iENGAGE Program for HIV Infection

Overseen By MICHELE JEAN-GILLES, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Virally suppressed

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: 13

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program specifically designed for Haitian immigrants living with HIV. It focuses on helping participants stay engaged in their healthcare and achieve viral suppression (when the virus is controlled and low in the body) within six months. Participants will attend four meetings over six months and complete questionnaires. Some will also take part in a photography project to share their experiences. The trial seeks individuals recently diagnosed with HIV or those not yet controlling the virus who have moved to the U.S. from Haiti. As an unphased trial, this study offers a unique opportunity to contribute to research that could significantly improve healthcare engagement and outcomes for Haitian immigrants with HIV.

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 this intervention is safe for participants?

Research shows that the iENGAGE program does not involve new drugs or invasive procedures. Instead, it helps Haitian immigrants with HIV stay engaged in their healthcare. This means the program itself poses no direct safety concerns, as it mainly involves meetings and discussions.

For questions about current HIV treatment, studies have shown that common HIV medications, like bictegravir/emtricitabine/tenofovir alafenamide, are generally safe and effective. Specifically, one study found that 93.8% of patients achieved successful treatment outcomes after 48 weeks, with no major safety issues reported.

Overall, the iENGAGE program appears safe since it focuses on support and engagement. Any concerns about specific HIV treatment should be discussed with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iENGAGE Program because it offers a unique approach to supporting Haitian immigrants living with HIV. Unlike traditional treatments focused solely on medication management, iENGAGE emphasizes cultural adaptation and personalized engagement through structured sessions. This intervention seeks to identify and address the specific barriers faced by Haitian immigrants, potentially leading to more effective and sustainable health outcomes. By incorporating photovoice techniques, it also provides participants a platform to share their experiences, which could uncover important insights and lead to improvements in how care is delivered.

What evidence suggests that the iENGAGE intervention is effective for engagement and retention in care for Haitian immigrants living with HIV?

Research shows that programs tailored to cultural needs can significantly enhance engagement in HIV care. Studies have found that personalized programs, such as iENGAGE, improve adherence to treatment plans and lead to better health outcomes. In this trial, the iENGAGE program specifically supports Haitian immigrants with HIV by offering regular meetings to maintain their engagement in care. While specific data on iENGAGE's effectiveness is still being gathered, similar programs have successfully helped participants adhere to care plans and reduce HIV levels in their blood. This approach addresses the unique cultural and social needs of participants, promoting better overall health. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Haitian immigrants in the U.S. who are HIV positive, either newly diagnosed within the last two months or not having their virus under control (non-virally suppressed).

Inclusion Criteria

You have tested positive for HIV.

I was diagnosed with HIV recently or my HIV is not under control.

You moved to the US from Haiti.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants complete baseline assessments and are enrolled in the study

1 week

1 visit (in-person)

Pilot Health Intervention

Participants engage in a culturally tailored intervention with 4 individual meetings approximately once monthly over a six-month period

6 months

4 visits (in-person)

Post-Intervention Assessment

Participants complete post-intervention assessments

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for engagement and viral suppression at 6 months post-enrollment

6 months

1 visit (in-person)

Photovoice Activity (Optional)

Six participants engage in photovoice activities to illustrate their experiences, involving 6 additional meetings

2.5 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• iENGAGE

Trial Overview The study tests a culturally tailored program called iENGAGE designed to help Haitian Immigrants Living With HIV stay engaged with care and achieve viral suppression. It includes four individual meetings over six months and questionnaires at different stages.

How Is the Trial Designed?

Group I: Haitian immigrant iENGAGE (H-iENGAGE) intervention Experimental Treatment 1 Intervention

1. Enrollment; 2. Baseline assessment; 3. Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4 4. Following Session 4, conduct Process evaluation; 5. Post-intervention assessment; 6. Six-month follow up assessment\* \*Six participants will complete AIM 3: Identify multi-level implementation factors contributing to intervention outcomes, using photovoice in mixed methods. 7. End of study participation

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

Approved in United States as Tenofovir alafenamide for:

• HIV-1 infection
• Chronic hepatitis B virus infection

Approved in European Union as Tenofovir alafenamide for:

• HIV-1 infection
• Chronic hepatitis B virus infection

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Published Research Related to This Trial

In a 48-week study involving 86 older adults with HIV, switching to the medication bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) resulted in a high rate of virologic suppression, with 90.7% of participants maintaining HIV-1 RNA levels below 50 copies/ml.

