PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2014
End Date:July 2016

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The purpose of this study is to observe patient response to current clinical practice
utilizing TRUVADA (emtricitabine and tenofovir disoproxil fumarate) for Pre-Exposure
Prophylaxis (PrEP) amongst HIV serodiscordant couples desiring to conceive across four U.S.
cities that are currently offering this method as standard of care. This study is an
observational cohort study, which will test the feasibility and acceptability of PrEP for
conception, while examining the challenges and generalizability of this current medical
practice. The CDC recently released formal clinical practice guidelines for the use of PrEP
in the United States. For high-risk serodiscordant heterosexual couples using PrEP during
conception, the guidelines state, "PrEP use periconception and during pregnancy by the
uninfected partner may offer an additional tool to reduce the risk of sexual HIV
acquisition. Both the FDA labeling information and the perinatal antiretroviral treatment
guidelines permit this use" (CDC 2014).

Based on CDC's guidance on PrEP as well as results of randomized controlled trials, the U.S.
Food and Drug Administration (FDA) approved this daily medication (comprised of one pill) to
reduce the risk of sexually acquired HIV in adults at high risk. Other medical practices to
avoid transmission within this population include assisted reproductive technologies such as
sperm washing (or donated sperm) coupled with in vitro fertilization, intracytoplasmic sperm
injection (an in vitro procedure where a single sperm is injected directly into an egg), and
intrauterine insemination (placing the sperm directly into the uterus). However, these
methods are costly and often regionally scarce. PrEP is more accessible and a less expensive
option for couples. When used consistently and as prescribed, PrEP has shown to
significantly reduce the risk of HIV infection among adult men and women. However, risk
reduction counseling and clinical monitoring are necessary for its effective implementation.
Therefore, beyond efficacy trials, it is important to conduct additional studies of
pre-exposure prophylaxis to observe what factors make PrEP feasible and acceptable to
couples, as well as identify other factors that impact level of adherence. The study will
take place in four U.S. cities: Boston, Baltimore, Philadelphia, and San Francisco and will
involve couples who have chosen to begin PrEP for conception as part of their clinical care
after receiving preconception counseling and reviewing their options with their health care
provider.

Inclusion Criteria:

- Between the ages of 18 to 40 years

- In relationship with HIV-positive male

- Chosen to take PrEP for conception after completing counseling with health care
provider

Exclusion Criteria:

- HIV-positive

- In relationship with HIV-negative female

- Partner has chosen to take PrEP for conception after completing counseling with
health care provider
We found this trial at
4
sites
1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Principal Investigator: Meg Sullivan, MD
Phone: 617-414-3574
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: Jenell Coleman Fennell, MD, MPH
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Emily Stinnett Miller, MD
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Chicago, IL
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Erika Aaron, MSN, CRNP
Phone: 215-762-6826
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Philadelphia, PA
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