I

104TH CONGRESS

2D SESSION H. R. 3176

To amend the Public Health Service Act to establish programs of research

with respect to women and cases of infection with the human

immunodeficiency virus.

IN THE HOUSE OF REPRESENTATIVES

MARCH 27, 1996

Mrs. MORELLA introduced the following bill; which was referred to the

Committee on Commerce

A BILL

To amend the Public Health Service Act to establish programs of research with respect to women and cases of

infection with the human immunodeficiency virus.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Women and AIDS Re5 search Initiative Amendments of 1996’’.
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1 SEC. 2. ESTABLISHMENT OF GENERAL PROGRAM OF RE2 SEARCH REGARDING WOMEN AND ACQUIRED

3 IMMUNE DEFICIENCY SYNDROME.

4 Part B of title XXIII of the Public Health Service

5 Act (42 U.S.C. 300cc–11 et seq.) is amended by adding

6 at the end the following section:

7 ‘‘SEC. 2321. RESEARCH REGARDING WOMEN.

8 ‘‘(a) IN GENERAL.—With respect to cases of infec9 tion with the human immunodeficiency virus, the Sec10 retary shall establish a program for the purpose of con11 ducting biomedical and behavioral research on such cases

12 in women, including research on the prevention of such

13 cases. The Secretary may conduct such research directly,

14 and may make grants to public and nonprofit private enti15 ties for the conduct of the research.

16 ‘‘(b) CERTAIN FORMS OF RESEARCH.—In carrying

17 out subsection (a), the Secretary shall provide for research

18 on the following:

19 ‘‘(1) The manner in which the human

20 immunodeficiency virus is transmitted to women, in21 cluding the relationship between cases of infection

22 with such virus and other cases of sexually transmit23 ted diseases, including clinical trials which examine

24 the question of how much human immunodeficiency

25 virus infection can be prevented by finding and

26 treating sexually transmitted diseases in women.
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1 ‘‘(2) Measures for the prevention of exposure to

2 and the transmission of such virus, including re3 search on the following:

4 ‘‘(A) The prevention of any sexually trans5 mitted disease that may facilitate the trans6 mission of the virus.

7 ‘‘(B) Rapid, inexpensive, easy-to-use sexu8 ally transmitted disease diagnostic tests for

9 women.

10 ‘‘(C) Inexpensive single dose therapy for

11 treatable sexually transmitted diseases.

12 ‘‘(D) The development of methods of pre13 vention for use by women.

14 ‘‘(E) The development and dissemination

15 of prevention programs and materials whose

16 purpose is to reduce the incidence of substance

17 abuse among women.

18 ‘‘(3) The development and progression of symp19 toms resulting from infection with such virus, in20 cluding research regarding gynecological infections

21 as well as breast changes, hormonal changes, and

22 menses and menopause changes, whose occurrence

23 becomes probable as a result of the deterioration of

24 the immune system.
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1 ‘‘(4) The treatment of cases of such infection,

2 including clinical research.

3 ‘‘(5) Behavioral research on the prevention of

4 such cases and research on model educational pro5 grams for such prevention.

6 ‘‘(6) Research leading to an understanding of

7 social, economic, and legal factors whose impact con8 tributes to an increased risk of such infection.

9 ‘‘(7) Research leading to an understanding of

10 social, economic, and legal factors whose impact con11 tributes to—

12 ‘‘(A) low levels of participation by women

13 in clinical trials; or

14 ‘‘(B) inadequate access to health care serv15 ices, or inadequate utilization of such services.

16 ‘‘(c) CLINICAL RESEARCH.—

17 ‘‘(1) GYNECOLOGICAL EVALUATIONS.—In clini18 cal trials regarding the human immunodeficiency

19 virus in which women participate as subjects, the

20 Secretary shall ensure—

21 ‘‘(A) that the designs of the trials include

22 adequate evaluation of prospective subjects

23 prior to enrollment, and adequate evaluation of

24 subjects during the course of the trials, includ25 ing evaluation of the reproductive tract, and ap-
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1 propriate follow-up services regarding such eval2 uations; and

3 ‘‘(B) the conduct of studies related to the

4 propensity for cases of infection with such virus

5 to cause abnormalities in the reproductive tract,

6 or to alter the natural history of other repro7 ductive-tract infections and diseases.

8 ‘‘(2) STANDARD TREATMENTS FOR GYNECO9 LOGICAL CONDITIONS.—The Secretary shall conduct

10 or support clinical trials under subsection (a) to de11 termine whether standard methods of treating gyne12 cological conditions are effective in the case of such

13 conditions that arise as a result of infection with the

14 human immunodeficiency virus.

15 ‘‘(3) EFFECTIVENESS OF CERTAIN TREATMENT

16 PROTOCOLS.—With respect to cases of infection with

17 the human immunodeficiency virus, the Secretary

18 shall conduct or support clinical research under sub19 section (a) to determine the effectiveness, on such

20 cases in women, of approved treatment protocols.

21 ‘‘(4) SUPPORT SERVICES.—

22 ‘‘(A) In conducting or supporting clinical

23 trials regarding the human immunodeficiency

24 virus in which women participate as subjects,

25 the Secretary shall take into account factors
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1 that can facilitate such participation, including

2 consideration of employment schedules and the

3 provision of support services. The Secretary

4 may provide such services accordingly, including

5 transportation services, child care services, med6 ical and mental health services, treatment for

7 drug abuse, social services (including services

8 addressing domestic violence), and other sup9 port services.

