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HRSA in the News

In 1995, HRSA awarded $23.3 million in grants to improve access to HIV comprehensive care and clinical research trials for children, youth, and women.39

In 2000, the FDA implemented the Clinical Hold Rule as new drugs were being rushed to clinical trials. The new ruling allowed the FDA to suspend any clinical trial that excluded women because of their reproductive potential.

Part D services include treatment of HIV-positive pregnant women and women of childbearing age. Services offered through Part D are having a significant impact on the health outcomes of children born to HIV-infected mothers. Studies show that these children are most often born HIV free if their mother is in a Part D treatment program.

For example, the Detroit Medical Center’s Perinatal Infectious Disease clinic in Michigan, provides prenatal and postpartum care to HIV-infected women. As a result of the clinic’s comprehensive work through Part D, no cases of perinatal infection have occurred among clinic patients in more than a decade. In Atlanta, Georgia, programs such as the Grady Family Clinic and SisterLove are a part of the Atlanta Family Circle Network, a group of Part D-funded providers. They work together to provide primary and specialized care, substance abuse treatment and support, oral health care, mental health, and social services. Many children who were born infected with HIV have grown up in Part D programs and have benefited from intensive case management throughout their lives.

Prevention of Perinatal Transmission

In March 1987, the U.S. Food and Drug Administration (FDA) approved the first antiretroviral drug to be used in the treatment of AIDS: AZT.17 Seven years later, in 1994, findings from the National Institutes of Health AIDS Clinical Trial Group (ACTG–076) demonstrated that with a particular regimen of AZT, the chance of perinatal HIV transmission plummeted. Preliminary findings showed that AZT was responsible for a 67.5 percent reduction in the transmission of the virus from mother to child.18 “Even though it was a clinical trial, the benefits were so significant that the study was halted in order to enable provision of AZT to more women in care,” Travieso-Palow says.

Jean Anderson, director of the John Hopkins HIV Women’s Health Program, remembers the impact of the ACTG–076 trial. “Before this intervention . . . between 25 and 45 percent of babies born to infected mothers would be born with HIV,” Anderson says. “We found that by using AZT as early as 14 weeks of pregnancy, we could cut transmissions by two-thirds and offer real hope to pregnant women with HIV.”

HRSA worked with partners throughout the Public Health Service to create guidelines for administering the AZT regimen for all Ryan White HIV/AIDS Program grantees as well as for providers in the many other HRSA programs.19 When the guidelines were issued, Philip R. Lee, assistant secretary for health and director of the Public Health Service, said, “In response to these important findings about the use of AZT in the perinatal setting, these programs will also emphasize prevention and early intervention for women and their children, and the integration of HIV prevention and treatment into broader systems of primary care.”20

The National HIV Pediatric Resource Center, a project of the University of Medicine and Dentistry of New Jersey that is supported through a HAB cooperative agreement, used the AZT study findings to provide technical assistance to clinics across the country.

HRSA added new standards of care for HIV-positive pregnant women to its expectations for grantees. In addition, training, technical assistance, and onsite support were made available to all organizations funded through the Federal Community and Migrant Health Centers Program.

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