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Trial record 43 of 1403 for:    Peru

Gender-Affirmative Transgender Care to Improve the HIV Treatment Cascade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757117
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
The Fenway Institute
Epicentro
amfAR, The Foundation for AIDS Research
Information provided by (Responsible Party):
Asociación Civil Impacta Salud y Educación, Peru

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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Feminizing hormone therapy Behavioral: Peer navigation Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Gender-Affirmative Medical Care to Improve HIV Treatment Cascade Among Transgender Women
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Feminizing hormone therapy and peer navigation
Drug: Feminizing hormone therapy

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


Behavioral: Peer navigation
Transgender women community peer navigation




Primary Outcome Measures :
  1. HIV viral suppression [ Time Frame: Twelve months ]
    Proportion of HIV positive participants who become HIV virally suppressed after 12 months of follow-up

  2. Knowledge of HIV serostatus [ Time Frame: Twelve months ]
    Proportion of HIV negative participants who know their HIV serostatus after 12 months of follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757117


Locations
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Peru
Epicentro
Lima, Peru, 15063
Sponsors and Collaborators
Asociación Civil Impacta Salud y Educación, Peru
The Fenway Institute
Epicentro
amfAR, The Foundation for AIDS Research
Investigators
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Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asociación Civil Impacta Salud y Educación, Peru
ClinicalTrials.gov Identifier: NCT03757117     History of Changes
Other Study ID Numbers: Féminas
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once all primary and secondary outcomes were assessed, individual participant data study documents would become available upon request and based on investigators´ decision after evaluation
Supporting Materials: Study Protocol
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asociación Civil Impacta Salud y Educación, Peru:
Peru
Health services
Transgender women
Patient navigation
Implementation science
Gender affirming care
HIV prevention
HIV treatment
HIV care cascade
Additional relevant MeSH terms:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs