Safer Conception for Women - Understanding Use of Periconception PrEP

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Conception; HIV Prevention

Treatments: Behavioral: PrEP for Safer Conception

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03194308

2016P001535

1R01MH108412 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.

Full description

In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing the risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children.

Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who intend to conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.

Enrollment: 330 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female, Aged 18-35 years
• Not pregnant, HIV-uninfected
• Likely to be fertile based on responses to reproductive history assessment
• Not on a long-acting family planning method
• Likely to have a child in the next year, either by response to modified CDC Pregnancy Risk Assessment [2-5]), or meeting the other inclusion criteria.
• With a stable (>= 6 months) partner she reports as HIV-infected or HIV-serostatus unknown, (if >1 desired pregnancy partner, we will ask her to identify the most likely pregnancy partner- based on her own assessment of sexual frequency, fertility, etc.)
• Able to participate in the informed consent process
• Fluent in English or isiZulu

Exclusion criteria

• Living at or planning to relocate to a location incompatible with study participation in the next year
• Active drug or alcohol use that, in the opinion of the research study team, would interfere with adherence to study requirements
• Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry that in the opinion of the research study team, might otherwise interfere with adherence to study requirements
• Inability to adhere to the study schedule and/or study procedures
• Enrolment in studies which may conflict with their participation in this proposed study.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

HIV-uninfected women

Other group

Description:

A sample of 350 HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a self-reported infected or unknown serostatus partner and personal or partner plans for pregnancy in the next 12 months. Women will be offered safer conception counseling based on South African guidelines plus daily, oral tenofovir/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) during periconception and pregnancy.

Treatment:

Behavioral: PrEP for Safer Conception