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NCT02233192 · ClinicalTrials.gov registry record
PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 50
- Enrollment target
NCT02233192: Completed study, sponsored by Boston Medical Center.
NCT02233192 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02233192 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study 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).
Primary Outcome
Adherence will be measured in two ways: (1) Dried blood spots (DBS) to measure drug level two times, once after the woman has been taking the drug for one month and once when pregnancy is confirmed. We will perform unadjusted, bivariate analyses comparing participants below and equal to the drug level threshold for daily dosing using a one sample t-test for normally distributed continuous or ordinal variables on adherence. We will also perform a paired t-test for measuring the difference, if any
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-06-15 |
What the finished NCT02233192 record still lists
NCT02233192 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02233192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02233192 about?
NCT02233192 is a clinical study titled "PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples". 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 th...
What is the current status of trial NCT02233192?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2014-07. Estimated completion is 2017-06-15.
Who is sponsoring clinical trial NCT02233192?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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