The purpose of this study is to test whether the peer support program is acceptable, possible, and can improve mental health among individuals accessing hormone care. Eligible participants will be enrolled and randomized to the support program or enhanced usual care arm. Participants will take part in this study for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A peer mentor will be matched to mentees with participant input. The first meeting is intended to establish contact and expectations. Sessions will be scheduled according to the participant's preferences, with a suggested frequency of once a month with more as necessary and feasible. Participants in the peer support group will have access to peer support options that include: one-one one meetings with a peer mentor; group meetings with mentors and other participants; and medical appointment buddy. Participants are not required to use every option each month. Study visits will be completed baseline-6 months.
Participants randomized to the usual care group will not have access to the peer support options but will complete the study visits (baseline-6 months). All participants will be given a resource document with community resources.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGFeasibility assessed by Acceptability based on the average total Abbreviated Acceptability Rating Profile (AARP) score at 6 months
The 9-item AARP is adapted to specifically address this peer support intervention for individuals seeking hormone care. Participants will respond to a 6-point Likert scale rating participants agreement with each acceptability statement. Total scores range from 9-54 with a higher score indicating greater acceptability.
Time frame: 6 months
Feasibility based on the number of participants that agreed to participate on the study out of total number of individuals approached for study participation.
Time frame: Up to 6 months (recruitment period)
Feasibility assessed by Practicality based on the total number of one-on-one in-person sessions vs one-on-one virtual sessions
This is defined as the total number of one-on-one in-person sessions vs one-on-one virtual sessions.
Time frame: 6 months
Feasibility assessed by Practicality based on the total the number participants engaged with group sessions in-person vs. number of participants engaged virtually
This is defined as the total number of participants engaged with group sessions in-person vs. number of participants engaged virtually.
Time frame: 6 months
Safety based on the number of related adverse events
Related events included will be definitely, probably, and possibly related events (defined per protocol). The grading scale that will be used for these events include: 1. \- Mild adverse event (AE) - No treatment needed 2. \- Moderate AE - Resolved with treatment 3. \- Severe AE - Inability to carry on normal activities, required professional medical attention 4. \- Life-threatening or disabling AE 5. \- Fatal AE
Time frame: 6 months
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