Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06316102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-11
Brief Title:
Promoting Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Piloting a Multilevel Intervention to Promote Viral Suppression Among Transgender Women Living With HIV in Santo Domingo
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study includes an adapted multilevel intervention Abriendo Puertas Opening Doors including individual counseling peer navigation and community mobilization for transfeminine people living with HIV in the Dominican Republic using an iterative consultation process Prior to this randomized controlled trial feasibility and initial effects on HIV care and treatment behaviors were assessed with 30 trans women living with HIV no control group and documented positive trends in antiretroviral therapy use 70 to 85 p003 missed care appointments 35 to 20 p039 and antiretroviral therapy adherence 86 to 96 p050 Participants emphasized that trusting intervention staff and being treated with respect in individual sessions allowed them to improve self-esteem Limited trust and cohesion among trans women however inhibited more extensive engagement with peer navigation and community activities In response the study team identified two key modifications to strengthen and further tailor the intervention for transfeminine people living with HIV 1 integrate more gender affirming content including with providers and 2 focus on building trust among transfeminine people through sequential implementation of individual and then community components The purpose of the proposed study is to conduct a pilot randomized trial of the Gender-affirming Abriendo Puertas intervention In Aim 1 the preliminary efficacy of the Gender-affirming Abriendo Puertas intervention on viral suppression among transfeminine people randomized to the intervention compared to those randomized to control will be assessed The research study will randomly assign transfeminine people living with HIV to the Gender-affirming Abriendo Puertas intervention n60 individual counseling peer navigation provider training and community support building or control group n60 There will be baseline 6 and 12-month surveys and viral load assessments to assess differences across study arms In Aim 2 the study team will examine pathways of influence eg decreased stigma increased cohesion and experiences with the intervention to identify specific areas for improvement and scale up Longitudinal qualitative interviews will be conducted at baseline 6 and 12 months with 20 intervention participants Together with surveys the study team will assess how Gender-affirming Abriendo Puertas participation affects pathways between stigma cohesion and HIV outcomes The study team will also elicit experiences and recommendations from providers and intervention staff in focus groups at 6 n2 and 12 months n2
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None