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

March 9, 2022 updated by: Public Health Foundation Enterprises, Inc.

Breaking Systems Barriers for Trans Women of Color Living With HIV

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • Recruiting
        • San Francisco Department of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mental Health and Substance Use support
Pilot Mental health and substance use peer navigation, ecological momentary assessments and virtual support group
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
Other Names:
  • Mental Health and Substance use linkage and initiation support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental health services initiation
Time Frame: 12 months
The proportion of participants enrolled in the study who initiate mental health services.
12 months
Substance use services initiation
Time Frame: 12 months
The proportion of participants enrolled in the study who initiate substance use services.
12 months
Mental health services engagement
Time Frame: 12 months
The proportion of participants who remain enrolled in mental health services throughout the follow-up period.
12 months
Substance use services engagement
Time Frame: 12 months
The proportion of participants who remain enrolled in substance use services throughout the follow-up period.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns and correlates of mental health and substance use services engagement
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Foundation Enterprises, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-34978

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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