Josiah Brown Poster Abstract

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David Shabsovich
Thomas Coates PhD
Dvora Joseph Davey PhD, David J. DiTullio PhD, Ulundi Shumza, Landon Myer MD,PhD
Prepping for PrEP: Evaluating pregnancy symptoms and ART side effects in pregnant women in Cape Town, South Africa
Global Health Research Fellowship

Introduction:  The incidence of HIV in pregnant women in South Africa is among the highest in the world.  HIV pre-exposure prophylaxis (PrEP) is a safe and effective HIV prevention strategy that is currently not offered to pregnant women in South Africa.  Consequently, the factors that affect adherence to PrEP in pregnant women at high risk for acquiring HIV in South Africa have not been studied.  Among these factors, side effects may represent a barrier to the success of PrEP as a means of preventing HIV infection during pregnancy.  Studies of PrEP and antiretroviral therapy (ART) in pregnant women focus on high grade symptoms and do not include evaluation of attribution of symptoms experienced.  PrEP and ART side effects and misattribution of pregnancy symptoms as side effects could diminish adherence to PrEP and ART in pregnant women in this setting, leading to decreased efficacy, increased risk of HIV acquisition (HIV-negative women) or viremia (HIV-positive women), and increased risk of mother-to-child transmission. 

Purpose: Our goal was to evaluate the following in a group of HIV-positive pregnant/recently pregnant women on ART: (1) frequency and attribution of symptoms experienced, (2) concerns about ART, (3) adherence to ART during pregnancy, and (4) understanding of and feelings about the survey.  Additionally, we will use ART as a proxy for PrEP in HIV-negative pregnant women, as PrEP and ART have similar side effects, to inform design of an upcoming study evaluating PrEP delivery in pregnant women in the same population.

Methods: We designed a mixed methods (quantitative and qualitative) survey that assessed the aforementioned factors in HIV-positive pregnant/recently pregnant women currently enrolled in an ongoing study evaluating sexually transmitted infections (STIs) in pregnancy at the Gugulethu Midwife Obstetrics Unit in Cape Town, South Africa.  Two groups of women were surveyed – Group A (n=11), which consisted of women that initiated ART during their current pregnancy, and Group B (n=20), which consisted of women that initiated ART before their current pregnancy.  The survey was administered by the study counselor in isiXhosa (the local language) during the participants’ study visits.  Statistical analysis included the following: 2 proportion z-test, 2 sample t-test for independent means, and matched pairs t-test.

Results:  In Group A, there were no significant differences in frequency of symptoms reported after ART initiation.  In Group B, there was a significant increase in the frequency of nausea, vomiting, and changes in mood reported after women found out they were pregnant.  There were no significant differences between the frequency and distribution of symptoms between Groups A and B during the time periods when women were pregnant and on ART.  A greater proportion of women in Group A attributed at least one symptom they experienced in the period when they were pregnant and on ART to ART compared to Group B (45% vs. 10%; p=0.0245).  Additionally, a greater proportion of women in Group A reported at least one concern about ART compared to women in Group B (55% vs. 15%; p=0.0204).  The most common concerns reported were about the number of medical visits they are required to attend and the effects of ART on their baby.  A total of 6 women reported missing at least one dose of ART during their current pregnancy, most often because they forgot.  However, there was no significant difference in the proportion of women that reported missing a dose of ART during their current pregnancy between Groups A and B (27% vs. 15%; p=0.4175).   Finally, all women understood the survey and reported that they were comfortable discussing their personal lives and feelings.

Conclusions: Despite similar symptom profiles, pregnant women who initiated ART during their current pregnancy were more likely to attribute symptoms they experienced to ART and have concerns about ART compared to pregnant women who initiated ART prior to their current pregnancy.  These data suggest the potential for misattribution of pregnancy symptoms in HIV-positive pregnant women on ART, which could be even more pronounced in the context of PrEP delivery to HIV-negative pregnant women.  This finding, along with the greater number of concerns reported by Group A, highlights the importance of adequate counseling about PrEP and ART initiation during pregnancy to allow for proper informed consent and management of expectations in the context of future studies.  Future research should evaluate these factors in a larger group and incorporate other variables to determine the optimal way to inform patients about PrEP and ART risks and benefits and address concerns about the medications.

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