New Jersey is a high prevalence state for HIV disease, ranked fifth in the country in cumulative reported AIDS cases, third in the country in cumulative reported pediatric AIDS cases, and first in the country in the proportion of women among reported cumulative AIDS cases. Ninety-four percent of the pediatric AIDS and HIV cases are attributed to perinatal transmission.

The approach taken by the New Jersey Department of Health and Senior Services (NJDHSS) was to conduct a needs assessment to determine the major missed opportunity to reduce vertical transmission, develop a the standard of care in collaboration with stakeholders with consensus facilitated by meeting with stakeholders individually (i.e. meetings with the obstetrical society), dissemination of information, and evaluation of implementation and effectiveness.

Needs Assessment

The need for a statewide standard of care for women who present in labor with the delivery team unaware of her HIV status was determined based on several factors. These include

• A review of missed opportunities that indicated that currently the major barrier to maximal reduction of vertical HIV transmission in New Jersey is women who present in labor with unknown HIV status;
• Advances in HIV diagnostic testing technology and medical management that led to recent national recommendations that women who present in labor with unknown HIV status should receive counseling, be offered rapid HIV diagnostic testing, and, if HIV positive, be offered short course therapy;
• Results of a study that was conducted in the highest risk areas in New Jersey that determined that none of the hospitals providing obstetrical care had policies, procedures, or laboratory capability to provide counseling and offer rapid testing and short course therapy; and
• Meetings with two ad hoc advisory committees of stakeholders.

Working with Stakeholders

• Two ad hoc advisory committees were developed and met to 1) determine if a statewide approach was appropriate and 2) to develop the prototype policy and algorithm that facilities providing obstetrical care could implement for women who present in labor with unknown HIV serostatus.

• One ad hoc advisory committee consisted of stakeholders responsible for writing and implementing the Standard of Care. This ad hoc advisory committee included representatives from the New Jersey Department of Health and Senior Services (Division of AIDS Prevention and Control and the Division of Family Health Services), obstetricians, pediatricians, Title IV providers, the New Jersey Family-Centered HIV Care Network, case managers, social workers, consumers, maternal and child health consortia, infection control professionals, the Academy of Medicine of New Jersey, the AIDS Education and Training Center, and Medicaid. This committee met three times. The unanimous decision was that a statewide Standard of Care was the best approach to take in New Jersey. The committee felt that the NJDHSS should be the lead on developing, disseminating, and evaluating the Standard of Care. In the fall of 2001, the NJDHSS approved the draft of the Standard of Care for Women Who Present in Labor With Unknown HIV Status, which was written with the ad hoc advisory committee.

• The second ad hoc advisory committee consisted of stakeholders responsible for facilitating implementation of the Standard of Care. This ad hoc advisory committee included representatives from the New Jersey Department of Health and Senior Services (Division of AIDS Prevention and Control and the Division of Family Health Services), the Medical Society of New Jersey, all three hospital associations in
  New Jersey, the Infectious Diseases Society of New Jersey, the New Jersey Association of Osteopathic Physicians and Surgeons, New Jersey Section of the American College of Obstetrics and Gynecology, the New Jersey Obstetrical and Gynecology Society, the New Jersey Section of the American Academy of Pediatrics, the New Jersey Academy of Family Physicians, pediatric and obstetrical providers with a high-volume client load. This committee met once and provided written comments on the draft Standard of Care. They concurred with the other committee that NJDHSS should take the lead on developing, disseminating, and evaluating the Standard of Care. The unanimous decision was that a statewide Standard of Care was the best approach to take in New Jersey.
  

• Individual meetings were held with some key organizations such as the New Jersey Obstetrical and Gynecology Society, the Infectious Diseases Society of New Jersey, Medicaid, the NJDHSS Laboratory Task Force, and the Association for Professionals in Infection Control and Epidemiology.

• A one-on-one meeting was held with a high-volume facility in a high-prevalence area to help ascertain the potential barriers to implementing a statewide Standard of Care.

