Full Text PA-96-074 DRUG USE, SEXUAL RISK BEHAVIORS, AND HIV IN MEN NIH GUIDE, Volume 25, Number 32, September 27, 1996 PA NUMBER: PA-96-074 P.T. 34 Keywords: AIDS Drugs/Drug Abuse Risk Factors/Analysis National Institute on Drug Abuse PURPOSE The purpose of this program announcement (PA) is to support epidemiological and HIV prevention research on drug use, sexual risk behaviors, and HIV in an especially high risk group: men who use drugs and have sex with men (DU MSM). DU MSM use drugs by injection and/or noninjection means (e.g., crack cocaine and smokable or intranasal forms of methamphetamine and heroin) and have same-gender sex regardless of their self-identified sexual orientation (gay, bisexual, or heterosexual). Because DU MSM may engage in both high risk drug use and sexual practices, and may have multiple and different drug use and sex partners and networks, they not only constitute an important HIV risk group in and of themselves but also have the potential to serve as a bridge for HIV transmission to heterosexual injecting drug users (IDUs) and non-IDU MSM. Promising directions for the epidemiology and prevention of HIV in this dual risk group will draw from cumulative research related to the epidemiology and prevention of HIV in MSM, IDUs, and noninjecting drug users. This PA seeks to stimulate research on (1) the co-occurrence of HIV risk behaviors among men who use injection and/or non- injection drugs and who have sex with men, and the adverse health consequences, (2) antecedents and correlates of high risk, especially social/situational contexts of HIV risk and protective behaviors among DU MSM and their drug use and/or sex partners and networks; (3) the efficacy and effectiveness of behavioral and biological HIV prevention interventions for diverse groups of DU MSM, including comparative evaluations of intervention outcomes and costs/benefits of community-based outreach, prevention, and treatment approaches to averting new HIV infection; and (4) development and evaluation of new behavioral therapies, drug abuse treatment approaches, health services, and health care services delivery to DU MSM. Within these research themes, investigators are encouraged to expand, test, and improve current identification and recruitment strategies, research designs, methods, and measures of behavioral risk and intervention effects among hard-to-reach subgroups of DU MSM. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This PA, Drug Use, Sexual Risk Behaviors, and HIV in Men, is related to the priority areas of reducing alcohol and other drug use and the transmission of HIV. Potential applicants may obtain a copy of "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through Superintendent of Documents, Government Printing Office, Washington DC 20402 (Telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms under this PA will include the traditional research project grant (R01), small grants (R03), and FIRST (R29) awards. Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of an award will also vary. RESEARCH OBJECTIVES Background Historically, HIV epidemiology and prevention research has focused on the highest prevalence and incidence exposure groups, i.e., either men who have sex with men or injecting drug users and noninjecting users of crack cocaine. Little attention has been given to the dual risk category of DU MSM, who may acquire HIV infection either sexually or parenterally. Nor has much attention focused on DU MSM who have recently initiated injecting drug use, though a recent report suggests new drug injectors may be at especially high risk for the HIV infection and hepatitis B and C, possibly from sexual activity prior to injecting drugs (Garfein et al., 1996). Fifteen years into the HIV/AIDS epidemic, attention has begun to focus on exposure groups in which HIV infection is emerging or increasing in prevalence and on the need to formulate new strategies for primary prevention and behavior change interventions for these populations. Compared to men who report sex with men as their only HIV risk factor (in whom the incidence of HIV is stable or declining), increasing proportions of HIV incidence cases are occurring among men who report injecting drug use as their only risk and among men who report dual risks from both drug injecting and sex with men, especially men of color. Since first recognized in early 1981, AIDS has been diagnosed in 434,719 male adolescents and adults in the U.S.(CDC, 1995). Of these, 259,672 cases (60%) occurred in MSM; 95,244 (22%) in IDUs; and 33,195 (8%) in the dual risk category of IDU MSM. In addition, an estimated half of all HIV incident infections in the U.S. are occurring among injecting drug users (Holmberg, 1996). Drug injection has gained a proportionately greater share of cases as a HIV risk category among Hispanic, African American, and American Indian/Alaskan Native men. HIV/AIDS surveillance data do not provide reports about noninjecting drug use among MSM; however, this group is at high risk, especially if they trade sex for drugs and/or money or engage in high risk sexual practices as a result of drug use before or during sex. Noninjecting drug users may have been former injectors or may never have injected drugs out of concern of exposure to the HIV infection from contaminated syringes, but many of these men are using crack, methamphetamines, and other drugs as well as engaging in high risk sexual practices. In certain situations and settings, they are also at risk of initiating injection drug use and resulting health consequences. Though the epidemiology, determinants, and mediators of high risk drug and sex practices, as well as HIV prevention strategies have been researched for some time with respect to IDUs, crack cocaine users, and gay men, the risk behaviors, consequences, and prevention strategies to limit the spread of HIV among the dual risk group of DU MSM remain inadequately understood. Only a handful of studies have focused on this group, though their risks of HIV infection are strikingly high. A recent multivariate analysis of data from NIDA~s Cooperative