Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408350
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-26
Brief Title:
Optimal Intervention to Full Viral Suppression Text Me Alexis
Sponsor:
Friends Research Institute Inc
Organization:
Friends Research Institute Inc
Study Overview
Official Title:
Comparative- and Cost-effectiveness Research Determining the Optimal Intervention for Advancing Transgender Women Living With HIV to Full Viral Suppression
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Text Me Alexis is a three-arm randomized controlled trial RCT to determine the optimal and most cost-effective intervention for advancing trans women living with HIV to full viral suppression Participants will be randomized 111 to Peer Health Navigation PHN alone SMS text messaging alone or PHNSMS Participants in the PHN alone and PHNSMS arms will receive unlimited navigation sessions over 3 months Participants in the SMS alone and PHNSMS arms will receive 3 daily theory-based text messages for 90 days for a total of 270 unique scripted messages
Detailed Description:
Text Me Alexis is a three-arm randomized controlled trial RCT to determine the optimal considering effectiveness and cost-effectiveness intervention or intervention combination for advancement along the HIV Care Continuum among trans women living with HIV N195 After screening informed consent and baseline assessment participants will be randomized 111 into one of three arms Peer Health Navigation PHN alone n65 SMS text messaging alone n65 or PHNSMS n65 The study uses repeated assessments at baseline and at 3- 6- 12- and 18-months post-enrollment via an intent-to-treat design where all assessments are administered to participants regardless of their engagement or retention All intervention content is tailored and culturally responsive to trans women living with HIV
Peer Health Navigation PHN alone PHN is based on the theoretical foundation of Social Cognitive Theory Participant-centered PHN helps to 1 identify barriers to HIV care 2 identify and link participants into needed auxiliary services and 3 increase participants self-efficacy in working with HIV care providers and other social service and treatment facilities PHNs do not provide counseling or psychotherapy rather they work with each participant to successfully navigate complicated healthcare and social service systems The PHN intervention utilizes an individualized Participant-centered Treatment Plan with the specific goal of removing multiple and complex barriers that can impede linkage-to and retention-in HIV care as well as the sustainment of medication adherence to achieve and maintain virological suppression Each participant will work with a PHN to develop a Participant-centered Treatment Plan and get linked to HIV care or other needed auxiliary physical mental health and psychosocial services eg hormone therapy dental care hepatitis testingcare tuberculosis testingcare substance use disorder treatment mental health treatment legal services job trainingdevelopment If necessary the PHN transports and accompanies the participant to and from her HIV care appointments provision of transportation falls under the purview of PHN activities The Participant-centered Treatment Plan identifies actions for the participant and PHN that must be taken by the next scheduled meeting to help achieve short- and long-term goals including participant access to needed behavioral health services and advancement across the HIV Care Continuum A priority of the first session is to schedule an HIV care appointment for the participant if needed The PHN also works with each participant to establish HIV self-efficacy regarding her treatment plan Participants are introduced to a PHN immediately following randomization PHN sessions are unlimited for 90 days
Simple Message System SMS text messaging alone Text messages are based on and equally distributed across three theories Social Support Theory SST Social Cognitive Theory SCT and Health Belief Model HBM Participants receive three daily theory-based text messages for 90 days 270 unique scripted messages evenly arrayed across the three theories and the HIV Care Continuum Text messages are scripted across 1 HIV Care Continuum HIV PositivityPhysical and Emotional Health LinkageRetention in HIV Care and Antiretroviral Therapy ART AdherenceViral Load Suppression and 2 theoretical foundation SST SCT or HBM Thus each day participants receive one HIV PositivityPhysical and Emotional Health one LinkageRetention in HIV Care and one ART AdherenceViral Load Suppression message each of which will be based on a theoretical foundation SST SCT or HBM Text messages are transmitted through gradual automation administration daily including weekends in real-time within a 10-hour period every five hours eg at 1200 PM 500 PM and 1000 PM Optimum hours were determined to be daily from 1200 PM to 1000 PM though participants may personalize the schedule to any 10-hour period and can choose to have the text messages delivered through their cell phone or email inbox The automated text message delivery system was developed by Dimagi dimagicom Dimagi designs clinical interfaces health information systems and mobile technologies to perform patient-level disease management clinical decision support and health system monitoring To maintain interest and enthusiasm for the intervention messages are systematically varied by theory and content and participants never receive the same message twice At the completion of the enrollment visit a Research Assistant RA orients the participant to the SMS intervention
