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Improving Engagement in HIV Care for High-risk Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03081559
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : October 12, 2018
Friends Research Institute, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Adherence, Medication Behavioral: Healthy Divas Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Engagement in HIV Care for High-risk Women
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
Healthy Divas intervention
Behavioral: Healthy Divas
Peer-based counseling to improve medication adherence and engagement in care

No Intervention: Control
Treatment as usual

Primary Outcome Measures :
  1. Change in virologic control [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    As indicated by an undetectable HIV-1 level on the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.)

Secondary Outcome Measures :
  1. Change in behavioral composite of engagement in HIV care [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Transgender women
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03081559

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Contact: Jae Sevelius 4154766358
Contact: Danielle Castro 4083900222

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United States, California
Friends Community Center Recruiting
Los Angeles, California, United States, 90028
Contact: Cathy Reback    213-716-4428   
Alliance Health Project Recruiting
San Francisco, California, United States, 94103
Contact: Jae Sevelius    415-476-6358   
Contact: Danielle Sevelius    4154766358   
Sponsors and Collaborators
University of California, San Francisco
Friends Research Institute, Inc.
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Principal Investigator: Jae Sevelius, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT03081559     History of Changes
Other Study ID Numbers: R01MH106373 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco: