PrEP Strategies for HIV Prevention

(POWER Up Trial)

Overseen By Sam Devlin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: HIV-positive

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

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to increase the use of PrEP, a medication that helps prevent HIV, among Black cisgender women in the U.S., who are at high risk for HIV but rarely use PrEP. Researchers will test four strategies: training healthcare providers, educating patients, improving electronic medical records (EMR), and guiding patients through the PrEP process. They aim to determine if these strategies boost PrEP usage and improve other related health outcomes. This trial is suitable for HIV-negative Black cisgender women who have not previously used PrEP.

As an unphased trial, this study offers participants the chance to contribute to innovative strategies that could significantly enhance HIV prevention efforts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these strategies are safe for increasing PrEP use among Black women?

Research shows that the treatments in this trial are generally safe for people. Studies indicate that PrEP (pre-exposure prophylaxis) effectively and safely prevents HIV. Although some areas have not fully utilized PrEP, its safety is well-proven.

Training healthcare providers has increased PrEP use without major safety concerns. Enhancing electronic medical records (EMR) helps identify individuals who could benefit from PrEP, improving accessibility without compromising safety.

Overall, these strategies focus on education, training, and system improvements, which typically pose low risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies for improving HIV prevention using PrEP. Unlike traditional methods that rely on standard care, this trial looks at a comprehensive approach combining patient education, provider training, electronic medical record optimization, and PrEP navigation. These components aim to enhance the identification and management of individuals who could benefit from PrEP, potentially leading to better prevention outcomes. By focusing on these multifaceted strategies, the trial could pave the way for more effective and personalized HIV prevention efforts.

What evidence suggests that this trial's strategies could be effective for increasing PrEP use among Black women?

Research shows that PrEP (pre-exposure prophylaxis) can lower the risk of contracting HIV by up to 99% when taken correctly. In this trial, participants in the intervention arm will receive a combination of strategies to enhance PrEP access and use. These strategies include PrEP education, which has effectively raised awareness and encouraged use, especially among those at high risk for HIV. PrEP navigation, another component, guides individuals through the process and has successfully increased the number of people starting and continuing with PrEP. Training healthcare providers on PrEP, also part of the intervention, has improved its delivery and use by addressing common issues like time and cost. Additionally, improving electronic medical records (EMR) can help identify patients who might benefit from PrEP, increasing the number of people who begin PrEP care. These strategies aim to improve PrEP access and use among Black women, who are at higher risk for HIV. Participants in the usual care arm will continue with the current mechanisms used at each healthcare site. ^{1 6 7 8 9}

Who Is on the Research Team?

Jessica Ridgway, MD, MS

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for Black cisgender women aged 18 or older who are HIV-negative. It aims to increase the use of PrEP, a medication that prevents HIV infection. Women under 18 or those already living with HIV cannot participate.

Inclusion Criteria

HIV-negative

Exclusion Criteria

I am under 18 years old.

HIV-positive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transition

Each clinic undergoes a 6-month transition period to prepare for the intervention package

6 months

Intervention

Implementation of patient education, provider PrEP training, EMR optimization, and PrEP navigation at community health clinics

24 months

Monthly site check-ins

Follow-up

Participants are monitored for PrEP uptake and persistence, and feedback is gathered from providers and participants

12 months

What Are the Treatments Tested in This Trial?

Interventions

• EMR Optimization
• PrEP Education
• PrEP Navigation
• Provider Audit and Feedback
• Provider training

Trial Overview The study tests four strategies: educating providers and patients about PrEP, optimizing electronic medical records (EMR) for better tracking, guiding patients through PrEP usage (navigation), and giving feedback to providers on their prescribing habits.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 5 Interventions

Implementation of 1) Patient Education, 2) Provider PrEP training, 3) EMR optimization, and 4) PrEP navigation, and the effect of these intervention components on the ability of each site to assess HIV risk/take a sexual history, assess PrEP eligibility, identify PrEP ineligibility for otherwise PrEP-eligible patients, provide PrEP education, offer PrEP, provide PrEP navigation, measure PrEP uptake, and measure PrEP persistence/retention.

Group II: Usual Care Active Control 1 Intervention

The current mechanisms used at each healthcare site to assess HIV risk/ take a sexual history, assess PrEP eligibility, identify PrEP ineligibility for otherwise PrEP eligible patients, provide PrEP education, offer PrEP, provide PrEP navigation, measure PrEP uptake, and measure PrEP persistence/retention.

EMR Optimization is already approved in United States, European Union for the following indications:

Approved in United States as Truvada for:

• HIV prevention

Approved in European Union as Truvada for:

• HIV prevention

Approved in United States as Descovy for:

• HIV prevention

Approved in European Union as Descovy for:

• HIV prevention

Approved in United States as Cabenuva for:

• HIV prevention

Approved in European Union as Cabenuva for:

• HIV prevention

Approved in United States as Apretude for:

• HIV prevention

Approved in European Union as Apretude for:

• HIV prevention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

AllianceChicago

Collaborator

Trials

8

Recruited

18,700+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

Howard Brown Health Center

Collaborator

Trials

11

Recruited

8,200+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

PrEP use in Rhode Island increased dramatically, by 31 times from 2012 to 2017, indicating growing awareness and uptake of this effective HIV prevention method among the population.

The study highlighted that infectious diseases providers were significantly more likely to prescribe PrEP compared to primary care providers, suggesting a need for increased training and awareness among primary care physicians to improve access, especially in underserved areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating statewide HIV preexposure prophylaxis implementation using All-Payer Claims Data. Raifman, J., Nocka, K., Galárraga, O., et al.[2021]

In a study involving 540 pregnant women, the use of tenofovir disoproxil fumarate and emtricitabine as pre-exposure prophylaxis (PrEP) was found to be non-inferior to deferred PrEP in terms of preterm birth and small for gestational age outcomes, suggesting it is a safe option during pregnancy.

