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

Trial Summary

What is the purpose of this trial?

Black women experience one of the highest incidences of HIV among all subpopulations in the United States, but pre-exposure prophylaxis (PrEP) use among Black cisgender women is very limited. The investigators will implement four strategies (provider training, patient education, EMR optimization, and PrEP navigation) at 12 community health clinics in the Midwest and South. The investigators predict that PrEP use and other related outcomes will improve for participants after the intervention period.

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 data supports the effectiveness of the drug Truvada for HIV prevention?

Research shows that Truvada, which contains tenofovir disoproxil fumarate and emtricitabine, is effective in reducing the risk of acquiring HIV when used as pre-exposure prophylaxis (PrEP). Studies have demonstrated its success in preventing HIV infection among various populations. ^{1 2 3 4 5}

Is PrEP generally safe for humans?

Research shows that PrEP, including medications like tenofovir disoproxil fumarate and emtricitabine, is generally safe for preventing HIV, though there are concerns about drug resistance and safety during pregnancy. ^{2 3 4 5 6}

How does this HIV prevention treatment differ from other treatments?

This treatment is unique because it includes long-acting injectable options like cabotegravir, which have been shown to be more effective than daily oral pills like tenofovir disoproxil fumarate plus emtricitabine. The injectable form also offers a different administration route, potentially improving adherence and reducing the risk of drug resistance. ^{2 3 4 7 8}

Research Team

Jessica Ridgway, MD, MS

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Evaluating statewide HIV preexposure prophylaxis implementation using All-Payer Claims Data. [2021]

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

PrEP 1.0 and Beyond: Optimizing a Biobehavioral Intervention. [2020]

3. Netherlands 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. [2023]

4. United States 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. [2022]

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

Uptake of HIV Preexposure Prophylaxis Among Commercially Insured Persons-United States, 2010-2014. [2017]

6. Netherlands 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. [2023]

7. United States 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. [2022]

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

Implications of HIV PrEP trials results. [2021]