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Women's Natural History Studies

July/August 1997

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

Much of what is known today about HIV/AIDS was learned from long-term natural history studies of gay men, such as the Multicenter AIDS Cohort Study (MAC) and the San Francisco Gay Men's Health Study. Current understanding of modes of transmission, biologic cofactors, behavioral cofactors, acute HIV infection, progression of HIV disease and case definitions of AIDS were derived from these studies. Until recently, no comparable long-term cohort studies had been conducted in women.

Globally, HIV is a disease acquired primarily via heterosexual intercourse. Although the male cohort studies advanced the overall understanding of HIV's behavior, they inevitably were unable to frame or answer basic questions regarding gynecologic manifestations of HIV infection, hormonal considerations in women, or the mechanics and epidemiology of heterosexual, female-to-female and perinatal transmission.

Critical to our current knowledge of the prevalence of HIV infection in women are data obtained from population-based studies of newborns that began in 1986. These studies, funded by the CDC, used anonymous samplings of newborns as a surrogate for uncovering the underlying HIV seroprevalence in women of childbearing age (see "Mandatory Testing" and "Management of HIV-Exposed Newborns" in this issue). These studies established that women living in economically depressed, urban centers throughout the U.S. had substantial seroprevalence of HIV infection (from 2% to 6% of women). Reports by various authors have tracked the epidemiologic status of women, an early example being a publication (JAMA, 1987) authored by Mary Guinan of the CDC, Epidemiology of AIDS in Women in the United States. Early, small cohort studies in women have also contributed to our knowledge base, particularly in the area of gynecologic disease. Carpenter published data in 1991 regarding 200 HIV-positive women followed in Rhode Island. Substantial data regarding abnormal Pap smear findings and risk for dysplasia and cervical cancer in women have been published, although treatment recommendations are lacking (see "Cervical Cancer," "Genital Warts," and "Candidiasis" in this issue). Investigation into the mechanics of maternal-infant HIV transmission led to the intervention study of use of zidovudine to reduce perinatal transmission (ACTG 076).

At the present time, there are various ongoing, longitudinal, natural history or heterosexual transmission studies of HIV in women; for example, EVE, HATS, HERS, WIHS. Women enrolled in these studies receive transportation, up to $80 payment per visit, and other incentives. Still they often complain about the long visits (four to five hours), the blood draws (9 to 10 tubes of blood), and the in-depth initial two-hour interviews asking about everything from anal intercourse, sexual abuse, and domestic violence to menstrual calendar data. What knowledge do we expect to gain over the next five years, and how will that knowledge be used to help women? At this interim point, the following data is emerging from two large cohort studies, WIHS and HERS. It is of enduring importance for consumers, advocates and clinicians to continue to monitor and provide critical input into these studies.

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Women's Interagency HIV Study (WIHS)

WIHS is a longitudinal study of 2,080 HIV-positive women and 575 HIV-negative high-risk women enrolled between October 1994 and November 1995. There are WIHS collaborative sites in: the Bronx/Manhattan; Brooklyn; Washington, D.C.; Chicago; San Francisco/Bay Area; and Los Angeles/Southern California/Hawaii. WIHS's objective is to investigate the spectrum of AIDS-defining and other HIV-related conditions in women, the predictors of genital infections and cervical disease, the immunological and clinical correlates of disease progression, risk behaviors, health care utilization, depression, domestic violence and quality of life. To date, WIHS has published substantial abstracted data from the entire cohort and from subcohorts. Some highlights include:
  • High prevalence of domestic violence and childhood sexual abuse in the cohort.

  • High prevalence of coinfection with Hepatitis C (40% of 269 women tested), with use of injection drugs the strongest predictive behavior for this coinfection.

  • 25% of the cohort reported ever having sex with a female partner.

  • HIV-positive women in the cohort have more comorbidity (diabetes, high blood pressure, etc.) than the HIV-negative women (25% vs. 18%).

