Feasibility StudiesSecureNCT06212544
An HIV Status-neutral Microeconomic Intervention
A study testing Immediate Intervention and Delayed Intervention in people with Feasibility Studies, run by University of Michigan at 1 site in United States.
Trial 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. 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
- Feasibility Studies
- What is being tested?
- Immediate Intervention and Delayed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 26 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- at least 18 years old;
- assigned male at birth;
- self identifies as female, transgender woman, or another feminine gender identity;
- self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white);
- reports earning less than $32,800 gross annual income (current living wage in Michigan);
- reports condomless sex in the past 6 months;
- lives in Detroit, MI greater metropolitan area (~50 mile radius);
- speaks English.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Community Responses to Economic Vulnerability and HIV Inequities
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:
- To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color.
- The determine acceptability of the intervention with transgender women of color.
Read the 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.
- Conditions
- Feasibility Studies
- Being tested
- Immediate Intervention, Delayed Intervention
- Keywords
- Transgender, HIV, microeconomic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate InterventionBehavioural
Enhanced microeconomic intervention
Delayed InterventionBehavioural
Usual care and then access to enhanced microeconomic intervention
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | 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 Receives: Behavioral: Immediate Intervention |
| Delayed Arm | Active comparator | 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. Receives: Behavioral: Delayed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 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 2024
- Study start7 Jun 2024
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Pilot waitlist randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kristi Gamarel, University of Michigan
- Investigators
- Kristi Gamarel, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212544
- Sponsor's protocol ID
- F00423
- Other IDs
- R34MH130207
- Acronym
- Secure
- Status last verified
- Jun 2025
- First submitted
- 20 Dec 2023
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators plan to share de-identified data per guidelines; however, data will be in aggregate form to ensure individuals are not identified in anyway.
Publications
Gamarel K, Mayo-Wilson LJ, Jadwin-Cakmak L, Reyes L, Monro D, Ubong IA, Sullivan S, Abad J, Poindexter J, Harris H, Riser C, Stephenson J, Ortiz G, Peitzmeier SM, Neilands TB, Poteat T. Strengthening Community Responses to Economic vulnerability (SeCuRE): a protocol of an HIV status-neutral pilot randomized clinical trial with transgender women of color in Detroit, Michigan. Pilot Feasibility Stud. 2024 Nov 8;10(1):135. doi: 10.1186/s40814-024-01558-5.
PubMed 39511631
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Community Responses to Economic Vulnerability and HIV Inequities
- ClinicalTrials.gov ID
- NCT06212544
- Acronym / sponsor ID
- Secure / F00423
- Conditions
- Feasibility Studies
- Keywords
- Transgender, HIV, microeconomic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To deliver a two-armed pilot RCT of the SeCuRE intervention with 40 transgender women of color.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot waitlist randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Immediate InterventionThe 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 |
| Delayed Arm | Active comparator | Behavioral: Delayed InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- at least 18 years old;
- assigned male at birth;
- self identifies as female, transgender woman, or another feminine gender identity;
- self identifies as a person of color (i.e., any racial/ethnic identity except non-Hispanic white);
- reports earning less than $32,800 gross annual income (current living wage in Michigan);
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Immediate InterventionEnhanced microeconomic intervention | Behavioural | Immediate Intervention |
| Delayed InterventionUsual care and then access to enhanced microeconomic intervention | Behavioural | Delayed Arm |
Primary outcome
Acceptability Quantitative
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39511631Gamarel K, Mayo-Wilson LJ, Jadwin-Cakmak L, Reyes L, Monro D, Ubong IA, Sullivan S, Abad J, Poindexter J, Harris H, Riser C, Stephenson J, Ortiz G, Peitzmeier SM, Neilands TB, Poteat T. Strengthening Community Responses to Economic vulnerability (SeCuRE): a protocol of an HIV status-neutral pilot randomized clinical trial with transgender women of color in Detroit, Michigan. Pilot Feasibility Stud. 2024 Nov 8;10(1):135. doi: 10.1186/s40814-024-01558-5.
- Individual participant dataSharing planned: No. The investigators plan to share de-identified data per guidelines; however, data will be in aggregate form to ensure individuals are not identified in anyway.
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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.
Kristi Gamarel, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Intervention and Delayed Intervention in people with Feasibility Studies, run by University of Michigan 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 5 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Quantitative (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06212544, which also lists 1 linked publication.
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 5 Jun 2025.