PrEP Group Model for Sex Workers

(C-PrEP+ Trial)

Overseen By Randi B Singer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Illinois at Chicago

Must be taking: PrEP

Disqualifiers: Under 18, Sex trafficking, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Using a participatory implementation science framework, I will test whether an adapted and community empowered group healthcare model, Centering PrEP+, is a feasible and acceptable health system intervention to improve the health of sex workers and their clients by increasing PrEP uptake and adherence. The conduct of this pilot study will provide an opportunity to gain experience with all aspects of intervention research, including recruitment, retention, implementing a randomization protocol, assessing measurement tools, delivering an intervention, and monitoring fidelity across two sites, tracking all metrics suggested by CONSORT, data collection and management of quantitative data from multiple sources (e.g., survey, laboratory), data analysis, and dissemination.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is PrEP safe for humans?

PrEP treatments like tenofovir disoproxil fumarate and emtricitabine have been studied for safety in various groups, including pregnant women and people at risk of HIV. While generally considered safe, there are some cases of drug-resistant HIV infections and potential safety concerns during pregnancy. Long-acting cabotegravir, another PrEP option, has shown safety in trials but may cause diagnostic delays and resistance issues. ^{1 2 3 4 5}

How is the drug C-PrEP+ different from other treatments for HIV prevention?

C-PrEP+ includes options like Truvada and Descovy, which are used as pre-exposure prophylaxis (PrEP) to prevent HIV. Truvada contains tenofovir disoproxil fumarate and emtricitabine, while Descovy contains tenofovir alafenamide and emtricitabine, with Descovy being perceived as having improved safety and a smaller pill size. Additionally, Apretude, which contains cabotegravir, offers an injectable option, providing flexibility in administration compared to daily oral pills. ^{6 7 8 9 10}

What data supports the effectiveness of the drug C-PrEP+ for sex workers?

The drug C-PrEP+ includes components like tenofovir disoproxil fumarate/emtricitabine and cabotegravir, which have shown effectiveness in reducing HIV risk. Studies have demonstrated that tenofovir disoproxil fumarate/emtricitabine is effective in preventing HIV in high-risk groups, and cabotegravir has been found to be superior to daily oral tenofovir disoproxil fumarate/emtricitabine in various populations. ^{11 12 13 14 15}

Who Is on the Research Team?

Randi B Singer, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for individuals aged 18 or older who are currently employed at Howard Brown Health, actively involved in HIV prevention programs, epidemiology, or GTZ 2030 projects. Participants must speak and understand English and be part of the Howard Brown Health personnel.

Inclusion Criteria

Speak and understand English

Engaged in sex work, defined as the exchange of oral, vaginal, or anal sex for something of value, in the past 12 months

Lives in Chicago area

Exclusion Criteria

Identify as a victim of sex trafficking

I am under 18 years old.

Not employed at Howard Brown Health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in group PrEP care through the C-PrEP+ intervention, focusing on PrEP uptake and adherence.

6 months

Regular group sessions with health assessments and interactive learning

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PrEP adherence and HIV-related knowledge.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• C-PrEP+

Trial Overview The study is testing an adapted group healthcare model called Centering PrEP+, aimed at increasing Pre-Exposure Prophylaxis (PrEP) uptake and adherence among sex workers and their clients to improve their health outcomes.

How Is the Trial Designed?

Group I: C-PrEP+ Experimental Treatment 1 Intervention

Sex Workers engaged in group PrEP care.

C-PrEP+ is already approved in United States, European Union for the following indications:

Approved in United States as Truvada for:

• HIV prevention

Approved in United States as Descovy for:

• HIV prevention

Approved in United States as Apretude for:

• HIV prevention

Approved in European Union as Truvada for:

• HIV prevention

Approved in European Union as Descovy for:

• HIV prevention

Approved in European Union as Apretude for:

• HIV prevention

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Daily oral PrEP with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for men who have sex with men, but its effectiveness in cisgender women has been inconsistent, highlighting the need for diverse HIV prevention options.

