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Improving Engagement in HIV Care for High-risk Women

Primary Purpose

HIV/AIDS, Adherence, Medication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Divas
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring transgender, women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Friends Community Center
  • Alliance Health Project

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Healthy Divas intervention

Treatment as usual

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

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.

Full Information

First Posted
March 6, 2017
Last Updated
November 12, 2020
Sponsor
University of California, San Francisco
Collaborators
Friends Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03081559
Brief Title
Improving Engagement in HIV Care for High-risk Women
Official Title
Improving Engagement in HIV Care for High-risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Friends Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Adherence, Medication
Keywords
transgender, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Healthy Divas intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Healthy Divas
Intervention Description
Peer-based counseling to improve medication adherence and engagement in care
Primary Outcome Measure Information:
Title
Change in virologic control
Description
As indicated by an undetectable HIV-1 level on the COBAS® AmpliPrep/COBAS® TaqMan® HIV test kit (Roche Molecular Systems, Inc.)
Time Frame
Baseline, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
Change in behavioral composite of engagement in HIV care
Description
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.
Time Frame
Baseline, 3, 6, 9, 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Transgender women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18+ years old; and Assigned male sex at birth but does not currently identify as male; and English- or Spanish-speaking; and HIV+ confirmed via antibody testing; and Evidence of suboptimal engagement in HIV care, as indicated by one or more of the following: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Sevelius, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Community Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Alliance Health Project
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36304034
Citation
Sevelius JM, Neilands TB, Reback CJ, Castro D, Dilworth SE, Kaplan RL, Johnson MO. An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of "Healthy Divas" to Improve HIV Care Outcomes. Front Reprod Health. 2021 Oct 27;3:665723. doi: 10.3389/frph.2021.665723. eCollection 2021.
Results Reference
derived
PubMed Identifier
35502891
Citation
Sevelius JM, Dilworth SE, Reback CJ, Chakravarty D, Castro D, Johnson MO, McCree B, Jackson A, Mata RP, Neilands TB. Randomized Controlled Trial of Healthy Divas: A Gender-Affirming, Peer-Delivered Intervention to Improve HIV Care Engagement Among Transgender Women Living With HIV. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):508-516. doi: 10.1097/QAI.0000000000003014. Epub 2022 Mar 5.
Results Reference
derived

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Improving Engagement in HIV Care for High-risk Women

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