Gender-Affirmative Medical Care to Improve HIV Treatment Cascade Among Transgender Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- HIV viral suppression
研究概览
简要总结
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.
详细描述
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 hormone therapy supported by peer health navigators for transgender women was implemented in Lima, Peru.
Adult individuals, ages ≥18 years, assigned a male sex at birth, who identified as male-to-female transgender or on the trans-feminine continuum, regardless of initiation or completion of gender enhancement procedures, were eligible to participate. The study target population was transgender women who were unaware of their HIV serostatus or were living with HIV but not engaged in routine HIV care.
Phase 1. Formative research.
Community Engagement and Education. Following principles of Good Participatory Practice to ensure ethical and scientific integrity, based on the specific needs of the target population and to enhance community engagement, a Task Force composed of transgender women community representatives was convened for the study. The Task Force informed the investigators on community issues, advised on study design, supported development of educational programs and campaigns, and facilitated collaborations with the study population. Tailored annual community engagement and education plans were designed in advance of study implementation to include: (1) formative research for stakeholder identification and educational material validation; (2) community awareness activities; and (3) study communication, including development of educational materials, community consultations, and communication of study results.
Mixed-Methods Formative Research. Formative research was conducted among transgender women to assess: (1) experiences accessing HIV prevention services and engagement in HIV primary care, including facilitators and barriers to medical access; (2) attitudes toward a peer navigation system to increase engagement in HIV care; (3) gender-affirmative procedures (experiences with previous and current use of hormone therapy, both personal experiences and community perspectives); (4) assessment of health care needs related to HIV care and gender-affirmation; and (5) attitudes toward having a dedicated facility to receive gender-affirmative care. Formative research also included healthcare professionals (including medical providers and administrators) to assess: (1) knowledge of and experience providing feminization hormone therapy for transgender woman patients; (2) feasibility and acceptability of providing cross-hormone therapy with the existing public health system; (3) acceptability and willingness to provide cross-sex hormone therapy; and (4) perceptions of stigma and discrimination resulting from providing hormone therapy to transgender women. Both transgender women and healthcare professionals were queried about: (1) perceived acceptability of intervention components; and (2) potential barriers to intervention success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Feminizing hormone therapy and peer navigation
干预措施: Feminizing hormone therapy (Drug)
Intervention
Feminizing hormone therapy and peer navigation
干预措施: Peer navigation (Behavioral)
结局指标
主要结局
HIV viral suppression
时间窗: Twelve months
Proportion of HIV positive participants who become HIV virally suppressed after 12 months of follow-up
Knowledge of HIV serostatus
时间窗: Twelve months
Proportion of HIV negative participants who know their HIV serostatus after 12 months of follow-up
次要结局
未报告次要终点
