionnaires at 4 weeks and 12 months after last genetic counseling contactpre-test genetic counseling. Discussion BRIDGE is being conducted in two healthcare systems with different clinical structures and patient populations. Innovative aspects of the trial include a randomized comparison of a chatbot-based genetic services delivery model to standard of care, as well as identification of at-risk individuals through a sustainable EHR-based system. The findings from the BRIDGE trial will advance the state of the science in identification of unaffected patients with inherited cancer susceptibility and delivery of genetic services to those patients. Trial registration BRIDGE is registered as NCT03985852. The trial was registered on June 6, 2019 at clinicaltrials.gov.

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