  • More acute genital tract infections in the HIV-negative women; positive women had more chronic genital tract infections.

  • High prevalence of lower genital tract symptoms in the positive women (itch, discharge, ulceration and vulvar pain) even in the absence of identified infection.

  • Amenorrhea linked to severe immune deficiency (13% of women with CD4 counts below 50).

  • Variability of HIV viral load in the genital tract.

  • Close correlation between viral load in cervicovaginal secretions and in plasma.

  • 10% of the 533 HIV-positive women coinfected with another retrovirus, HTLV-II, with injection drug use again being the strongest predictor.


HIV Epidemiology Research Study (HERS)

HERS is a multicenter study of women with or at high risk for HIV infection. Study sites are in Baltimore, the Bronx, Detroit, and Providence, RI. HERS has conducted observational and demographic research in the entire cohort (863 HIV-positive and 430 HIV-negative women) as well as selected subcohort studies. Some significant data thus far, include:
  • Underutilization of anti-HIV therapy and opportunistic infection prophylaxis.

  • 28% of positive women reported having at least one family member with HIV infection.

  • 40% of women with or at high risk for HIV experienced childhood sexual abuse.

  • Longer persistence of human papillomavirus (HPV) in the positive women, compared to the at-risk women.

  • Oral and vaginal colonization of candidiasis associated with low CD4 counts.

  • Rare fluconazole resistance among oral and vaginal candida isolates.

  • High prevalence of bacterial vaginosis (BV) in women with or at risk for HIV.

  • Women with female sex partners were 3 times more likely, and women with male partners were 1.7 times more likely to have BV than women without partners.


Office on Women's Health Finally Gets Around to HIV

by Saundra Johnson

On July 8, 1997, the U.S. Public Health Service's Office on Women's Health finally developed a formal interest in women and HIV disease. Approximately 60 women attended the July meeting either in person or via the telephone. The goal of the gathering was to address issues that contributed to the 3% increase in the women's AIDS-related death rate observed in the first half of 1996 while the death rate in other AIDS populations decreased. To its credit, the Office on Women's Health admitted its tardiness on the subject of HIV/AIDS. But the absence of a representative from the NIH's Division of AIDS was strikingly noticeable and did nothing to improve the Office's credibility.

Since the issues affecting women living with HIV are many and varied, the group decided to divide the issues into six general categories -- prevention, care, research, partnership, policy and "interfaith issues" -- with the understanding that there would be some overlap. In addition, the group was asked to consider policy, partnerships and interfaith issues within each of the first three categories.

Under prevention, female-controlled microbicides and integration of prevention into institutions already used by women were major issues. The care category included access to care within the realm of Medicaid managed care. Separate analyses by gender, a central database for the Women's Interagency HIV Study (WIHS) and HIV Epidemiology Research Study (HERS) were just two issues in the research category. Cross-category issues included social conditioning of women as a deterrent to self-care and advocacy and vaccine trials.

Instead of attempting to prioritize issues within the categories in the short time remaining, a suggestion was made that the Office on Women's Health produce a document that will look at past prevention, care, research and policy agendas and list where there has been improvement and where there has not. The checklist approach will better allow the group to see where the gaps still exist and to prioritize future efforts.

Still, the question on the minds of most of the community women present was, "just how much authority, if any, does the Office on Women's Health have to support any recommendations that are eventually put forth?" Many felt that too often, women have sat through many meetings like this, volunteered for work groups and drafted numerous recommendations only to have their hard work and the issues concerning women living with HIV ignored.

A draft of the document should be ready in time for discussion at the next meeting, which is scheduled for September 12, 1997. For information regarding participation, contact Frances Page in the Office on Women's Health at 202/690-7650.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by Gay Men's Health Crisis. It is a part of the publication GMHC Treatment Issues. Visit GMHC's website to find out more about their activities, publications and services.
 
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HIV/AIDS Resource Center for Women
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