PrEP Adherence Strategies for HIV Prevention in Women

Not currently recruiting at 3 trial locations

Overseen By Marta Paez-Quinde

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: HIV, Hepatitis B, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well women adhere to taking Truvada, a medication that helps prevent HIV. The goal is to understand attitudes toward this medication and assess its accessibility and consistent use among women. Suitable candidates for this trial include women who have had unprotected sex with partners of unknown HIV status, have been treated for STIs, or have shared needles, among other risk factors. Participants must be HIV-negative and interested in using this medication for prevention. As a Phase 4 trial, Truvada is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study staff or your doctor.

What is the safety track record for Truvada?

Research has shown that Truvada, a combination of two medicines, is generally safe for preventing HIV. Studies indicate it is well-tolerated when used as PrEP (pre-exposure prophylaxis) to help prevent HIV. The FDA has approved this combination for HIV prevention, underscoring its safety.

A safety review found Truvada to be a strong and recommended option for preventing HIV, even during pregnancy. However, it is important to note that Truvada is not recommended for individuals with certain kidney problems. Specifically, those with a creatinine clearance below 60 mL/min should avoid it.

Overall, Truvada is a well-established choice for reducing the risk of HIV, with a proven track record of safety in its approved uses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatment using Truvada for HIV prevention in women because it combines two powerful drugs, tenofovir disoproxil and emtricitabine, into one pill. This combination is already a well-established standard in HIV prevention, known for its effectiveness in reducing the risk of infection. The focus on adherence strategies is crucial because ensuring that women consistently take PrEP can significantly enhance its protective benefits, offering a reliable method to prevent HIV transmission. By optimizing adherence, this approach could improve real-world outcomes, making HIV prevention more accessible and effective for women.

What is the effectiveness track record for Truvada as PrEP for HIV prevention in women?

Research has shown that Truvada, a combination of two medicines, effectively prevents HIV when used as PrEP (pre-exposure prophylaxis). Studies suggest that taking Truvada four times a week can reduce the risk of contracting HIV by 96%. In areas where Truvada is commonly used, new HIV cases have significantly decreased. While Truvada is highly effective, it does not completely prevent HIV. Its effectiveness also relies on taking the medication as directed. Participants in this trial will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP. ^{6 7 8 9 10}

Who Is on the Research Team?

Shobha Swaminathan, MD

Principal Investigator

New Jersey Medical School

Are You a Good Fit for This Trial?

This trial is for US women aged 18-64 who are at risk of HIV, which includes those with unprotected sex, evaluated for STIs recently, used shared needles, engaged in transactional sex or have partners at substantial risk. They must be able to consent and desire PrEP. Excluded are those with Hepatitis B, poor kidney function, drug dependence affecting adherence to the study requirements, pregnant or breastfeeding women.

Inclusion Criteria

I am at risk for HIV due to my sexual behavior or drug use.

Able to give consent

Exclusion Criteria

Underlying medical condition with survival unlikely during follow-up period

Pregnant or breast feeding

My kidney function is reduced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Truvada PrEP for 24 weeks to assess attitudes, feasibility, and adherence

24 weeks

Visits at weeks 12 and 24 for questionnaires and adherence assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tenofovir Disoproxil and Emtricitabine

Trial Overview The study tests attitudes towards and feasibility of obtaining Truvada PrEP (tenofovir disoproxil and emtricitabine), as well as how well US women adhere to this medication regimen designed to prevent HIV before exposure.

How Is the Trial Designed?

Group I: PrEP with Truvada Experimental Treatment 1 Intervention

All study participants will be assigned to this arm and will receive Truvada tablets (tenofovir disoproxil and emtricitabine) for PrEP

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

In the FEM-PrEP trial involving seroconverting women, there was no significant difference in HIV-1 RNA levels or CD4+ T-cell counts between those on PrEP and those on placebo, indicating that PrEP did not lead to better outcomes in these measures.

