Improving Health Outcomes for Women Living With HIV

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Peer Navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03525340

R34MH112177 (U.S. NIH Grant/Contract)

112177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 113 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

Participants in the standard of care arm will receive no navigation assistance to remain in care. They will provide informed consent, respond to baseline and endline surveys, and have clinic record data extracted for the 9 months of their study participation, but no additional services to remain engaged in care other than what is provided as standard by the clinic.

Peer Navigation

Experimental group

Description:

Participants in the peer navigation arm will meet with a peer navigator at least once per month for nine months in-person, and have at least one other navigator contact per month. Like the standard of care arm, they will provide informed consent, respond to baseline and endline surveys, and have clinic record data extracted for the 9 months of their study participation.

Treatment:

Behavioral: Peer Navigation