HOPE act

On November 19 and 21, 2015, we made OPTN policy and system changes to implement the HIV Organ Policy Equity (HOPE) Act, which allows for research into transplanting organs from HIV-positive donors into HIV-positive recipients.

HOPE Act participating hospitals (PDF; 07/2023)

Policy and System Changes

OPTN policy 15: Identification of transmissible diseases (PDF - 2.5 M)

HOPE Act variance request form (4/2020)

Complete the form and email it to HOPEAct.VarianceRequest@unos.org.

Frequently Asked Questions

(4/2020)

HOPE Act
Re-execute the match

Frequently asked questions: HOPE Act (4/2020)

What is the HIV Organ Policy Equity Act?

The HIV Organ Policy Equity Act (HOPE Act), enacted on November 21, 2013, called for the development and publication of research criteria relating to transplantation of HIV positive organs into HIV positive individuals. The following actions were taken to fulfill HOPE Act requirements:

The Secretary of HHS revise the section of the OPTN Final Rule (42 CFR 121.6) that previously required the OPTN to adopt and use standards to prevent the recovery of HIV positive organs.
The OPTN to revise policies to allow for the recovery and transplantation of organs from HIV positive donors in accordance with the criteria developed by the Secretary.
The Secretary of HHS developed and publish criteria for research relating to transplantation of organs from donors infected with HIV into individuals who are infected with HIV before receiving such organs.

When did the OPTN policies take effect?

The OPTN policies became effective on November 21, 2015.

Are the research criteria available?

Yes. The research criteria, published on November 23, 2015, include required study team experience as well as clinical and safety guidelines to be addressed in research protocols.

Section 3.1 (Specific Transplant Hospital Criteria) of the NIH research criteria addresses the specific transplant hospital prerequisites, which include the following:

i. An established program for the care of individuals infected with HIV.

ii. In order for a transplant hospital to initiate HIV-positive to HIV-positive transplantation, there must be a study team consisting of (at a minimum) a transplant surgeon, a transplant physician, and an HIV physician. The transplant physician and HIV physician collectively must have experience with at least five HIV-negative to HIV-positive transplants with the designated organ(s) during the prior four years. This constitutes the minimal experience necessary. In addition, the IRB must evaluate key personnel (i.e., transplant surgeon, transplant physician, and HIV physician) in the context of total expertise and experience with respect to HIV and/or organ transplantation (confirm and document HIV-negative to HIV-positive transplant experience of the team).

The research criteria are referenced in the OPTN Final Rule as follows:

§121.6 Organ procurement.
(b) HIV. (1) Organs from individuals infected with human immunodeficiency virus (HIV) may be transplanted only into individuals who—
(i) Are infected with HIV before receiving such organ(s); and
(ii)(A) Are participating in clinical research approved by an institutional review board, as defined in 45 CFR part 46, under the research criteria published by the Secretary under subsection (a) of section 377E of the Public Health Service Act, as amended; or
(B) The Secretary has published, through appropriate procedures, a determination under section 377E(c) of the Public Health Service Act, as amended, that participation in such clinical research, as a requirement for transplants of organs from individuals infected with HIV, is no longer warranted.
(2) Except as provided in paragraph (b)(3) of this section, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV to the extent the Secretary determines necessary to allow the conduct of research in accordance with the criteria described in paragraph (b)(1)(ii)(A) of this section.
(3) If the Secretary has determined under paragraph (b)(1)(ii)(B) of this section that participation in clinical research is no longer warranted as a requirement for transplants of organs from individuals infected with HIV, the OPTN shall adopt and use standards of quality with respect to organs from individuals infected with HIV as directed by the Secretary, consistent with 42 U.S.C. 274, and in a way that ensures the changes will not reduce the safety of organ transplantation.

Why did the OPTN create an open variance?

Transplants performed under the National Institutes of Health (NIH) research criteria will be evaluated, as outlined in the HOPE Act, by the Secretary of HHS in conjunction with the OPTN. This evaluation will help determine whether the OPTN policies should be revised and whether continuing to require that HIV positive to HIV positive transplants be conducted as clinical research consistent with the NIH research criteria is warranted.

The OPTN created an open variance to evaluate this effort in a specific timeframe as outlined in Policy 1.3 (Variances). The Executive Committee approved an expiration date of January 1, 2018 for Policy 15.6 (Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors). In December 2021, the Board of Directors extended the variance expiration date to January 15, 2026, to allow more time to study the feasibility and safety of performing HIV-positive donor to HIV-positive recipient transplants.

