Clinical trial NCT03525340: Improving Health Outcomes for Women Living With HIV
Official title: Improving Health Outcomes for HIV-Positive Women in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Engagement to care, peer navigation, transgender
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-05-15
Enrollment: 113
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned 2:1 to intervention group with peer navigation or standard of care
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will develop and conduct a trans-specific peer navigation intervention in Brazil, which integrates the I-Care approach developed in South Africa with the Model of Gender Affirmation (GA), developed by the investigators to specifically address HIV prevention and care among trans women.

Detailed description: Globally, transgender ('trans') women have 49 times higher odds of HIV infection compared to other groups and trans women living with HIV (TWH) access HIV care and adhere to medication at significantly lower rates than other at-risk groups. Poor engagement in HIV care for TWH is a result of reduced access to and avoidance of healthcare due to stigma and negative experiences with providers, and occurs in the context of social and economic marginalization that foments unstable employment and housing, familial alienation, limited social support, and substance abuse. Interventions to mitigate these barriers to care are critical to reducing HIV-related disparities and poor health outcomes for this highly vulnerable population, particularly where disparities are most apparent, including Brazil. Peer-based navigation (PN) interventions have demonstrated success in improving engagement in HIV care in low-resource settings. The investigators recently conducted a PN intervention ('I-Care') in rural South Africa that significantly improved both linkage to care and retention for men and women. While the PN intervention addresses HIV care engagement by providing social support and skills to work with health providers and family, it requires specific adaptation and a conceptual model that addresses the unique needs of TWH identified during formative research and in consultations with Brazilian stakeholders in 2015. The investigators propose to develop and conduct a trans-specific PN intervention in Brazil, tentatively named 'TransAmigas', which integrates the I-Care approach with the Model of Gender Affirmation (GA), developed by the research team to specifically address HIV prevention and care among trans women. The investigators will use the ADAPT-ITT methodology to develop TransAmigas, incorporating the GA model in the Brazilian context (Aim 1). The investigators will then conduct a pilot study to test the feasibility and acceptability of TransAmigas in São Paulo, Brazil (Aim 2) by randomizing TWH to the intervention (n=100) or to clinical referral (n=50). During the nine month pilot, the investigators will track both navigator and patient adherence to the program, recruitment needs, cohort retention, and reported satisfaction and preferences for program content through surveys at baseline and nine months. Finally, the investigators will prepare for a multi-site efficacy trial (Aim 3) by extracting clinical data from participants' records at the referral clinic, generating preliminary efficacy data by comparing retention in HIV care and viral load by intervention arm. Clinical data will inform future trial sample size. The study will be implemented in Sao Paulo, Brazil, where universal access to care and public support for gender transition care provide an enabling environment for this work to be most effective and where the team has established academic partnerships and a collaboration with the State-run reference and training clinical site (CRT), which includes trans-specific clinical services. If feasible, acceptable, and ultimately proven efficacious, TransAmigas will be the first evidence-based HIV care intervention for TWH globally - filling a crucial gap in programming.

Eligibility criteria: Inclusion Criteria:

* have either a recent HIV diagnosis (within the prior 12 months) or be out of care for previously diagnosed HIV
* be a resident of the São Paulo area
* consent for study staff to review their clinical records

Exclusion Criteria:

* female sex at birth
* less than 18 years of age
* not HIV-positive
* currently engaged in care
* unable to provide informed consent
* reside outside of the São Paulo area

Primary outcomes:
measure: Acceptability of Peer Navigation Intervention
timeFrame: Baseline
Secondary outcomes:
measure: Feasibility of Peer Navigation Intervention: Patient Satisfaction
timeFrame: At 9 months
measure: Feasibility of Peer Navigation Intervention: Enrollment rate
timeFrame: At 9 months
measure: Feasibility of Peer Navigation Intervention: Navigator Retention
timeFrame: At 9 months
measure: Trial Planning - Linkage to ART
timeFrame: At 9 months
measure: Trial Planning - Linkage to confirmatory testing
timeFrame: At 9 months
measure: Trial Planning - Retention
timeFrame: At 9 months
measure: Trial Planning - Defaulting
timeFrame: At 9 months
measure: Trial Planning - Adherence
timeFrame: At 9 months
measure: Trial Planning - Viral Suppression
timeFrame: At 9 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Casa Medical School
Study officials:
affiliation: University of California, San Francisco
name: Sheri Lippman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: