NCT03194308

Safer Conception for Women - Understanding Use of Periconception PrEP

Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• HIV Prevention
• Conception

Interventions

Type	Name	Description
BEHAVIORAL	PrEP for Safer Conception	Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up.

Timeline

• Start date: 2017-11-13
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2017-06-21
• Last updated: 2023-10-23

Locations

1 site across 1 country: South Africa