10 ‘‘(B) Services under subparagraph (A)

11 shall include services designed to respond to the

12 particular needs of women with respect to par13 ticipation in the clinical trials involved, includ14 ing, as appropriate, training of the individuals

15 who conduct the trials.

16 ‘‘(d) PREVENTION PROGRAMS.—

17 ‘‘(1) SEXUAL TRANSMISSION.—

18 ‘‘(A) With respect to preventing the sexual

19 transmission of the human immunodeficiency

20 virus and other sexually transmitted diseases,

21 the Secretary shall conduct or support research

22 under subsection (a) on topical microbicide and

23 physical barrier methods of prevention that

24 women can use without their sexual partner’s

25 cooperation or knowledge.
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1 ‘‘(B) In carrying out subparagraph (A),

2 the Secretary shall—

3 ‘‘(i) give priority to carrying out the

4 topical microbicide research agenda of the

5 National Institutes of Health, including

6 agendas regarding basic research, product

7 development, and clinical evaluation of new

8 and existing products; and

9 ‘‘(ii) give special consideration to re10 search on topical microbicides that are not

11 spermicides and that otherwise are meth12 ods that do not pose a threat to the ability

13 of women to conceive and bear healthy

14 children.

15 ‘‘(2) EPIDEMIOLOGICAL RESEARCH.—The Sec16 retary shall conduct or support epidemiological re17 search under subsection (a) to determine the factors

18 of risk regarding infection with the human

19 immunodeficiency virus that are particular to

20 women, including research regarding—

21 ‘‘(A) the use of spermicides and other con22 traceptive methods;

23 ‘‘(B) the use of vaginal products, including

24 douches, tampons, and vaginal medications;
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1 ‘‘(C) the relationship between such infec2 tion and other sexually transmitted diseases;

3 ‘‘(D) the relationship between such infec4 tion and various forms of substance abuse (in5 cluding use of the form of cocaine commonly

6 known as crack); and

7 ‘‘(E) the relationship between such infec8 tion and noncoital forms of sexual activity.

9 ‘‘(e) INTERAGENCY STUDY.—With respect to the

10 study (known as the Women’s Interagency HIV Study)

11 that, as of March 1996, is being carried out by the Sec12 retary through various agencies of the Public Health Serv13 ice for the purpose of monitoring the progression in

14 women of infection with the human immunodeficiency

15 virus, and determining whether such progression is dif16 ferent in women than in men, the following applies:

17 ‘‘(1) The Secretary shall ensure that not less

18 than 2,500 women with such infection are included

19 in the study, and that the demographic variability of

20 the cohort is maintained.

21 ‘‘(2) The Secretary shall ensure that the study

22 period is extended for a minimum of 5 years.

23 ‘‘(3) With respect to markers of human

24 immunodeficiency virus disease progression and viral

25 activity (including the cells commonly known as CD4
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1 cells and including quantitative viral load measures),

2 the Secretary shall ensure that the study adequately

3 addresses the relationship between such markers and

4 the development of serious illnesses in such women.

5 For purposes of the preceding sentence, the study

6 shall address gynecological conditions, and other

7 conditions particular to women, that are not cur8 rently included in the list of conditions arising from

9 such infection that, for surveillance purposes, is

10 maintained by the Director of the Centers for Dis11 ease Control and Prevention.

12 ‘‘(f) DEFINITIONS.—For purposes of this section, the

13 term ‘human immunodeficiency virus’ means the etiologic

14 agent for acquired immune deficiency syndrome.

15 ‘‘(g) AUTHORIZATIONS OF APPROPRIATIONS.—

16 ‘‘(1) CLINICAL RESEARCH.—In addition to any

17 other authorizations of appropriations that are avail18 able for the following purposes:

19 ‘‘(A) For the purpose of carrying out sub20 section (c)(1), there are authorized to be appro21 priated $20,000,000 for fiscal year 1997, and

22 such sums as may be necessary for each of the

23 fiscal years 1998 through 1999.

24 ‘‘(B) For the purpose of carrying out sub25 section (c)(2), there are authorized to be appro-
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1 priated $10,000,000 for fiscal year 1997, and

2 such sums as may be necessary for each of the

3 fiscal years 1998 through 1999.

4 ‘‘(C) For the purpose of carrying out sub5 section (c)(3), there are authorized to be appro6 priated $10,000,000 for fiscal year 1997, and

7 such sums as may be necessary for each of the

8 fiscal years 1998 through 1999.

9 ‘‘(D) For the purpose of carrying out sub10 section (c)(4), there are authorized to be appro11 priated $15,000,000 for fiscal year 1997, and

12 such sums as may be necessary for each of the

13 fiscal years 1998 and 1999.

14 ‘‘(2) PREVENTION PROGRAMS.—In addition to

15 any other authorizations of appropriations that are

16 available for the following purposes:

17 ‘‘(A) For the purpose of carrying out sub18 section (d)(1), there are authorized to be appro19 priated $10,000,000 for fiscal year 1997, and

20 such sums as may be necessary for each of the

21 fiscal years 1998 through 1999.

22 ‘‘(B) For the purpose of carrying out sub23 section (d)(2), there are authorized to be appro24 priated $10,000,000 for fiscal year 1997, and
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1 such sums as may be necessary for each of the

2 fiscal years 1998 through 1999.

3 ‘‘(3) INTERAGENCY STUDY.—In addition to any

4 other authorizations of appropriations that are avail5 able for the purpose of carrying out subsection (e),

6 there are authorized to be appropriated for such

7 purpose $6,000,000 for fiscal year 1997, and such

8 sums as may be necessary for each of the fiscal

9 years 1998 through 1999.’’.

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