Barriers Experienced by Organ Procurement Organizations in Implementing the HOPE Act and HIV-Positive Organ Donation

Abstract

In the seven years since the HIV Organ Policy Equity (HOPE) Act made HIV-positive organ donation to HIV-positive recipients legally permissible in the United States, there have been fewer HIV-positive organ donations than expected. Organ procurement organizations (OPOs) play a key role in the transplant system and barriers at OPOs may be responsible in part for the relatively low number of HIV-positive donors. To understand potential barriers at OPOs, we conducted semi-structured interviews with 20 OPO staff members. Interviews were recorded, transcribed, and analyzed using a conventional content analytic approach with two coders. OPO staff had high levels of knowledge about HOPE. Many had experience evaluating referrals of HIV-positive donors and approaching their families for authorization. Barriers to HIV-positive organ recovery were identified, including obtaining authorization for donation, potentially disclosing HIV status to next-of-kin, and fear of HIV infection among those engaged in organ recovery and transplantation. Strategies to overcome these barriers include providing continuing education about the specific tasks required to procure organs from HIV-positive donors, implementing targeted interventions to reduce fear of infection among health care workers, and developing and maintaining partnerships with HIV advocacy and care organizations. Given the central role OPOs play in the transplant system, HIV-positive donations are unlikely to occur in significant numbers unless these barriers can be overcome.

Introduction

The United States organ shortage has led to interest in expanding the pool of donors to include older donors, donors with malignancies, and non-heart-beating donors (Alexander & Zola, 1996; Bozkurt & Kιlιç, 2015; Busuttil & Tanaka, 2003). With antiretroviral therapy, people living with HIV (PLWH) can be donors. However, concerns about safety and a federal ban on the use of HIV-positive donors in the US prevented this until recently.

Encouraged by HIV-positive donor transplantation in South Africa (Muller, Kahn, & Mendelson, 2010), research estimated 500–600 potential HIV-positive deceased donors (HIVDDs) annually in the US (Boyarsky et al., 2011). Using these projections, advocacy organizations lobbied Congress to pass the HIV Organ Policy Equity (HOPE) Act in 2013 (Meyer, 2013). The final rule allowing HIV-positive organ transplantation under research protocols was promulgated in 2015 (Durand, Segev, & Sugarman, 2016). The first transplants under HOPE were performed in 2016 (Durand et al., 2016).

However, by March 2019, only 57 HIVDDs had organs recovered for transplant in the US (Boyarsky, Bowring, Shaffer, Segev, & Durand, 2019). The reasons for this are unclear. Studies show that more than 5,000 PLWH may benefit from transplant (Sawinski et al., 2018), transplant candidates with HIV are willing to accept these organs (Seaman et al., 2020), and PLWH are willing to donate (Nguyen et al., 2018). Other barriers have been noted (Doby, Tobian, Segev, & Durand, 2018; Durand et al., 2016) and a survey formally assessed knowledge and attitudes among transplant centers (Van Pilsum Rasmussen et al., 2018).

OPOs are 58 independently-operated non-profit organ donation providers. They are responsible for evaluating all US deceased organ donors, each within their own designated donation service area (DSA). Prior to HOPE, OPO staff were trained not to pursue potential donors with HIV. OPOs aim to increase the number of organ donors (Evans, Orians, & Ascher, 1992; Whiting et al., 2006), but they vary in their performance and practices (Ozcan, Begun, & McKinney, 1999; Theodoropoulos, Jaramillo, Ladner, & Ison, 2013). In this study, we used a qualitative approach to identify potential barriers to HIV-positive donation, resistance to implementation of HOPE, and ways to overcome barriers at the OPO level.

Methods

Interviewees were recruited using purposive sampling to include OPOs of various size, geography, and experience with HIV-positive organ transplantation. Participants from OPOs that had not yet recovered HIV-positive organs were targeted for interviews. A semi-structured interview guide was developed through an informal literature review and input from subject matter experts. Topics included OPO organizational goals, HOPE knowledge, experiences with HIVDDs, perceived barriers, and experiences with research initiatives. The interview guide was adaptive, differed according to the interviewee role, and was updated over time based on earlier interviews. Sample questions are provided in Table 1.

Table 1.

Interview Domains and Sample Questions

Content Area	Sample Question
Background and role	Can you describe your typical responsibilities dealing with a referral (not necessarily for HOPE/HIV-positive case)?
Goals of the OPO	What do you see as the goals of your OPO?
Knowledge of HOPE Act	How have you learned about the HOPE Act? Probe: local training at the OPO, national meetings, presentations from HOPE in Action study team.
Experiences working with HIV-positive donors	For those with experience: In your experience, how was this referral different from a standard evaluation? Probe: initial referral evaluation, approaching the family, obtaining authorization, placing organs for donation. For those without experience: Do you think you would feel comfortable approaching the family of a potential HIV-positive donor?
Attitudes towards HIV-positive donors	For leadership: how do you think coordinators and recovery teams at your OPO views the HOPE Act and HIV-positive donation? For coordinators: how do you think leadership of your OPO views the HOPE Act and HIV-positive donation?
Perceived barriers	What do you think are the major barriers to pursuing HIV-positive donors? Probe: operational barriers, legal barriers, ethical barriers
Comparison with other research initiatives	Regarding a previously mentioned non-HOPE research initiative: How does your experience with this initiative compare to the HOPE Act? Probe: were there more resources? Was it easier to work with local researchers versus a national team?

Participants gave oral informed consent. No incentives were provided. An experienced interviewer (ZP) conducted all interviews, which were audio-recorded, transcribed, deidentified, and uploaded into ATLAS.ti Version 8.4.3 (Friese, 2019). A codebook was developed consisting of 11 parent codes. A coder (ZP) applied codes, which were reviewed by a secondary coder (DB). Coders discussed any disagreements in coding and reached consensus. Data were analyzed using a conventional content analysis approach (Hsieh & Shannon, 2005). This study was deemed exempt from human subjects review by the Johns Hopkins School of Public Health Institutional Review Board.

Results

Interviews were conducted with 20 OPO employees at 14 OPOs between March 2019 and February 2020 and ranged in length from 30–60 minutes. Interviewee characteristics are in Table 2.

Table 2.

Characteristics of the Study Population. Respondents worked at all levels of OPOs, had varying levels of experience with HIV-positive donation, and came from OPOs of differing sizes.

Characteristics	Number (%) (n=20)
Position at OPO
Coordinator	6 (30%)
Manager	8 (40%)
CEO/Executive leader	6 (30%)
Successful HIV-positive transplant	12 (60%)
Large OPO*	14 (70%)

^*Large OPOs were defined as those in the upper half in terms of number of deceased donors in 2018

Key interview findings are summarized below and in Table 3.

Table 3.

Areas of Inquiry and Major Themes Identified

Areas of Inquiry	Themes
Knowledge
Learning about the HOPE Act	OPO staff report learning about the HOPE Act from a variety of sources, including presentations at national meetings, their own involvement with lobbying, and the news media.
Training at the OPO	OPO staff report many receiving training from several different sources, including staff at Johns Hopkins. Some developed their own training materials, and some reported training hospitals within their DSA.
Experiences
Evaluating referrals	Most (but not all) OPOs have incorporated review of HIV-positive referrals into their workflows, though some report unofficial mechanisms of ruling out these donors.
Family approach	Some OPO staff perceive difficulty around approaching families of HIV-positive potential donors, usually because of concerns about complicated family dynamics they felt were more commonly seen in HIV-positive donors.
Authorization	Obtaining authorization for an HIV-positive donor, especially where the family did not know the donor’s HIV status, was generally seen as more difficult. Most OPO staff felt they needed to obtain research authorization for these donors, even though HIV-positive transplantation is not donor intervention research and therefore donor research authorization is not necessary for transplantation.
Disclosure	There was confusion among OPOs about whether they need to disclose the donor’s HIV status to family. OPO staff who had more experience with HIV-positive donation had correctly determined that the responsibility for disclosure fell to other medical professionals per state law.
Placement of organs	Some OPO staff reported difficulty placing organs or felt that it would be more difficult to place these organs.
Barriers
Legal	Some state bans to HIV-positive organ donation still exist, and cautious OPO legal departments have prevented these donations.
Financial	A few OPO staff reported that perceived lower probability of successful donation from an HIV-positive donor made pursuing these donors more financially risky from the standpoint of the OPO.
Ethical	Some OPO staff reported concerns about special treatment of HIV-positive individuals on transplant waiting lists.
Fear of infection	Several OPO staff had observed fear of infection among other staff they work with at their OPO or at a hospital within their DSA.

