$$XID RFA PA9175 PA-91-75 P1O1 ***************************************** RESEARCH ON RELATIONSHIPS BETWEEN ALCOHOL USE AND SEXUAL BEHAVIORS ASSOCIATED WITH HIV TRANSMISSION PA: PA-91-75 P.T. 34; K.W. 0404003, 0715008, 0715182, 0404000 National Institute on Alcohol Abuse and Alcoholism INTRODUCTION The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites researchers to submit research grant applications that propose to identify and explain associations between alcohol use or misuse and unprotected sexual intercourse, which has been linked to the transmission of the human immunodeficiency virus (HIV), the etiologic agent of AIDS. Persons of heterosexual or homosexual orientation who may be at heightened risk of contracting HIV through unprotected intercourse with an infected sexual partner are of interest to the research effort of NIAAA. Groups of special concern include sexually active adolescents; women, who have become increasingly prominent among AIDS statistics over the past few years, including sexual partners of intravenous (IV) drug users; ethnic and racial minority populations that have been found to have higher prevalence rates of HIV infection; and gay men who are not practicing safer sex. More than 165,000 Americans have been diagnosed with AIDS since the first case was identified approximately ten years ago. Perhaps as many as two million people in this country are infected with HIV. Behavioral interventions are still the only tools available to prevent further spread, and strategies to maintain safer sex practices have become increasingly more important as prevalence rates of the disease rise. For uninfected people living in high prevalence areas, lapses from safer practices can be very costly, and infected individuals must maintain a life-long commitment to safer sexual techniques. Many studies conducted during the first decade of the epidemic have noted impressive levels of behavioral change among some populations (Becker and Joseph, 1988; Stall et al., 1988; Office of Technology Assessment, 1988; Catania et al., 1989). However, appropriate behavioral change has not been universally adopted. Research efforts are beginning to identify factors that support or inhibit protective action. Studies of populations, such as gay men and heterosexual adolescents, suggest that a relationship exists between alcohol consumption behaviors and sexual risk taking. Gay men who drink alcoholic beverages or use illicit drugs in the context of sexual intercourse have been reported to be less likely to use condoms than men who use neither alcohol nor other drugs during sexual activity. Several decades of research on adolescents have provided compelling evidence of covariance among alcohol use, sexual activity, and other problem behaviors. There is a growing appreciation of the diversity of the populations that may be at increased risk for HIV infection as a result of sexual contact in the context of alcohol use. A number of hypotheses have been advanced to explain the observed association between alcohol use and unsafe sex, but few attempts have been made to differentiate between correlational and causal relationships. Thus, NIAAA seeks to encourage in-depth research on the linkage between unprotected sexual behavior and alcohol use or misuse in order to inform and improve the design and implementation of programs to prevent HIV transmission. 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 program announcement for Research on Relationships Between Alcohol Use and Sexual Behaviors Associated with HIV Transmission is related to the priority area of reducing the incidence and prevalence of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone: 202-783-3238). BACKGROUND AIDS case data and information on HIV seroprevalence, inasmuch as it is available, point to the populations that are currently at highest risk for this infection. Because alcohol may be part of the lifestyle of many at-risk individuals, attention needs to be given to the role that alcohol may play in sexual risk taking. A. Same-Gender Sexual Behavior and Alcohol Use The first cases of AIDS in this country were diagnosed among male homosexuals, and that subpopulation continues to account for the majority of cases reported each year. Recent data on alcohol use and sexual behaviors among gay men provide a varied picture of the role that alcohol may play in sexual risk taking in this group. Several studies of gay men have reported a relationship between alcohol use and sexual practices known to be associated with HIV transmission (Stall et al., 1986; Stall, 1988, 1989; Valdiserri et al., 1988; McKirnan and Peterson, 1989a, 1989b; Peterson and McKirnan, 1989; McCusker et al., 1990). According to Stall (1988), drinking in the context of sexual activity (as opposed to overall drinking patterns) is predictive of high-risk sex among gay men in the San Francisco area. Alcohol use also appears to be related to relapse from safer sexual practices to more risky behaviors, especially among men who are not involved in a primary relationship (McKirnan and Peterson, 1989b; Peterson and McKirnan, 1989; Stall et al., 1990b). Other surveys of gay men have found that men who are heavy drinkers are twice as likely as moderate or nondrinkers to become infected (Penkower et al., 1990). Yet an expanded review of the literature does not show a consistent association