PrEP for Conception PurposesNCT02233192
PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
An observational study of PrEP for Conception Purposes, run by Boston Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PrEP for Conception Purposes
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2014to 15 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- HIV-positive
- In relationship with HIV-negative female
- Partner has chosen to take PrEP for conception after completing counseling with health care provider
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Boston University Medical Center
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60201
Drexel University
Philadelphia, Pennsylvania, 19102
About this study
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).
Read the 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
- Keywords
- PrEP, conception, HIV, serodiscordant
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PrEP adherence levels throughout regimen
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year
Secondary outcomes (3)
Changes in creatinine clearance from the baseline compared to creatinine clearance at the conclusion of PrEP for the same subject
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.
Measured: 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
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.
Measured: 1 year
HIV transmission rates
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.
Measured: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJul 2014
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP for Conception PurposesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Margaret Sullivan, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233192
- Sponsor's protocol ID
- H-33071
- Status last verified
- Jul 2017
- First submitted
- 19 Aug 2014
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
- ClinicalTrials.gov ID
- NCT02233192
- Acronym / sponsor ID
- H-33071
- Conditions
- PrEP for Conception Purposes
- Keywords
- PrEP, conception, HIV, serodiscordant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jul 2014 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- HIV-positive
- In relationship with HIV-negative female
- Partner has chosen to take PrEP for conception after completing counseling with health care provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Sullivan, MD principal investigator
Boston University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PrEP for Conception Purposes, run by Boston Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.