Status:
COMPLETED
Gender-Affirmative Transgender Care to Improve the HIV Treatment Cascade
Lead Sponsor:
Asociación Civil Impacta Salud y Educación, Peru
Collaborating Sponsors:
The Fenway Institute
Epicentro
Conditions:
HIV-1-infection
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Public health strategies are urgently needed to improve HIV disparities among transgender women, highly burdened by the epidemic globally, including holistic approaches that address those health needs...
Detailed Description
A three-phase sequential implementation science study that culturally tailored an informed consent model of transgender care integrating routine HIV prevention and treatment as part of cross-sex hormo...
Eligibility Criteria
Inclusion
- Self-identification as transgender man-to-woman (e.g., "trans", "transgender", "transvestite", or "in the female trans man-woman spectrum)
- 18 years of age or older
- Unaware of HIV serostatus o living with HIV but not engaged in care
- Be willing and able to provide written informed consent to participate, including the understanding of the importance of adhering to the requirements of the study protocol, especially in incorporating prevention, testing and treatment of HIV/STI with feminization hormone therapy with peer-to-peer healthcare navigator support.
- Residence in the city of Lima
- Laboratory values obtained within 21 days prior to their participation in the study:
- Absolute neutrophil count ≥ 750 cells/mm3
- Hemoglobin ≥7.0 g/dL
- Platelet count ≥50,000 cells/mm3
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase ≤5 times below the lower limit of normal
- Serum lipase ≤1.5 times below the lower limit of normal
- Serum creatinine ≤1.4 times below the lower limit of normal
- Calculated creatinine clearance (CrCl) ≥50 mL/min according to the Cockcroft-Gault formula
Exclusion
- Medical evaluation resulting in a contraindication of the use of hormone therapy
- Measure of non-conformity with his gender inconsistent with the identity of transgender woman
- Allergy or sensitivity or known hypersensitivity to any component of hormones for feminization or their formulations
- Use or active drug or alcohol dependence that in the investigator's opinion, would interfere with adherence to study requirements
- Active tuberculosis
- History of pancreatitis
- Serious medical or psychiatric condition that in the investigator's opinion, would interfere with the ability to adhere to study requirements
- Current treatment with any of the following drugs:
- Systemic corticosteroids. A short cycle of less than or equal to 21 days of corticosteroids is allowed
- Systemic chemotherapeutic agents
- Systemic hepatotoxic or nephrotoxic agents
- Immunomodulatory treatments
- Investigational agents
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03757117
Start Date
October 1 2016
End Date
March 31 2018
Last Update
November 28 2018
Active Locations (1)
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1
Epicentro
Lima, Peru, 15063