African-American Consultation Meeting and NIDA’s Revised HIV Testing & Counseling Policy Jacques Normand, Ph.D. Director, AIDS Research Program National Institute on Drug Abuse

CONSULTATION ON RESEARCH INITIATIVES: HIV TESTING AND COUNSELING IN THE AFRICAN AMERICAN COMMUNITY December 11, 2006

Objective of Presentation Highlight research challenges & recommendations raised in meeting –Health disparities –Conspiracy beliefs/distrust –Stigma –Early HIV identification –Criminal Justice Background on nature and magnitude of problem

African Americans bear a disproportionate burden of HIV/AIDS in US

Expansion of HIV Testing Implementation of scaled-up HIV Testing and Counseling will identify a disproportionate number of African Americans as being HIV+. Must ensure that research minimizes potential harmful effects (e.g., stigmatization) while optimizing potential benefits (e.g., early diagnosis and linkage to care).

Awareness of Serostatus Among People with HIV and Estimates of Transmission ~25% Unaware of Infection ~75% Aware of Infection People Living with HIV/AIDS: 1,039,000-1,185,000 New Sexual Infections Each Year: ~32,000 Accounting for: ~54%of New Infections ~46% of New Infections Marks, et al AIDS 2006;20:

Late HIV Testing is Common Among 4,127 persons with AIDS*, 45% were first diagnosed HIV-positive within 12 months of AIDS diagnosis (“late testers”) Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more likely to be: –Younger (18-29 yrs) –Heterosexual –Less educated –African American or Hispanic MMWR June 27, 2003*16 states

OBJECTIVES OF MEETING To ensure that NIDA identifies all potential harmful and beneficial effects associated with conducting research on HIV testing and counseling To solicit suggestions on how to enhance the beneficial effects while mitigating the harmful effects of HIV testing.

AIDS advocacy (e.g., NAPWA, NMAC) Drug policy organizations (NASADAD) Federal agencies (NIH, SAMHSA, CDC) Faith community Researchers –substance abuse treatment, –criminal justice, –health disparities, and –primary care. Participants

African Americans are more segregated than any other racial/ethnic group. Segregation determines SES by affecting quality of education and employment opportunities, income, and health. Conditions linked to segregation can constrain the practice of healthy behaviors and encourage unhealthy ones. Impact of segregation on health disparities is not disease specific and can adversely impact access to quality care. Health Disparities Challenge

Develop, implement, & evaluate interventions that addresses Social Context to improve access and utilization of health care services including HIV Testing and Counseling. Train Health care professionals to be more culturally sensitive. Develop strategies to better utilize social institutions within the community to deliver interventions. Health Disparities Recommendations

HIV/AIDS Conspiracy Beliefs A lot of information about AIDS is being held back (58%). HIV is a man-made virus (48%). AIDS was produced in a government laboratory (27%). A cure for AIDS exists, but it is being withheld from the poor (53%). People who take the new medicines for HIV are human guinea pigs for the government (44%). Bogart and Thorburn, J Acquir Immune Defic Syndr, 2005

HIV/AIDS Conspiracy Beliefs are: A manifestation of some African Americans’ mistrust of the federal government and health care system. Imbedded in the context of historical and current racial discrimination and mistreatment. Conspiracy Beliefs/Distrust Challenge

Conspiracy Beliefs/Distrust: Recommendations Better understand conspiracy beliefs in order to effectively address them. What models of community participation in research are most useful for mitigating distrust.

Stigma Related to: Homophobia HIV seropositivity Drug use Prevention messages do not adequately address stigma Stigma Challenge

Develop new strategies to identify and engage community institutions (e.g., Faith Base) to address stigma. Better understand sources of information used by diverse African Americans subgroups. Develop culturally sensitive educational programs to address stigma across African American subgroups. Stigma Recommendations

HIV Testing Challenge African American will test positive at a higher rate the other ethnic groups. Linkage to treatment given funding limitations (Ryan White flat funding for 4 yrs & regional variations). African Americans are late testers even though their rate of having been tested is about equal to other ethnic groups

