Improving Engagement in HIV Care for High-risk Women

HIV/AIDS Clinical Trial

Official title:

Improving Engagement in HIV Care for High-risk Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081559
• Other study ID #: R01MH106373
• Status: Completed
• Phase: N/A
• Start date: November 9, 2016
• Est. completion date: October 30, 2020

Study information

• Verified date: November 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18+ years old; and

2. Assigned male sex at birth but does not currently identify as male; and

3. English- or Spanish-speaking; and

4. HIV+ confirmed via antibody testing; and

5. Evidence of suboptimal engagement in HIV care, as indicated by one or more of the following:

1. Not on ART; (b) If on ART, reporting less than perfect adherence on a validated adherence rating scale; or (c) Reporting no HIV primary care appointments in the prior 6 months.

Exclusion Criteria:

Evidence of severe cognitive impairment or active psychosis, as determined by the Project Director in consultation with the Principal Investigator.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence, Medication
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Healthy Divas
Peer-based counseling to improve medication adherence and engagement in care

Locations

Country	Name	City	State
United States	Friends Community Center	Los Angeles	California
United States	Alliance Health Project	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in virologic control	As indicated by an undetectable HIV-1 level on the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.)	Baseline, 3, 6, 9, 12 months
Secondary	Change in behavioral composite of engagement in HIV care	Composite measure which integrates current/past ART use, HIV appointments timeline followback , ART adherence (adherence rating and visual analog scale), and knowledge of current CD4 cell count.	Baseline, 3, 6, 9, 12 months