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Improving Engagement in HIV Care for High-risk Women

NCT ID: NCT03081559

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-09

Study Completion Date

2020-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV/AIDS Adherence, Medication

Keywords

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transgender women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Healthy Divas intervention

Group Type EXPERIMENTAL

Healthy Divas

Intervention Type BEHAVIORAL

Peer-based counseling to improve medication adherence and engagement in care

Control

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Healthy Divas

Peer-based counseling to improve medication adherence and engagement in care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Friends Research Institute, Inc.

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Sevelius, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Friends Community Center

Los Angeles, California, United States

Site Status

Alliance Health Project

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35502891 (View on PubMed)

Sevelius J, Veras MASM, Gomez JL, Saggese G, Mocello AR, Bassichetto KC, Neilands TB, Lippman SA. Reducing intersectional stigma among transgender women in Brazil to promote uptake of HIV testing and PrEP: study protocol for a randomised controlled trial of Manas por Manas. BMJ Open. 2024 Jun 21;14(6):e076878. doi: 10.1136/bmjopen-2023-076878.

Reference Type DERIVED
PMID: 38908840 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36304034 (View on PubMed)

Other Identifiers

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R01MH106373

Identifier Type: NIH

Identifier Source: org_study_id

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