PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples

NCT ID: NCT02233192

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-06-15

Brief Summary

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).

Detailed Description

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.

Conditions

PrEP for Conception Purposes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Sullivan, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Northwestern University

Chicago, Illinois, United States

The Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

H-33071

Identifier Type: -

Identifier Source: org_study_id