The immediate initiation of PrEP did not increase the risk of adverse pregnancy outcomes such as low birthweight or stillbirth, providing reassurance for its use among pregnant women not living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. Moodley, D., Lombard, C., Govender, V., et al.[2023]

A study analyzing the MarketScan database from 2010 to 2014 found a significant increase in the number of commercially insured individuals prescribed tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for HIV preexposure prophylaxis (PrEP), rising from 417 users in 2010 to 9,375 in 2014.

Despite the overall increase in PrEP uptake, the number of women using PrEP remained very low, highlighting the need for targeted interventions to encourage PrEP use among women at high risk for HIV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake of HIV Preexposure Prophylaxis Among Commercially Insured Persons-United States, 2010-2014. Wu, H., Mendoza, MC., Huang, YA., et al.[2017]

Tenofovir disoproxil fumarate coformulated with emtricitabine (TDF/FTC) is a safe and highly effective medication for preventing HIV transmission, yet only about 200,000 Americans have started using it for pre-exposure prophylaxis (PrEP), leaving 80%-90% of those at highest risk without access.

Barriers to PrEP uptake include costs, anticipated side effects, and stigma, but innovative strategies like engaging nonmedical staff and developing new technologies are being explored to improve adherence and make PrEP more accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEP 1.0 and Beyond: Optimizing a Biobehavioral Intervention. Mayer, KH., Allan-Blitz, LT.[2020]

The annual prevalence of PrEP use in the U.S. increased significantly from 3.3 to 36.7 per 100,000 population between 2012 and 2017, indicating a 56% annual increase, particularly among men and younger age groups.

Despite the overall rise in PrEP usage, disparities remain, with lower usage rates among women and individuals in the Southern U.S., highlighting the need for targeted efforts to improve access to PrEP in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in the use of oral emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis against HIV infection, United States, 2012-2017. Sullivan, PS., Giler, RM., Mouhanna, F., et al.[2022]

In the first unblinded year of the HPTN 083 study, long-acting injectable cabotegravir demonstrated high efficacy for HIV prevention, with an incidence rate of 0.82 per 100 person-years compared to 2.27 per 100 person-years for daily oral tenofovir disoproxil fumarate plus emtricitabine, resulting in a hazard ratio of 0.35, indicating a significant reduction in HIV risk.

Despite the high efficacy, there were concerns about diagnostic delays and the emergence of integrase strand-transfer inhibitor (INSTI) resistance in some cases of HIV infection among those receiving cabotegravir, highlighting the need for careful monitoring and further investigation into potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. Landovitz, RJ., Hanscom, BS., Clement, ME., et al.[2023]

Six randomized clinical trials have been conducted to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) and TDF/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for preventing HIV-1 infection, indicating a strong interest in finding effective preventive measures against HIV.

A consultation involving key stakeholders, including researchers and representatives from major health organizations, was held to discuss the implications of the trial results and potential adjustments to ongoing studies, highlighting the collaborative effort to optimize HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of HIV PrEP trials results. Veronese, F., Anton, P., Fletcher, CV., et al.[2021]

In a study involving 121 individuals who seroconverted to HIV, those using the combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) had a higher rate of resistance mutations (57%) compared to those using tenofovir alone (5.3%), indicating that FTC may increase the risk of resistance during breakthrough infections.

Resistance mutations were more likely to occur when PrEP was initiated during an undetected acute HIV infection, highlighting the importance of screening for HIV before starting PrEP to minimize the risk of treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of drug resistance among persons acquiring HIV within a randomized clinical trial of single- or dual-agent preexposure prophylaxis. Lehman, DA., Baeten, JM., McCoy, CO., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40576614/

HEalth Record Optimization for Identifying Candidates ... Electronic health record (EHR)-based models to identify individuals who may benefit from pre-exposure prophylaxis (PrEP) outperform traditional ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38412047/

Using Electronic Health Records to Improve HIV ... Conclusion: An EHR-based intervention guided by an HIV risk prediction model substantially increased initiation of PrEP care among patients of ...

3. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/09564624221079070

Effectiveness of an electronic health record model for HIV ... We evaluated this model to determine its effectiveness in identifying patients and its use by providers for increasing prescription of PrEP.

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-025-23460-2

Development of an electronic health record-based Human ... This study developed a women-specific model to predict HIV risk within a year using electronic health record (EHR) data and social determinants of health (SDoH ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352301819301377

Use of electronic health record data and machine learning ... We developed and validated an HIV prediction model to identify potential PrEP candidates in a large health-care system.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11812645/

Increasing pre-exposure prophylaxis (PrEP) in primary care This study, MOST: PrEP, follows the multiphase optimization strategy (MOST) framework. The purpose is to identify a multi-level intervention among patients and ...

7. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X24006450

Mapping Implementation Strategies to Address Barriers ... The POWER Up strategies include (1) routine PrEP education, (2) standardized provider training, (3) EMR optimization, (4) PrEP navigation, and (5) PrEP clinical ...

8. academic.oup.com academic.oup.com/ofid/article/11/6/ofae297/7696971

Get2PrEP2—A Provider Messaging Strategy to Improve PrEP ... A clinical decision support implementation strategy for increasing the prescribing of HIV preexposure prophylaxis (PrEP) in Alabama.

9. formative.jmir.org formative.jmir.org/2018/1/e2/

A Simple Pre-Exposure Prophylaxis (PrEP) Optimization ... Conclusions: Given the critical role HCPs serve in disseminating PrEP, we created an easy-to-use PrEP optimization intervention deemed feasible ...