HIV testing Recommendations Identify the factors that deter people from accessing HIV screening How to implement and evaluate integration of HIV/AIDS services as part of drug abuse treatment How can research better address concerns about confidentiality What strategies and resources are needed to better engage primary care physician for T & C in African American communities

High prevalence of HIV infection in criminal justice populations Denial, fear of illness and concern about confidentiality are major deterrents for inmates HIV transmission among criminal justice populations Prevalence of comorbid condition is high, incarcerated populations have multiple health care needs. How to ensure continuity of care upon release Criminal Justice Challenge

Criminal Justice Recommendations Research to compare various modalities of HIV testing and counseling in prisons and jails (e.g., voluntary vs mandatory, pre-test counseling vs no pre-test counseling, etc.) Develop and evaluate health discharge- planning strategies. Develop HIV transmission prevention interventions for re-entry into the community.

Update on HIV Testing and Counseling: Revised Policy NATIONAL INSTITUTE ON DRUG ABUSE POLICY ON HIV EDUCATION, COUNSELING, TESTING, AND TREATMENT FOR RESEARCH SUBJECTS

AIDS Ethics Workgroup One year ago Council established the AIDS Ethics Workgroup: David Vlahov Jeanne Brooks-Gunn Mark Greenberg Patricia Ordorica Claire Sterk Ellie Schoenbaum Robert Levine/Kaveh Khoshnood, Yale Celia Fisher/Meena Mahadevan, Fordham

Assigned Tasks Review and update, NIDA’s 2001 Policy on Counseling and Testing for HIV/AIDS and Other Infectious Diseases. Develop guidelines for NIDA-supported investigators engaged in domestic and international HIV prevention trials. The guidelines are to ensure that proper ethical principles for protecting human participants and that adequate provision of care are being addressed after their trials are completed.

Historical Perspective June 9, 1995: HIV/AIDS Counseling & Testing Policy for the National Institute on Drug Abuse –The policy strongly encourages NIDA-funded researchers to make HIV risk reduction counseling and HIV testing available to research subjects at high risk for acquiring or transmitting HIV. –Studies where contacts are brief, researchers encouraged to provide HIV risk reduction materials available. –Provide Admin. Suppl. to implement recommendation

Historical Perspective (Cont.) January 4, 2001: National Institute on Drug Abuse Policy on Counseling and Testing for HIV/AIDS and Other Infectious Diseases –Expand to include: HBV, HCV, TB, STDs, and other infectious agents. –Studies where contacts are brief researchers encouraged to provide easy to read materials on drug abuse, HIV, other comorbid & infectious conditions. –NIDA’s policy is that NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction counseling and testing, treatment, and other appropriate interventions, as needed, to prevent acquisition and transmission of infectious agents.

Revised Policy 2007 Revised Policy: National Institute on Drug Abuse Policy on HIV/AIDS Education, Counseling, Testing, and Treatment. –NIDA’s policy is:” NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. –Rationale Document describe changes –Take note of significant advancement in Rapid testing and effective Tx for HIV –Applies to domestic and international.

Revised Policy (Cont.) 2007 Revised Policy: –Special consideration should be given to providing educational materials focused on the prevention, testing, and treatment for other infectious diseases (e.g. HBV and HCV) that are common among drug abusers. –At minimum, education in a verbal format or easy- to-read materials on drug abuse and HIV/AIDS should be available to research subjects when the study is not based in or directly affiliated with a counseling, testing or treatment facility.

Revised Policy (Cont.) 2007 Revised Policy: –In keeping with NIH’s authority to conduct research, 42 U.S.C. §284(b)(1), NIDA funds are not to be used to support testing, counseling and treatment services for HIV that are outside the scope of the NIDA sponsored research design. It is, however, important that research subjects who are at risk for HIV receive such services. Therefore, investigators are strongly encouraged to seek and identify alternative sources of funding for the provision of appropriate diagnostic and therapeutic services for their research subjects. (policy statement provides link to free services) –NIDA grantees should provide in all Progress and Final Reports submitted to the Agency a rationale and description of the services provided or their efforts to link subjects to appropriate services provided under this policy.