What do transplant programs need to do to receive organs as part of the HOPE Act research study?

Transplant hospitals must notify the OPTN Contractor in writing that they intend to participate in an institutional review board (IRB) approved research protocol that meets the criteria published by the Secretary under subsection (a) of section 377E of the Public Health Service Act. The transplant hospital must submit:

A request to join the open variance for the recovery and transplantation of organs from HIV positive donors using the request form created by the OPTN Contractor. Complete the form and send it to HOPEAct.VarianceRequest@unos.org.
A detailed schedule of required deadlines for IRB data safety monitoring reports that address the requirements in the HHS research criteria. This must include the actual dates when DSMB reports will be submitted to the OPTN contractor. If a central DSMB is used as part of a multi-center trial, this must be indicated in the request.

Transplant programs will be required to submit IRB data safety monitoring reports at each deadline in their IRB approved data safety monitoring schedule.

The OPTN Contractor will track when an active transplant program has IRB approval to conduct a research study that is consistent with requirements of the HOPE Act following submission of the required documentation. The transplant programs will then be able to indicate in Waitlist, the HIV status and willingness of each candidate to accept an HIV positive organ. A second user must verify in Waitlist the HIV status and willingness of the candidate to accept an HIV positive organ as outlined in Policy 15.6.

A program’s approval to participate in the open variance will expire with the expiration of their IRB approval. In order to continue to participate, the program will need to send in a new IRB approval letter before the expiration date. Programs who lose IRB approval before the expiration date must notify the OPTN.

What do OPOs need to do to participate in an IRB approved HOPE Act research study?

There are no specific requirements in OPTN policy that OPOs must follow prior to allocating HIV positive organs to transplant hospitals participating in a research study. However, the research criteria published by the Secretary of HHS contain specific OPO responsibilities, and OPOs must adhere to those requirements. OPOs must accurately report donor HIV test results. If the results are positive, the OPO will only be able to run matches that show the candidates at hospitals that are participating in a research study and whose HIV status and willingness to accept an HIV positive organ has been verified by a second user.

Are living donors eligible to participate in an IRB approved HOPE Act research study?

Yes. As of November 21, 2015, the change to living donor policies (located in Table 14-9: Living Donor Exclusion Criteria) allow for an exception to the HIV exclusionary criteria if qualifying under the research study. Living donor transplant hospitals must meet all the requirements outlined in Policy 15.6: Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors and the research criteria as referenced in the Final Rule §121.6(b)(ii)(A). The research criteria developed by the NIH under the authority of the Secretary of HHS contain additional requirements for living donors participating in a HOPE Act research study. Note that transplant hospitals need to have a separate IRB protocol for following living donors who are a part of the HOPE Act study.

How will the OPTN evaluate the research study results?

The HOPE Act states that “not later than 4 years after the date of enactment and annually thereafter, the Secretary shall review the results of scientific research in conjunction with the OPTN to determine whether the results warrant revision of the standards of quality.” The OPTN Executive Committee approved a modification to the variance requirements in October 2015 that requires members participating in a HOPE Act research study to provide periodic reports from their data safety monitoring boards to the OPTN. This will allow the OPTN Contractor to identify issues or trends across multiple research studies and proactively address potential problems. The OPTN Contractor is developing the process for reviewing the data safety monitoring board reports.

What are the OPTN member obligations related to the HOPE Act?

All HIV positive to HIV positive transplants must be conducted as part of an IRB approved research study that is consistent with the research criteria published by the Secretary of Health and Human Services. OPTN members failing to comply with the research criteria may be subject to OPTN sanctions.

Frequently asked questions: Re-executing a match run (4/2020)

Background Information

The proposal to require another match run based on change in infectious disease test results was approved by the BOD in June 2015. Policy requires that OPOs re-execute a match when infectious disease test results for hepatitis C (HCV), hepatitis B (HBV), HIV or cytomegalovirus (CMV) are changed to positive. The CMV change applies to intestine matches only.

When did the policy go into effect?

The policy went into effect on November 19, 2015.

What happens if infectious disease results that impact the match run are changed to positive?

