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Gender-Affirmative Transgender Care to Improve the HIV Treatment Cascade

NCT03757117 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-11-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • The Fenway Institute

    collaborator OTHER

  • Epicentro

    collaborator UNKNOWN

  • amfAR, The Foundation for AIDS Research

    collaborator OTHER

  • Asociación Civil Impacta Salud y Educación, Peru

    lead OTHER

Principal Investigators

  • Javier R Lama, MD, MPH · Asociación Civil Impacta Salud y Educación

  • Sari Reisner, ScD · The Fenway Institute

  • Kenneth H Mayer, MD · The Fenway Institute

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757117 on ClinicalTrials.gov