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Safer Conception for Women - Understanding Use of Periconception PrEP

NCT03194308 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-10-23

No results posted yet for this study

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.

Conditions

  • HIV Prevention
  • Conception

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Witwatersrand, South Africa

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Lynn T Matthews, MD, MPH · Mass General Hosptial

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2021-07-21
Completion
2021-07-21

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194308 on ClinicalTrials.gov