Agreement for AIDS Community-Based Outreach/ Intervention Research Program found that the strongest single predictor of HIV seropositivity in a sample of not-in-treatment male drug users was being homosexual. Other significant predictors were having ever injected drugs and residing in a high HIV seroprevalence (15% and higher) area. Bisexual status alone was not a significant predictor of seropositivity, but being both bisexual and African American increased the likelihood to over 4 times that of heterosexual IDUs. In 1995, NIDA and CDC initiated a multi-site pilot study of the drug use and sex risk behaviors of not-in-treatment MSM who injected drugs or used crack cocaine. Although all the men reported drug use and having sex with men, there was a wide range in types and frequencies of drugs us-ed and in sex partners and sexual risk behaviors as well as a wide array of age groups and racial/ethnic categories involved. Findings from this study attest to the diversity of the DU MSM population and point to the need to go beyond uniform health models to better address their HIV risk-taking behaviors. NIDA and CDC plan to use study data to develop appropriate HIV intervention strategies, but to date, no prevention programs have been specifically tailored for this under-researched population. It is important to understand the extent to which HIV research and prevention efforts designed to study and moderate the risk behaviors of gay men and/or heterosexual drug users can be adopted and made effective for the dual risk group of DU MSM, especially with respect to contextual factors that influence HIV risk behaviors. Moreover, understanding the future of this epidemic will improve dramatically if researchers begin to shift their thinking from an individual-level perspective of behavior to viewing risk behaviors as social transactions between individuals and groups and begin to focus on the contexts in which multiperson use of drug injection equipment and sex risks take place. Applicants are encouraged to pay attention to social factors which can influence the initiation of risk as well as behavior change among DU MSM and that involve not only the individual but also couples, groups, or networks to which the DU MSM belongs and in which norms of behavior are practiced and preserved. Various research approaches, including epidemiology, ethnography, controlled clinical trials, and evaluation are applicable to a comprehensive HIV prevention research portfolio alone or in phased stages of multidisciplinary study. Research Areas This PA will support research on the epidemiology and prevention of HIV-related behaviors and adverse health consequences among DU MSM. Researchers are encouraged to review the cumulative literature on the epidemiology and prevention of HIV in gay men, IDUs, and non-injection drug users and to adapt and refine research protocols and models of HIV prevention that have proven to be effective with drug using men or men who have sex with men. Investigators are encouraged to integrate such information into new theory-based primary prevention and behavior change interventions and health services. A broad range of studies are envisioned, including but not limited to the following research areas: (1) Epidemiology of HIV-related behaviors and health consequences (morbidity/mortality) in DU MSM. Suggested topics include, but are not limited to: o Studies in areas of high, moderate, and low HIV seroprevalence of the incidence, prevalence, trends and predictions of DU MSM~s drug use patterns and the co- occurrence of high risk drug use and sex behaviors (e.g., types of drug used, multiperson use of injection equipment, numbers and types of sex partners). o Studies of syringe acquisition, drug acquisition, drug preparation, injection practices, and syringe disposal behaviors among IDU MSM as well as biological/ serological studies of the HIV transmissibility risks associated with these behaviors. o Studies of risk and/or protective antecedents and correlates associated with the initiation of drug injection among MSM, including factors influencing the transition from non-injection to injection use (e.g., roles of community culture, social networks, peer influence) and the continuation of use (may involve injection/non-injection patterns associated with specific drugs or drug combinations). o Research on the epidemiology of physical, sexual, and emotional violence (including stigmatization) against or among DU MSM, and on the relationship of such violence to the co-occurrence of HIV-related risk behaviors and other adverse health consequences. o Research to improve epidemiologic methods and measures for monitoring, reporting, and predicting the course and spread of HIV seroincidence in DU MSM and among their drug use and sex partners. (2) Antecedents, correlates, and contexts of HIV risk/protective behaviors. Suggested topics include, but are not limited to: o Studies of the effects of macro-level factors on the epidemiology and adoption, maintenance, change, and relapse of HIV-related behaviors of DU MSM (e.g., community policies toward needle exchange and condom distribution programs, including closures/relocations of services); law enforcement practices in areas where sex is traded for drugs or money or where drugs are used in public settings; and other access and barrier issues related to community-based HIV/AIDS education and prevention programs. o Social network research to characterize the HIV-related behaviors of DU MSM in their immediate injection/non- injection drug use risk networks, sex risk networks, and combined drug use and sex risk networks. Social network research is also needed to understand the out-group contacts and mixing strategies of DU MSM who act as bridges to other networks (e.g., networks of non-drug using MSM; networks of IDUs who do not engage in same- gender sex). o Research on intrapersonal, dyadic, and group factors affecting the adoption, maintenance, and change of HIV risk and protective behaviors among DU MSM (e.g., testing seropositive or learning that one's drug use or sex risk partner has