Knowledge of HOPE and training

All interviewees were familiar with basic provisions of HOPE. Some learned about it through national organizations such as Association of Organ Procurement Organizations (AOPO) and a few learned about it from media.

Most interviewees received HOPE-specific training. One respondent summarized the need for this training:

“Early on we didn’t have a whole lot of training – we just kind of navigated each case on a case-by-case basis which just led to confusion and discomfort for everybody involved. Because you’re not doing them very often.”

Many OPOs relied on training provided by research teams [NCT03500315, NCT03734393]; some developed their own training materials. One respondent reported training staff on how to obtain clinical information from HIV care providers, since this information was not part of typical donor evaluations. Several described training staff at hospitals in their DSA, whose staff are responsible for making HIV-positive referrals to the OPO.

Experience with HIV-positive referral evaluation, donation, and transplantation

OPO respondents distinguished between referrals where the donor was known HIV-positive and referrals where HIV was discovered during evaluation through testing. While almost all OPOs evaluated referrals initially believed to be HIV-negative and would continue if HIV was discovered, several OPOs were not evaluating known HIV-positive cases. Several OPO staff suggested although positive HIV status was not an official rule-out, they declined to move forward on these cases using other justifications:

“We have found other ways to exclude them previously. So, if there were other ways to rule out those organs or those cases, we didn’t move forward.”

The interviewee went on to explain specific ways they would rule out an HIV-positive donor, including excluding HIV-positive donations after cardiac death and looking for other comorbidities to rule out:

“we looked for other comorbidities to help not move [the case] forward.”

No interviewees reported being more likely to pursue donors to participate in HOPE research:

“HIV is no longer automatically a ruleout, but just because they have HIV doesn’t automatically mean they’re a donor. They still have to be a good donor first.”

Family approach:

Several interviewees suggested PLWH were more likely to be estranged from family or have more complicated situations.

“I would say a barrier is the fact that a large population of HIV patients are homeless. And it’s very hard to get in contact with families or a treating physician to obtain any kind of medical records on these patients ... And most of them have estranged families and whatnot.”

Authorization and disclosure:

Issues surrounding the disclosure of donor HIV status were frequently discussed by interviewees when describing experiences working with families of HIV-positive donors to obtain donation authorization. To prepare for approaching families, OPO staff felt a need to assess family knowledge of the donor’s HIV status (though not necessarily inform the family). This uncertainty could complicate the family dynamic.

“Coordinators are a little uncomfortable with if the family knows or doesn’t know [the donor’s HIV status]. And what they can say and what they can’t say and how they should approach it.”

One OPO staff member described not being responsible for disclosing HIV status according to state law:

“These families have given us authorization. We draw blood for serological testing. It comes back they’re HIV-positive but the family does not know. During that process we advise the hospital staff so they can let the family know that the patient does have HIV.”

Research consent on the part of the HIV-positive potential recipient is always required before any HIV-positive transplantation. However, authorization for research on the part of the donor or their next-of-kin is not a federal requirement for an HIV-positive transplantation under HOPE (Liverman, Domnitz, & Childress, 2017), though some OPOs still require authorization for research for HIVDDs. One respondent described their OPO’s policy regarding this issue:

“In general, we have the same conversation with families about donation whether they’re a potential HOPE donor or not. The difference is they would need to be authorized for research to participate [in HOPE].”

Hospital and health system factors:

Several aspects of hospital and health system were cited as potential barriers. Several respondents said OPOs had difficulty accessing health information for some HIV-positive potential donors. Historically, HIV providers have not been involved in the donation process, so OPO staff may need to connect new ambulatory care physicians obtain information:

“With HIV and [HOPE], we found that many times it wasn’t the care team at the hospital who was caring for the patient. It was their HIV care provider that had the information that we would need. So, we may have to wait until between 8:00am and 4:00pm to get the information we want.”

Some respondents reported bias towards PLWH among hospital staff. This was described are resulting in hospitals not referring potential HIV-positive donors to OPOs :

“I think for the most part since most health care providers feel that this is not a potential donor or the kind of see just HIV as a deadly disease […] the case is kind of pushed aside by the hospital. It really requires someone on the hospitals to either be educated on the process […] which is them calling the referral regardless of it being HIV or not.”

