AIDS has emerged as the international health crisis of the 20th century. The Centers for Disease Control and Prevention estimates that 1 million people are infected with HIV-1 in the United States. Through December 1995, CDC reported 513,486 cases of AIDS in adults and 6,948 in children.

Racial and ethnic minorities now account for over 60 percent of the reported AIDS cases in the United States. Through December 1995, 39 percent of the reported AIDS cases were among African Americans and 19 percent were among Hispanics/Latinos. AIDS is now responsible for one-third of all deaths among African American men ages 25 to 44. In addition, HIV infection acquired through injection drug use has been a major factor affecting minority communities. During 1995, 50 percent of the AIDS cases acquired as a result of injection drug use were in African Americans and 24 percent were in Hispanics/Latinos.

Approximately 78 percent of HIV-infected women are of minority background and most became infected through heterosexual transmission. As a consequence, the majority of HIV-infected children are African American or Hispanic/Latino. In 1995, 84 percent of the children reported with AIDS were African American or Hispanic/Latino.

One of the greatest challenges facing AIDS researchers today is the recruitment and retention of minority patients for clinical trials. People of minority background face unique social, economic, and medical problems in coping with the challenges attendant to HIV infection. As the epidemic expands in minority communities, inclusion of these patients in clinical trials is particularly urgent as it is important that the results of the research are applicable to all populations affected by the disease. An additional challenge is the recruitment of underrepresented minority investigators to AIDS and AIDS-related clinical and basic research disciplines.

The four major areas in which NIAID specifically addresses minority issues in HIV disease are treatment research, epidemiologic research, vaccine and prevention research, and infrastructure development and training of minority researchers.

Treatment Research

In treatment research, NIAID, through its extramural and intramural programs, directs a large national clinical trials program that consists of four components: the Adult AIDS Clinical Trials Group (A-ACTG), the Pediatric AIDS Clinical Trials Group (P-ACTG), the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), and the Division of AIDS Treatment Research Initiative (DATRI). All of these networks strive to ensure that a sufficient proportion of minority subjects are enrolled into clinical trials so that the results of the research may be generalizable to the affected HIV population at large. NIAID works with these networks to identify the need for and assist in the development of culturally sensitive educational materials, to recognize real or potential barriers to recruitment and retention in clinical research for these groups, and to establish mechanisms to overcome these barriers.

The A-ACTG is a nationwide multicenter clinical trials network that tests new drugs and treatment strategies for adults infected with HIV. Thirty-one institutions are currently funded as adult AIDS Clinical Trials Units (ACTUs). Three of these institutions were originally funded in FY 1993 in response to an RFA released by NIAID titled AAIDS Clinical Trials in Minority Institutions." These institutions, which serve predominantly minority populations, are Howard University (Washington, D.C.), University of Puerto Rico (San Juan), and University of Hawaii (Honolulu). The A-ACTG has also established a minority young investigator fellowship program to encourage the participation of minorities in clinical research. Two awards were made in 1996.

The P-ACTG is a national multicenter clinical trials network that conducts studies designed to test and improve therapies to prevent and treat HIV infection and its complications in infants, children, and adolescents. The development of more effective treatments for infected children and improved methods for preventing perinatal transmission offer significant benefit to minority communities, given the prevalence of pediatric AIDS in children from these communities. Results from one NIAID-supported clinical trial (ACTG 076), which were disseminated in 1994, demonstrated that zidovudine (ZDV) reduces the rate of transmission from mother to infant. These findings have been translated into prevention efforts that have contributed to a reduction in the number of new cases of pediatric HIV infection.

In an effort to provide greater flexibility in the conduct of pediatric AIDS clinical trials, NIAID released an RFA titled ARecompetition of the Pediatric AIDS Clinical Trials Group" in 1996. This competitive renewal will enable the P-ACTG to address high-priority scientific questions and quickly build on new and emerging insights into the pathogenesis of HIV infection. Awards are anticipated in 1997.

In FY 1996, 35 percent of the patients enrolled in A-ACTG trials were African American, 25 percent were Hispanic/Latino, and 1.5 percent were other minorities. In NIAID-supported P-ACTG studies during the same period, 51.7 percent of the patients enrolled in the main studies were African American, 29.7 percent were Hispanic/Latino, and less than 1 percent were other minorities.

