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Behavioural Intervention

WePrEP Tool for HIV Prevention

N/A

Waitlist Available

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Participants in the transgender women group are excluded if they currently live with HIV or do not meet one or more of the inclusion criteria above.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for oral prep: prep serum concentrations are measured at 3 months. for injectable prep: prep serum concentrations are measured at 2 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to develop a digital tool called "WePrEP" to help transgender women (TW) and healthcare providers make informed decisions about using HIV pre-exposure prophylaxis (PrEP).

Who is the study for?

This trial is for transgender women in the United States who are at risk of HIV and interested in exploring pre-exposure prophylaxis (PrEP) options, including a new long-acting injectable form. Participants should be comfortable with English or Spanish to use the WePrEP decision-making tool.

What is being tested?

The study tests 'WePrEP,' a bilingual digital tool designed to help transgender women decide between oral PrEP and a new injectable option by facilitating discussions with healthcare providers. The effectiveness of WePrEP will be compared to standard CDC recommendations through a randomized controlled trial.

What are the potential side effects?

Since this trial focuses on developing and testing a decision-making tool rather than medication, there are no direct side effects from interventions being studied. However, potential side effects would relate to the chosen PrEP method after consultation.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

As a transgender woman, I do not have HIV and meet all other inclusion criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at follow-up (for oral prep users, this is at 3 months; for injectable prep users, this is at 2 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at follow-up (for oral prep users, this is at 3 months; for injectable prep users, this is at 2 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at follow-up (for oral prep users, this is at 3 months; for injectable prep users, this is at 2 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability

Feasibility

Secondary study objectives

Mechanisms of action: Evidence of shared decision-making (4th of 7 measures)

Mechanisms of action: Knowledge, motivation and self-efficacy to use PrEP (6th of 7 measures)

Mechanisms of action: Patient/provider communication (1st of 7 measures)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Intervention group: Transgender womenExperimental Treatment1 Intervention

Transgender women randomized to the intervention group will use WePrEP with a PrEP service provider. WePrEP will be stored on providers' tablets and will present oral PrEP and CAB-LA priority information points, identified during preliminary studies, and cue relevant discussions. Once a transgender woman assigned to the control group selects her preferred PrEP method, the provider will review the appropriate adherence strategies using WePrEP.

Group II: Intervention group: PrEP service providersExperimental Treatment1 Intervention

During the study, PrEP service providers randomized to the intervention group will use WePrEP with transgender women participants in the intervention group who are potential PrEP patients. WePrEP will be stored on providers' tablets and will present oral PrEP and CAB-LA priority information points, identified during preliminary studies, and cue relevant discussions. Once the participant selects her PrEP method, the provider will review the appropriate adherence strategies. To ensure that they are able to provide feedback on WePrEP in IDIs, intervention group PrEP service providers will use WePrEP with a minimum of 8 different transgender women in this study.

Group III: Control group: Transgender womenActive Control1 Intervention

Transgender women randomized to the Control Group will receive a standard of care PrEP explanation from a PrEP services provider designated to deliver this trial condition. This explanation follows the 2021 CDC PrEP Clinical Guidelines, which have been updated to include information about CAB-LA.

Group IV: Control group: PrEP service providersActive Control1 Intervention

PrEP service providers randomized to the Control Group will give transgender women enrolled in this study a standard of care PrEP explanation. This explanation follows the 2021 CDC PrEP Clinical Guidelines, which have been updated to include information about CAB-LA.

0 / 1Eligibility criteria met