Safer Conception for Women
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|ClinicalTrials.gov Identifier: NCT03194308|
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : January 28, 2019
|Condition or disease||Intervention/treatment|
|HIV Prevention Conception||Behavioral: PrEP for Safer Conception|
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.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women|
|Actual Study Start Date :||November 13, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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.
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.
- Evaluation of uptake of and adherence to PrEP [ Time Frame: minimum of 12 months through pregnancy outcome (maximum 21 months) ]The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up.
- Safer Conception Strategies [ Time Frame: minimum of 12 months through pregnancy outcome (maximum 21 months) ]Secondary outcomes include uptake of safer conception strategies including CHCT, ART for the infected partner, uptake of contraception for those who decide not to conceive; HIV transmission events, infant outcomes, and findings from qualitative interviews to further inform the conceptual framework for periconception PrEP uptake and adherence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194308
|Contact: Tricia Smith, MSemail@example.com|
|Contact: Kasey M ONeil, MPHfirstname.lastname@example.org|
|Maternal, Adolescent, and Child Health Research Unit (MRU)||Recruiting|
|Durban, KwaZulu-Natal, South Africa, 4001|
|Contact: Yolandie Kriel, MSc email@example.com|
|Contact: Manjeetha Jaggernath, MBChB firstname.lastname@example.org|
|Principal Investigator: Jenni Smit, PhD|
|Principal Investigator:||Lynn T Matthews, MD, MPH||Mass General Hosptial|