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mHealth Systems Navigation- Breaking Systems Barriers for Trans Women Living With HIV (mSN)

Primary Purpose

Mental Health Issue, Substance Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth peer navigation and social support
Sponsored by
Public Health Foundation Enterprises, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Issue focused on measuring HIV, Transgender Women, Implementation Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Intervention study:

    1. Provision of signed and dated informed consent form
    2. Declaration of willingness to comply with all study procedures and availability during the study
    3. Age 18 years old or older
    4. Male sex designated at birth
    5. Identify as trans woman, woman or another gender identity not associated with being a man
    6. Desire to join the mSN intervention
    7. Access to a cell phone compatible with social networks (smartphone) to participate in a technology-based intervention or willing to use a study provided cell phone
    8. Speaks English or Spanish
    9. Living in San Francisco Bay Area
    10. Attend a clinic within the San Francisco Department of Public Health

Potential participants living with HIV must meet the following criteria:

  1. Documented diagnosis of HIV infection
  2. Have missed one recent HIV care appointment or have a detectable viral load
  3. Have not initiated or are regularly engaged in mental health and/or substance use services
  4. Screen positive for having an alcohol disorder OR drug misuse OR screen positive for psychological distress.

Exclusion Criteria:

  1. Participation in another intervention study to promote HIV care in the last year or participation in another study that prevents concomitant inclusion (co-enrollment)
  2. Any health condition that, in the investigator's opinion, makes it impossible to participate in the study or impairs the potential participant

Sites / Locations

  • San Francisco Department of Public HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mental Health and Substance Use support

Arm Description

Pilot Mental health and substance use peer navigation, ecological momentary assessments and virtual support group

Outcomes

Primary Outcome Measures

Mental health services initiation
The proportion of participants enrolled in the study who initiate mental health services.
Substance use services initiation
The proportion of participants enrolled in the study who initiate substance use services.
Mental health services engagement
The proportion of participants who remain enrolled in mental health services throughout the follow-up period.
Substance use services engagement
The proportion of participants who remain enrolled in substance use services throughout the follow-up period.

Secondary Outcome Measures

Patterns and correlates of mental health and substance use services engagement
Combined analysis of mental health and substance use services engagement as measured by self report. Patterns and correlates of engagement will be measures using data from self report surveys.

Full Information

First Posted
November 15, 2021
Last Updated
March 9, 2022
Sponsor
Public Health Foundation Enterprises, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05196009
Brief Title
mHealth Systems Navigation- Breaking Systems Barriers for Trans Women Living With HIV
Acronym
mSN
Official Title
Breaking Systems Barriers for Trans Women of Color Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health Foundation Enterprises, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study will test a mHealth peer navigation intervention for trans women living with HIV in a trans public health clinics to increase initiation and engagement in mental health and substance use services. The peer will navigate and provide support in-person and via mobile phone with HIPAA-compliant text messaging. Ecological momentary assessments will be conducted to enhance self-monitoring of mental health stress and coping-related substance use.
Detailed Description
Trans women carry the largest population burden of HIV in San Francisco and have low utilization of mental health and substance use services. The investigators' goal is to use lessons learned in a prior previously-funded Special Projects of National Significance to conduct a pilot peer delivered mHealth support and navigation intervention for trans women living with HIV. The investigators will work with partners in San Francisco Department of Public Health (SFDPH) clinics. The SFDPH is a HRSA-funded entity with trans-specific clinics and a host of in-house referrals to trans-competent mental health and substance use services. Despite availability of trans-specific services, considerable systems barriers exist. Trans clinics have limited clinic hours, and providers have large patient loads wherein medical gender affirmation and HIV care needs must be attended to in short visits. Visit and clinic time and large patient volume leaves providers with little time to ensure continuity in mental health and substance use referrals. To overcome these issues, a peer navigator will deliver mobile and in-person support and navigation to increase substance use and mental health service initiation and engagement among trans women living with HIV in trans health clinics. The research team has already conducted formative research with community members, key stakeholders and providers in San Francisco to help shape and refine the intervention model during the implementation phase of the research.In the implementation phase, the research team will pilot the mSN intervention to improve initiation and engagement in mental health and substance use (MHSU) services.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Substance Use
Keywords
HIV, Transgender Women, Implementation Science

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mental Health and Substance Use support
Arm Type
Experimental
Arm Description
Pilot Mental health and substance use peer navigation, ecological momentary assessments and virtual support group
Intervention Type
Behavioral
Intervention Name(s)
mHealth peer navigation and social support
Other Intervention Name(s)
Mental Health and Substance use linkage and initiation support
Intervention Description
Peer navigation, asynchronous support via SMS, Motivational Interviewing, virtual social support group focused on mental health and substance use, linkage and follow-up
Primary Outcome Measure Information:
Title
Mental health services initiation
Description
The proportion of participants enrolled in the study who initiate mental health services.
Time Frame
12 months
Title
Substance use services initiation
Description
The proportion of participants enrolled in the study who initiate substance use services.
Time Frame
12 months
Title
Mental health services engagement
Description
The proportion of participants who remain enrolled in mental health services throughout the follow-up period.
Time Frame
12 months
Title
Substance use services engagement
Description
The proportion of participants who remain enrolled in substance use services throughout the follow-up period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Patterns and correlates of mental health and substance use services engagement
Description
Combined analysis of mental health and substance use services engagement as measured by self report. Patterns and correlates of engagement will be measures using data from self report surveys.
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Trans women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Intervention study: Provision of signed and dated informed consent form Declaration of willingness to comply with all study procedures and availability during the study Age 18 years old or older Male sex designated at birth Identify as trans woman, woman or another gender identity not associated with being a man Desire to join the mSN intervention Access to a cell phone compatible with social networks (smartphone) to participate in a technology-based intervention or willing to use a study provided cell phone Speaks English or Spanish Living in San Francisco Bay Area Attend a clinic within the San Francisco Department of Public Health Potential participants living with HIV must meet the following criteria: Documented diagnosis of HIV infection Have missed one recent HIV care appointment or have a detectable viral load Have not initiated or are regularly engaged in mental health and/or substance use services Screen positive for having an alcohol disorder OR drug misuse OR screen positive for psychological distress. Exclusion Criteria: Participation in another intervention study to promote HIV care in the last year or participation in another study that prevents concomitant inclusion (co-enrollment) Any health condition that, in the investigator's opinion, makes it impossible to participate in the study or impairs the potential participant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Wilson, DrPH
Phone
628-217-6113
Email
erin.wilson@sfdph.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Arayasirikul, PhD
Phone
415-554-9000
Email
sean.arayasirikul@gmail.com
Facility Information:
Facility Name
San Francisco Department of Public Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

mHealth Systems Navigation- Breaking Systems Barriers for Trans Women Living With HIV

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