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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1
Mbarara University of Science and Technology
Mbarara, Uganda