NCT03081559

Improving Engagement in HIV Care for High-risk Women

Completed NA Last updated 16 November 2020

What this trial tests

NA trial testing Healthy Divas in HIV/AIDS in 278 participants. Completed in 30 October 2020.

Timeline

9 November 2016

Primary endpoint
30 October 2020

30 October 2020

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	278
Start date	9 November 2016
Primary completion	30 October 2020
Estimated completion	30 October 2020
Sites	2 locations across United States

Drugs / interventions tested

• Healthy Divas

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Adherence, Medication — all drugs for Adherence, Medication →

Sponsor

University of California, San Francisco

Who can join

18 and older, male only, with HIV/AIDS or Adherence, Medication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gender Affirmation through Correct Pronoun Usage: Development and Validation of the Transgender Women's Importance of Pronouns (TW-IP) Scale.
   Sevelius JM, Chakravarty D, Dilworth SE, Rebchook G, et al · · 2020 · cited 15× · PMID 33352630 · DOI 10.3390/ijerph17249525
2. Randomized Controlled Trial of Healthy Divas: A Gender-Affirming, Peer-Delivered Intervention to Improve HIV Care Engagement Among Transgender Women Living With HIV.
   Sevelius JM, Dilworth SE, Reback CJ, Chakravarty D, et al · · 2022 · cited 13× · PMID 35502891 · DOI 10.1097/qai.0000000000003014
3. An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of "<i>Healthy Divas"</i> to Improve HIV Care Outcomes.
   Sevelius JM, Neilands TB, Reback CJ, Castro D, et al · · 2021 · cited 5× · PMID 36304034 · DOI 10.3389/frph.2021.665723
4. 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.
   Sevelius J, Veras MASM, Gomez JL, Saggese G, et al · · 2024 · cited 4× · PMID 38908840 · DOI 10.1136/bmjopen-2023-076878