Mental Health IssuemSNNCT05196009
mHealth Systems Navigation- Breaking Systems Barriers for Trans Women Living With HIV
A study testing mHealth peer navigation and social support in people with Mental Health Issue and Substance Use, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Substance Use
- What is being tested?
- mHealth peer navigation and social support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue, Substance Use
- Being tested
- mHealth peer navigation and social support
- Keywords
- HIV, Transgender Women, Implementation Science
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth peer navigation and social supportBehavioural
Also called Mental Health and Substance use linkage and initiation support
Peer navigation, asynchronous support via SMS, Motivational Interviewing, virtual social support group focused on mental health and substance use, linkage and follow-up
| Study group | Role | What they receive |
|---|---|---|
| Mental Health and Substance Use support | Experimental | Pilot Mental health and substance use peer navigation, ecological momentary assessments and virtual support group Receives: Behavioral: mHealth peer navigation and social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health services initiation
The proportion of participants enrolled in the study who initiate mental health services.
Measured: 12 months
Substance use services initiation
The proportion of participants enrolled in the study who initiate substance use services.
Measured: 12 months
Mental health services engagement
The proportion of participants who remain enrolled in mental health services throughout the follow-up period.
Measured: 12 months
Substance use services engagement
The proportion of participants who remain enrolled in substance use services throughout the follow-up period.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Feb 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196009
- Sponsor's protocol ID
- 21-34978
- Acronym
- mSN
- Status last verified
- Feb 2022
- First submitted
- 15 Nov 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Systems Barriers for Trans Women of Color Living With HIV
- ClinicalTrials.gov ID
- NCT05196009
- Acronym / sponsor ID
- mSN / 21-34978
- Conditions
- Mental Health Issue, Substance Use
- Keywords
- HIV, Transgender Women, Implementation Science
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental Health and Substance Use support | Experimental | Behavioral: mHealth peer navigation and social supportPilot Mental health and substance use peer navigation, ecological momentary assessments and virtual support group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Intervention study:
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth peer navigation and social supportAlso: Mental Health and Substance use linkage and initiation supportPeer navigation, asynchronous support via SMS, Motivational Interviewing, virtual social support group focused on mental health and substance use, linkage and follow-up | Behavioural | Mental Health and Substance Use support |
Primary outcome
Mental health services initiation
Time frame: 12 months
The proportion of participants enrolled in the study who initiate mental health services.
Substance use services initiation
Time frame: 12 months
The proportion of participants enrolled in the study who initiate substance use services.
Mental health services engagement
Time frame: 12 months
The proportion of participants who remain enrolled in mental health services throughout the follow-up period.
Substance use services engagement
Time frame: 12 months
The proportion of participants who remain enrolled in substance use services throughout the follow-up period.
1 secondary outcome
Patterns and correlates of mental health and substance use services engagement
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth peer navigation and social support in people with Mental Health Issue and Substance Use, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin Wilson, DrPH (628-217-6113, erin.wilson@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health services initiation (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.