HIV PreventionNCT06656676
WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women
A study testing WePrEP: A shared decision-making tool and Active comparator: CDC recommendations for discussing PrEP in people with HIV Prevention, run by University of Colorado, Denver at 1 site in United States.
Trial summary
HIV prevalence among transgender women (TW) in the United States is high (~14%). The best way to reduce HIV incidence in this population is to link TW to HIV pre-exposure prophylaxis (PrEP), which can reduce HIV transmission by up to 86%, with optimal adherence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV Prevention
- What is being tested?
- WePrEP: A shared decision-making tool and Active comparator: CDC recommendations for discussing PrEP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants in the transgender women group (N=69) must:
- Self-identify as a transgender woman (e.g., was assigned male at birth, but currently reports a feminine gender identity)
- Be between the ages of 18 and 65
- Currently live in the Denver area
- Speak English or Spanish
- Be HIV-negative (via Alere Determine)
Show all 12Show fewer
- Not have participated in the development of WePrEP
- Not currently take PrEP, but report they are "interested in doing more to protect themselves from HIV" **We note that 1/3 of our RCT participants in the transgender women's group will be Black and/or Hispanic/Latina
- Eligible participants in the PrEP service providers group (N=6) must:
- Not have participated in the development of WePrEP
- Live in the Denver area and (as a part of their employment responsibilities) discuss PrEP use with potential end-users.
- Have helped at least 1 TW make a decision about PrEP (e.g., whether or not to use it, which specific PrEP modality, etc...) in the last month.
Who cannot join
- Participants in the transgender women group are excluded if they:
- Currently live with HIV
- Do not meet one or more of the inclusion criteria above
- Participants in the PrEP service providers group are excluded if they:
- Do not live in the Denver area
- Do not meet one or more of the inclusion criteria above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Transgender Center of the Rockies
Sheridan, Colorado, 80110
Mel Golden, MSW, 720-256-6525, mgolden@mhbhc.org
Zane Guilfoyle, LPC, LAC, ACS, MAC, ADS, (720)-382-5900, zguilfoyle@mhbhc.org
About this study
Official title: WePrEP: A Bilingual Shared Decision-making Tool to Facilitate Conversations Between Transgender Women and Their Providers as They Select an Ideal PrEP Method
HIV prevalence among transgender women (TW) in the United States is high (~14%). The best way to reduce HIV incidence in this population is to link TW to HIV pre-exposure prophylaxis (PrEP), which can reduce HIV transmission by up to 86%, with optimal adherence. The FDA approved the first long-acting form of PrEP, injectable cabotegravir (CAB-LA), in late 2021, which has the potential to decrease HIV transmission and increase PrEP adherence among TW. The addition of CAB-LA to available PrEP options necessitates TW and PrEP service providers select the best method (oral vs injectable) for each TW. However, TW have unique concerns about PrEP (e.g., interactions with gender-affirming hormones) and report that patient/provider discussions on this medication are suboptimal. Thus, to inform this shared decision process, the proposed study builds on formative work by developing and pilot-testing "WePrEP," a PrEP-focused bilingual digital shared decision-making tool (SDMT), tailored to diverse English- and Spanish-speaking TW and PrEP service providers. WePrEP will support communication between TW and PrEP service providers as they identify the ideal PrEP product for each TW and discuss associated adherence strategies by cuing conversations on TW's unique PrEP needs/concerns and presenting pertinent information that is culturally relevant and tailored to this population. To develop and test WePrEP, the investigators will partner with the Mile High Behavioral Healthcare Transgender Center of the Rockies, a Denver-based transgender-serving organization. They will use McNulty et al.'s adapted Shared Decision-Making Model for TW to guide the iterative participatory design process we will use with a group of racially/ethnically diverse TW and PrEP service providers, to develop WePrEP; we will begin this process using prototypes created from preliminary data (Aim 1a). The investigators will rigorously assess the usability of WePrEP via simulated patient/provider discussions (Aim 1b). Next, they will pilot test WePrEP in a randomized controlled trial (RCT; N=69 TW) with 2:1 randomization. In the RCT, PrEP service providers (N=4, of which n=1 is bilingual) will use WePrEP with intervention TW to select CAB-LA or oral PrEP and discuss adherence. Other providers (N=2, of which n=1 is bilingual) will give control TW a standard of care explanation of PrEP (CDC recommendations) to help them make their PrEP choice. TW will be referred to Sheridan Health Services to start PrEP. We will assess primary (feasibility; acceptability) and secondary (potential mechanisms of action of WePrEP; preliminary impact) outcome measures using validated scales and rigorous qualitative methods (Aims 2, 3). By creating a bilingual digital SDMT to enhance communication between TW and PrEP service providers as TW choose their ideal PrEP modality, this project is likely to make a widespread and lasting impact on TW's uptake and adherence to PrEP.