between alcohol use and high-risk sex (or HIV infection) among gay and bisexual men (Doll, 1989; Molgaard, 1989; Leigh, 1990b; Martin and Hasin, 1990; Zielinski and Beeker, 1989). In a longitudinal study of gay men in the San Francisco area, those who reported consuming greater volumes of alcohol in 1985 were more likely to also report engaging in unprotected anal intercourse than men who drank less (Ekstrand and Coates, 1990). However, in the 1988 wave of data collection, volume of alcohol consumed was not a significant predictor of unprotected anal sex (Ekstrand and Coates, 1990). Other researchers (Doll, 1989; Zielinski and Beeker, 1989) have found a stronger association between high-risk sex and alcohol when it is used in combination with other drugs than when used alone. Moreover, Martin and Hasin (1990) found an association between alcohol use and low-risk sexual practices (insertive and receptive oral sex) but not high-risk behaviors (unprotected insertive and receptive anal intercourse). It is not clear why the association between alcohol use and sexual risk taking is unstable in this population. The variability may reflect the dynamic nature of the behaviors being studied or heterogeneity in the populations being sampled. In addition, measurement problems may have contributed to the lack of clarity that has emerged from research conducted to date. Comparisons across studies have been thwarted by a range of methodological problems, including the use of relatively small convenience samples and nonstandardized instruments. Thus, the variability in the association between alcohol use and unsafe sex warrants additional research attention. B. Heterosexual Risk Taking and Alcohol Use Unprotected vaginal and anal intercourse poses a potential threat to heterosexual individuals. As the AIDS epidemic has progressed, the proportion of cases associated with gay men has decreased while the proportion associated with heterosexual intercourse has increased, largely as a result of contact with infected IV drug users. According to the Centers for Disease Control (CDC) surveillance data, the proportion of all AIDS cases attributed to homosexual and bisexual contact among men dropped from 64.9 percent in 1981 to 55.3 percent in 1989 while, over the same period of time, the cases attributed to heterosexual contact increased tenfold (from 0.5 percent in 1981 to 5.0 percent in 1989) (Miller et al., 1990:45). Epidemiologic data indicate that Blacks and Hispanics are over-represented in the CDC statistics on AIDS cases associated with heterosexual transmission. The increased number of women among reported AIDS cases raises perplexing prevention problems regarding transmission to and from sexual and drug-use partners, as well as perinatal spread to infants. Attempts to probe the association between alcohol and unprotected sex among heterosexual couples have identified a variety of factors that warrant further examination. In the general heterosexual population, alcohol use appears to play a more important role in risky sexual practice at first intercourse with a new partner than during subsequent episodes of sexual contact (Cooper et al., 1989; Cooper et al., 1990; Trocki, 1990; Temple and Leigh, 1991). Use of alcohol also appears to be more prevalent in unanticipated sexual encounters (Temple and Leigh, 1991). Limited data from heterosexual alcoholics indicate that there are subsets who engage in frequent and diverse high-risk sexual activities (Windle, 1989). One small serologic survey of 99 alcohol-abusing patients recruited from a Newark, NJ, treatment center found that 4.5 percent of those with no history of IV drug use were infected with HIV (Schleifer et al., 1989). Because sexually transmitted diseases (STDs) are markers for sexual risk taking and may serve as cofactors in the acquisition and transmission of HIV infection, individuals presenting at STD clinics are generally considered to be at higher risk for AIDS than the general population. A study of heterosexual patients recruited from an STD clinic in San Francisco in late 1989 found that almost all reported some condom use in the past, but only 25 percent had used a condom at last intercourse (CDC, 1990). In a multivariate analysis that controlled for age, race, income, number of sexual partners, and other variables, condom use was lowest among men who had used alcohol or other drugs at the most recent episode of intercourse. However, it is important to note that no statistically significant association between alcohol or other drug use and condom use was found among females who participated in this study. C. Adolescents, Alcohol, and AIDS Early research in the area of adolescent pregnancy prevention found a link between alcohol use and sexual risk taking. A number of researchers working in the area of adolescent health and development (e.g., Jessor and Jessor, 1977; Ensminger and Kane, 1985; Mott and Haurin, 1988; Robertson and Plant, 1988; Elliott and Morse, 1989; Dryfoos, 1990) has noted a clustering of problem behaviors that includes drinking, drug use, delinquent behavior, and precocious sexuality. The early onset of sexual behavior and drug use (including alcohol consumption) do not appear to be isolated events but rather part of a complex pattern of interrelated activities. However, it is not clear whether the association among these activities is correlational