Overview

This trial is active, not recruiting.

Condition prep for conception purposes
Sponsor Boston Medical Center
Collaborator Gilead Sciences
Start date July 2014
End date July 2016
Trial size 25 participants
Trial identifier NCT02233192, PrEPception

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change in PrEP adherence levels throughout regimen
time frame: Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year
Change in condom use and sexual practice over time
time frame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
Change in number of couples who complete a clinical protocol for PrEP compared to the total number of couples that initiate PrEP
time frame: Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year
Change in beliefs and sexual behavior at different time points for the same subject
time frame: Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year

Secondary Outcomes

Measure
Changes in creatinine clearance from the baseline compared to creatinine clearance at the conclusion of PrEP for the same subject
time frame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
Measuring the rates of teratogenicity as compared to the general population as determined by medical record review
time frame: 1 year
HIV transmission rates
time frame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.