WePrEP Tool for HIV Prevention

Overseen By Samantha Stonbraker, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: HIV positive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new bilingual tool called WePrEP, designed to assist transgender women and their healthcare providers in selecting the best HIV prevention method, whether oral or injectable PrEP. The goal is to enhance communication and decision-making about PrEP options, taking into account unique needs and concerns, such as interactions with gender-affirming hormones. Transgender women in Denver who are HIV-negative and interested in starting PrEP can participate. Participants will either use the WePrEP tool with a provider or receive the standard explanation of PrEP choices. The trial aims to determine if WePrEP more effectively guides decisions and boosts adherence to PrEP. As an unphased trial, this study offers a unique opportunity to contribute to the development of a tool that could improve healthcare experiences for transgender women.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on participants who are not currently taking PrEP but are interested in starting it.

What prior data suggests that the WePrEP tool is safe for use in shared decision-making for PrEP among transgender women?

Research shows that the WePrEP tool aids transgender women and their healthcare providers in discussing and selecting the best HIV prevention methods. This tool is not a medication and therefore lacks the side effects associated with drugs. Instead, it enhances conversations about HIV prevention options, such as taking a daily pill (oral PrEP) or receiving an injection every two months (injectable cabotegravir, or CAB-LA).

Both oral PrEP and CAB-LA have FDA approval for HIV prevention. Studies indicate that most people tolerate these methods well. Some individuals might experience mild side effects, such as headaches or fatigue, when starting them, but serious side effects are rare. CAB-LA, a newer option, has been proven safe and effective in preventing HIV.

This trial focuses on using WePrEP to guide these discussions. It assists transgender women and their providers in making informed decisions about which prevention method to use, based on personal preferences and needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WePrEP tool because it offers a personalized and interactive approach to HIV prevention for transgender women. Unlike the standard method, which involves a general explanation of PrEP based on CDC guidelines, WePrEP uses digital technology to tailor discussions and strategies to each individual's needs and preferences. This tool not only simplifies complex information about different PrEP options, like oral PrEP and CAB-LA, but also actively engages users by involving them in the decision-making process, potentially improving adherence and outcomes.

What evidence suggests that the WePrEP tool is effective for improving PrEP adherence among transgender women?

Studies have shown that using PrEP (pre-exposure prophylaxis) can lower the risk of acquiring HIV by up to 86% when taken correctly. Injectable cabotegravir (CAB-LA), a long-lasting form of PrEP, received approval in 2021. It may improve adherence among transgender women, who sometimes face challenges with oral PrEP, such as concerns about interactions with gender-affirming hormones. This trial tests the WePrEP tool to assist transgender women and their healthcare providers in selecting the most suitable type of PrEP and discussing adherence strategies. Research indicates that digital tools like WePrEP can enhance adherence by identifying challenges early and improving communication. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Eligible participants in the PrEP service providers group must not have participated in the development of WePrEP, live in the Denver area and discuss PrEP use with potential end-users as part of their employment responsibilities, and have helped at least 1 transgender woman make a decision about PrEP in the last month.

I am a transgender woman, 18-65, living in Denver, HIV-negative, interested in HIV prevention but not on PrEP.

Exclusion Criteria

Participants in the PrEP service providers group are excluded if they do not live in the Denver area or do not meet one or more of the inclusion criteria above.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Testing

Development and pilot-testing of the WePrEP tool with transgender women and PrEP service providers

Not specified

Simulated patient/provider discussions

Randomized Controlled Trial

Pilot test WePrEP in a randomized controlled trial with transgender women to select CAB-LA or oral PrEP and discuss adherence

Not specified

Multiple visits for intervention and control groups

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-3 months

Follow-up visits at 2 months for injectable PrEP users and 3 months for oral PrEP users

What Are the Treatments Tested in This Trial?

Interventions

• WePrEP

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention group: Transgender women Experimental Treatment 1 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 providers Experimental Treatment 1 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 women Active Control 1 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 providers Active Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Mile High Behavioral Healthcare Transgender Center of the Rockies

Collaborator

Trials

1

Recruited

80+

The Gay Lesbian Bisexual & Transgender Community Center of Colorado

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

The PrEP-OI study demonstrated that a panel management intervention, which included PrEP coordinators and a web-based tool, significantly increased the number of PrEP prescriptions from 1.85 to 2.44 per month across 10 primary care clinics in San Francisco.