The treatment was well tolerated, with no serious adverse events related to the drug and a high adherence rate of 98.6%, indicating that B/F/TAF is a safe and effective option for older adults living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People with HIV Aged ≥ 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial. Maggiolo, F., Rizzardini, G., Molina, JM., et al.[2021]

In a Phase 2 study involving 170 antiretroviral naive adults, both tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) showed high rates of virologic suppression in HIV-1 patients after 48 weeks, with 88.4% and 87.9% respectively achieving less than 50 copies of HIV RNA per milliliter.

Patients treated with TAF experienced significantly less impact on kidney function and bone mineral density compared to those treated with TDF, indicating a potentially safer profile for TAF in terms of renal and bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. Sax, PE., Zolopa, A., Brar, I., et al.[2022]

Mitonafide, a new compound with intercalative properties, was tested in a phase I study involving 30 patients, but the study was halted due to significant central nervous system toxicity observed at higher doses (above 118 mg/m2), including irreversible memory loss and confusion.

The toxicity was deemed dose-limiting and related to the short intravenous infusion schedule, leading to a recommendation against this administration method, while further studies with a longer administration schedule are currently being pursued.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of mitonafide in solid tumors. Llombart, M., Poveda, A., Forner, E., et al.[2019]

Intraperitoneal (i.p.) administration of gemcitabine was found to be tolerated within a range of doses (40-160 mg/m²) in 30 patients with peritoneal carcinomatosis, although some experienced dose-limiting toxicities such as nausea and respiratory issues.

The study demonstrated that gemcitabine achieves significantly higher concentrations in the peritoneal cavity compared to plasma, with a median peak concentration 1,116-fold higher, suggesting its potential effectiveness for treating conditions like optimally debulked ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of intraperitoneal gemcitabine in the treatment of advanced malignancies primarily confined to the peritoneal cavity. Morgan, RJ., Synold, TW., Xi, B., et al.[2022]

The single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) is as effective as the traditional TDF-based regimen for treating HIV in naive patients and shows improved efficacy in those switching from TDF-based treatments.

E/C/F/TAF demonstrates significant safety benefits, including improved renal function and bone mineral density compared to TDF, making it a promising option for enhancing the tolerability of HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide for the treatment of HIV in adults. Bonora, S., Calcagno, A., Trentalange, A., et al.[2021]

Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) demonstrated high efficacy in maintaining HIV-1 suppression, with 98.6% of participants achieving HIV-1 RNA levels below 50 copies/mL after 240 weeks of treatment.

The treatment was found to be safe, with only 1.6% of participants discontinuing due to adverse events, and no cases of treatment-emergent resistance were detected, indicating its long-term durability and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bictegravir/emtricitabine/tenofovir alafenamide as initial treatment for HIV-1: five-year follow-up from two randomized trials. Sax, PE., Arribas, JR., Orkin, C., et al.[2023]

In a study of ART-naive adults, the tenofovir alafenamide (TAF) regimen showed similar viral suppression rates to the tenofovir disoproxil fumarate (TDF) regimen at 24 weeks, but had a slightly lower rate at 48 weeks due to higher discontinuation rates in the TAF group.

TAF demonstrated significantly better renal and bone safety profiles compared to TDF, with less proteinuria and less reduction in bone mineral density, making it a promising option for initial HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate in the First Protease Inhibitor-Based Single-Tablet Regimen for Initial HIV-1 Therapy: A Randomized Phase 2 Study. Mills, A., Crofoot, G., McDonald, C., et al.[2022]

In a study of 60 patients receiving ifosfamide, 26.6% developed encephalopathy, with varying severity, indicating a notable risk of neurological symptoms associated with this treatment.

The study found no significant risk factors related to age or dosage that could predict encephalopathy, suggesting that individual patient predisposition plays a key role, and ifosfamide can be safely administered to older patients without increased neurotoxicity risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and severity of ifosfamide-induced encephalopathy. Rieger, C., Fiegl, M., Tischer, J., et al.[2019]

The combination of topotecan and ifosfamide as a salvage treatment for advanced ovarian cancer showed a 41% objective response rate in a study of 39 patients who had previously undergone platinum-based chemotherapy.

