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

Trial Summary

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 data supports the effectiveness of the WePrEP treatment for HIV prevention?

The research highlights the effectiveness of pre-exposure prophylaxis (PrEP) strategies, like using coordinators and web tools to optimize PrEP care, and the approval of long-acting injectable PrEP, which suggests that similar approaches could support the WePrEP treatment in preventing HIV. ^{1 2 3 4 5}

Is the WePrEP tool for HIV prevention safe for humans?

The WePrEP tool, which involves using medications like Truvada for HIV prevention, has been shown to have a good safety profile in clinical trials. Common side effects are mild and include nausea, vomiting, and diarrhea, but regular monitoring is recommended to prevent long-term issues with liver, kidneys, and bones. ^{6 7 8 9 10}

How is the WePrEP tool for HIV prevention different from other treatments?

The WePrEP tool is unique because it focuses on identifying individuals, such as pregnant women or men who have sex with men, who would most benefit from preexposure prophylaxis (PrEP) to prevent HIV, thereby minimizing unnecessary exposure to PrEP. This targeted approach aims to enhance adherence and effectiveness by ensuring that PrEP is used by those at substantial risk of HIV acquisition. ^{8 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions. [2023]

2. Netherlands 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Sexual Behaviors After PrEP Discontinuation Among HIV Serodiscordant Couples in Kenya and Uganda. [2022]

4. United States 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). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Missed opportunities for HIV pre-exposure prophylaxis among people with recent HIV infection: The French ANRS 95041 OMaPrEP study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis is efficacious for HIV-1 prevention among women using depot medroxyprogesterone acetate for contraception. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis for HIV prevention: where have we been and where are we going? [2022]

9. England 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. [2021]

10. United States 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A Risk Assessment Tool for Identifying Pregnant and Postpartum Women Who May Benefit From Preexposure Prophylaxis. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis: a useful tool to prevent human immunodeficiency virus infection? [2017]

13. United States 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. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Context Matters: PrEP Adherence is Associated With Sexual Behavior Among HIV Serodiscordant Couples in East Africa. [2022]