NCT03081559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

March 6, 2017

Last Update Submit

November 12, 2020

Conditions

HIV/AIDSAdherence, Medication

Keywords

transgenderwomen

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in behavioral composite of engagement in HIV care

    Baseline, 3, 6, 9, 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Healthy Divas intervention

Behavioral: Healthy Divas

Control

NO INTERVENTION

Treatment as usual

Interventions

Healthy DivasBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTransgender women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Friends Community Center

Los Angeles, California, 90028, United States

Location

Alliance Health Project

San Francisco, California, 94103, United States

Location

Related Publications (3)

  • 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.

    PMID: 38908840DERIVED

  • 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.

    PMID: 36304034DERIVED

  • 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.

    PMID: 35502891DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeMedication Adherence

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jae Sevelius, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 16, 2017

Study Start

November 9, 2016

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

November 16, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)