or causal. Since the advent of the AIDS epidemic, concern about sexual risk taking has gone beyond the problem of unintended pregnancy. The available epidemiologic data indicate that HIV infection has infiltrated the adolescent population in this country, albeit at varying rates in different locations. In some areas, there are localized pockets of teenagers with relatively high rates of infection (Miller et al., 1990). Even for the United States as a whole, AIDS was the sixth leading cause of death for 15- to 24-year-olds in 1987 (Kilbourne et al., 1990). National and local surveys of adolescents have demonstrated that they possess impressive levels of knowledge about the routes of HIV transmission (CDC, 1988; Hingson et al., 1990a). Unfortunately, however, these surveys have also demonstrated that the great majority of at-risk teens have not consistently adopted safer sexual practices (Strunin and Hingson, 1987; Kegeles et al., 1988; Hingson et al., 1989; 1990b; Keller et al., 1990). For example, a random sample survey of 860 16- to 19-year olds from Massachusetts found that 70 percent were sexually active, but only 15 percent reported changing sexual practices out of concern for AIDS. Of those who reported change, only 20 percent were using effective methods (Strunin and Hingson, 1987). Moreover, 74 percent of sexually active teens in this study who reported five to nine sexual partners in the past year indicated that they did not always use condoms (Hingson et al., 1990b). This lack of adherence to recommended practices is confirmed by a survey of more than 300 14- to 19-year olds attending a San Francisco adolescent health clinic (Kegeles et al., 1988). It was found that only 2.1 percent of females and 8.2 percent of males used condoms every time they had intercourse during this one-year study. Several studies of adolescents have noted that alcohol is associated with sexual behaviors known to transmit HIV infection. In a study of 407 New Jersey adolescents recruited from a general medical clinic and a public high school, Keller and coworkers (1990) found that the strongest predictor of high-risk sexual behavior was moderate use of alcohol or marijuana. Hingson and colleagues (1990b) found that 61 percent of teens participating in a population-based survey in Massachusetts were sexually active; less than one third of sexually active respondents reported consistent condom use, and those who averaged five or more drinks daily were 2.8 times less likely to use condoms than those who reported more moderate drinking. Although national survey data indicate that condom use among American teens doubled during the 1980s (Sonenstein et al., 1989; Forrest and Singh, 1990), overall reduction of sexual risk taking in the context of alcohol use may be more modest. For many teens, sexual contact occurs after drinking, and a significant proportion report that alcohol use reduces the likelihood of engaging in safer sexual practices (Hingson et al., 1990c). Being older and in college does not necessarily protect youth against sexual risk taking in the context of alcohol use. A study of female college students that was conducted prior to the AIDS epidemic, found that heavier drinkers were less likely to use contraception than women who drank less or not at all (Zucker et al., 1981). Research conducted since the onset of the epidemic affirms the association between alcohol use and sexual risk taking among older adolescents and young adults. Among college students reporting on the first occasion of intercourse with a new partner, the likelihood of engaging in risky sexual behaviors appears to be greater when alcohol is consumed than when it is not, regardless of age or sex. Thus, a small study of college students (Cooper et al., 1989) found that alcohol use prior to a sexual encounter significantly increased the likelihood of selecting a casual new partner, of having unplanned intercourse with a new partner, of failing to discuss intercourse prior to enacting it with that partner, and neglecting to use condoms during such intercourse. These relationships persisted when age, sex, and typical pattern of alcohol use were controlled. D. General Caveats It is important to note that, regardless of sexual orientation, abstinence from alcohol use does not imply a complete absence of risky sexual behaviors and that alcohol use does not inevitably lead to unprotected sex. For example, Stall and coworkers (1986) found that 22 percent of gay male respondents who had never used alcohol in association with sexual encounters scored in the highest category for sexual risk taking (defined as engaging in unprotected intercourse in a nonmonogamous relationship), while 14 percent of those who drank in sexual contexts were classified as being at no risk for HIV transmission (i.e., were celibate). Moreover, a small proportion (eight percent) of adolescents in Hingson and coworkers' survey (1990b) reported greater use of condoms after drinking than when not drinking. Our understanding of these complex issues is far from complete. In addition to the methodological problems noted earlier, there are other difficulties inherent in studying this dynamic process. Drinking, sexual patterns, and their interrelationships have been observed to change over time (Martin and Hasin, 1990); they are also likely to show variation across geographic locations