seroconverted, interpersonal skills at negotiating behavior change, economic dependence on one~s partner, affiliative ties, coercion and violence) as well as factors associated with relapse to risky behavior, relapse prevention, and recovery. o Factors which influence HIV seropositive DU MSM to notify injecting drug use and sex risk partners of their serostatus, to take precautions against secondary spread of the HIV infection to others, or to risk transmitting HIV to persons who are not infected by sharing injecting equipment and/or by engaging in unprotected sex. (3) Evaluation of behavioral and biological HIV prevention interventions specifically tailored for DU MSM. Multilevel, multicomponent interventions are encouraged, and the complexity of sexual and drug-related risks should be addressed when developing appropriate interventions. Suggested studies include, but are not limited to: o Theoretically guided, community-based studies to investigate the effectiveness and acceptability of new HIV prevention and intervention approaches, singly or in combination, among divergent groups and risk networks of DU MSM. Studies of community outreach, condom and bleach distribution, syringe exchange, HIV counseling and testing, and partner notification projects are needed to evaluate what works, for whom it works, under what circumstances it works, and how long it works. o Studies of the optimal sequencing of risk reduction interventions taking into account the types and levels of risk engaged in as well as the episodic nature of HIV risk behaviors/ behavior change and need for intermittent reinforcement. o Studies of the diffusion of innovative interventions, including credible opinion leaders and social change processes affecting the adoption and/or maintenance of lower sexual and drug using risk behaviors of DU MSM. o Single-site studies or comparative evaluations are needed to address the attributes and relative costs/benefits of peer-initiated, social network-based, and community-based risk reduction interventions and/or treatment programs with respect to changing multiple risk behaviors and averting HIV infections. (4) Research on Drug Abuse Treatment and Health Care Delivery for DU MSM. Suggested topics include but are not limited to: o Research to develop and pilot test new behavioral therapies for drug abuse or to modify existing therapies for use with DU MSM. o Studies to identify, develop, and pilot test HIV risk reduction interventions which can be integrated within drug abuse treatment programs for DU MSM. o Clinical trials of well-specified behavioral therapies and risk reduction interventions identified as promising in pilot testing with divergent groups of DU MSM both within and outside of the gay community. o Health services research on the delivery of drug abuse treatment and other health care to DU MSM, including studies of factors that impact access and utilization of services, effectiveness of services, barriers to effective service delivery, and strategies for improving service delivery. NIDA POLICY ON HIV COUNSELING AND TESTING Researchers funded by NIDA, who are conducting research in community outreach settings, clinics, hospital settings, or clinical laboratories, and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk-reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection include injection drug users, crack cocaine users, and sexually active drug users and their sex partners. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning this policy. Confidentiality. The Public Health Service (PHS) has a formal policy concerning Certificates of Confidentiality and communicable disease reporting. In brief, the policy reflects the expectation that research projects will cooperate with State and local health departments to assure that the purposes of reporting are accomplished, and the expectation that health departments will develop relationships with research projects that assist their mission without thwarting the research goals. A description of the policy as well as Instructions for Applicants can be obtained after award. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard AIDS receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, NIH, 6701 Rockledge Drive, MSC 7762, Bethesda, MD 20892-7762, telephone 301-710-0267, email: asknih@odrockm1.od.nih.gov. The title and number of this PA must be typed in Item 2 on the face page of the application. The completed original and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific or technical significance and originality of the proposed research; o appropriateness and adequacy of the research approach and methodology proposed to carry out the research; o qualifications and research experience of the principal investigator and staff; o availability of resources necessary to the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues involving epidemiologic and HIV prevention and intervention research to: Richard H. Needle, Ph.D., M.P.H. or Elizabeth Y. Lambert, M.Sc. and Helen Cesari, M.Sc. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-42 Rockville, MD 20857 Telephone: (301) 443-6720 FAX: (301) 443-2636 Email: RN28E@NIH.GOV; EL46I@NIH.GOV; HC30X@NIH.GOV Direct inquiries regarding programmatic issues involving research in clinical/drug abuse treatment settings to: Robert J. Battjes, D.S.W. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-38 Rockville, MD 20857 Telephone: (301)443-6697 FAX: (301) 443-2317 Email: RB97H@NIH.GOV Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8-A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: GF6S@NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279 and 93.242. Awards are authorized under the Public Health Service Act, Section 301 and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Grants will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. April 1994). This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103- 227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care of early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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