Status:

COMPLETED

Periconception PrEP for HIV-exposed Ugandan Women

Lead Sponsor:

Massachusetts General Hospital

Collaborating Sponsors:

Mbarara University of Science and Technology

Conditions:

HIV Prevention

Eligibility:

FEMALE

18-35 years

Phase:

NA

Brief Summary

In this mixed-methods research study, the study team will offer comprehensive safer conception services to 150 HIV-uninfected women reporting an HIV-infected or high-risk partner and personal or partn...

Detailed Description

The study plans to enroll 150 HIV-uninfected women with an HIV-positive or HIV-serostatus unknown partner and personal or partner pregnancy plans. Eligible women will participate in comprehensive safe...

Eligibility Criteria

Inclusion

  • Self Report Inclusion Criteria:
  • Female
  • Aged 18-35
  • Likely to be fertile based on reproductive health history \[55\]
  • Reported personal or partner desire to have a child in the next year \[56-59\]
  • With a partner she reports as HIV-infected or likely to be HIV-infected (e.g. taking medicine daily, goes to clinic routinely, has HIV-infected partners, he has implied that he is "sick" but has not disclosed).
  • Live within 60km of clinic. Not planning on relocating to an area incompatible with ability to attend quarterly clinic over a 9-month follow-up period
  • Objective Inclusion Criteria:
  • HIV-negative (onsite rapid testing)
  • Not currently pregnant (onsite urine b-hcg testing)
  • Fluent in English or local language
  • Otherwise able to participate in the informed consent process
  • Exclusion Criteria
  • Currently pregnant
  • HIV-positive

Exclusion

    Key Trial Info

    Start Date :

    November 27 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 30 2020

    Estimated Enrollment :

    150 Patients enrolled

    Trial Details

    Trial ID

    NCT03832530

    Start Date

    November 27 2017

    End Date

    December 30 2020

    Last Update

    May 26 2021

    Active Locations (1)

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    Mbarara University of Science and Technology

    Mbarara, Uganda