Gender-Affirmative Transgender Care to Improve the HIV Treatment Cascade

• Status: Completed
• Trial end date: 2018-03-31
• Target enrollment: 0
• Participant gender: Male

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 prioritized by the community. To address this urgent need, a three-phase implementation science study of an integrated HIV service delivery model that combined HIV prevention and treatment services with gender-affirming primary medical care for transgender women was implemented in Lima, Peru, supported by peer navigation to improve outcomes across the HIV continuum of care: regular HIV testing for HIV-uninfected participants and linkage to preventive services; and engagement in treatment resulting in viral suppression for HIV-infected participants.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asociación Civil Impacta Salud y Educación, Peru
• Collaborators: amfAR, The Foundation for AIDS Research; Epicentro; The Fenway Institute
• Treatments: Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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