• Support for the statewide Standard of Care was obtained from the Governor’s Advisory Council on AIDS.

Identification and Overcoming Barriers

Several barriers were encountered in implementation of the standard of care. The first barrier was that the advisory committee members did not have enough information on rapid testing. To overcome this obstacle, a half-day continuing medical education conference with a didactic lecture on rapid testing by Dr. Bernard Branson from CDC and case studies of women who presented in labor with unknown HIV status preceded the advisory committee meeting. The committee then felt that they had enough information on rapid testing to proceed with development of the standard of care.

The second barrier was that providers were uncertain about the content of counseling for women in labor. To overcome this, a template counseling session was developed with assistance from focus groups composed of postpartum women. The template counseling session was disseminated statewide through five train-the-train sessions conducted in collaboration with all the local maternal-child health consortia.

The third barrier identified was that hospital laboratory directors were under the misimpression that preliminary positive rapid or expedited test results could not be given to the providers and patients. To overcome this, a fact sheet on rapid testing was sent to each hospital with other information related to the standard of care, information was provided in a series of lectures given statewide, and an article was published in New Jersey Medicine.

The fourth barrier was that some hospitals requested a template policy to use. This was provided to them.

Dissemination of the Statewide Standard of Care

A multimedia comprehensive approach is underway to disseminate the Standard of Care. This consists of free Internet-based continuing medical education (available at www.acadmed.org), publication of articles in New Jersey Medicine, publication of articles in AIDSLine, a laminated pocket card for providers, poster presentations, train-the-trainer sessions, and continuing medical education lectures statewide. A mailing was sent to the chair of pediatrics, the chair of obstetrics, the laboratory director, the infection control professional, the chief executive officer, the medical director, the head nurse for labor and delivery, the executive committee, the vice-president of risk management, and the emergency room director of each hospital. The information packet included a cover letter from the Deputy Commissioner, the Standard of Care, the laboratory alert, the laboratory algorithm, and information on continuing medical education and train-the-trainer sessions.

Evaluation

Evaluation will be conducted to look at process measures and outcome measures.

• Repeat the hospital survey to determine if the Standard of Care has been incorporated into hospital policies and procedures and identify barriers to its implementation

• Retrospective medical record review to evaluate the implementation and effectiveness of the Standard of Care

• Continuous evaluation of efforts to reduce vertical transmission through surveillance, survey for childbearing women, and special studies.

Funding

Funding to develop, disseminate, and evaluate the Standard of Care came from state and federal funds. These funds allowed NJDHSS to contract with the National Pediatric and Family HIV Resource Center to help develop the counseling session, conduct the train-the-trainer sessions, provide three of the continuing medical education programs, and evaluate the implementation and effectiveness of the Standard of Care.

Review of the Implementation of Perinatal HIV Rapid Testing
Medical Center of Louisiana, New Orleans
Robert T. Maupin, M.D.

This is a summary of the initial clinical experience with the SUDS assay, for obstetric rapid testing, at the Medical Center of Louisiana.

In October of 1998, the Medical Center of Louisiana, New Orleans (formerly Charity Hospital), initiated rapid HIV-1 screening for obstetric patients admitted to the labor and delivery unit without prior documentation of HIV status. This program was approved by the Hospital Executive Committee and was established in conjunction with the use of rapid screening for employee occupational exposures. The program was developed by the hospital’s Infection Control Division to address disease prevention and health care delivery needs of a subgroup of obstetric patients shown to have a two- to threefold greater HIV seroprevalence as compared with patients receiving obstetric prenatal care in the hospital’s clinics. As a standard of care, all obstetric patients presenting to the labor and delivery unit with an undocumented HIV serostatus are offered voluntary HIV testing. Patients at risk for delivery prior to the completion of conventional HIV testing were offered initial screening with the FDA-licensed Single-Use Diagnostic System Test (SUDS), a rapid enzyme-linked immunosorbent assay (EIA). Patient acceptance of HIV testing was documented with written informed consent based on hospital policy and standards of care and in accordance with State guidelines for HIV testing at public facilities. Request for SUDS testing are submitted via the computer laboratory entry system. Patients consenting for screening were tested concurrently with a conventional HIV EIA and the SUDS HIV-1 rapid assay. SUDS assay determinations were conducted in the hospital blood bank laboratory service. This laboratory resource was selected based on the presence of adequate technical staff on a 24-hour basis. A confirmatory Western blot was used to document a true positive HIV result. The results of the SUDS test are reported electronically via the computerized laboratory inquiry system and are read out as SUDS reactive or non-reactive, and patients are informed of their SUDS test result by their treating physician.

