Research Topic #3

HIV treatment outcomes in women, including during pregnancy

Research Topic 3, Aim 1: Outcomes of ART will be analyzed separately for women and men, with a focus on health issues specific to women.

Three sites (Argentina, Chile, Haiti) already have extensive data on outcomes of the disease and treatment in women with HIV that include woman-specific issues, primarily because they provide PMTCT. The available data includes routine care during more than one pregnancy, Pap smears, and/or HPV testing for some women. Databases at sites currently collecting this data will be harmonized and further developed to include uniform woman-specific data including pregnancy dates / outcomes, and HPV or Pap smear data. This will also be done as feasible at additional sites (although latter may require more than one year for completion).

The rationale for this is that outcomes of HIV disease and treatment must be considered separately from men for both biological and sociobehavioral reasons. The differences in child care roles, jobs, economic independence, and health-related decision-making may affect their health care access and their adherence to medications. It is also important to study issues that only affect women (effect of pregnancy on health, cervical cancer risks).

Research Topic 3, Aim 2: The impact of initial and subsequent pregnancies on HAART outcomes will be determined.

We hypothesize that pregnant women present earlier for care, that good prenatal care impacts positively on the mother's health, and that HIV outcome (viral load and CD4 count) will be improved during a woman's first pregnancy compared to non-pregnant women (controlled for baseline predictors). In contrast, we predict that prior perinatal prophylaxis with nevirapine (in the absence of accompanying agents) during an earlier pregnancy will negatively impact on effectiveness of a nevirapine-containing regimen for HIV control in the mother in a subsequent pregnancy. (Although we also hypothesize a negative impact on preventing transmission to the neonate, this question will not be studied here unless data collection opportunities change.)

Research Topic 3, Aim 3: Clinical course, drug toxicities, and drug dosing will be studied together to judge whether adult protocols are suitable for Latina and Caribbean women who may be much smaller in body mass index, height, weight, and weight-for-height than HIV-infected North American or European women.

The rationale for this is that with the feminization of the HIV epidemic, increased knowledge of specific women's health issues including HPV-related disease, vaginal ecology and its relation to transmission risk, and tolerability of and response to ART is greatly needed. We hypothesize toxicities of ART will be increased compared with men or women with larger BMI. We also believe that there is an important link between our women's research agenda and our attention to treatment impact on opportunistics infections.

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