Status:
COMPLETED
Same-Day PrEP Initiation and Sexual Health for Transgender Women
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Massachusetts General Hospital
Harvard Medical School (HMS and HSDM)
Conditions:
HIV
PrEP
Eligibility:
MALE
14+ years
Phase:
NA
Brief Summary
Transgender women (trans women; assigned male sex at birth but identify as female) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Trans wo...
Detailed Description
The overall goal of this study is to evaluate the feasibility and acceptability of same-day F/TAF initiation and characterize F/TAF persistence among trans women taking PrEP. This research will be con...
Eligibility Criteria
Inclusion
- Report male sex assigned at birth but currently identify as female
- Age ≥18, or if 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
- Report unprotected anal intercourse in the past 6 months
- Able and willing to provide written informed consent
- Possess a valid recruitment coupon
- HIV-uninfected based on negative HIV rapid tests at the enrollment visit
Exclusion
- Currently enrolled in a biomedical HIV prevention study
- Any clinically significant or chronic medical condition that is considered progressive or in the opinion of the investigator would make the participant unsuitable for the study, including severe infections requiring treatment such as tuberculosis, alcohol or drug abuse, or mental illness which precludes provision of informed consent
- Not planning to remain in the geographic area for the duration of the study
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04491422
Start Date
November 2 2021
End Date
July 5 2023
Last Update
October 12 2023
Active Locations (1)
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1
Infectious Diseases Institute Kasangati
Kampala, Uganda