For Health Care Providers
 

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What is the Registry?

The Antiretroviral Pregnancy Registry is intended to provide an early signal of any major teratogenic effect associated with a prenatal exposure to the products monitored through the Registry. The Registry is a voluntary prospective, exposure-registration, observational study designed to collect and evaluate data on the outcomes of pregnancy exposures to antiretroviral products.

An Advisory Committee was established to review data and establish a consensus regarding results of the data at that time and makes recommendations on data collected and on issues arising during the conduct of the Registry. The Committee also encourages referral of reports to the Registry and disseminates Registry information. The Advisory Committee with representatives from the Sponsor companies comprise the Registry Steering Committee. The Steering Committee meets semi-annually to discuss issues, review data, update the interim report published following each meeting, and to discuss the general conduct of the Registry.

Assuring patient confidentiality is a very high priority for the Registry, for this reason no patient identifiers are collected. The Registry has sought and obtained IRB (institutional review board) approval. With the IRB approval of the protocol, the Registry was granted a waiver from obtaining patient informed consent. Additionally, the Registry reviews data privacy issues related to Registry processes on a regular basis.

Because the Registry is very careful to protect the patient's confidentiality participation in the Registry is conducted through a health care provider rather than directly with the patient. The Registry does not collect or maintain patient identifiers such as name, initials, contact information, or date of birth to assure confidentiality. If you would like to know more about the Registry, please ask your health care provider to contact us. .

Why is the Registry Important?

This Registry is the only project expressly established to evaluate first trimester, as well as later prenatal exposures to antiretroviral medications. Registry data supplement other sources of data and assist clinicians and patients in weighing potential risks and benefits of treatment.

There are completed and ongoing clinical trials of several antiretrovirals in pregnant women. However, the manufacturers of these antiretroviral products recognize the need to continuously monitor the safety of their products, particularly for rare events that are difficult to identify in small populations.

How to participate in the Registry?

Health care providers are asked to prospectively (before outcome of pregnancy is known) register women who have been exposed during pregnancy to the medications followed in the Registry. Patient confidentiality is strictly guarded, with no identifying patient information collected.

  • Minimal initial information is collected on each patient (including age, LMP, exposure, dosage, and timing of exposure).
  • At the time of delivery, the health care provider is prompted to provide follow-up data on the pregnancy outcome.
  • The Registry strongly encourages prospective enrollment as early in pregnancy as possible (preferably before any prenatal testing for birth defects is done) to maximize the validity of the data.
  • "Retrospective" information that is reported only after the outcome of the pregnancy is known is accepted.

It should be noted the Registry systematically collects information on the exposures and information available on major structural or chromosomal defects reported to the Registry. Although the Registry does collect information on maternal and other fetal and perinatal events when provided, the Registry does not systematically collect these data. These data are sent to the manufacturers of the products referred to in the report and reviewed by the Advisory Committee established to oversee the Registry process and analysis, but are not part of the Registry analysis. Therefore, reporters are also encouraged to report any maternal or non-defect fetal and perinatal events to the manufacturer of the products used and/or the FDA (Food and Drug Administration).

Click here for enrollment procedures.
Is Patient Informed Consent Required?

No, the Antiretroviral Pregnancy Registry (APR) has been granted an Institutional Review Board (IRB) approved waiver of informed consent and a waiver of authorization for use and disclosure of protected health information (PHI).

For any enrollment initiated by the pregnant woman’s healthcare provider, the APR meets the criteria specified under CFR 46.116 (d) waiver of informed consent requirement and CFR 45, part 164.512 waiver criteria for post marketing surveillance. Western Institutional Review Board (WIRB) approved the waivers based on the following criteria:

  1. The use or disclosure of the PHI involves no more than minimal risk to the individuals
  2. The research could not be practicably conducted without access to and use of the PHI, and
  3. The research could not practicably be conducted without the waiver.

The IRB determined that a waiver of authorization for use of PHI is needed and approved for this research. The waiver does not adversely affect the rights and welfare of the participants as there is: a) an adequate plan to protect identifiers from improper use and disclosure; b) an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law); and c) adequate written assurances that the PHI will not be reused or redisclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use of disclosure of PHI would be permitted by HIPAA.

Patient confidentiality is protected as no identifying information is sent to the coordinating center through the health care provider and extensive safeguards are in place to ensure that patients’ privacy is protected. The privacy risks to individuals whose PHI is to be used or disclosed are reasonable in relation to the anticipated benefits to future patients, and the importance of the knowledge that may reasonably be expected to result from the research.

How are the data collected by the Registry analyzed and reported?

An important aspect of the Registry is its Advisory Committee. The scientific conduct and analysis of the Registry are overseen by an Advisory Committee consisting of members from the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), the National Institutes of Health (NIH), as well as the private sector. Members include specialists in maternal and fetal medicine, teratology, infectious disease, epidemiology, and biostatistics. The Advisory Committee reviews the Registry data, develops the Advisory Committee Consensus Statement, provides recommendations on modifications or enhancements to the Registry, and assists in the dissemination of information and formulation of strategies to encourage enrollment in the Registry. The Advisory Committee and the Sponsor Company representatives constitute the Steering Committee, which jointly manages the general conduct of the Registry.

The Advisory Committee meets with representatives of the sponsoring manufacturers semi-annually with additional interim conference calls, if needed, to evaluate the Registry data and assist in disseminating information about the Registry. A Registry Interim Report is prepared semiannually summarizing the aggregate data and is available to all interested health care providers.

To request an Interim Report by Mail, please email us at SM_APR@INCResearch.com..

For an online copy, click "Interim Report"
How does participation benefit me and my patients?

The Registry is a primary source for evaluating use of antiretroviral products in pregnancy. Your contribution to this collaborative monitoring of exposures to antiretrovirals during pregnancy enables you and your colleagues to obtain information on available data in the Antiretroviral Pregnancy Registry Interim Report printed and distributed semi-annually.

How can I get more information?
For details of how to contact the Antiretroviral Pregnancy Registry click here.

For information about a specific product, contact the product manufacturer.
Click here to go to the product list with links to their manufacturer.

The success of the Registry depends on the continued participation of health care providers who register patients and assist in providing follow-up information postpartum. The support and participation of providers who enroll and continue to enroll patients are greatly appreciated.