Placement of HIV-positive organ:

Most interviewees noted at least one transplant center in their DSA listing HIV-positive candidates for HIVDDs. Placing HIV-positive livers was cited as difficult on West Coast; fewer transplant programs there were accepting these organs.

Differences with other research initiatives:

The HOPE in Action research program includes two multicenter prospective trials of transplantation with HIVDD organs which differ from OPOs’ previous research collaborations. The national study did not rely on preexisting relationships with OPOs in contrast to local studies where some OPO staff felt they had stronger connections with researchers. The HOPE in Action study pager was consistently cited as a strength, key to building a relationship, and many programs that had procured HIV-positive organs had used this resource. Second, the HOPE in Action study is relatively well-resourced; resources were allocated for OPO training and outreach. One OPO staff member summed this up:

“We have contacts for the HOPE team. To me it’s a little bit more genuine of a relationship than working with [a previous national study]. It just didn’t have that personal connection like HOPE does.”

Barriers to HIV-positive donation and transplantation:

When asked generally about barriers to HIV-positive donation, interviewees identified several including legal, financial, ethical, and fear of infection.

Legal barriers:

Several respondents cited state bans on HIV-positive organs as a barrier, though typically one they could overcome. Staff from one OPO reported working with HIV advocacy organizations and state legislators to overturn the ban. Another OPO staff suggested lobbying efforts required to repeal a ban would not be a good use of OPO resources:

“I think in the spirit, there would be support but I don’t know if they would spend the time to help us get that legislation [to overturn the state ban]”

Financial barriers:

Some respondents were familiar with their OPO billing and reimbursement practices. Among those who were, most stated that time costs associated with HIVDDs were absorbed into program costs. However, one respondent cited costs as an issue:

“Nobody wants to pour resources into a donor … to find out at the end they had PCP [Pneumocystis pneumonia] and it was a rule out. We’d flown coordinators. We were paying the hospital case rate. We were probably $40,000 invested. And then you recoup zero of the cost for that. We’re a non-profit; it just drives up the whole cost of the system because it gets spread over the acquisition cost of all of our organs. Continuing to have these referrals that end up not being suitable [for transplant] is financially devastating to the whole system.”

Ethical barriers:

One interviewee discussed ethical challenges related to justice and asked whether HIV-positive transplantation was unfair for people without HIV.

“The only ethical concern that a hospital partner raised was that the HIV recipients were getting special treatment because they could receive HIV-positive organs. And we explained that by removing these patients from the list more organs that were not HIV were becoming available to other people.”

Fear of HIV infection:

Several respondents cited fear of HIV infection among both OPO and hospital staff as a major barrier.

“I do think there’s a lot of people still from hospital nursing staff to OPO professionals who still get nervous about the concept of doing these fast-paced rapid recoveries on an HIV patient. They’re afraid of injuries to themselves, increased risk.”

Several described examples of reluctance among hospital staff, possibly related to fear of infection during HIV-positive cases. One respondent described reluctance lessening over time:

“I sometimes remember when we were starting to transplant HIV positive patients and some of the OR staff not wanting to initially be involved in it…There may be a little bit of that view in the donor hospital staff … They do have an option to opt out. I think as we did more it became not an issue.”

Strategies for overcoming barriers:

Education of OPO and hospital staff was frequently mentioned as a remedy for barriers, despite many staff having received HOPE training and reporting providing this training to others. Forging relationships with HIV providers and advocacy organizations was helpful in this regard:

“[Our region] has one of the largest HIV populations in the [US]. And there [are] a lot of HIV advocacy organizations here that are participating and trying to educate the community and help the HIV population. And we’re partnering up with these foundations because it’s the only way to really infiltrate the community and educate them that if they have HIV they could help someone that has it as well.”

HIV advocacy organizations were also mentioned as a way to reduce logistical challenges with collecting HIV care records.

Discussion

OPOs play multiple roles in the US transplant system, and implementation of HOPE is unlikely to occur without their buy-in. This study sought to better understand OPO knowledge of HOPE and experiences to date to identify common barriers.

While OPO staff noted barriers to HIV-positive organ procurement across many domains, most were knowledgeable about HOPE. National efforts to educate OPOs about HOPE, feasibility of these transplants, and required steps seem successful. On-the-job training and support during complex cases from HOPE studies were cited as a critical resource.