Scenario 1: An OPO executes a match run and discovers that the donor tests positive for HBV, HCV, or CMV (intestine only). Before the test results are available, the deceased donor organ is accepted for a potential transplant recipient. The OPO must:

Stop allocation from the original match run.
Enter the updated donor test result in DonorNet^®.
Report the new test result to the first transplant hospital that accepted the organ as soon as possible, but within one hour of receiving this new test information.
If the transplant hospital accepts the organ for the primary potential transplant recipient despite the new donor test result, allocation is complete. The match run does not need to be re-executed.
If the transplant hospital refuses the organ based upon this new information, the OPO must re-execute the match run. The OPO cannot offer the organ from the original match run to other potential recipients, even if they have accepted back up offers.

Scenario 2: An OPO executes a match run and discovers that the donor tests positive for HBV, HCV, or CMV (intestine only). No one has accepted the organ offer. The OPO must:

Stop allocation from the original match run.
Report the updated donor test result in DonorNet^®.
Re-execute the match run.
Resume allocation using the new match run.

Scenario 3: An OPO executes a match run and discovers that the donor is HIV positive. Because of the federal HOPE Act (effective November 21, 2015), transplant centers that have HOPE Act IRB approval may transplant HIV positive donor organs into candidates that are HIV positive and have agreed to accept an HIV positive organ. The OPO must:

Stop allocation from the original match run.
Enter the positive HIV result in DonorNet^®.
Withdraw any pending offers, regardless of whether the transplant hospital has accepted an offer.
Re-execute the match run.

Does an OPO have to re-execute the match run for all organ types if they receive a positive test result for CMV?

No. Only the intestine match must be re-executed when the CMV test result is changed to positive.

Does an OPO have to re-execute the kidney match runs if both the right and left kidneys have been provisionally accepted and the offer for either the right or left kidney is declined after learning of the change in infectious disease test results to positive?

Yes. When infectious disease test results are changed to positive after a kidney match has been run, the OPO must contact both the transplant hospitals that accepted the right and left kidneys. If one of the potential transplant recipients is not willing to accept the organ (right or left kidney) after being informed of the change in infectious disease test results, the match run must be re-executed to allocate the kidney that was refused. This also applies to lung and split liver placement where organs have been accepted for two primary potential transplant recipients.

What does it mean when a match run is “locked”?

A “locked” match status means that electronic notifications have been disabled for that particular match because of a change in an infectious disease test result to positive. OPOs must continue to comply with existing policy to submit PTR (Potential Transplant Recipient) information within 30 days after the match run date for each deceased donor organ that is offered.

Does an OPO have to re-execute the match run if they already have one HIV positive result and then receive a second HIV positive result?

No. If any positive HIV test result has already been indicated in DonorNet^® and a subsequent positive HIV test result is received, the OPO does not have to re-execute the match. DonorNet^® should reflect the most up to date HIV test results.

Re-execute a match run: Effective practices and process steps

OPTN policy requires members to re-execute a match run when there is a change in infectious disease test results to positive.

Re-execute a match run: Effective practices and process steps

When kidney and liver matches are re-executed after HIV test results change to positive, only candidates from centers that have HOPE Act IRB-approved kidney and liver programs will be included in the match results.

Effective Practices

Rapid screen testing for HIV, HBV, HCV

Blood for serology testing should be drawn as early as possible at the start of a case.
Results typically in 20-40 minutes.
If rapid screening results are positive, a match run can be delayed until serology results are available.

In-house laboratory

Serology results typically available within 4-6 hours.
Automated platform expedites process.

Multiple verifications

Multiple staff members verify test results before generating match run.
Verifiers include supervisor on-call.

When these effective practices are not an option and it is necessary to re-execute a match run, review the following process steps, as they outline appropriate decision-making points to comply with policy.

The transplant hospital (TH) must obtain informed consent before transplanting organs with positive HIV, HBV, HCV, CMV* test results, per OPTN policy.

Process steps

When OPO gets new positive donor HIV test results:

OPO stops allocation process.
OPO enters positive test results in DonorNet^®.
OPO withdraws any pending offers.
OPO re-executes match run for kidney and liver only.
OPO allocates organ.

When OPO gets new positive donor HBV, HCV, CMV* test results

OPO stops allocation process.
OPO enters positive test results in DonorNet^®.
Organ accepted before positive test results?
- If yes:
  - OPO notifies TH of updated test results.
  - TH accepts organ on behalf of primary potential transplant recipient.
  - Within 1 hour of notification, TH informs OPO of decision.
    - If TH accepts, OPO allocates the organ.
    - If TH declines, OPO re-executes the match run and allocates the organ.
- If no:
  - OPO re-executes the match run and allocates the organ.

*CMV test is for intestine only.