While no tenofovir resistance was found, FTC resistance was detected in some participants, suggesting that infections may have occurred before starting PrEP, rather than as a result of low adherence to the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. Grant, RM., Liegler, T., Defechereux, P., et al.[2022]

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]

In a study of 350 men who have sex with men, adherence to HIV pre-exposure prophylaxis (PrEP) using emtricitabine/tenofovir was influenced by factors such as location (Harlem vs. Bangkok), education level, and alcohol use, highlighting the importance of understanding social determinants in medication adherence.

The study found that plasma and hair drug concentrations, along with electronic pill bottle data, provided complementary measures of adherence, indicating that multiple methods can be used to assess how well individuals are following their PrEP regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT. Velloza, J., Bacchetti, P., Hendrix, CW., et al.[2023]

In a study of women aged 18-35 in Durban, South Africa, daily oral PrEP (tenofovir disoproxil fumarate/emtricitabine) showed an overall mean adherence of 63%, highlighting the importance of adherence for effective HIV prevention during periconception.

Four distinct adherence patterns were identified: high steady adherence (22%), moderate steady adherence (31%), initially high but declining adherence (21%), and initially moderate with a rebound (26%), suggesting that targeted strategies are needed to maintain high adherence levels over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to daily, oral TDF/FTC PrEP during periconception among HIV-exposed South African women. Hurwitz, KE., Isehunwa, OO., Hendrickson, KR., et al.[2023]

In the FEM-PrEP trial, over half of the women were not using effective contraception at enrollment, but 98% adopted either injectable or oral contraceptives, with a pregnancy rate of 9.6 per 100 woman-years overall.

Women using combined oral contraceptives (COCs) had a higher pregnancy rate and lower adherence to the HIV prevention drug TDF-FTC compared to those using injectables, suggesting that long-acting contraceptive methods may be more effective in such trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial. Callahan, R., Nanda, K., Kapiga, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6453722/

Review of real-world implementation data on emtricitabine ... Patients should be made aware that PrEP is not 100% effective and will not prevent the acquisition of HIV strains resistant to FTC and TDF. Cost effectiveness.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2816036

HIV Preexposure Prophylaxis With Emtricitabine and ... These findings were consistent with modeling data that estimated an HIV risk reduction of 76% for 2 doses per week, 96% for 4 doses per week, ...

3. gilead.com gilead.com/news/news-details/2018/gilead-announces-new-data-on-the-impact-of-truvada-emtricitabine-and-tenofovir-disoproxil-fumarate-for-pre-exposure-prophylaxis-prep-on-the-number-of-hiv-diagnoses-in-the-united-states

Gilead Announces New Data on the Impact of Truvada® ... Data show that states with highest use of Truvada for PrEP had significant declines in new HIV infections.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3721979/

Emtricitabine-tenofovir exposure and pre ... An intracellular tenofovir-diphosphate (TFV-DP) concentration of 16 fmol per million vPBMCs was associated with a 90% reduction in HIV acquisition relative to ...

5. descovyhcp.com descovyhcp.com/discover-clinical-trial

DESCOVY FOR PrEP® (pre-exposure prophylaxis) Efficacy ... Proven prevention with powerful results: 99.7% remained HIV negative with DESCOVY.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/021752s035lbl.pdf

Truvada (emtricitabine tenofovir disoproxil fumarate) tablets ... TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high ...

7. gilead.com gilead.com/-/media/files/pdfs/medicines/hiv/truvada/truvada_pi.pdf

truvada_pi.pdf TRUVADA for HIV-1 PrEP is not recommended in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [see Warnings and Precautions (5. ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010110/

Safety review of tenofovir disoproxil fumarate/emtricitabine ... In summary, TDF/FTC PrEP is a potent and recommended HIV prevention option, with a demonstrably good safety profile, including in pregnancy. While safety data ...

9. mayoclinic.org mayoclinic.org/drugs-supplements/emtricitabine-and-tenofovir-oral-route/description/drg-20061833

Emtricitabine and tenofovir (oral route) - Side effects & ... This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and helps the immune system. This may ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT02213328

Acceptability, Safety, and Use of Daily Truvada Pre- ... The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package.