NCT05196009

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 25, 2022

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

November 15, 2021

Last Update Submit

March 9, 2022

Conditions

Mental Health IssueSubstance Use

Keywords

HIVTransgender WomenImplementation Science

Outcome Measures

Primary Outcomes (4)

  • Mental health services initiation

    The proportion of participants enrolled in the study who initiate mental health services.

    12 months

  • Substance use services initiation

    The proportion of participants enrolled in the study who initiate substance use services.

    12 months

  • Mental health services engagement

    The proportion of participants who remain enrolled in mental health services throughout the follow-up period.

    12 months

  • Substance use services engagement

    The proportion of participants who remain enrolled in substance use services throughout the follow-up period.

    12 months

Secondary Outcomes (1)

  • Patterns and correlates of mental health and substance use services engagement

    12 months

Study Arms (1)

Mental Health and Substance Use support

EXPERIMENTAL

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

Behavioral: mHealth peer navigation and social support

Interventions

mHealth peer navigation and social supportBEHAVIORAL

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

Also known as: Mental Health and Substance use linkage and initiation support
Mental Health and Substance Use support

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTrans women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • Any health condition that, in the investigator's opinion, makes it impossible to participate in the study or impairs the potential participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Central Study Contacts

Erin Wilson, DrPH

CONTACT

628-217-6113erin.wilson@sfdph.org

Sean Arayasirikul, PhD

CONTACT

415-554-9000sean.arayasirikul@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

January 19, 2022

Study Start

February 15, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 25, 2022

Record last verified: 2022-02

Locations

US(1)