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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Page 1 of 1 (1 locations)

1

Infectious Diseases Institute Kasangati

Kampala, Uganda