Interviewees reported overwhelmingly that HIV-positive referrals were treated the same as HIV-negative referrals. They insisted since HIV-positive transplantation had become legal, OPOs did not factor HIV into decisions to pursue donors. However, some interview statements suggested despite official policy, HIV-positive donors were not being treated the same. Some interviewees claimed others stigmatized PLWH, such as by assuming HIV was a deadly disease or PLWH were more often homeless or have disrupted families. Additionally, OPO staff reported observing fear of infection among others, including OPO and hospital staff. Given the potential for social desirability bias among respondents, this fear is likely more widespread among OPOs than reported, despite near-zero rates of occupationally-acquired HIV infection in the US in the last 20 years (Joyce, Kuhar, & Brooks, 2015).

Given the range of barriers and resistance to HIV-positive donation observed, future success of HIV-positive transplantation will depend on how OPOs and organizations like UNOS and AOPO are able to address them. Some barriers will likely lessen with time. As changes in OPTN policy now allow transplantation of HIV-positive hearts and lungs, OPOs may see greater opportunities to save additional lives. As more HIV-positive candidates are listed for HIV-positive transplantation, the likelihood of successful matches increases. However, other barriers will require significant effort to overcome. For example, OPOs in areas with low HIV prevalence may not have local advocacy organizations to engage for donor registration or education. Given the relatively low prevalence of HIV in the general US population, engaging with HIV-positive potential donors may never be prioritized.

One complex barrier consistently cited was confusion surrounding disclosure of a potential donor’s HIV-positive status to next-of-kin. Staff at OPOs that had not transplanted HIV-positive organs often reported being worried about these disclosures. While the laws surrounding mandatory HIV disclosure to sexual partners vary state-to-state, and the applicability of these laws after death has not been fully determined, most successful OPOs simply applied pre-existing policies for disclosure of other transmissible diseases in accordance with state law. Typically, the responsible physician communicated as needed with the family, and OPO staff did not discuss HIV unless the family indicated knowledge of the HIV status. Further clarity on this issue from the OPTN to OPOs may be helpful.

A perceived need for research authorization from deceased donors also complicated the process for many OPOs. However, HIV-positive transplants have occurred without having additional research authorization as these transplants are considered recipient research. Educational efforts on the requirements surrounding research authorization for deceased donors and standardize the research authorization processes across OPOs could increase the rate of HIV-positive organ donation.

Our study had some limitations. Experiences and views expressed may not be representative of the experiences of OPOs as a whole. The purposive sampling strategy may have biased the sample towards OPOs more involved in HOPE advocacy. Though there was good representation of OPOs that had not had an HIV-positive donation, all of the OPOs had supported efforts to increase the annual number of HIV-positive transplants. Social desirability bias may have been present, whereby interviewees report being more interested in HIV-positive donation than they truly are.

This work has important implications for stakeholders interested in fully implementing HOPE. In addition, it has implications for efforts to expand the donor pool more generally. For example, as donation from Hepatitis C-positive donors becomes more common (Gonzalez & Trotter, 2018), barriers noted here may apply for Hepatitis C-positive donation. As OPO performance has become a topic of increased focus within the transplant system (Goldberg, Karp, Shah, Dubay, & Lynch, 2019), understanding OPO experiences and attitudes are increasingly important.

There is no single barrier preventing OPOs from procuring and transplanting HIV-positive organs. For OPOs to successfully implement, OPOs must train staff, be operationally prepared for differences between HIV-positive and HIV-negative family approaches, be ready to combat HIV stigma as well as fear of infection internally and at donor hospitals, and be ready to place organs with transplant centers. Given the central role of OPOs, HIV-positive donations are unlikely to occur in significant numbers unless these barriers are overcome.

Abbreviations:

AIDS

Acquired Immunodeficiency Syndrome

AOPO

Association of Organ Procurement Organizations

DCD

donation after cardiac death

DSA

Donation Service Area

HIV

Human immunodeficiency virus

HIVDD

HIV-positive deceased donor

HOPE Act

HIV Organ Policy Equity Act

OPO

Organ procurement organization

OPTN

Organ Procurement and Transplantation Network

PCP

Pneumocystis pneumonia

PLWH

people living with HIV

UNOS

United Network for Organ Sharing

Data availability statement

The data that support the findings of this study are available from the corresponding author, ZP, upon reasonable request.