Clinical trial NCT02233192: PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
Official title: PrEPception: Expanding Assisted Reproductive Options for Serodiscordant Couples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PrEP for Conception Purposes
Keywords: PrEP
conception
HIV
serodiscordant
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2014-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in PrEP adherence levels throughout regimen
timeFrame: Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year
measure: Change in condom use and sexual practice over time
timeFrame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
measure: Change in number of couples who complete a clinical protocol for PrEP compared to the total number of couples that initiate PrEP
timeFrame: Monthly; participants will be followed for the duration of trying to conceive, an expected average of 1 year
measure: Change in beliefs and sexual behavior at different time points for the same subject
timeFrame: 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
timeFrame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
measure: Measuring the rates of teratogenicity as compared to the general population as determined by medical record review
timeFrame: 1 year
measure: HIV transmission rates
timeFrame: Participants will be followed for the duration of trying to conceive, an expected average of 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: The Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Boston University
name: Margaret Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: