PrEP Adherence Strategies for HIV Prevention in Women

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

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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.

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 data supports the effectiveness of the drug Tenofovir Disoproxil and Emtricitabine for HIV prevention in women?

Research shows that when women adhere well to taking Tenofovir Disoproxil and Emtricitabine daily, it can significantly reduce the risk of HIV infection. High adherence levels (taking the drug consistently) are linked to high protection, with studies indicating up to 95.9% reduction in HIV incidence with near-daily use. ^{1 2 3 4 5}

Is PrEP safe for women using Tenofovir Disoproxil and Emtricitabine?

The World Health Organization recommends PrEP (pre-exposure prophylaxis) with Tenofovir Disoproxil and Emtricitabine for people at high risk of HIV, indicating it is generally considered safe. However, effectiveness depends on adherence, and low adherence may lead to drug resistance. ^{1 2 3 6 7}

How is the drug Tenofovir Disoproxil and Emtricitabine unique for HIV prevention in women?

Tenofovir Disoproxil and Emtricitabine is a daily oral medication used as pre-exposure prophylaxis (PrEP) to prevent HIV, but its effectiveness in women has been inconsistent due to challenges with adherence and differences in how the drug penetrates vaginal tissues. This highlights the need for additional HIV prevention strategies tailored to women's needs. ^{2 7 8 9 10}

Research Team

Shobha Swaminathan, MD

Principal Investigator

New Jersey Medical School

Eligibility Criteria

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

I am between 18 and 64 years old.

Exclusion Criteria

Underlying medical condition with survival unlikely during follow-up period

Pregnant or breast feeding

My kidney function is reduced.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States 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. [2023]

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

Brief Report: Preventing HIV-1 Infection in Women Using Oral Preexposure Prophylaxis: A Meta-analysis of Current Evidence. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to daily, oral TDF/FTC PrEP during periconception among HIV-exposed South African women. [2023]

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

Efficacy estimates of oral pre-exposure prophylaxis for HIV prevention in cisgender women with partial adherence. [2023]

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

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

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

Pregnancy and contraceptive use among women participating in the FEM-PrEP trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women. [2022]

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

Plasma Tenofovir Levels to Support Adherence to TDF/FTC Preexposure Prophylaxis for HIV Prevention in MSM in Los Angeles, California. [2022]

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

Randomized Controlled Trial of Daily Text Messages to Support Adherence to Preexposure Prophylaxis in Individuals at Risk for Human Immunodeficiency Virus: The TAPIR Study. [2022]

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

Challenges and Opportunities for Preexposure Prophylaxis. [2021]