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Behavioural Intervention

Gender-Affirming Intervention for HIV Risk and IPV Reduction (STARS Trial)

N/A

Recruiting

Led By Shufang Sun, PhD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

STARS Trial Summary

This trial will examine the efficacy of a gender-affirming intervention to reduce HIV risk and IPV among transgender women. It involves 10-12 hours of assessments, surveys, and interventions over 6 months.

Who is the study for?

This trial is for transgender women over 18 who were assigned male at birth, have experienced intimate partner violence in the past year, and had unprotected sex recently. It's not open to those already diagnosed with or testing positive for HIV.Check my eligibility

What is being tested?

The study compares a new gender-affirming program called STARS aimed at reducing HIV risk and empowering participants against a relaxation technique program. Participants will be randomly placed into one of these two groups.See study design

What are the potential side effects?

Since this trial involves counseling programs rather than medications, traditional side effects are not expected. However, discussing sensitive topics may cause emotional discomfort.

STARS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of online STARS as measured by a session evaluation form

Acceptability of online STARS as measured by semi-structured qualitative exit interview

Acceptability of online STARS as measured by the Client Satisfaction Questionnaire

+6 more

Secondary outcome measures

Rates of STI/HIV testing and outcomes

Self-reported discrete behavioral risk indicators

STARS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Program STARS (Supporting Trans Affirmation, relationships, and Sex)Experimental Treatment1 Intervention

STARS is an HIV prevention intervention for trans women/femmes with recent intimate partner violence (IPV). Delivered by peer counselors, STARS consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. STARS is an empowerment-based intervention that integrates trauma-informed and gender affirmation approaches. The first session emphasizes education and discussion around HIV and IPV, as well as the interaction between IPV and HIV risk. The second session focuses on identifying partners where HIV/IPV risk exists and developing an empowerment plan to address those risks. Participants create an empowerment plan in session 2 and this plan is reviewed and updated in the booster sessions.

Group II: Relaxation and Stress ReductionActive Control1 Intervention

The Relaxation and Stress Reduction Program is structured to mirror STARS (time matched, attention-controlled). Delivered by peer counselors, the Relaxation and Stress Reduction Program consists of two one-hour sessions held one week apart and two brief 20-30 minute booster sessions held two- and four-weeks after the 2nd hour long session. Requirements for peer counselors include identifying as trans women or trans feminine and having leadership roles in the trans community. The relaxation and stress reduction protocol is an attention and time-matched control condition. The intervention focuses on providing both education and opportunities to practice various relaxation strategies. In addition, education is provided on healthy eating as an additional tool for reducing stress. Booster sessions focus on providing participants with additional practice of relaxation strategies.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,669 Total Patients Enrolled

Brown UniversityLead Sponsor

456 Previous Clinical Trials

558,314 Total Patients Enrolled

The University of AkronOTHER

9 Previous Clinical Trials

845 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants presently being accepted for this clinical investigation?

"At present, this clinical trial is actively recruiting participants - as evidenced by the data available on Clinicaltrials.gov. This study was initially posted to the website on June 20th and was last updated August 21st of this year."

Answered by AI

What is the limit for total enrollment in this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, recruitment for this medical trial commenced on June 20th of 2021 and was recently updated on August 21st of 2021. This research is seeking 40 volunteers from 1 single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Supporting Trans Affirmation, Relationships, and Sex, Phase 3

2023. "Supporting Trans Affirmation, Relationships, and Sex, Phase 3". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001307.

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