NP-PC PrEP for Hiv

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Montefiore Medical Center, Bronx, NY
Hiv
NP-PC PrEP - Other
Eligibility
18+
Female
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Study Summary

This study is evaluating whether a nurse practitioner can deliver PrEP to women who are at risk for HIV.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether NP-PC PrEP will improve 2 primary outcomes in patients with Hiv. Measurement will happen over the course of 1 year.

1 year
Acceptability of intervention
Uptake of PrEP

Trial Safety

Trial Design

2 Treatment Groups

NP-PC PrEP
1 of 2
OBGYN-PrEP
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. NP-PC PrEP is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

NP-PC PrEP
Other
NP-PC PrEP incorporates the standard of care and practices in OBGYN-PrEP but enhances access to additional skilled providers, as the PrEP provider burden is shifted to a Nurse Practitioner (NP) who will use a sexpositive approach to deliver PrEP services via telemedicine
OBGYN-PrEP
Other
OBGYN-PrEP has 4 parts: (1) prioritize PrEP; (2) train providers in PrEP and intervention; (3) identify PrEP-appropriate women through a risk screen; and (4) monitor progress and fidelity to protocol.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Montefiore Medical Center - Bronx, NY

Eligibility Criteria

This trial is for female patients aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
≥18 years of age Female (biological female at birth) Ability to speak and read English or Spanish Patient at Montefiore Medical Center, Eastchester Professional Center (EPC). No gross evidence of cognitive impairment precluding consent and participation Willing to have interview digitally recorded

Patient Q&A Section

How serious can hiv be?

"Although a variety of causes can manifest at any age, hiv was an important cause of death in all age subgroups. HIV deaths were more common in individuals younger than 25 who smoked cigarettes." - Anonymous Online Contributor

Unverified Answer

What is hiv?

"Human Immunodeficiency Viral HIV infection is typically known for affecting people of African ancestry. HIV infection occurs mostly among men who have sex with men, especially in North and South America, and it is responsible for the majority of reported deaths worldwide." - Anonymous Online Contributor

Unverified Answer

How many people get hiv a year in the United States?

"In most years fewer than two persons get hiv, and the general lack of incidence in many of the U.S. population is likely driven by the fact that most of the time an HIV-infected person remains asymptomatic." - Anonymous Online Contributor

Unverified Answer

Can hiv be cured?

"Patients with HIV who develop and maintain a durable undetectable viral load are well treated. These patients have a greater chance of avoiding disease progression, shorter and increased survival time to immunologic failure, and improved quality of life. With the current HIV drug treatment and with proper counseling, hiv can be cured." - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv?

"The major symptoms at diagnosis are: (i) fever: HIV infection is the cause of chronic fever in up to 80% of HIV patients. Seizures are an uncommon but characteristic effect of HIV. In a survey of 101 AIDS patients in Los Angeles, the most frequent causes of seizures were toxoplasmosis (40%), untreated HIV infection (13%), cocaine use (12%), and cryptococcal meningitis (7%). Myelopathy, central nervous system opportunistic infections and the AIDS dementia complex are rare but serious complications of AIDS and can cause seizures. Severe immunodeficiency is a common contributor to increased neuropathology." - Anonymous Online Contributor

Unverified Answer

What causes hiv?

"Individuals, couples, and entire communities at risk for HIV/AIDS may share risk factors to the virus. Effective prevention requires awareness of multiple transmission pathways, including sexual, shared needle, or public/private needles transmission pathways." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hiv?

"Common treatments for hiv infection include the use of various antiretroviral agents. Two of the most commonly used for antiretroviral therapy are lamivudine and nevirapine. These agents are similar in their potency and have similar side effects. The most common side effects that occur when using these agents includes nausea. The use of lamivudine and nevirapine can also reduce sexual function in hiv." - Anonymous Online Contributor

Unverified Answer

Is np-pc prep typically used in combination with any other treatments?

"Results from a recent paper provide some insight into the use of nP-PC as a stand-alone treatment. However, while it may be effective for many patients, it is not a cure therapy and requires further study in clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in np-pc prep for therapeutic use?

"The treatment of HIV infection has continued to show advances over the years. The use of drugs that can directly target the virus itself, and the use of drugs to decrease the virus replication and increase host immunity are the current trends for the treatment of HIV." - Anonymous Online Contributor

Unverified Answer

How does np-pc prep work?

"All patients received the vaccine. Patient satisfaction was high with only negligible side effects. Positive reactions to vaccine were rare. The vaccine was an acceptable alternative to conventional needle sharing\n\n- "" - Anonymous Online Contributor

Unverified Answer

What does np-pc prep usually treat?

"A history of sexual activity is frequently cited as a reason for the utilization of a HIV testing. However, among the reasons cited was not having ever been tested for the HIV virus and being unaware of the infection's consequences." - Anonymous Online Contributor

Unverified Answer

Does np-pc prep improve quality of life for those with hiv?

"Preparing those with HIV to perform their daily living activities at home was a practical, cost-effective strategy that significantly improved the quality of life of the participants of the study even when compared to those receiving standard care alone." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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