and subpopulations. Factors other than alcohol may also impinge on sexual risk taking. Studies of various subpopulations have noted the role of other drugs, such as crack, in risky sexual practices. Indeed, some compulsive risk taking may exhibit pathologic characteristics, reflecting underlying mental health issues that require additional attention. Co-morbidity increases the dimensions of an already complex problem. EXPLANATORY THEORIES The existing theories regarding the nature of the relationship between sexual activity and alcohol use remain largely speculative. The following conceptual scheme proposes a structure for the various hypotheses set forth in the literature. A. Correlational Explanations It can be argued that linkages between drinking behavior and unprotected sex are simply a function of selection processes. That is, certain groups of people or personalities may exist who engage in a variety of risky behaviors, including excessive drinking, use of illicit drugs, unprotected intercourse, and other hazardous behaviors. If so, any relationship between alcohol consumption and sexual behaviors associated with HIV transmission may be correlational or spurious (rather than causal) -- i.e., the relationship may simply be a product of predisposing variables that influence both drinking and unsafe sexual practices. However, analyses of data from one small study of adolescents found that the relationship between alcohol use and sexual risk taking on specific occasions, most notably first intercourse with a new partner, could not be adequately accounted for by some underlying dimension of personality or lifestyle (Cooper et al., 1990). Alternatively, situational factors may be involved in the linkage between alcohol use and unsafe sex. The tavern, cocktail party, or weekend fraternity party may facilitate meeting and entertaining potential sexual partners. In such a context, alcohol and sex are juxtaposed, perhaps increasing the likelihood of risk taking. Trocki (1989) has observed that nonmonogamous individuals spend more time in bars and report more alcohol problems than monogamous people. Other researchers (Stall et al., 1990a; Peterson and McKirnan, 1989) have also reported high levels of sexual risk taking among both heterosexual and homosexual bar patrons. The hedonistic character of the social milieu may reduce or negate caution during the ensuing sexual encounter. That is, although alcohol is an important part of the ambience, it may not in itself contribute to unsafe sexual behavior. The primary contributor might be the broader permissive climate of the social setting that could facilitate risky sexual encounters among homosexual or heterosexual couples. B. Causal Explanations Alcohol may have a direct impact on exposure to and transmission of HIV through a variety of hypothesized mechanisms, including denial, disinhibition, and other factors that affect perceptions, beliefs, intentions, and actual behavior. Some researchers have hypothesized that alcohol used in the context of sexual encounters may lead people to temporarily deny their risk for HIV infection (McKirnan and Peterson, 1989a). People who have a "social orientation" toward bars (i.e., use bars as a primary social setting or social resource) may be particularly vulnerable to risk taking due to their level and frequency of exposure to alcohol, beliefs concerning the properties of this drug, and inadequate or inappropriate reference groups and other social resources (McKirnan and Peterson, 1989a). It is not entirely clear what factors lead individuals to deny or suspend the notion of vulnerability or susceptibility to HIV infection. Alcohol use may result in a disregard for social norms, moral obligations, and behavioral restraint, either from the pharmacologic effects of the drug or from a more complex process involving social and cultural expectations about those effects (Crowe and George, 1989). The physiologic effects of alcohol have been hypothesized to reduce self-control. Perceived effects may enter into the process by overcoming anxiety and other negative feelings that serve to inhibit undesirable actions or by increasing feelings or expectations of pleasurable sensations. In a survey of more than 2,500 gay men, McKirnan and Peterson (1989a) found that alcohol expectancies did not predict the number of sexual partners, except for subjects who believed alcohol would reduce tension or decrease self-awareness. Inappropriate behavior may be attributed to the effects of alcohol and not to any intrinsic characteristic of the individual who drinks. Indulgence and overindulgence in alcohol may thus be used as an excuse for socially unacceptable behavior (Lang, 1983; Crowe and George, 1989). Moreover, blaming inappropriate behavior on alcohol may be anticipated in advance (so-called anticipatory attribution), thereby enabling the questionable action. If adolescents are engaging in drinking as an anticipatory excuse, they should, according to Cooper and colleagues, "hold a particular constellation of beliefs regarding the excuse-giving properties of alcohol. They should, for example, believe that alcohol promotes uncharacteristic behavior, that one cannot be held accountable for his or her behavior when drinking and that alcohol disinhibits sexual behavior" (Cooper et al., 1990). Understanding the belief structure underlying this phenomenon