Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safer Conception for Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194308
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Witwatersrand, South Africa
Information provided by (Responsible Party):
Lynn T Matthews, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment
HIV Prevention Conception Behavioral: PrEP for Safer Conception

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV-uninfected women
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Female, Aged 18-30 years, Not pregnant, HIV-uninfected, Likely to be fertile based on responses to reproductive history assessment, Not on a long-acting family planning method, Personal or partner desire to have a child in the next year (by response to modified CDC Pregnancy Risk Assessment), 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, and 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 and Enrollment in studies which may conflict with their participation in this proposed study.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Tricia Smith, MS 1-647-229-0079 tricia2679@yahoo.com
Contact: Kasey M ONeil, MPH 6177241129 koneil7@mgh.harvard.edu

Locations
Layout table for location information
South Africa
Maternal, Adolescent, and Child Health Research Unit (MRU) Recruiting
Durban, KwaZulu-Natal, South Africa, 4001
Contact: Yolandie Kriel, MSc       ykriel@matchresearch.co.za   
Contact: Manjeetha Jaggernath, MBChB       mjaggernath@matchresearch.co.za   
Principal Investigator: Jenni Smit, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
University of Witwatersrand, South Africa
Investigators
Layout table for investigator information
Principal Investigator: Lynn T Matthews, MD, MPH Mass General Hosptial

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lynn T Matthews, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03194308     History of Changes
Other Study ID Numbers: 2016P001535
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lynn T Matthews, Massachusetts General Hospital:
HIV risk reduction
Safer Conception
Pre-exposure prophylaxis
South Africa
Women
Reproductive Health