- Conditions
- HIV Prevention
- Being tested
- WePrEP: A shared decision-making tool, Active comparator: CDC recommendations for discussing PrEP
- Keywords
- PrEP, Biomedical HIV prevention, CAB-LA, Cabenuva, Truvada, Tenofovir, oral PrEP, injectable PrEP, shared decision-making, transgender women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WePrEP: A shared decision-making toolBehavioural
WePrEP will be bilingual, both patient- and provider-facing, stored on the provider's electronic device (and will have the capability to integrate with electronic health records in the future to enable scalability), and easily accessible during in-person or virtual patient-provider encounters. WePrEP is designed to present pertinent PrEP information to transgender women and their PrEP service providers to stimulate discussions about PrEP choice and support adherence (once a PrEP strategy has been chosen). We hypothesize that this will ensure selection of the ideal PrEP method and improve subsequent adherence.
Active comparator: CDC recommendations for discussing PrEPBehavioural
Standard of care recommendations to discuss PrEP with potential end-users, endorsed by the CDC.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Transgender women | Experimental | 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. Receives: Behavioral: WePrEP: A shared decision-making tool |
| Control group: Transgender women | Active comparator | 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. Receives: Behavioral: Active comparator: CDC recommendations for discussing PrEP |
| Intervention group: PrEP service providers | Experimental | 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. Receives: Behavioral: WePrEP: A shared decision-making tool |
| Control group: PrEP service providers | Active comparator | 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. Receives: Behavioral: Active comparator: CDC recommendations for discussing PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility of Intervention Measure (FIM) [Range: 1-5; Higher scores mean greater feasibility]
Measured: At enrollment
Acceptability
Acceptability of Intervention Measure (AIM) [Range: 1-5; Higher scores mean greater acceptability]
Measured: At enrollment
Secondary outcomes (10)
Preliminary impact (1st of 3 measures)
Proportion of transgender women who receive their first dose of either form of PrEP (measured at enrollment).
Measured: The proportion of transgender women who receive either form of PrEP is measured at enrollment.
Preliminary impact (2nd of 3 measures)
Proportion of transgender women who have a high enough serum concentration of either form of PrEP to prevent HIV at the second dose (measured at follow-up).
Measured: For oral PrEP: PrEP serum concentrations are measured at 3 months. For injectable PrEP: PrEP serum concentrations are measured at 2 months.
Preliminary impact (3rd of 3 measures)
Proportion of transgender women who refill (oral PrEP) or take an injection (injectable PrEP) at the second dose (measured at follow-up).
Measured: For oral PrEP: PrEP refills are measured at 3 months. For injectable PrEP: Injections are measured at 2 months.
Mechanisms of action: Patient/provider communication (1st of 7 measures)
Communication composite measure from the Consumer Assessment of Healthcare Providers \& Systems (CAHPS) [Range: 1-4; Higher scores mean better communication]
Measured: Measured at enrollment
Mechanisms of action: Satisfaction with communication (2nd of 7 measures)
Combined Outcome Measure for Risk Communication and Treatment Decision-making Effectiveness (COMRADE) [Range: 1-5 where higher scores mean greater satisfaction]
Measured: Measured at enrollment
Mechanisms of action: Patient/provider engagement (3rd of 7 measures)
Engagement with Health Care Providers (HCP) scale [Range: 1-5, where higher scores mean greater engagement]
Measured: Measured at enrollment
Mechanisms of action: Evidence of shared decision-making (4th of 7 measures)
Control Preferences Scale (CPS) - domain measuring actual control over decision [Range: 1-5, where higher scores mean greater control]
Measured: Measured at enrollment
Mechanisms of action: Satisfaction with control over PrEP decision (5th of 7 measures)
Control Preference Scale (CPS) - domain measuring control satisfaction [Range: 1-5, where higher scores mean greater satisfaction]
Measured: Measured at enrollment
Mechanisms of action: Knowledge, motivation and self-efficacy to use PrEP (6th of 7 measures)
PrEP Knowledge, Motivation, \& Self-Efficacy Assessment [Range: 1-5, where higher scores mean greater knowledge, motivation, and self-efficacy]
Measured: Measured at enrollment
Mechanisms of action: Satisfaction with PrEP choice (7th of 7 measures)
Treatment Satisfaction Questionnaire [Range: 1-5, where higher scores mean greater satisfaction]
Measured: Measured at follow-up (for oral PrEP users, this is at 3 months; for injectable PrEP users, this is at 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start29 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Mile High Behavioral Healthcare Transgender Center of the Rockies, The Gay Lesbian Bisexual & Transgender Community Center of Colorado
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656676
- Sponsor's protocol ID
- R34MH136932
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WePrEP: A Bilingual Shared Decision-making Tool to Facilitate Conversations Between Transgender Women and Their Providers as They Select an Ideal PrEP Method
- ClinicalTrials.gov ID
- NCT06656676
- Acronym / sponsor ID
- R34MH136932
- Conditions
- HIV Prevention
- Keywords
- PrEP, Biomedical HIV prevention, CAB-LA, Cabenuva, Truvada, Tenofovir, oral PrEP, injectable PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Mile High Behavioral Healthcare Transgender Center of the Rockies, The Gay Lesbian Bisexual & Transgender Community Center of Colorado
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV prevalence among transgender women (TW) in the United States is high (~14%). The best way to reduce HIV incidence in this population is to link TW to HIV pre-exposure prophylaxis (PrEP), which can reduce HIV transmission by up to 86%, with optimal adherence. The FDA approved the first long-acting form of PrEP, injectable cabotegravir (CAB-LA), in late 2021, which has the potential to decrease HIV transmission and increase PrEP adherence among TW. The addition of CAB-LA to available PrEP options necessitates TW and PrEP service providers select the best method (oral vs injectable) for each TW. However, TW have unique concerns about PrEP (e.g., interactions with gender-affirming hormones) and report that patient/provider discussions on this medication are suboptimal. Thus, to inform this shared decision process, the proposed study builds on formative work by developing and pilot-testing "WePrEP," a PrEP-focused bilingual digital shared decision-making tool (SDMT), tailored to diverse English- and Spanish-speaking TW and PrEP service providers. WePrEP will support communication between TW and PrEP service providers as they identify the ideal PrEP product for each TW and discuss associated adherence strategies by cuing conversations on TW's unique PrEP needs/concerns and presenting pertinent information that is culturally relevant and tailored to this population. To develop and test WePrEP, the investigators will partner with the Mile High Behavioral Healthcare Transgender Center of the Rockies, a Denver-based transgender-serving organization. They will use McNulty et al.'s adapted Shared Decision-Making Model for TW to guide the iterative participatory design process we will use with a group of racially/ethnically diverse TW and PrEP service providers, to develop WePrEP; we will begin this process using prototypes created from preliminary data (Aim 1a). The investigators will rigorously assess the usability of WePrEP via simulated patient/provider discussions (Aim 1b). Next, they will pilot test WePrEP in a randomized controlled trial (RCT; N=69 TW) with 2:1 randomization. In the RCT, PrEP service providers (N=4, of which n=1 is bilingual) will use WePrEP with intervention TW to select CAB-LA or oral PrEP and discuss adherence. Other providers (N=2, of which n=1 is bilingual) will give control TW a standard of care explanation of PrEP (CDC recommendations) to help them make their PrEP choice. TW will be referred to Sheridan Health Services to start PrEP. We will assess primary (feasibility; acceptability) and secondary (potential mechanisms of action of WePrEP; preliminary impact) outcome measures using validated scales and rigorous qualitative methods (Aims 2, 3). By creating a bilingual digital SDMT to enhance communication between TW and PrEP service providers as TW choose their ideal PrEP modality, this project is likely to make a widespread and lasting impact on TW's uptake and adherence to PrEP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Transgender women | Experimental | Behavioral: WePrEP: A shared decision-making toolTransgender 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. |
| Control group: Transgender women | Active comparator | Behavioral: Active comparator: CDC recommendations for discussing PrEPTransgender 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. |
| Intervention group: PrEP service providers | Experimental | Behavioral: WePrEP: A shared decision-making toolDuring 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. |
| Control group: PrEP service providers | Active comparator | Behavioral: Active comparator: CDC recommendations for discussing PrEPPrEP 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Self-identify as a transgender woman (e.g., was assigned male at birth, but currently reports a feminine gender identity)
- Be between the ages of 18 and 65
- Currently live in the Denver area
- Speak English or Spanish
- Be HIV-negative (via Alere Determine)
Key exclusion criteria (6 listed)
- Currently live with HIV
- Do not meet one or more of the inclusion criteria above
- Do not live in the Denver area
- Do not meet one or more of the inclusion criteria above
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 |
|---|---|---|
| WePrEP: A shared decision-making toolWePrEP will be bilingual, both patient- and provider-facing, stored on the provider's electronic device (and will have the capability to integrate with electronic health records in the future to enable scalability), and easily accessible during in-person or virtual patient-provider encounters. WePrEP is designed to present pertinent PrEP information to transgender women and their PrEP service providers to stimulate discussions about PrEP choice and support adherence (once a PrEP strategy has been chosen). We hypothesize that this will ensure selection of the ideal PrEP method and improve subsequent adherence. | Behavioural | Intervention group: PrEP service providers, Intervention group: Transgender women |
| Active comparator: CDC recommendations for discussing PrEPStandard of care recommendations to discuss PrEP with potential end-users, endorsed by the CDC. | Behavioural | Control group: PrEP service providers, Control group: Transgender women |
Primary outcome
Feasibility
Time frame: At enrollment
Feasibility of Intervention Measure (FIM) [Range: 1-5; Higher scores mean greater feasibility]
Acceptability
Time frame: At enrollment
Acceptability of Intervention Measure (AIM) [Range: 1-5; Higher scores mean greater acceptability]
10 secondary outcomes
Preliminary impact (1st of 3 measures)
Time frame: The proportion of transgender women who receive either form of PrEP is measured at enrollment.
Preliminary impact (2nd of 3 measures)
Time frame: For oral PrEP: PrEP serum concentrations are measured at 3 months. For injectable PrEP: PrEP serum concentrations are measured at 2 months.
Preliminary impact (3rd of 3 measures)
Time frame: For oral PrEP: PrEP refills are measured at 3 months. For injectable PrEP: Injections are measured at 2 months.
Mechanisms of action: Patient/provider communication (1st of 7 measures)
Time frame: Measured at enrollment
Mechanisms of action: Satisfaction with communication (2nd of 7 measures)
Time frame: Measured at enrollment
Mechanisms of action: Patient/provider engagement (3rd of 7 measures)
Time frame: Measured at enrollment
Mechanisms of action: Evidence of shared decision-making (4th of 7 measures)
Time frame: Measured at enrollment
Mechanisms of action: Satisfaction with control over PrEP decision (5th of 7 measures)
Time frame: Measured at enrollment
Mechanisms of action: Knowledge, motivation and self-efficacy to use PrEP (6th of 7 measures)
Time frame: Measured at enrollment
Mechanisms of action: Satisfaction with PrEP choice (7th of 7 measures)
Time frame: Measured at follow-up (for oral PrEP users, this is at 3 months; for injectable PrEP users, this is at 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WePrEP: A shared decision-making tool and Active comparator: CDC recommendations for discussing PrEP in people with HIV Prevention, run by University of Colorado, Denver 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 12 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine T Rael, PhD (303-734-8541, christine.rael@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.