has important implications for intervention strategies targeted toward adolescents and adults. From their review of the literature on alcohol and sexuality, Crowe and George (1989) conclude that "alcohol does have excuse-giving properties and that these properties vary as a function of personal and situational characteristics. The question remains, however, as to the mechanism by which these excuse-giving qualities of expectancy facilitate sexual arousal." More research is needed to understand when and how being "drunk" serves as an acceptable excuse for risky sexual behavior and whether the formulation of such an excuse precedes the act. Finally, AIDS researchers have hypothesized that the physiologic effects of drugs may increase libidinal intensity and thus decrease control of sexual behavior (Ostrow, 1988). At higher doses, alcohol can suppress physiological responses to sexual stimuli, and such suppression appears to be dependent on the pharmacologic action of alcohol (Crowe and George, 1989). Although alcohol, amyl nitrite, and marijuana have all been found to be associated with unsafe sex among gay men (Stall, 1988), it is questionable whether a libidinal hypothesis applies in the case of depressants such as alcohol (Ostrow, 1988), and whether such disparate drugs could each have a similar and profound effect on the libido. A number of studies suggest that the physiological effects of alcohol may be less important than the user's expectations about those effects (McKirnan and Peterson, 1989b; Lang, 1983; Reinarman and Leigh, 1987; Room and Collins, 1983; Crowe and George, 1989; Leigh, 1990a). Alcohol expectancies may contribute to feelings of sexual arousal, interfere with mechanisms that suppress arousal, or facilitate the selective disengagement of self-evaluative processes. The resulting disinhibition is likely to be a function of both pharmacological effects (such as cognitive impairment) and psychological processes that can act separately or together (Crowe and George, 1989). Hingson and colleagues (1990b) hypothesize that cognitive impairment results in a lack of consistent condom use among adolescents who reported using alcohol and other drugs. The authors suggest that "concerns about condom use may seem less pressing when people are intoxicated" (Hingson et al., 1990b). Proper condom use additionally depends on memory, judgment, and the implementation of behavioral intentions that can also be impaired by alcohol use. Risk reduction efforts that target the individual may need to be supplemented with activities that take into account the broader social context in which alcohol use and sexual expression exist. According to Reinarman and Leigh (1987), "if 'alcohol-induced sexual disinhibition' is in important ways a socially constructed phenomenon, then it is possible to imagine it being socially deconstructed as well." If there exists a causal relationship between alcohol use and unsafe sex, there should be a consistent, significant association between these two practices in cross-sectional data, which should also demonstrate that these two behaviors occur on the same occasion. Moreover, longitudinal data should show increased risk with the initiation of alcohol use and decreased risk with cessation of alcohol use. Indeed, one small prospective study (McCusker et al., 1990) of gay men recruited from a Boston community health center provides some support for a causal relationship. Men who reduced their frequency of alcohol use also reported reduction of unsafe sexual practices, while men who maintained or increased their frequency of drinking were twice as likely to report continued high-risk sex (McCusker et al., 1990). Also inherent in causal relationships is the notion that cause precedes effect. Unfortunately, the temporal sequence of events is difficult to establish from cross-sectional and retrospective surveys. Stall and colleagues conclude that the direction of the relationship between drug use and risky sex is not known; that is, we do not know to what extent "risky sex drives drug use, drug use drives risky sex, or some combination of both pathways exists" (Stall et al., 1986). These researchers contend that additional data are needed to distinguish causal and correlational associations. The aforementioned hypotheses represent various attempts to explain linkages between alcohol use and unsafe sex that exist in the literature. The explanations are not intended to be exhaustive but rather indicative of the wide range of possible interpretations of these empirically observed relationships. RESEARCH OBJECTIVES OF NIAAA Under this announcement, researchers are encouraged to study possible relationships between alcohol use and unsafe sexual practices; to determine whether associations are causal or correlative; and to identify specific components of the causal or correlative process, particularly those that have implications for prevention and relapse prevention programs. The objective of this research is to gain a better understanding of the relationship between alcohol use and sexual risk taking as well as the individual and environmental determinants of risky sexual practices enacted in the context of alcohol use. Investigators from a variety of relevant fields are encouraged to apply. These disciplines might include: social psychology, psychology, sociology, anthropology, epidemiology, health