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PrEP N' Shine Program for HIV Prevention (PrEP N Shine Trial)
N/A
Recruiting
Led By Matthew Mimiaga, ScD, MPH, MA
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18 years or older
Male sex at birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage 2: 6 months post-baseline
Awards & highlights
PrEP N Shine Trial Summary
This trial is testing a way to help transgender women take and stick to a medicine that can prevent HIV.
Who is the study for?
This trial is for transgender women over 18 who have not started PrEP, meet CDC guidelines for PrEP use, and can communicate in English or Spanish. Participants must own or be willing to use a cell phone. Those with severe mental/physical illness, recent relocation, Hepatitis B, kidney issues, or untreated major mental illness are excluded.Check my eligibility
What is being tested?
'PrEP N' Shine' is testing a two-stage behavioral intervention aimed at improving the start and consistent use of PrEP among transgender women. The study involves strength-based case management followed by adherence training and counseling.See study design
What are the potential side effects?
Since this trial focuses on behavior interventions rather than medication side effects may include discomfort from discussing personal health behaviors but no physical side effects from drugs as it's about adherence to already established PreP protocols.
PrEP N Shine Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I was assigned male at birth.
Select...
I can understand and speak English or Spanish.
PrEP N Shine Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ stage 2: 6 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage 2: 6 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentrations of TFV-DP in Dried Blood Spots at 3 months
Concentrations of TFV-DP in Dried Blood Spots at 6 months
Verified medical visit and PrEP prescription
Secondary outcome measures
Change in sexual risk behavior based on self report
PrEP N Shine Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Strength Based Case Management (SBCM)Experimental Treatment1 Intervention
Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
Group II: PrEP adherence training and counselingExperimental Treatment1 Intervention
Stage 2: Stepped Intervention:
Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and
Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist.
Group III: Standard of Care:Stage 1Active Control1 Intervention
Stage 1: Referral to local PrEP clinic
Group IV: Standard of Care: Stage 2Active Control1 Intervention
Stage 2: Standard clinical PrEP care: Doctor visit every three months to assess for side effects, do blood work, and receive a HIV test.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,530 Previous Clinical Trials
10,264,602 Total Patients Enrolled
2 Trials studying Prevention
520 Patients Enrolled for Prevention
Brown UniversityOTHER
456 Previous Clinical Trials
558,248 Total Patients Enrolled
2 Trials studying Prevention
611 Patients Enrolled for Prevention
Matthew Mimiaga, ScD, MPH, MAPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I identify as a woman or on the male-to-female gender spectrum.If you are currently having thoughts of hurting yourself or have a serious mental illness that is not being treated, you will be referred for immediate help. Once you receive treatment and feel better, you may be able to join the study.I am 18 years old or older.I was assigned male at birth.I can understand and speak English or Spanish.I own a cell phone or am willing to use one for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care:Stage 1
- Group 2: Standard of Care: Stage 2
- Group 3: Strength Based Case Management (SBCM)
- Group 4: PrEP adherence training and counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants to join this experiment?
"Indeed. Clinicaltrials.gov indicates that the trial, which was initially advertised on October 18th 2022 and recently updated November 2nd 2022, is actively recruiting volunteers for its research. 106 participants will be sourced from two locations across the country."
Answered by AI
How many subjects are involved in the current clinical experiment?
"Indeed, per the details available on clinicaltrials.gov, this research trial is presently enrolling participants. It was originally posted on October 18th 2022 and recently updated November 2nd 20202; a total of 106 test subjects are needed from two sites."
Answered by AI
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