The intervention also improved PrEP-related discussions, HIV risk assessments, and risk reduction counseling during clinic visits, indicating enhanced overall care for patients at risk of HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions. Saberi, P., Stoner, MCD., Ming, K., et al.[2023]

A new HIV risk assessment tool for pregnant women was developed using data from 654 participants, which effectively predicts the risk of HIV acquisition based on factors like partner's HIV status and history of infections, achieving a high predictive accuracy (AUC of 0.84).

The tool can help prioritize women for preexposure prophylaxis (PrEP), as those with higher risk scores (over 6) accounted for a significant portion (56%) of HIV acquisitions, despite only representing 16% of the population studied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Risk Assessment Tool for Identifying Pregnant and Postpartum Women Who May Benefit From Preexposure Prophylaxis. Pintye, J., Drake, AL., Kinuthia, J., et al.[2019]

In a study of 567 HIV serodiscordant couples in Kenya and Uganda, discontinuation of PrEP by HIV-negative partners did not lead to significant changes in their sexual behaviors, including total and condomless sex acts.

The findings support the effectiveness of transitioning from PrEP to relying on the HIV-positive partner's adherence to antiretroviral therapy (ART) for HIV prevention, indicating that this strategy can be safely implemented without increasing risky sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Behaviors After PrEP Discontinuation Among HIV Serodiscordant Couples in Kenya and Uganda. Stalter, R., Mugwanya, K., Thomas, K., et al.[2022]

Pre-exposure prophylaxis (PrEP) has shown variable efficacy rates (0%-86%) in preventing HIV infection, with its effectiveness closely linked to adherence and the levels of antiretroviral drugs in the bloodstream.

PrEP is recommended by the WHO for individuals at high risk of HIV, and while adverse events are rare, there is a risk of developing drug-resistant strains in those who start PrEP without knowing they are already HIV positive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis: a useful tool to prevent human immunodeficiency virus infection? Pialoux, G., Delaugerre, C., Cotte, L., et al.[2017]

The EquiPrEP Project aims to optimize the rollout of long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) in New York City by enrolling 210 participants from underrepresented groups, including Black and/or Latine men who have sex with men, women, and transgender individuals, over a one-year follow-up period.

The project focuses on increasing LAI-PrEP initiation and retention while identifying barriers to access, using equity-oriented implementation frameworks to ensure marginalized populations benefit from this innovative HIV prevention method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EquiPrEP: An implementation science protocol for promoting equitable access and uptake of long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP). Kaul, CM., Moore, BE., Kaplan-Lewis, E., et al.[2023]

In a study of 224 patients diagnosed with recent HIV, only 26% received information about pre-exposure prophylaxis (PrEP), and just 5% actually used it, highlighting a significant gap in communication from healthcare providers.

The main reasons for not using PrEP included fear of side effects and a low perceived risk of HIV infection, indicating that increasing awareness and addressing concerns could improve PrEP uptake among eligible individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities for HIV pre-exposure prophylaxis among people with recent HIV infection: The French ANRS 95041 OMaPrEP study. Lions, C., Laroche, H., Mora, M., et al.[2023]

Preexposure prophylaxis (PrEP) has been proven effective in reducing the risk of HIV acquisition, particularly with the approval of the combination drug emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for sexual HIV prevention.

The success of PrEP is closely linked to adherence; therefore, understanding how to encourage and maintain adherence in high-risk populations is crucial for maximizing its public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis for HIV prevention: where have we been and where are we going? Baeten, JM., Haberer, JE., Liu, AY., et al.[2022]

In a study involving 373 HIV-uninfected partners from serodiscordant couples, SMS surveys revealed that PrEP adherence was high, averaging 92% when participants reported sexual activity, indicating effective monitoring of adherence in real-time.

The findings suggest that while high PrEP adherence is beneficial, it is also associated with increased risk for HIV acquisition during periods of sexual activity, highlighting the importance of ongoing risk assessment in PrEP programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa. Haberer, JE., Ngure, K., Muwonge, T., et al.[2022]

A new HIV risk prediction model developed using electronic health record data from over 3.7 million patients effectively identified individuals at high risk for HIV, achieving an area under the curve (AUC) of 0.86 in the development dataset and 0.84 in the validation dataset.

The model flagged 13,463 patients as high or very high risk, successfully identifying a significant portion of incident HIV cases, demonstrating its potential to enhance the targeting of pre-exposure prophylaxis (PrEP) for those who need it most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of electronic health record data and machine learning to identify candidates for HIV pre-exposure prophylaxis: a modelling study. Marcus, JL., Hurley, LB., Krakower, DS., et al.[2023]

The Seattle PrEP Score, developed from a study of 16,448 HIV-negative men who have sex with men (MSM) over a 14.3-year period, effectively predicts the risk of HIV acquisition, helping to identify individuals who may benefit from pre-exposure prophylaxis (PrEP).

The score demonstrated a sensitivity of 76% and specificity of 63% at a cutoff score of ≥11, while a simplified model using fewer predictors showed a 62% sensitivity and 70% specificity, indicating its potential utility in targeted public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Derivation and Validation of an HIV Risk Prediction Score Among Gay, Bisexual, and Other Men Who Have Sex With Men to Inform PrEP Initiation in an STD Clinic Setting. Tordoff, DM., Barbee, LA., Khosropour, CM., et al.[2022]

In a study of 4747 HIV-1 serodiscordant couples, preexposure prophylaxis (PrEP) was found to be effective for HIV-1 prevention among women using depot medroxyprogesterone acetate (DMPA) for contraception, with efficacy rates of 64.7% compared to 75.5% for those not using hormonal contraception.

For men whose partners used DMPA, PrEP efficacy was also similar, showing 90.0% effectiveness compared to 81.7% for those with partners not using hormonal contraception, indicating that PrEP can safely be used alongside DMPA to reduce the risk of HIV-1 transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis is efficacious for HIV-1 prevention among women using depot medroxyprogesterone acetate for contraception. Heffron, R., Mugo, N., Were, E., et al.[2018]

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

In a study involving 1456 participants across 14 sites in Sub-Saharan Africa, monitoring the fidelity of counseling for the dapivirine vaginal ring was feasible and effective, with 54.1% of expected counseling sessions being audio-recorded.

The majority of reviewed sessions (83.9%) were rated as 'good' or 'fair', indicating that consistent and high-quality counseling can be maintained, which is crucial for supporting adherence to PrEP interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a fidelity monitoring process to assess delivery of an evidence-based adherence counseling intervention in a multi-site biomedical HIV prevention study. Balán, IC., Lentz, C., Giguere, R., et al.[2021]

Oral HIV pre-exposure prophylaxis (PrEP) has been shown to be effective in preventing HIV-1 among high-risk groups, including injection drug users and men who have sex with men, but there is limited research on its implementation in HIV-serodiscordant heterosexual couples.

Implementing PrEP in serodiscordant couples presents unique challenges related to adherence, safety, and clinical monitoring, but it also offers new opportunities for enhancing primary prevention and reproductive health in these relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral pre-exposure prophylaxis (PrEP) for prevention of HIV in serodiscordant heterosexual couples in the United States: opportunities and challenges. McMahon, JM., Myers, JE., Kurth, AE., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06656676

WePrEP: Developing a PrEP Shared Decision-making Tool ... 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%, ...

2. withpower.com withpower.com/trial/phase-hiv-prevention-9-2024-80139

WePrEP Tool for HIV Prevention The findings support the effectiveness of transitioning from PrEP to relying on the HIV-positive partner's adherence to antiretroviral therapy (ART) for HIV ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11365445/

Using an interactive web application to identify pre ... An interactive and intuitive web application can help identify individuals who may have nonadherent behaviors, resulting in improved medication adherence.

4. academic.oup.com academic.oup.com/ofid/article/11/10/ofae569/7804282

Trajectories of Adherence to Oral Pre-exposure Prophylaxis ... A meta-analysis of RCTs also showed a strong association between PrEP adherence and PrEP efficacy, reporting 86% HIV risk reduction with at ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11260538/

Digital HIV Pre-exposure Prophylaxis Interventions - PMC When taken daily as prescribed, PrEP reduces the risk of getting HIV from sex by 99% and from injection drug use by at least 74%. There is a strong connection ...

6. trialx.com trialx.com/clinical-trials/listings/295776/weprep-developing-a-prep-shared-decision-making-tool-for-transgender-women/

WePrEP: Developing a PrEP Shared Decision-making Tool ... 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 ...

7. cdc.gov cdc.gov/hiv/prevention/prep.html

Preventing HIV with PrEP For receptive vaginal sex and injection drug use, PrEP pills reach maximum protection at about 21 days of daily use. No data are available for ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0281728

Development of a tool to assess HIV prevention readiness of ... We assessed the predictive value of HPRM scores with PrEP adherence, defined as tenofovir-diphosphate (TFV-DP) concentrations in dried blood ...