Patients with a positive SUDS test result were counseled by their treating physician about the implications of the presumptive HIV positive status and were counseled about options for intervention to reduce vertical transmission of HIV. Laboring patients were administered peripartum antiretroviral prophylaxis consistent with the Public Health Service (PHS) guidelines. Infants delivered to mothers with positive SUDS tests were considered HIV exposed and initiated postpartum antiretroviral prophylaxis consistent with the PHS guidelines. When conventional HIV test results were discordant with the SUDS test and failed to confirm infection, the newborn prophylaxis was discontinued. All mothers with a confirmed HIV infection and their HIV-exposed infants were referred for HIV primary care follow-up at time of hospital discharge. The results of all obstetric patients who underwent both conventional and rapid HIV testing were recorded in the Office of Hospital of Infection Control’s database.

Initial laboratory implementation and training was accomplished over several months. Blood bank technologists participated in a half-day “hands on” training session conducted by a SUDS vendor representative. Validation testing was conducted on site at the Medical Center of Louisiana, New Orleans Blood Bank Laboratory. The validation laboratory protocol required running 100 “unknown” serum samples with positive and negative controls. Compliance with accreditation guidelines required an evaluation of the new testing program with a proficiency testing survey. Subscription to the Wisconsin State Lab of Hygiene HIV Survey for HIV-1/2, formerly the Health Care Financing Administration (now called Centers for Medicare and Medicaid Services) approved and vendor recommended, was acquired to meet these requirements. The initial implementation cost of the hospital program for SUDS testing was approximately $2,000.

An examination of the Hospital’s perinatal HIV rapid testing program through the first 12 months demonstrated a SUDS test performance with a sensitivity and specificity of 100% and 99.2%, and positive and negative predictive value of 79% and 100%, respectively. The overall seroprevalence in the tested population was 2.9%. The positive predictive value of the SUDS assay was highest among laboring women with inadequate prenatal care and an undocumented HIV status, which represented the highest seroprevalence group (>5%).

An evaluation of the initial clinical experience with perinatal HIV rapid testing demonstrated that nearly 20% of the HIV exposed births at the facility were identified through rapid testing. The majority of these mothers had inadequate or absent prenatal care. All SUDS positive laboring mothers with a subsequent confirmed positive HIV status had evidence of advance labor or rupture of membranes at admission. All of these mothers had inadequate prenatal care. Of note upon review of medical records, it was determined that as many as 50% these mothers had evidence of a positive HIV test prior to the current pregnancy, but did not disclose their HIV status to their treating physician at time of presentation. Intrapartum antiretroviral prophylaxis was successfully initiated in the majority of these mothers, and newborn prophylaxis was initiated for all infants prior to hospital discharge. All infants entered HIV primary care follow-up post hospital discharge. A preliminary assessment of a small number of HIV-exposed infants identified with HIV rapid testing demonstrated significantly reduced transmission rate in contrast to that expected among HIV-exposed infants without peripartum antiretroviral prophylaxis.

This medical center’s experience highlights the capacity to effectively develop and implement targeted strategies for perinatal HIV rapid testing in a high-seroprevalence, obstetric population, and the potential impact of similar public health measures/interventions to reduce mother-to-child HIV transmission among childbearing women with an undocumented HIV status and poor prenatal care.