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

Mental Health Issue Clinical Trial

— mSN  

Official title:

Breaking Systems Barriers for Trans Women of Color Living With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196009
• Other study ID #: 21-34978
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2022
• Source: Public Health Foundation Enterprises, Inc.
• Contact: Erin Wilson, DrPH
• Phone: 628-217-6113
• Email: erin.wilson[@]sfdph.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• mHealth peer navigation and social support
Peer navigation, asynchronous support via SMS, Motivational Interviewing, virtual social support group focused on mental health and substance use, linkage and follow-up

Locations

Country	Name	City	State
United States	San Francisco Department of Public Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Public Health Foundation Enterprises, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental health services initiation	The proportion of participants enrolled in the study who initiate mental health services.	12 months
Primary	Substance use services initiation	The proportion of participants enrolled in the study who initiate substance use services.	12 months
Primary	Mental health services engagement	The proportion of participants who remain enrolled in mental health services throughout the follow-up period.	12 months
Primary	Substance use services engagement	The proportion of participants who remain enrolled in substance use services throughout the follow-up period.	12 months
Secondary	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.	12 months