Newer strategies like injectable long-acting cabotegravir have shown superior effectiveness compared to daily oral TDF/FTC, and ongoing studies are exploring other formulations like islatravir and lenacapavir, which may offer more flexible and effective prevention methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and Opportunities for Preexposure Prophylaxis. Cambou, MC., Landovitz, RJ.[2021]

HIV preexposure prophylaxis (PrEP) has shown varying levels of efficacy in different studies, with the highest efficacy observed in the Partners PrEP Study (62% to 73%) and the iPrEx trial (44%) for high-risk populations, indicating that PrEP can significantly reduce the risk of HIV acquisition when adhered to properly.

PrEP has been found to be safe and well tolerated, with rare instances of resistance to the drugs primarily occurring in individuals who were already HIV positive at the start of treatment, highlighting its potential as a preventive strategy against HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV preexposure prophylaxis: new data and potential use. Celum, CL.[2021]

Pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate and emtricitabine is highly effective in reducing HIV acquisition, but its success heavily depends on adherence, particularly among at-risk populations like women and young individuals.

New PrEP options are being developed, including long-acting injectables and innovative delivery systems like implants and vaginal rings, aiming to provide more accessible and appealing prevention methods for diverse individuals throughout their sexually active lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis 2.0: new drugs and technologies in the pipeline. Coelho, LE., Torres, TS., Veloso, VG., et al.[2021]

In the iPrEx study involving participants on FTC/TDF PrEP, drug resistance mutations were rare, with only two cases of minor variants detected among 48 infections, indicating that FTC/TDF is generally effective in preventing HIV without significant resistance development.

For individuals who started PrEP during acute HIV infection, any resistance mutations present quickly diminished after stopping the medication, suggesting that the risk of developing drug resistance is low when using FTC/TDF as PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV-1 drug resistance in the iPrEx preexposure prophylaxis trial. Liegler, T., Abdel-Mohsen, M., Bentley, LG., et al.[2021]

In the iPrEx study involving 2499 participants, PrEP with emtricitabine and tenofovir was found to be effective in preventing HIV acquisition among transgender women, but adherence to the medication was low, with only 18% of those in the PrEP group having detectable drug levels at the time of HIV testing.

Transgender women reported higher risk behaviors compared to men who have sex with men (MSM), yet the study indicated that PrEP use did not correlate with these risk behaviors, highlighting the need for tailored interventions to improve adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. Deutsch, MB., Glidden, DV., Sevelius, J., et al.[2018]

A case was reported of a 50-year-old man who contracted wild-type HIV-1 despite consistent use of PrEP (emtricitabine and tenofovir disoproxil fumarate) for 8 months, highlighting that infections can occur even with high adherence to the medication.

The patient exhibited an atypical seroconversion pattern, with no detectable HIV RNA in plasma initially, suggesting that healthcare providers should be vigilant for unusual seroconversion signs and conduct regular HIV testing, even in patients on PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report. Hoornenborg, E., Prins, M., Achterbergh, RCA., et al.[2022]

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 case study of a 21-year-old man showed that despite high adherence to PrEP (measured through various methods), he acquired an HIV strain that was resistant to emtricitabine but susceptible to tenofovir disoproxil fumarate, highlighting a potential limitation of PrEP.

This case emphasizes the importance of regular HIV screening for individuals on PrEP, as early detection and linkage to care can help prevent further transmission, even when adherence to the medication is high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acquisition of tenofovir-susceptible, emtricitabine-resistant HIV despite high adherence to daily pre-exposure prophylaxis: a case report. Cohen, SE., Sachdev, D., Lee, SA., et al.[2023]

In the DISCOVER trial involving 5,387 participants, emtricitabine and tenofovir alafenamide (F/TAF) demonstrated non-inferiority to emtricitabine and tenofovir disoproxil fumarate (F/TDF) in preventing HIV, with a significant reduction in HIV infections (0.14 vs. 0.25 per 100 person-years).

