Status:
UNKNOWN
Peer-Delivered HIV Self-Testing, STI Self-Sampling and PrEP for Transgender Women in Uganda
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Massachusetts General Hospital
Harvard Medical School (HMS and HSDM)
Conditions:
HIV
Sexually Transmitted Infections
Eligibility:
MALE
14+ years
Phase:
NA
Brief Summary
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than ot...
Detailed Description
Transgender women (TGW) are at high risk for HIV infection, and are an important, under-researched population in sub-Saharan Africa. Globally, HIV acquisition risk among TGW is 13 times higher than ot...
Eligibility Criteria
Inclusion
- Report male sex assigned at birth
- Age ≥18
- If 14-17 years, qualification as a mature or emancipated minor due to having a sexually transmitted infection or cater for own livelihood
- Report condom-less 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
- Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min
- Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test
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 :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04328025
Start Date
October 26 2020
End Date
June 1 2022
Last Update
May 3 2021
Active Locations (1)
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1
Infectious Diseases Institute Kasangati
Kampala, Uganda