PHNSMS combined Participants in the PHNSMS arm will receive the same PHN and SMS interventions described above but in concert to determine the effectiveness of the combined intervention when compared to PHN or SMS alone
Peer Health Navigation PHN alone PHN is based on the theoretical foundation of Social Cognitive Theory Participant-centered PHN helps to 1 identify barriers to HIV care 2 identify and link participants into needed auxiliary services and 3 increase participants self-efficacy in working with HIV care providers and other social service and treatment facilities PHNs do not provide counseling or psychotherapy rather they work with each participant to successfully navigate complicated healthcare and social service systems The PHN intervention utilizes an individualized Participant-centered Treatment Plan with the specific goal of removing multiple and complex barriers that can impede linkage-to and retention-in HIV care as well as the sustainment of medication adherence to achieve and maintain virological suppression Each participant will work with a PHN to develop a Participant-centered Treatment Plan and get linked to HIV care or other needed auxiliary physical mental health and psychosocial services eg hormone therapy dental care hepatitis testingcare tuberculosis testingcare substance use disorder treatment mental health treatment legal services job trainingdevelopment If necessary the PHN transports and accompanies the participant to and from her HIV care appointments provision of transportation falls under the purview of PHN activities The Participant-centered Treatment Plan identifies actions for the participant and PHN that must be taken by the next scheduled meeting to help achieve short- and long-term goals including participant access to needed behavioral health services and advancement across the HIV Care Continuum A priority of the first session is to schedule an HIV care appointment for the participant if needed The PHN also works with each participant to establish HIV self-efficacy regarding her treatment plan Participants are introduced to a PHN immediately following randomization PHN sessions are unlimited for 90 days
Simple Message System SMS text messaging alone Text messages are based on and equally distributed across three theories Social Support Theory SST Social Cognitive Theory SCT and Health Belief Model HBM Participants receive three daily theory-based text messages for 90 days 270 unique scripted messages evenly arrayed across the three theories and the HIV Care Continuum Text messages are scripted across 1 HIV Care Continuum HIV PositivityPhysical and Emotional Health LinkageRetention in HIV Care and Antiretroviral Therapy ART AdherenceViral Load Suppression and 2 theoretical foundation SST SCT or HBM Thus each day participants receive one HIV PositivityPhysical and Emotional Health one LinkageRetention in HIV Care and one ART AdherenceViral Load Suppression message each of which will be based on a theoretical foundation SST SCT or HBM Text messages are transmitted through gradual automation administration daily including weekends in real-time within a 10-hour period every five hours eg at 1200 PM 500 PM and 1000 PM Optimum hours were determined to be daily from 1200 PM to 1000 PM though participants may personalize the schedule to any 10-hour period and can choose to have the text messages delivered through their cell phone or email inbox The automated text message delivery system was developed by Dimagi dimagicom Dimagi designs clinical interfaces health information systems and mobile technologies to perform patient-level disease management clinical decision support and health system monitoring To maintain interest and enthusiasm for the intervention messages are systematically varied by theory and content and participants never receive the same message twice At the completion of the enrollment visit a Research Assistant RA orients the participant to the SMS intervention
PHNSMS combined Participants in the PHNSMS arm will receive the same PHN and SMS interventions described above but in concert to determine the effectiveness of the combined intervention when compared to PHN or SMS alone
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