education, and others. Prevention research not only encompasses studies of the effectiveness of interventions per se, but it also includes domains of pre-intervention research that lay the groundwork for full-fledged intervention trials. Thus, prevention research spans a range of investigative activities, from social epidemiology used to describe the nature and scope of the problem, to basic research needed to develop hypotheses and theories regarding potential for behavioral change, to applied research required to intervene effectively in the problem (Flay, 1986). Moreover, the applied research itself has a logical sequence, from pilot tests of possible strategies (in laboratory and real-world environments), to small-scale and then larger-scale controlled trials, to technology transfer studies (i.e., tests of dissemination strategies and to effect the adoption of approaches that have proven to be effective). And overarching this spectrum are methodological issues and techniques that also require indepth attention from investigators. Research on the association of alcohol use and unprotected sex is needed at every point on this spectrum. Some investigators who are already involved in AIDS prevention research may be prepared to work on the latter phases of this spectrum, implementing and testing interventions to change alcohol-related behaviors that increase the risk of HIV exposure. Other researchers may prefer to engage in pre-intervention studies. Examples of possible research topics relevant to this announcement include, but are not limited to: o studies to elaborate on the existing descriptions of relationships between alcohol use and unsafe sex, such as: (1) the role of the environment in which alcohol is used (e.g., singles and gay bars, cocktail parties, the home) as a contributor to sexual risk taking; (2) the contribution of particular alcohol consumption patterns (e.g., binge drinking) to unsafe sexual practices; (3) possible variations in linkages between alcohol consumption and sexual risk taking across various types of couples (e.g., monogamous couples, extramarital coupling, sex between strangers, and others) and across different subpopulations (e.g., by gender, race, ethnicity); o methodologic studies to identify innovative, appropriate techniques (e.g., the use of diaries) for gathering data and probing the strength and stability of associations over time and to ascertain the strengths and weaknesses of different measures of pertinent variables; o ethnographic research to provide detailed descriptions of norms governing sexual behavior while drinking and not drinking and to provide detailed information on what makes condom use difficult or appealing in different contexts and how alcohol may affect perceptions of condom usage; o prospective, longitudinal studies to examine the stability and variability of key behaviors over time and to establish the temporal relationships between a range of critical variables that address alcohol use and sexual behaviors known to transmit HIV infection; o studies leading to multivariate analyses that may identify direct, indirect, and interactive effects of a range of variables contributing to sexual risk taking (including the use and misuse of alcohol; expectancies about alcohol; sexual norms, roles, and orientation; impulsivity; perceived vulnerability; and risk taking related to other behaviors); o the design, implementation, and evaluation of intervention programs that seek to prevent risk taking and promote condom use among individuals who use alcohol in the context of sexual activity. Although NIAAA has particular interest in behaviors that increase the risk of HIV infection, it is also important to understand the behaviors that reduce that risk. Thus, researchers alternatively might study drinking and non-drinking populations that protect themselves against exposure to HIV. The use of alcohol in a sexual encounter does not inevitably lead to unprotected sex, and some subsets of people may be more cautious in their sexual behavior when drinking. Perhaps these individuals anticipate possible cognitive impairment and plan ahead. Some inebriated individuals may exercise extreme caution in their sexual behavior (much like drunk drivers who go excessively slowly) because they are afraid of their possible impairment and its consequences, particularly when strangers are involved. Similarly, the use of alcohol may paradoxically result in safer sexual behavior, perhaps by removing some of the inhibitions associated with the negotiation and use of condoms. Research on underlying behavioral processes associated with safer and risky sexual encounters could provide valuable information to scientists who are trying to develop more effective intervention strategies. In confronting the issue at hand, applicants must attempt to understand how alcohol contributes or does not contribute to unsafe sexual practices, keeping in mind the need to disentangle correlational and causal processes. If intervention strategies are proposed for testing, applicants should indicate how their research bears on sexual risk taking in the context of alcohol use. ELIGIBILITY Applications may be submitted by public or private, nonprofit or for-profit, organizations such as universities, colleges, hospitals, research institutes and organizations, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are eligible to apply. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF ADAMHA POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for ADAMHA grants and cooperative agreements are required to include both women and minorities in study populations for clinical research, unless compelling scientific or other justification for not including either woman or minorities is provided. This requirement is intended to ensure that research findings will be of benefit to all persons at risk of the disease, disorder, or condition under study. For the purpose of these policies, clinical research involves human studies of etiology, treatment, diagnosis, prevention, or epidemiology of diseases, disorders or conditions, including but not limited to clinical trials; and minorities include U.S. racial/ethnic minority populations (specifically: American Indians or Alaskan Natives, Asian/Pacific Islanders, Blacks, and Hispanics). ADAMHA recognizes that it may not be feasible or appropriate in all clinical research projects to include representation of the full array of U.S. racial/ethnic minority populations. However, applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. Applications should include a description of the composition of the proposed study population by gender and racial/ethnic group, and the rationale for the numbers and kinds of subjects selected to participate. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. Applications should incorporate in their study design gender and/or minority representation appropriate to the scientific objectives of the work proposed. If representation of women or minorities in sufficient numbers to permit assessment of differential effects is not feasible or is not appropriate, the reasons for this must be explained and justified. The rationale may relate to the purpose of the research, the health of the subjects, or other compelling circumstances (e.g., if in the only study population available, there is a disproportionate representation in terms of age distribution, risk factors, incidence/prevalence, etc., of one gender or minority/majority group). If the required information is not contained within the application, the review will be deferred until it is complete. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If gender and/or minority representation/ justification are judged to be inadequate, reviewers will consider this as a deficiency in assigning the priority score to the application. All applications/proposals for clinical research submitted to ADAMHA are required to address these policies. ADAMHA funding components will not award grants that do not comply with these policies. AIDS INSTITUTIONAL REVIEW BOARD GUIDELINES Applicants are advised to obtain from their Institutional Review Board (IRB) a copy of the "Guidance for Institutional Review Boards for AIDS Studies," that was disseminated from the Office for Protection from Research Risks (OPRR) on December 16, 1984. If a copy is not available locally, one may be obtained from OPRR, Building, 31, Room 4B09, National Institutes of Health, Bethesda, Maryland 20892 or by phone on (301) 496-7005. This office may be consulted for advice on how to deal with difficult issues relating to human subjects protection in AIDS research. These guidelines emphasize the special considerations that must be taken into account in AIDS research and stipulate some important protections that must be taken into account in the design of AIDS research projects. A particularly important requirement is that subjects must be informed of the results of AIDS antibody testing, if any such testing is done. EXPEDITED AIDS APPLICATION RECEIPT AND REVIEW SCHEDULE Receipt Dates Initial Advisory Earliest New and Renewal Review Council Review Start Date January 2 Feb./Mar. May/June June May 1 June/July Sept./Oct. Nov. Sept. 1 Oct./Nov. Jan./Feb. Feb. APPLICATION PROCESS Applicants must use the grant application form PHS 398 (rev. 10/88). The number and title of this program announcement, "PA-91-75, Research on the Relationships Between Alcohol Use and Sexual Behaviors Associated with HIV Transmission", must be typed in item number 2 on the face page of the PHS 398 application form. Application kits containing the necessary forms and instructions may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application material: National Clearinghouse for Alcohol and Drug Information P.O. Box 2345 Rockville, MD 20852 Telephone: (301) 468-2600 The signed original and 24 permanent, legible copies of the completed application must be sent to the address listed below. The number of copies of appendix materials to be sent is six. Applicants who do not submit 24 copies of their application will be requested to do so. Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** AIDS HUMAN SUBJECTS CERTIFICATIONS AND ANIMAL SUBJECTS VERIFICATIONS If the applicant has an approved assurance covering the research (multiple project assurance for human subjects/full assurance of compliance for animal subjects), the applicant should provide, with the application, certification of IRB approval if humans are involved and verification of Institutional Animal Care and Use Committee (IACUC) approval if animals are involved. These reviews and approvals must occur PRIOR TO SUBMISSION of the application, and certifications and verifications must be SUBMITTED WITH the application. Failure to provide required certifications and verifications within the application could result in deferral or rejection. If animals or humans will be the subjects at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION, the applicant must identify, within the application, the assurance status of each participant. Failure to provide this information within the application could result in deferral or rejection. REVIEW PROCEDURES The Division of Research Grants, NIH, serves as the central point for receipt of applications under this program announcement. Applications received will be assigned to an Initial Review Group (IRG) in accordance with established Public Health Service Referral Guidelines. The IRG, consisting primarily of non-Federal scientific and technical experts, will review applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by an appropriate National Advisory Council, where reviews may be based on policy considerations as well as scientific merit considerations. Only applications recommended for approval by these advisory bodies will be considered for funding. REVIEW CRITERIA Criteria to be used in the scientific and technical review of applications will include the following: o the overall scientific and technical merit of the proposal, including the significance of the goals from a scientific standpoint and the adequacy of the methodology to carry out the proposed research; o evidence that the investigators are familiar with the state-of-the-art and existing knowledge gaps in their proposed area of study; o degree of scientific rigor in the design and implementation of the study; o adequacy of the methodology proposed to collect and analyze data, including the instrumentation and analysis plan; o qualifications and research experience of the Principal Investigator and other key research personnel; o availability of adequate facilities, other resources, and collaborative arrangements necessary for the research; o appropriateness of budget estimates for the proposed research activities; o adequacy of provisions for the protection of human subjects; o plans for inclusion of women and minorities. AWARD CRITERIA AND AVAILABILITY OF FUNDS Applications recommended for approval by a National Advisory Council will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, program needs and balance, and the availability of funds. In Fiscal Year 1992, it is estimated that approximately $1.1 million will be available to support approximately four new grants under this announcement. The expected average amount of an award is approximately $250,000. However, the amount of funding available will depend on appropriated funds and program priorities at the time of award. TERMS AND CONDITIONS OF SUPPORT Grant funds may be used for expenses clearly related and necessary to carry out research projects, including direct costs that can be specifically identified with the project and allowable indirect costs of the institution. Research grant support may not be used to establish, add a component to, or operate a prevention, rehabilitation, or treatment service program. Support for research-related prevention, rehabilitation, or treatment services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs that promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. Grants must be administered in accordance with the PHS Grants Policy Statement (rev. October 1, 1990), which should be available from your office of sponsored research. Federal regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. FURTHER INFORMATION Potential applicants are encouraged to seek preapplication consultation. For further information on preparing an application under this announcement, please contact: Heather G. Miller, Ph.D. Prevention Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 5600 Fishers Lane, Room 13-C-23 Rockville, MD 20857 Telephone: (301) 443-1677 For fiscal and administrative matters, contact: Ed Ellis Office of Grants Management National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 16-86 5600 Fishers Lane Rockville, MD 02857 Telephone: (301) 443-4703 SUPPORT MECHANISMS Research support may be requested through applications for a research grant (RO1), small grant (RO3), and First Independent Research Support and Transition (FIRST) Award (R29). Specialized announcements for the FIRST Award program (R29) and the small grant program (R03) are available from: The National Clearinghouse for Alcohol and Drug Information (NCADI), P.O. Box 2345, Rockville, Maryland 20852, telephone (301) 468-2600. Applications for RO1 and R29 awards may request support for up to five years. Small grants are limited to two years. It is recognized that applicants may want to extend the time to continue a longitudinal study of subjects. Whenever such a design is considered, applicants should outline the full scope of the project in the current application and propose to reapply for competitive continuation funding at a later date. FIRST and small grants can not be renewed. Annual awards will be made, subject to continued availability of funds and progress achieved. This program is described in the Catalog of Federal Domestic Assistance No. 93.273. The statutory authorities for these grant awards are sections 301 and 510 of the Public Health Service Act (42 USC 241 and 290bb). 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