Translating Clinical Trial Results into Practice: The Effect of an AIDS Clinical Trial on Prescribed Antiretroviral Therapy for HIV-Infected Pregnant Women

15 June 1999 | Volume 130 Issue 12 | Pages 979-986

Background: The success of Pediatric AIDS Clinical Trials Group (PACTG) Protocol 076 in preventing vertical HIV transmission prompted intensive efforts to inform laypersons and professionals about the trial's results.

Objective: To explore community responsiveness to these efforts by assessing temporal, maternal, and health care factors associated with prescribed antiretroviral therapy before and after PACTG Protocol 076.

Design: Retrospective cohort study.

Setting: New York State Medicaid program.

Patients: 2607 HIV-infected women who delivered a living child between January 1993 and September 1996.

Measurements: Adjusted odds of being prescribed antiretroviral treatment in the second or third trimester for women who delivered in period 1 (during the trial [January 1993 to February 1994]), period 2 (after the trial's end and announcement of the results to publication of the results [March 1994 to November 1994]), and period 3 (after publication of the trial results [December 1994 to September 1996]).

Results: The adjusted odds of being prescribed antiretroviral therapy increased 21% per month in period 2 and decreased to 3% per month in period 3. In all time periods, the adjusted odds of being prescribed antiretroviral therapy were at least 60% greater (P < 0.05) for women who were treated at an institution that performed HIV clinical trials, received HIV-focused ambulatory care, or had adequate prenatal care visits. After the trial, women receiving methadone treatment had at least twofold (95% CI, 1.5- to 4.3-fold) greater adjusted odds of being prescribed antiretroviral therapy than women who did not take any illicit drugs. Latin-American women, older women, and women born in the United States had greater adjusted odds (P < 0.05) of being prescribed treatment in period 3.

Conclusion: Community practice responded rapidly to efforts to disseminate the results of PACTG Protocol 076; however, the absolute increase in prescribed therapy was greatest for women who had adequate prenatal visits or were receiving HIV-focused care, care at a site that performed clinical trials, or methadone therapy.

Author and Article Information

From Jefferson Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania; and the New York State Department of Health, Albany, New York.

Presented in part at the National Conference on Women and HIV, Pasadena, California, 4-7 May 1997.

Disclaimer: The opinions of the authors do not necessarily reflect those of the New York State Department of Health.

Acknowledgments: The authors thank Martha Rogers, MD, from the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention and Barbara Warren from the AIDS Institute of the New York State Department of Health for their help in describing the educational efforts that took place after the announcement of PACTG Protocol 076.

Grant Support: By the National Institute on Drug Abuse (RO1 DA07904).

Requests for Reprints: Barbara J. Turner, MD, MSEd, Thomas Jefferson University, 1025 Walnut Street, Room 132, Philadelphia, PA 19107-5083; e-mail, barbara.turner{at}mail.tju.edu.

Current Author Addresses: Dr. Turner: Thomas Jefferson University, 1025 Walnut Street, Room 132, Philadelphia, PA 19107-5083.

Dr. Newschaffer and Mr. Zhang: Thomas Jefferson University, 1025 Walnut Street, Room 119, Philadelphia, PA 19107-5083.

Dr. Fanning: New York State Department of Health, Corning Tower Building, 20th Floor, Empire State Plaza, Albany, NY 12237.

Dr. Hauck: Thomas Jefferson University, 1170 Main Building, Philadelphia, PA 19107-5083.