Women and AIDS Research Initiative Amendments of 1993

Summary: Women and AIDS Research Initiative Amendments of 1993 - Amends the Public Health Service Act to establish a program to conduct or support biomedical and behavioral research on cases of infection with the human immunodeficiency virus (HIV) in women.  Regulates clinical trials with women subjects.  Mandates the conduct or support of:  (1) clinical trials regarding the effectiveness of standard gynecological treatments in treating conditions arising from HIV infection; (2) clinical trials regarding whether the treatment protocols approved for men with HIV infection are effective for women with HIV infection; (3) research on barrier methods for the prevention of sexually transmitted diseases that women can use without their sexual partner's cooperation or knowledge; and (4) epidemiological research to determine HIV risk factors particular to women. Mandates support services for women in clinical trials.  Regulates the Women's Interagency HIV Study.  Authorizes appropriations.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Women and AIDS Research Initiative 
Amendments of 1993''.

SEC. 2. ESTABLISHMENT OF GENERAL PROGRAM OF RESEARCH REGARDING WOMEN 
              AND ACQUIRED IMMUNE DEFICIENCY SYNDROME.

    Part B of title XXII of the Public Health Service Act (42 U.S.C. 
800cc-11 et seq.) is amended by adding at the end the following 
section.

``SEC. 2321. RESEARCH REGARDING WOMEN.

    ``(a) In General.--With respect to cases of infection with the 
human immunodeficiency virus, the Secretary shall establish a program 
for the purpose of conducting biomedical and behavioral research on 
such cases in women, including research on the prevention of such 
cases. The Secretary may conduct such research directly, and may make 
grants to public and nonprofit private entities for the conduct of the 
research.
    ``(b) Certain Forms of Research.--In carrying out subsection (a), 
the Secretary shall provide for research on--
            ``(1) the manner in which the human immunodeficiency virus 
        is transmitted to women, including the relationship between 
        cases of infection with such virus and other cases of sexually 
        transmitted diseases, and clinical trials which examine the 
        question of the how the level of HIV infection can be prevented 
        by finding and treating sexually transmitted diseases in women;
            ``(2) measures for the prevention of exposure to and the 
        transmission of such virus, including research on--
                    ``(A) the prevention of any sexually transmitted 
                disease that may facilitate the transmission of the 
                virus;
                    ``(B) rapid, inexpensive, easy-to-use sexually 
                transmitted disease diagnostic tests for women;
                    ``(C) inexpensive single dose therapy for treatable 
                sexually transmitted diseases;
                    ``(D) the development of methods of prevention for 
                use by women; and
                    ``(E) the development and dissemination of 
                prevention programs and materials whose purpose is to 
                reduce the incidence of substance abuse among women;
            ``(3) the development and progression of symptoms resulting 
        from infection with such virus, including research regarding 
        gynecological infections as well as breast changes, hormonal 
        changes, and menses and menopause changes, whose occurrence 
        becomes probable as a result of the deterioration of the immune 
        system;
            ``(4) the treatment of cases of such infection, including 
        clinical research; and
            ``(5) behavioral research on the prevention of such cases 
        and research on model educational programs for such prevention.
    ``(c) Clinical Trials.--
            ``(1) Gynecological evaluations.--In clinical trials under 
        this title in which women participate as subjects, the 
        Secretary shall ensure that--
                    ``(A) each female subject who is infected with the 
                human immunodeficiency virus--
                            ``(i) undergoes a gynecological examination 
                        as part of the evaluation of the medical status 
                        of the woman prior to participation in the 
                        trial; and
                            ``(ii) receives appropriate follow-up 
                        services regarding such examination; and
                    ``(B) the results of the gynecological examinations 
                are analyzed to determine the relationship between 
                gynecological conditions and the infection with such 
                virus.
            ``(2) Standard treatments for gynecological conditions.--
        The Secretary shall conduct or support clinical trials under 
        subsection (a) to determine whether standard methods of 
        treating gynecological conditions are effective in the case of 
        such conditions that arise as a result of infection with the 
        human immunodeficiency virus.
            ``(3) Effectiveness of certain treatment protocols.--With 
        respect to cases of infection with the human immunodeficiency 
        virus, the Secretary shall conduct or support clinical trials 
        under subsection (a) to determine whether treatment protocols 
        approved for men with such cases are effective for women with 
        such cases.
            ``(4) Support services.--
                    ``(A) In conducting or supporting clinical trials 
                under this title in which women participate as 
                subjects, the Secretary shall provide the women with 
                such transportation, child care, and other support 
                services (including medical and mental health services, 
                treatment for drug abuse, and social services), 
                including services addressing domestic violence as may 
                be necessary to enable the women to participate as such 
                subjects.
                    ``(B) Services under subparagraph (A) shall include 
                services designed to respond to the particular needs of 
                women with respect to participation in clinical trials 
                under this title, including, as appropriate, training 
                of the individuals who conduct the trials.
    ``(d) Prevention Programs.--
            ``(1) Sexual transmission.--
                    ``(A) With respect to preventing the sexual 
                transmission of the human immunodeficiency virus, the 
                Secretary shall conduct or support research under 
                subsection (a) on barrier methods for the prevention of 
                sexually transmitted diseases, including HIV disease, 
                that women can use without their sexual partner's 
                cooperation or knowledge.
                    ``(B) In carrying out subparagraph (A), the 
                Secretary shall give priority to identified research 
                needs and opportunities identified at the National 
                Institutes of Health sponsored meeting on Development 
                of Topical Microbicides that was held in May of 1993, 
                including research on--
                            ``(i) the early stages in infectious 
                        processes;
                            ``(ii) the identification, formulation and 
                        preclinical evaluation of new preparations;
                            ``(iii) clinical testing for safety and 
                        efficacy; and
                            ``(iv) studies concerning the acceptability 
                        and compliance of safe, effective microbicides.
            ``(2) Epidemiological research.--The Secretary shall 
        conduct or support epidemiological research under subsection 
        (a) to determine the factors of risk regarding infection with 
        the human immunodeficiency virus that are particular to women, 
        including research regarding--
                    ``(A) the use of various contraceptive methods;
                    ``(B) the use of tampons;
                    ``(C) the relationship between such infection and 
                other sexually transmitted diseases;
                    ``(D) the relationship between such infection and 
                various forms of substance abuse (including use of the 
                form of cocaine commonly known as crack); and
                    ``(E) the relationship between such infection and 
                sexual activity.
    ``(e) Interagency Study.--With respect to the study being carried 
out by the Secretary (as of June 1993) through various agencies of the 
Public Health Service for the purpose of monitoring the progression in 
women of infection with the human immunodeficiency virus, and 
determining whether such progression is different in women than in men, 
which study is known as the Women's Interagency HIV Study, the 
following applies:
            ``(1) The Secretary shall ensure that not less than 5,000 
        women with such infection are included in the study.
            ``(2) The Secretary shall provide for an increase in the 
        number of sites at which the study is to be conducted.
            ``(3) The Secretary shall ensure that the study period is 
        for a minimum of 8 years.
            ``(4) With respect to the human cells commonly known as CD4 
        cells, the Secretary shall ensure that the study adequately 
        addresses the relationship between the number of such cells and 
        other markers in women with such infection and the development 
        of serious illnesses in such women. For purposes of the 
        preceding sentence, the study shall address gynecological 
        conditions, and other conditions particular to women, that are 
        not currently included in the list of conditions arising from 
        such infection that, for surveillance purposes, is maintained 
        by the Director of the Centers for Disease Control and 
        Prevention.
    ``(f) Definition.--For purposes of this section, the term `human 
immunodeficiency virus' means the etiologic agent for acquired immune 
deficiency syndrome.
    ``(g) Authorizations of Appropriations.--
            ``(1) Clinical trials.--
                    ``(A) For the purpose of carrying out subsection 
                (c)(1), there are authorized to be appropriated 
                $20,000,000 for fiscal year 1994, and such sums as may 
                be necessary for each of the fiscal years 1995 through 
                1996.
                    ``(B) For the purpose of carrying out subsection 
                (c)(2), there are authorized to be appropriated 
                $10,000,000 for fiscal year 1994, and such sums as may 
                be necessary for each of the fiscal years 1995 through 
                1996.
                    ``(C) For the purpose of carrying out subsection 
                (c)(3), there are authorized to be appropriated 
                $10,000,000 for fiscal year 1994, and such sums as may 
                be necessary for each of the fiscal years 1995 through 
                1996.
                    ``(D) For the purpose of carrying out subsection 
                (c)(4), there are authorized to be appropriated 
                $15,000,000 for fiscal year 1994, and such sums as may 
                be necessary for each of the fiscal years 1995 and 
                1996.
            ``(2) Prevention programs.--
                    ``(A) For the purpose of carrying out subsection 
                (d)(1), there are authorized to be appropriated 
                $30,000,000 for fiscal year 1994, and such sums as may 
                be necessary for each of the fiscal years 1995 through 
                1996.
                    ``(B) For the purpose of carrying out subsection 
                (d)(2), there are authorized to be appropriated 
                $10,000,000 for fiscal year 1994, and such sums as may 
                be necessary for each of the fiscal years 1995 through 
                1996.
            ``(3) Interagency study.--For the purpose of carrying out 
        subsection (e), there are authorized to be appropriated 
        $15,000,000 for fiscal year 1994, and such sums as may be 
        necessary for each of the fiscal years 1995 through 1996.''.