Improving Health Outcomes for Women Living With HIV

HIV/AIDS Clinical Trial

Official title:

Improving Health Outcomes for HIV-Positive Women in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525340
• Other study ID #: 112177
• Secondary ID: R34MH112177
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Behavioral:
• Peer Navigation
Peer navigators help participants identify barriers that pose challenges to the participant's engagement in care and adherence and help develop an overall action plan for addressing these barriers by identifying specific changes that can be made/attempted to overcome an identified barrier. This may involve accompanying a participant to their social services/health appointments, or assisting a participant with disclosure of her HIV status to a family member or friend. The overall goal is to develop knowledge of social/HIV-related health services and good problem-solving skills in order to tackle multiple, potentially overlapping barriers. Over time, participants are encouraged to take increasing degrees of responsibility for identifying and implementing their own problem-solving strategies.

Locations

Country	Name	City	State
Brazil	Santa Casa Medical School	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Peer Navigation Intervention	Proportion of transgender women offered navigation services who accept invitation	Baseline
Secondary	Feasibility of Peer Navigation Intervention: Patient Satisfaction	Proportion in TransAmigas who report satisfaction with navigation quality, duration, contact schedule, thematic content, support.	At 9 months
Secondary	Feasibility of Peer Navigation Intervention: Enrollment rate	Proportion of transgender women living with HIV who are screened, eligible, enrolled, and successfully complete navigation.	At 9 months
Secondary	Feasibility of Peer Navigation Intervention: Navigator Retention	Proportion of navigators who remain in program.	At 9 months
Secondary	Trial Planning - Linkage to ART	Time from diagnosis to antiretroviral therapy initiation	At 9 months
Secondary	Trial Planning - Linkage to confirmatory testing	Time from diagnosis to CD4+ T-cell count results	At 9 months
Secondary	Trial Planning - Retention	Proportion of patients who remain on treatment following 9 months of enrollment in pilot	At 9 months
Secondary	Trial Planning - Defaulting	Proportion of participants not in care 90 days after prescribed medication estimated to last 90	At 9 months
Secondary	Trial Planning - Adherence	Proportion of days covered (# of dispensed days of medication / # of days between refills)	At 9 months
Secondary	Trial Planning - Viral Suppression	Proportion of participants with viral load 1) undetectable and 2) below 1000 copies/mL	At 9 months