What side effects are associated with this type of intervention?

The most common treatments for HIV/AIDS, including pre-exposure prophylaxis (PrEP) with drugs like tenofovir and emtricitabine, can have several side effects. These may include gastrointestinal issues such as nausea and diarrhea, headaches, and fatigue. Some patients may experience renal toxicity or decreased bone mineral density with long-term use. Additionally, antiretroviral therapy (ART) in general can lead to side effects like lipid abnormalities, liver toxicity, and hypersensitivity reactions. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several antiretroviral medications for the treatment and prevention of HIV/AIDS. For Pre-exposure Prophylaxis (PrEP), the most notable FDA-approved drugs are Truvada (tenofovir disoproxil fumarate and emtricitabine) and Descovy (tenofovir alafenamide and emtricitabine). These medications are taken by individuals at high risk of HIV infection to prevent the virus from establishing an infection if they are exposed.

What other types of research exist?

Promising novel alternatives to Pre-exposure Prophylaxis (PrEP) for HIV/AIDS patients include long-acting injectable antiretrovirals, such as cabotegravir, which can be administered every two months, and broadly neutralizing antibodies (bNAbs) that target multiple strains of HIV. Additionally, advancements in HIV vaccines and gene-editing technologies like CRISPR are being explored for their potential to provide long-term protection against HIV infection.

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Antiretroviral

PrEP for HIV Prevention

N/A

Waitlist Available

Led By Corina Lelutiu-Weinberger, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

age ≥ 18;

male sex at birth and current male identity;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help gay and bisexual men in Romania prevent HIV by using a program called PrEP Romania. The program includes personal meetings to motivate them to start the medication and a smartphone app that offers ongoing support. This approach addresses their high risk of HIV and the challenges they face in accessing healthcare.

Who is the study for?

This trial is for gay and bisexual men in Central-Eastern Europe, at least 18 years old, who've had unprotected sex with an HIV-positive or unknown status partner or had a sexually transmitted infection recently. They must want to start PrEP, be HIV-negative, own a mobile device (with support for phone plans if needed), and identify as male both at birth and currently.

What is being tested?

The study tests 'PrEP Romania', which combines in-person visits with mobile health technology to help these men start and stick to PrEP—a medication that prevents HIV. The program's success could guide similar efforts across Central-Eastern Europe.

What are the potential side effects?

While the description doesn't specify side effects of PrEP directly, common ones include nausea, headaches, stomach pain, weight loss; however most are temporary and often resolve over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I was born male and currently identify as male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PrEP Adherence via biological measures

Secondary study objectives

Anxiety

Depression

HIV risk

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants will receive PrEP and motivational counseling and adherence support

Group II: ControlActive Control1 Intervention

Participants will receive PrEP and counseling

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HIV/AIDS, such as antiretroviral therapies (ART), work by targeting various stages of the HIV life cycle to prevent the virus from replicating. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. PrEP, a preventive measure, typically uses NRTIs like tenofovir and emtricitabine to inhibit the reverse transcriptase enzyme, essential for viral replication. This is crucial for HIV/AIDS patients as it helps maintain a low viral load, prevents disease progression, and reduces the risk of transmission.

[HIV infection : Reaching a zero risk of transmission].