Using a Bayesian model, the study estimated that F/TAF has a median HIV prevention efficacy of 96% compared to a counterfactual background HIV incidence, indicating it is highly effective as a PrEP option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial. Glidden, DV., Das, M., Dunn, DT., et al.[2021]

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]

A survey of 573 infectious disease physicians revealed that while most support the use of PrEP (preexposure prophylaxis) for HIV prevention, only 9% have actually prescribed it, indicating a gap between support and practice.

Barriers to the real-world provision of PrEP exist despite CDC guidance, suggesting that comprehensive programs and guidelines are needed to improve its implementation among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are we prepped for preexposure prophylaxis (PrEP)? Provider opinions on the real-world use of PrEP in the United States and Canada. Karris, MY., Beekmann, SE., Mehta, SR., et al.[2022]

Emtricitabine/tenofovir disoproxil fumarate (Truvada) has been approved as an effective preexposure prophylaxis (PrEP) therapy for adults at high risk of acquiring HIV through sexual contact.

The article reviews data that supports the efficacy of PrEP, highlighting its role in preventing HIV infection in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. Blackwell, CW.[2015]

A study involving 5,034 participants found that over half of those switching from TDF (Truvada) to TAF (Descovy) for PrEP did so based on their doctor's recommendation, highlighting the influence of healthcare providers on medication choices.

Despite both TAF and TDF being considered safe, 32% of participants believed Descovy was safer, indicating that messaging around PrEP safety may be affecting public perception and potentially undermining the use of the more affordable TDF formulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Are Patients Switching from Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) to Tenofovir Alafenamide/Emtricitabine (Descovy) for Pre-Exposure Prophylaxis? D'Angelo, AB., Westmoreland, DA., Carneiro, PB., et al.[2022]

A peri-coital regimen of Truvada (FTC and TDF) was shown to fully protect macaques from vaginal SHIV infection after 18 exposures, indicating its efficacy in preventing HIV transmission.

Despite lower concentrations of the drug in vaginal tissues compared to rectal tissues, the treatment was effective, suggesting that simplified PrEP regimens could be developed for women to prevent HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. Radzio, J., Aung, W., Holder, A., et al.[2021]

Oral tenofovir disoproxil and emtricitabine (FTC) for HIV preexposure prophylaxis (PrEP) is generally safe and well tolerated, with common gastrointestinal side effects that typically resolve within weeks.

While there is a slight decline in kidney function (eGFR) and bone mineral density (BMD) associated with the treatment, these changes are not clinically significant and tend to resolve after stopping the medication, making it a viable option for most adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults. Liegeon, G.[2022]

Citations

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

Challenges and Opportunities for Preexposure Prophylaxis. [2021]

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

HIV preexposure prophylaxis: new data and potential use. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis 2.0: new drugs and technologies in the pipeline. [2021]

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

HIV-1 drug resistance in the iPrEx preexposure prophylaxis trial. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Acquisition of wild-type HIV-1 infection in a patient on pre-exposure prophylaxis with high intracellular concentrations of tenofovir diphosphate: a case report. [2022]

7. 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]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Acquisition of tenofovir-susceptible, emtricitabine-resistant HIV despite high adherence to daily pre-exposure prophylaxis: a case report. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial. [2021]

10. 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]

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

Are we prepped for preexposure prophylaxis (PrEP)? Provider opinions on the real-world use of PrEP in the United States and Canada. [2022]

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

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]

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

Why Are Patients Switching from Tenofovir Disoproxil Fumarate/Emtricitabine (Truvada) to Tenofovir Alafenamide/Emtricitabine (Descovy) for Pre-Exposure Prophylaxis? [2022]

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

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. [2021]

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

Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults. [2022]