HIV-1-infection Clinical Trial
Official title:
Gender-Affirmative Medical Care to Improve HIV Treatment Cascade Among Transgender Women
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.
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.
Training. Formative research informed the development of training plans to educate study
providers, peer health navigators, and community stakeholders on the hormone therapy
intervention. Transgender women community representatives and healthcare providers received
medical education training in health care needs, services, and strategies including a gender
affirmative approach to transgender medical care, cross-sex hormone therapy, managing HIV
infection, and the peer health navigation to improve linkage and retention in care.
Phase 2. Interventional study.
Study Design. Between October 2016 and April 2017, a 12-month, non-randomized, single-arm,
pilot cohort study was implemented in Lima, Peru to assess the feasibility, acceptability,
and potential effectiveness of integrating routine HIV prevention and treatment services with
gender-affirming care (i.e., feminizing hormone therapy) supported by transgender women
community peer health navigators. The study was grounded in an implementation science
framework, which aimed to test and translate research to promote evidence-based practices for
improving health and well-being. Specific design considerations were given to elements that
could be replicated by different institutions, including the Ministry of Health,
non-governmental organizations and community-based organizations providing HIV care for
transgender women, and/or researchers seeking to develop health interventions culturally
tailored to the needs of transgender women.
Recruitment. Purposive sampling through peer-recruitment was used to recruit individuals from
the target population who were unaware of their HIV serostatus, believed they were
HIV-uninfected, or were living with HIV but not engaged in care. Socially well-connected
transgender women members and community leaders acted as peer recruiters inviting fellow
transgender women to participate in the study. Peer recruiters conducted outreach work by
visiting transgender women-specific socialization venues (e.g., commercial sex work areas,
beauty parlors, sporting events, community events), where they approached potential
participants and referred them to the study site. This recruitment strategy was complemented
by social media initiatives to promote study participation.
Screening. Counselors explained the study objectives to potential participants and obtained
written informed consent to be screened for participation, HIV and sexually transmitted
infection testing, sample storage for further testing, and contact for future studies.
Participants who agreed and provided voluntary informed consent underwent a computer-assisted
self-interview (CASI) which included questions on demographics, gender identity, sexual
orientation and role, sexual risk behavior, previous HIV testing and diagnosis, history of
body enhancement procedures and hormone therapy use, life expectations, problems and barriers
perceived due to being transgender women, HIV testing history, and prior engagement in care,
if HIV positive. Counselors assisted participants in cases of computer unfamiliarity.
Physicians obtained a brief medical history and performed a targeted physical examination,
including examination of the genitals, anus, lymph nodes, skin, and oropharynx. A peripheral
blood sample was obtained for assessment of HIV, syphilis, hepatitis B virus and hepatitis C
virus infection, as well as hematology and biochemistry laboratory tests. Participants
underwent oropharyngeal and rectal swabbing, and provided a urine sample for the diagnosis of
Neisseria gonorrhoeae and Chlamydia trachomatis infection. An anal cytobrush was used to
assess the presence of cytological abnormalities induced by human papillomavirus infection.
Participants were asked to provide two sputum samples and undergo a chest x-ray to rule out
active tuberculosis. Volunteers were convened to return to the site in 2 weeks for the
provision of results and enrollment if they were eligible and agreed to participate.
Enrollment. Peer health navigators remained in contact with screened participants and
facilitated their return to the research site for enrollment. At the site, a physician
assessed eligibility, which included transgender women who resided in Lima and normal
hematology and biochemistry laboratory results. Individuals presenting with active
tuberculosis, history of pancreatitis, alcohol or drug consumption or other behavioral health
condition that in the opinion of the investigator would interfere with the evaluation of the
study objectives, severe medical comorbidity, use of immunosuppressive, nephrotoxic or
hepatotoxic therapy were excluded. Volunteers received a detailed explanation of the risks
and benefits of the medical intervention. Consenting participants underwent a CASI
questionnaire, which included questions about personal and social network support for
resilience to societal stigma and discrimination, hormone therapy expectations, and housing.
Questions about tuberculosis knowledge and attitudes toward its prevention and treatment were
also included. A peripheral blood sample was obtained for assessment of baseline fasting
glucose and lipids, estradiol and total testosterone levels. For those enrolled without any
contraindications, feminization hormone therapy comprised of spironolactone and estradiol
valerate was prescribed and dispensed to all participants.
Follow-up. Participants were asked to return to the site for study visits at months 1, 3, 6,
9 and 12, which included follow-up clinical assessment, laboratory testing, and hormone
therapy adherence counseling and education following standard protocols. At quarterly visits,
participants also received pre- and post-test counseling and sexual risk behavior reduction
education, underwent HIV and syphilis testing, and answered a CASI questionnaire on gender
identity and body image sexual risk behavior, substance use, attitudes toward HIV testing,
personal and social network support, hormone therapy expectations, mental health, adherence
to hormone therapy, and involvement in transgender women community building activities.
Hormone therapy was dispensed on site on a monthly basis. Peer health navigation facilitated
retention in care by outreach work, social media, and phone contact.
Regimen for 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 daily and increased every 4 weeks to 200 mg daily.
Medical Care for HIV Positives and Diagnosed with Sexually Transmitted Infections (STI).
Participants diagnosed with HIV infection were referred to standard Peru Ministry of Health
protocol care was offered, including initiation of antiretroviral therapy and assessment of
baseline and quarterly plasma HIV-1 RNA and cluster of differentiation 4 (CD4+) lymphocyte
cell count monitoring. Participants diagnosed with non-HIV STI received international
standard treatment and those susceptible to hepatitis B virus were referred for vaccination.
Laboratory Procedures. HIV antibody screening was conducted on whole blood. Positive samples
were sent for confirmatory testing to the Peru National Institute of Health laboratory by
means of indirect immunofluorescence, unless a previous positive confirmatory result was
identified in the Peru NIH database. Plasma HIV-1 RNA and CD4+ lymphocyte cell count
assessments were also conducted at the Peru NIH laboratory. Antibodies to Treponema pallidum
were detected using a rapid plasma reagin test and confirmed by a T. pallidum particle
agglutination assay. Both hepatitis B virus and anti-hepatitis C virus serologies were tested
by means of chemiluminescent microparticle immunoassay. N. gonorrhoeae and C. trachomatis
infections were diagnosed by a DNA amplification test. Cytological slides were manually
colored using standard papanicolaou staining. Sputum testing for tuberculosis used the
Ziehl-Neelsen stain. Hematology, biochemistry and hormone tests were assessed automatically.
All laboratory test results were provided to participants within a maximum of 14 days, and
those with abnormal tests results were referred to clinical care.
Phase 3. Dissemination of intervention and study results.
When intervention 12-month follow-up was near completion, the study team prepared
communication plans for disseminating and interpreting study results. Investigators convened
the Task Force, Ministry of Health representatives and scientific stakeholders in a community
forum to on the implications of the intervention. In this forum, investigators presented a
draft version of "Best Practices" for dissemination of integrated transgender women health
care services and asked the audience for input that was further incorporated.
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