Behavioral Intervention to Reduce Stress Among Black Gender Minority Women

BEHAVIORAL

Adaptive Intervention Approach

This is an adaptive intervention approach with 7 module-based sessions selected on the basis of post-session assessments of acceptability and satisfaction; 1. weekly group sessions will be co-led by a community member with expertise in working with transgender women and a public health nurse, 2. supplemental educational content will be available for individual consumption via an online portal or application (and tracked via participant click counts), and 3. additional social resources will be available through the online portal or app.

Intervention Retention Rate

Time frame: Throughout the intervention (up to 12 weeks)

number screened per month; number enrolled per month and per source; rate of eligibility ≥40%); (≥50% retention rate; reasons for dropouts; acute crisis or avoidance behaviors; incentive structure);

Average time delay from screening to enrollment and average time to enroll enough participants to form cohorts

Time frame: From screening to Baseline

The average time it takes for participants to be screened and complete enrollment depending on the study cohorts

Overall attendance/adherence

Time frame: 2 weeks post-intervention

Session attendance ≥67%; online engagement with educational material via click counts

Changes in the intervention fidelity

Time frame: Throughout the intervention (up to 12 weeks)

Fidelity rates within and between interventionists; range from 0-3, with 2 or higher indicative of high fidelity per domain via the Seeking Safety Adherence Scale (SASS). Tailoring of the SASS will be based on the format used to deliver the intervention content and the focus of the content. For example, the original scale has the following items that may not be appropriate for the created intervention: "Focused on how the topic related to substance use; Gave handouts and made use of them during the session." Thus, these items may be removed or modified to align with content delivery and subject matter. The SASS will be used to periodically assess the fidelity of intervention delivery among each interventionist. Mean scores will be compared between interventionists and scores below 80% will require remediation in the form of individual training with the PI and the interventionist.

Changes in the proportion of acceptability

Time frame: Baseline, Mid-intervention (3-6 weeks from baseline assessment), 2 weeks post intervention, 3 months post-intervention

assessment acceptability will be assessed by calculating the proportion of planned assessments that are completed and satisfaction ratings ≥75%; duration of assessment visits; reasons for dropouts);

Changes in the Intervention acceptability

Time frame: Throughout the intervention (up to 2 weeks post-intervention)

intervention acceptability (acceptability ≥75%; qualitative assessments; reasons for dropouts; preference/satisfaction ratings ≥75% via Client satisfaction questionnaire); Client satisfaction questionnaire (CSQ-8; Cronbach's alpha .93; 8-item; 4-point Likert) will be administered at the end of every intervention session to address individual session utility and at T3 for overall satisfaction

Accessibility of the intervention

Time frame: Throughout the intervention (up to 2 weeks post-intervention)

intervention accessibility (qualitative assessments; reasons for dropouts and adherence; technological literacy; ability to access reliable internet). There is no scale for this instrument.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.