The Women's Interagency HIV Study (WIHS) was established in August 1993 to investigate the impact and progression of

HIV The human immunodeficiency viruses (HIV) are two species of '' Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the im ...

disease in women. The WIHS enrolls both

HIV-positive The human immunodeficiency viruses (HIV) are two species of '' Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the im ...

and HIV-negative women. The core portion of the study includes a detailed and structured interview, physical and gynecologic examination, and laboratory testing. The WIHS participants are also asked to enroll in various sub-studies, such as cardiovascular, metabolic, musculoskeletal, and neurocognition. New proposals for WIHS sub-studies are submitted for approval by various scientific investigators from around the world.

Funding

The WIHS is funded primarily by the

National Institute of Allergy and Infectious Diseases The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. NIAID's mis ...

(NIAID), with additional co-funding from the

Eunice Kennedy Shriver National Institute of Child Health and Human Development The ''Eunice Kennedy Shriver'' National Institute of Child Health and Human Development (NICHD) is one of the National Institutes of Health (NIH) in the United States Department of Health and Human Services. It supports and conducts research ai ...

(NICHD), the

National Cancer Institute The National Cancer Institute (NCI) coordinates the United States National Cancer Program and is part of the National Institutes of Health (NIH), which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. ...

(NCI), the

National Institute on Drug Abuse The National Institute on Drug Abuse (NIDA) is a United States federal government research institute whose mission is to "advance science on the causes and consequences of drug use and addiction and to apply that knowledge to improve individual ...

(NIDA), and the National Institute on Mental Health (NIMH). Targeted supplemental funding for specific projects is also provided by the

National Institute of Dental and Craniofacial Research The National Institute of Dental and Craniofacial Research (NIDCR) is a branch of the U.S. National Institutes of Health. The institute aims to improve the oral, dental, and craniofacial health through research and the distribution of important ...

(NIDCR), the

National Institute on Alcohol Abuse and Alcoholism The National Institute on Alcohol Abuse and Alcoholism (NIAAA), as part of the U.S. National Institutes of Health, supports and conducts biomedical and Behavioral research, behavioural research on the causes, consequences, treatment, and prevent ...

(NIAAA), the

National Institute on Deafness and other Communication Disorders The National Institute on Deafness and Other Communication Disorders (NIDCD), a member of the U.S. National Institutes of Health, is mandated to conduct and support biomedical and behavioral research and research training in the normal and diso ...

(NIDCD), and the NIH

Office of Research on Women's Health An office is a space where the employees of an organization perform administrative work in order to support and realize the various goals of the organization. The word "office" may also denote a position within an organization with specific dut ...

(ORWH). WIHS data collection is also supported by UL1-TR000004 (UCSF CTSA) and UL1-TR000454 (Atlanta CTSA).

Clinical sites

WIHS clinical sites are located in and around 10 cities in the United States. Each is headed by one or more Principal Investigators. * Atlanta, Georgia (Igho Ofotokun, Gina Wingood) * Birmingham, Alabama (Michael Saag, Mirjam-Colette Kempf) * Bronx, New York (Kathryn Anastos) * Brooklyn, New York (Howard Minkoff, Deborah Gustafson) * Chapel Hill, North Carolina ( Ada Adimora) * Chicago, Illinois (Mardge Cohen) * Jackson, Mississippi (Deborah Konkle-Parker) * Miami, Florida (

Margaret Fischl Margaret Fischl is an American physician, HIV/AIDS researcher, and professor of medicine at the University of Miami. She is notable for being one of the first researchers to discover the effectiveness of the antiretroviral medication azidothymidi ...

, Lisa Metsch) * San Francisco, California (Ruth Greenblatt, Bradley Aouizerat, Phyllis Tien) * Washington, DC (Seble Kassaye) In addition, the WIHS Data Management and Analysis Center (Stephen Gange, Elizabeth Topper) is located in Baltimore, MD. Each consortium is affiliated with local research institutes to see study participants. Each also has its own Community Advisory Board.

Recruitment

WIHS was funded in five cycles: * WIHS I: November 1, 1992 – October 31, 1997 * WIHS II: November 1, 1997 – October 31, 2002 * WIHS III: November 1, 2002 – December 31, 2007 * WIHS IV: January 1, 2008 – December 31, 2012 * WIHS V: January 1, 2013 - December 31, 2017 Initial enrollment into the WIHS occurred between October 1994 and November 1995. The total initial enrollment for the WIHS was 2,056

women and 569 HIV-negative women. Since WIHS recruited its initial population, several new trends developed as the

epidemic An epidemic (from Greek ἐπί ''epi'' "upon or above" and δῆμος ''demos'' "people") is the rapid spread of disease to a large number of hosts in a given population within a short period of time. For example, in meningococcal infection ...

evolved, all of which argued for an expansion of the WIHS

cohort Cohort or cohortes may refer to: Cohort Sociological * Cohort (military unit), the basic tactical unit of a Roman legion * Cohort (educational group), a group of students working together through the same academic curriculum Scientific * Cohort ...

. First, despite careful follow-up of the cohort, the inevitable course of

illness A disease is a particular abnormal condition that adversely affects the structure or function (biology), function of all or part of an organism and is not immediately due to any external injury. Diseases are often known to be medical condi ...

and time had led to attrition and

death Death is the end of life; the irreversible cessation of all biological functions that sustain a living organism. Death eventually and inevitably occurs in all organisms. The remains of a former organism normally begin to decompose sh ...

. Additionally, increased sample sizes were needed because the effectiveness and consequences of Highly Active Antiretroviral Therapy (HAART) added new strata to many key analyses, and decreased the incidence of clinical outcomes. And finally, as the original cohort continued to age, it became less able to support studies of risk behaviors,

sexually transmitted diseases A sexually transmitted infection (STI), also referred to as a sexually transmitted disease (STD) and the older term venereal disease (VD), is an infection that is spread by sexual activity, especially vaginal intercourse, anal sex, oral ...

, and reproductive function. Thus, WIHS funding was augmented in 2001 to empower the study to efficiently and precisely meet the study's specific aims through the recruitment of additional women. Total enrollment in 2001-02 (WIHS visits 15 and 16) was 738

and 403 HIV-negative participants. Beginning in January 2011, the WIHS opened enrollment again, in order to replace those women who had died during WIHS III and WIHS IV. Total enrollment in 2011-12 (WIHS visits 35-37) was 276

and 95 HIV-negative participants. In the summer of 2013, the WIHS began enrolling approximately 800 women from the WIHS Southern sites (Atlanta, GA; Chapel Hill, NC; Miami, FL; Birmingham, AL; Jackson, MS). All potential study participants underwent an initial screening to determine study eligibility. If the woman was willing to take part in the study and gave informed consent, she participated in an in-depth interview, physical exam, and specimen collection. In 2019, the WIHS merged with the Multicenter AIDS Cohort Study (MACS), to form the MACS/WIHS Combined Cohort Study (MWCCS).

References

External links

WIHS web site

Multicenter AIDS Cohort Study (MACS) web site

The North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) web site
{{AIDS HIV/AIDS Clinical trials related to HIV Cohort studies 1993 establishments in the United States

Funding

Clinical sites

Recruitment

See also

References

Further reading

External links