In 1989, NIAID created the CPCRA, a community-based clinical trials network currently located at 16 sites in 15 cities. Because these sites are located in community settings such as health care centers and clinics, the CPCRA is able to expand opportunities for women, minorities, and injection drug users (IDUs) to participate in clinical research. In FY 1996, 31 percent of the new enrollees in CPCRA trials were African American, 12 percent were Hispanic/Latino, and 1.7 percent were other minorities. In addition, 16 percent of these study participants were women, and 46 percent were IDUs.

DATRI conducts innovative or intensive studies not easily performed within the ACTG or CPCRA. In FY 1996, DATRI initiated a new multicenter, placebo-controlled study to examine whether low-dose oral alpha-interferon (LDOAI) therapy is effective in reducing the symptoms of AIDS. This study, which is of particular interest to minority communities, is being conducted at several sites in the United States and compares three preparations of LDOAI. Patients receive treatment (either one of the three products or placebo) for 6 months; approximately 560 patients are expected to enroll. As of October 1996, more than 100 patients were enrolled in the study.

Epidemiologic Research

In epidemiologic research, NIAID supports studies that explore the clinical, natural history, and transmission implications of HIV infection in a variety of populations, including minorities. Groups of inner-city women, children, and IDUs are the focus of the Women and Infants Transmission Study (WITS), which evaluates factors related to perinatal HIV transmission and disease progression in women and children. As of December 1996, 86 percent of the women enrolled in WITS/WITSII were minorities.

The Women’s Interagency HIV Study (WIHS), which was established in 1993, is designed to describe the spectrum and course of clinical manifestations of HIV infection in women, particularly minorities. WIHS operates in tandem with the HIV Epidemi-ology Research Study, initiated in 1992 and sponsored by NIAID and CDC. These studies provide information essential to the design of clinical trials and other research projects to evaluate better therapeutic modalities for women. When the WIHS’s enrollment closed in November 1995, 56 percent of the participants were African American and 24 percent were Hispanic/Latina.

The Multicenter AIDS Cohort Study (MACS) completed its 12th year of study of HIV infection in homosexual/bisexual men volunteers, including minorities. These men are among the longest followed and most intensively studied persons with HIV infection in the world and continue to provide important new insights into the mechanisms by which HIV damages the immune system and how the immune system of the host combats HIV infection. In June 1996, 15 percent of those enrolled in the MACS were of minority backgrounds.

Vaccine and Prevention Research

In the clinical component of vaccine research, NIAID directs the AIDS Vaccine Evaluation Group (AVEG), which includes six AIDS Vaccine Evaluation Units located at academic research centers throughout the United States. The AVEG continues efforts to increase the enrollment of minorities in its phase I and phase II clinical studies of the safety and immunogenicity of candidate HIV vaccines. As of June 1996, 14 percent of those enrolled in AVEG trials were from minority communities.

NIAID now is preparing for the conduct of HIV vaccine efficacy trials through its HIV Network for Prevention Trials (HIVNET). HIVNET’s goals are to conduct domestic and international multicenter trials to evaluate the safety and efficacy of promising vaccines and other interventions to prevent sexual, perinatal, and parenteral transmission using HIV seroincidence as the primary trial endpoint. The domestic HIVNET sites have implemented the Vaccine Preparedness Study (VPS) to determine HIV seroincidence, the relative risk of HIV seroconversion with counseling, and the willingness of individuals to enroll in HIV vaccine efficacy trials. The VPS has enrolled participants at high risk for HIV infection, including gay men, IDUs, and women at heterosexual risk. Two of these cohorts, IDUs and women, involve predominantly minorities. More than 1,100 IDUs are participating in VPS prospective seroincidence and risk reduction studies to determine if this would be an appropriate target population for vaccine efficacy trials. A study to identify optimal methods for obtaining informed consent from IDUs and others at high risk for HIV infection has been completed and analysis is under way.

The international HIVNET sites are located in Brazil, Haiti, India, Kenya, Malawi, Senegal, Thailand, Uganda, and Zimbabwe. Studies of behavioral, microbicide, and perinatal transmission interventions are currently in progress at these sites.