Partnering for Care in HIV Prevention Trials

Abstract

Qualitative Case Studies Were conducted at seven international sites conducting HIV prevention research in Africa, Asia, and the Americas to identify strategies for ensuring that health needs of research participants identified in the course of research are adequately addressed. Key factors were identified that contribute to the balance between direct care and healthcare referrals at a research site, as well as the overall quality of the healthcare made available to research participants. The case studies exemplify the concept of “moral negotiation” in research (Weijer & LeBlanc, 2006), that is, a process where researchers and sponsors negotiate with increasingly empowered local communities and host countries to achieve meaningful and substantive benefits from biomedical research for all stakeholders.

Planning for Ancillary Care Provision

“…In the case of the former, advance planning for ancillary care provision includes staffing research teams with individuals who have the skills to provide such care. In the case of the latter, planning involves identifying organizations able to provide the types of care likely to be needed, connecting with these organizations, developing co-operative agreements for care provision (Krubiner, Syed, & Merritt, 2015) and putting in place systems for following up on referrals (MacQueen & May, 2008). A final strategy identified in the literature is for research teams to play a role in building the capacity of the local health system to respond to the population's needs (Krubiner, Syed, & Merritt.…”

Shared responsibility for ensuring appropriate management of incidental findings: a case study from South Africa

“…Hospital Y, located in close proximity of the research site, was a longstanding referral partner of the researchers 11. Hospital Y, which functioned autonomously within the public health sector, was equipped to provide the appropriate level of care for the referral.…”

“…Thus, the researchers’ responsibility is to ensure provision of appropriate referrals for management of incidental findings that cannot be treated at the research site. In order to ensure provision of further care, researchers establish partnerships with local healthcare facilities (hospitals and clinics) to facilitate referral and management of participants experiencing any health-related problems during their trial participation 10 11…”

“…This adds another layer of complexity in terms of managing the safety of the participant, specifically if the local SOC for a condition is not provided by the healthcare facility 11. In most cases, these healthcare facilities are autonomous and provide care within the context of local guidelines and SOC.…”

The Exploitation of “Exploitation” in the Tenofovir PrEP Trial in Cameroon: Lessons Learned from Media Coverage of an HIV Prevention Trial

“…For HIV prevention trials, this further highlighted and complicated a difficult ethical challenge: what obligations did HIV prevention trialists hold for people who became infected with HIV while enrolled in a trial? Was the obligation limited to referrals to the local standard of care, or was there an obligation to provide the best global standard of care, or something in between (MacQueen et al, 2008)?…”