PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples

July 5, 2017 updated by: Boston Medical Center
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60201
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will take place in teaching hospitals 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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, between the two adherence tests at the different time points for each individual. Adherence will also be measured through (2) participant self-report via a continuous variable of number of doses missed in the past month. We will perform unadjusted, bivariate analyses comparing the observed participant self-reported adherence levels to the gold standard of ≥95% self-reported adherence using a one-sample t test of means for normally distributed continuous or ordinal variables.
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
Condom use will be measured through participant self-report on number of times a condom was used during the past month compared to the number of times the participant had sexual intercourse with his/her partner or other individuals in the past month. We will perform unadjusted bivariate analyses comparing the observed participants in a one-sample student's t-test for normally distributed variables on condom use or a paired t-test for measuring the difference between two variables at different time points for the same subject (i.e. at baseline and at end-line evaluation). For a non-normal distribution, we will use the non-parametric equivalent such as Sign or Wilcoxon Signed rank test for a symmetric distribution.
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
We will quantify this outcome measure by examining the number of couples who complete a clinical protocol for PrEP compared to the total number of couples that initiate PrEP, while examining other variables that could make the two groups statistically different. We will perform unadjusted bivariate analyses comparing the number of couples that complete the clinical protocol and those who withdraw or become ineligible throughout the duration of the study. We will use a one-way ANOVA or Kruskal-Wallis non-parametric test for continuous variables with two or more categories such as those that complete the protocol versus those that withdraw from PrEP versus those that become ineligible. We will perform a two-sample test of means to compare the overall categories of those that complete the protocol versus those that do not complete the protocol and create cross-tabulations with chi-square and Fisher's exact tests.
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
For this outcome measure, we will perform unadjusted bivariate analyses in a paired t-test for measuring the difference in beliefs and sexual behavior at different time points for the same subject. For a non-normal distribution, we will use the non-parametric equivalent such as Sign or Wilcoxon Signed rank test for a symmetric distribution.
Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
To assess renal toxicities, we will perform unadjusted bivariate analyses in a paired t-test for measuring the difference of creatinine clearance from the baseline compared to creatinine clearance at the conclusion of PrEP for the same subject. For a non-normal distribution, we will use the non-parametric equivalent such as Sign or Wilcoxon Signed rank test for a symmetric distribution. We will also report on basic drug side effects, while summarizing other self-reported effects of PrEP.
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
We will perform unadjusted bivariate analyses in a two-sample test of means to compare rates of teratogenicity of newborns with HIV-negative females using PrEP as compared to rates of birth defects within the general population in similar age group women.
1 year
HIV transmission rates
Time Frame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
For this outcome measure, we will report descriptively on whether there is a transmission or not within the observed participants taking PrEP for conception purposes.
Participants will be followed for the duration of trying to conceive, an expected average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margaret Sullivan, MD, Boston University Medical Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-33071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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