Improving Engagement in HIV Care for High-risk Women

Status Completed

Clinical Trial Summary

Transgender women (assigned 'male' at birth but who do not identify as male) are disproportionately impacted by HIV and have culturally unique barriers and facilitators to engagement in HIV care. Transgender women living with HIV (TWH) are less likely than others to take antiretroviral therapy (ART), and those who initiate ART have lower rates of ART adherence, lower self-efficacy for integrating ART into daily routines, and report fewer positive interactions with health care providers than non-transgender adults. As a result, TWH have an almost three-fold higher viral load than non-transgender adults in San Francisco; in Los Angeles, TWH are less likely to be virally suppressed than any other behavioral risk group. In formative work, the investigators have identified culturally-specific and modifiable barriers to HIV treatment engagement among TWH, including prioritization of transition-related health care (i.e. hormone therapy) at the expense of HIV treatment, avoidance of HIV care settings due to past negative health care experiences, misinformation about ART including potential drug interactions with hormones, intensified HIV stigma, low levels of social support, and poor coping skills. There are both individual and public health consequences to poor engagement in care among TWH stemming from high transmission risk factors, including substance abuse, high numbers of sex partners, engagement in sex work, and high rates of mental illness. These findings strongly suggest that TWH face unique challenges to engaging in and adhering to HIV treatment, and that the public health consequences for poor engagement in this population are of grave concern. Interventions to mitigate these barriers to engagement in care are critical in efforts to alter the pattern of HIV-related disparities that lead to disproportionately poor health outcomes for this highly vulnerable and marginalized population. The investigators are conducting a randomized controlled trial of a theory-driven, population-specific, piloted intervention to improve engagement in care for TWH. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, the proposed research is the first to systematically intervene on complex barriers to optimal engagement in HIV care for TWH. The investigators have developed and piloted the Healthy Divas intervention to optimize engagement in HIV care for TWH at elevated risk for treatment failure and consequential morbidity, mortality, and transmission of HIV.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
Adherence, Medication
HIV Infections
HIV/AIDS

Clinical Trial Details

NCT number	NCT03081559
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Completed
Phase	N/A
Start date	November 9, 2016
Completion date	October 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03215901` - Life Plans Intervention Study	N/A
Completed	`NCT03289676` - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV	Phase 1
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting	`NCT04064567` - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK	N/A
Completed	`NCT04121962` - A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)	N/A
Completed	`NCT04013295` - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya	N/A
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT03984136` - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM	N/A
Completed	`NCT02928900` - Patient Actor Training to Improve HIV Services for Adolescents in Kenya	N/A
Recruiting	`NCT03268109` - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Not yet recruiting	`NCT05813964` - Efficacy, Acceptability and Safety of Event-driven HIV PrEP Using TAF/FTC in MSM in Thailand and France.	Phase 3
Completed	`NCT02797262` - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System	N/A
Completed	`NCT02376582` - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS	Phase 1
Completed	`NCT01957865` - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda	N/A
Terminated	`NCT01443923` - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV	Phase 4
Completed	`NCT01616940` - Minority AIDS Initiative Retention and Re-Engagement Project	N/A
Completed	`NCT01910714` - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth	N/A
Completed	`NCT01084421` - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos	N/A
Completed	`NCT01596322` - International HIV Antiretroviral Adherence, Resistance and Survival	N/A