While the treatment was feasible, it resulted in moderate toxicity, including significant neutropenia and anemia, indicating that careful monitoring and management of side effects are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topotecan and ifosfamide as salvage treatment in advanced ovarian cancer. Chiara, S., Tognoni, A., Pastrone, I., et al.[2013]

The single-tablet regimen (STR) of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) has shown non-inferior virological efficacy compared to traditional dolutegravir-based regimens in treating HIV, based on large clinical trials over 96 weeks.

BIC/FTC/TAF is designed to be highly tolerable and has a high barrier against drug resistance, making it a promising option for managing HIV while also addressing associated comorbidities like cardiovascular disease and renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential role of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) single-tablet regimen in the expanding spectrum of fixed-dose combination therapy for HIV. Stellbrink, HJ., Lazzarin, A., Woolley, I., et al.[2021]

In a study of 5888 patients across six randomized controlled trials, tenofovir alafenamide (TAF) showed similar viral suppression rates to tenofovir disoproxil fumarate (TDF) at 48 weeks, with TAF being particularly effective for patients switching from TDF regimens.

TAF demonstrated better safety profiles, with less impact on kidney function and bone density compared to TDF, making it a potentially safer option for both treatment-naive and experienced HIV-1 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tenofovir alafenamide versus tenofovir disoproxil fumarate in antiretroviral regimens for HIV-1 therapy: Meta-analysis. Wang, H., Lu, X., Yang, X., et al.[2022]

Tenofovir alafenamide (TAF) is a prodrug that achieves higher intracellular concentrations of tenofovir while maintaining lower serum levels, leading to similar efficacy in HIV-1 treatment compared to tenofovir disoproxil fumarate (TDF) but with reduced risks of kidney damage and bone density loss.

Clinical trials have confirmed that TAF-containing regimens provide effective virological suppression and have led to the approval of three combination products for HIV-1 management, making TAF a recommended option for initial treatment in antiretroviral-naïve patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenofovir Alafenamide. Gibson, AK., Shah, BM., Nambiar, PH., et al.[2021]

Tenofovir alafenamide (TAF) is expected to revolutionize HIV-1 treatment due to its better safety profile compared to the older drug tenofovir disoproxil fumarate (TDF), making it suitable for both new and experienced patients.

TAF has already been included in international treatment guidelines for HIV-1, indicating its efficacy and acceptance in clinical practice, despite challenges related to budget constraints and varying global healthcare spending.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Development Agenda on Tenofovir Alafenamide in Clinical Practice. Di Biagio, A., Riccardi, N., Rusconi, S., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39564653/

Effectiveness, safety, and patient-reported outcomes of ... Treatment per sistence at 48 weeks was 99.3% (TN) and 99.5% (TE). Virological suppression rates (<200/<50 copies/mL) at 24 weeks were 97.4/88% ( ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772707625000578

Effectiveness and safety of tenofovir alafenamide ... TAF/FTC/BIC showed low virological failure in newly diagnosed people with HIV. •. Estimated TAF/FTC/BIC durability was 84.8% at 12 months, 75.5% at 24 months.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39476488/

Final 24-month results from the prospective German ... Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

4. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf162/8098170

Real-world Effectiveness and Safety of Bictegravir ... This study compares bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with other first-line antiretroviral therapies in treatment-naive adults.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/hiv.13728

Effectiveness, safety, and patient‐reported outcomes of ... Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772707625001201

Real-world effectiveness, safety, and health-related quality ... Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) confirmed a high effectiveness of 92% in persons with HIV after 12 months. •. No major mutations ...

7. academic.oup.com academic.oup.com/ofid/article/11/11/ofae630/7826499

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir ... At week 48, 93.8% (122/130) of the patients achieved HIV-1 RNA levels <50 copies/mL. CD4 increased by 150.0 cells/μL, and CD4/CD8 increased by 0.16 (P < .001).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02842086

NCT02842086 | Study to Evaluate the Safety and Efficacy ... The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men.

9. symtuzahcp.com symtuzahcp.com/symtuza-real-world-data/

Comparing ARV-Related Weight Gain in a Real-World Study Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing ...