Feasibility Studies
Conditions
Keywords
Transgender, HIV, microeconomic
Brief summary
The aim is the current study is to establish feasibility and acceptability of the SeCuRE intervention to improve HIV prevention and care continua outcomes. To meet this aim, the study has the following objectives: 1. To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color. 2. The determine acceptability of the intervention with transgender women of color.
Detailed description
This is a two-arm randomized waitlist controlled trial in which transgender women of color will be randomly allocated to either the enhanced microeconomic intervention that builds on the Trans Sistas of Color Project's existing microeconomic interventions, which includes: (1) $250 in emergency assistance; and (2) peer support to obtain legal gender affirmation (i.e., legal name and gender markers on identification documents). The existing intervention will be enhanced to include (1) 12 weekly educational group sessions on economic empowerment (i.e., job acquisition, income generation through micro-business, and financial literacy) and HIV prevention and care; (2) employment-focused mentoring; and (3) an unconditional grant ($1,200) for use towards acquiring self-led or formal employment. Each condition will complete a baseline survey prior to randomization, a follow-up survey immediately following intervention completion, and 3-month survey after intervention completion. Participants will also complete qualitative exit interviews within one month of completion of intervention completion for both conditions.
Interventions
BEHAVIORALImmediate Intervention
Enhanced microeconomic intervention
BEHAVIORALDelayed Intervention
Usual care and then access to enhanced microeconomic intervention
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot waitlist randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. at least 18 years old; 2. assigned male at birth; 3. self identifies as female, transgender woman, or another feminine gender identity; 4. self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white); 5. reports earning less than $32,800 gross annual income (current living wage in Michigan); 6. reports condomless sex in the past 6 months; 7. lives in Detroit, MI greater metropolitan area (\ 50 mile radius); 8. speaks English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Quantitative | 3 months | The Client Satisfaction Questionnaire (CSQ-8) will be used to assess intervention satisfaction. This is an 8-item scale where each individual item is scored separately with a range of 1 to 4 and a score of 3 or 4 on each item will be considered indicative of acceptable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Intervention The intervention condition builds on our community partners' existing microeconomic intervention of: (1) a one-time emergency cash grant and (2) peer and legal support to obtain legal gender affirmation - plus a 12-week microeconomic intervention that adds: (3) weekly educational sessions and HIV prevention; (4) community mentoring; and (5) weekly posts of job openings in Detroit; and (6) a micro-grant for use towards acquiring self-led or formal employment
Immediate Intervention: Enhanced microeconomic intervention | 19 |
| Delayed Arm Participants randomized to the control condition will receive UC during the 12-week period following randomization. Usual care consists of emergency assistance and access to legal name/gender marker change. After the RCT follow-up period is complete, waitlist control participants will be offered delayed access to the same intervention that is provided immediately to intervention arm participants.
Delayed Intervention: Usual care and then access to enhanced microeconomic intervention | 20 |
| Total | 39 |
Baseline characteristics
| Characteristic | Immediate Intervention | Delayed Arm | Total |
|---|---|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 9.2 | 32.5 years STANDARD_DEVIATION 6.6 | 32.8 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 18 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 18 Participants | 33 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 19 participants | 20 participants | 39 participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Acceptability Quantitative
The Client Satisfaction Questionnaire (CSQ-8) will be used to assess intervention satisfaction. This is an 8-item scale where each individual item is scored separately with a range of 1 to 4 and a score of 3 or 4 on each item will be considered indicative of acceptable.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Intervention | Acceptability Quantitative | 3.9 score on a scale | Standard Deviation 0.3 |
| Delayed Arm | Acceptability Quantitative | 3.8 score on a scale | Standard Deviation 0.7 |
p-value: <0.05ANOVA