Gender-Affirmative Transgender Care to Improve the HIV Treatment Cascade

NCT03757117 | Completed Phase 4 DMC

• 1 other identifier: Féminas
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV-1-infection

Keywords

Peru; Health services; Transgender women; Patient navigation; Implementation science; Gender affirming care; HIV prevention; HIV treatment; HIV care cascade

Outcome Measures

Primary Outcomes (2)

• HIV viral suppression

  Proportion of HIV positive participants who become HIV virally suppressed after 12 months of follow-up

  Twelve months

• Knowledge of HIV serostatus

  Proportion of HIV negative participants who know their HIV serostatus after 12 months of follow-up

  Twelve months

Study Arms (1)

Intervention

EXPERIMENTAL

Feminizing hormone therapy and peer navigation

Drug: Feminizing hormone therapy; Behavioral: Peer navigation

Interventions

Feminizing hormone therapy DRUG

Estradiol valerate was initiated at 2 mg PO daily and increased to 4 mg after 4 to 12 weeks Antiandrogen therapy with spironolactone started at a dose of 50 mg PO daily and increased every 4 weeks to 200 mg daily

Intervention

Peer navigation BEHAVIORAL

Transgender women community peer navigation

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals assigned a male sex at birth, who identified as male-to-female transgender or on the trans-feminine continuum (e.g., "trans", "travesti", "transgender", "transsexual"), regardless of initiation or completion of gender enhancement procedures.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identification as transgender man-to-woman (e.g., "trans", "transgender", "transvestite", or "in the female trans man-woman spectrum)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asociación Civil Impacta Salud y Educación, Peru: lead
• The Fenway Institute: collaborator
• Epicentro: collaborator
• amfAR, The Foundation for AIDS Research: collaborator

Study Sites (1)

Epicentro

Lima, 15063, Peru

Location

Related Publications (1)

• Lama JR, Mayer KH, Perez-Brumer AG, Huerta L, Sanchez H, Clark JL, Sanchez J, Reisner SL. Integration of Gender-Affirming Primary Care and Peer Navigation With HIV Prevention and Treatment Services to Improve the Health of Transgender Women: Protocol for a Prospective Longitudinal Cohort Study. JMIR Res Protoc. 2019 Jun 27;8(6):e14091. doi: 10.2196/14091.

  PMID: 31250829 DERIVED

Study Officials

• Javier R Lama, MD, MPH

  Asociación Civil Impacta Salud y Educación

  PRINCIPAL INVESTIGATOR

• Sari Reisner, ScD

  The Fenway Institute

  PRINCIPAL INVESTIGATOR

• Kenneth H Mayer, MD

  The Fenway Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twelve-month, non-randomized, single-arm, pilot cohort study to assess the feasibility, acceptability, and potential effectiveness of integrating routine HIV prevention and treatment services with gender-affirming care supported by transgender woman community peer health navigators.

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: November 28, 2018
• Study Start: October 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol and informed consent forms in Spanish are available upon request
• Access Criteria: Individual participant data availability will depend on investigators´ decision after evaluation

Locations

PE (1)