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NP-PC PrEP for HIV (Human Immunodeficiency Virus)
N/A
Waitlist Available
Led By Jessica Atrio, MD, MSc
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No gross evidence of cognitive impairment precluding consent and participation
≥18 years of age female (biological female at birth)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test two different models for providing PrEP services to women through OBGYN offices. One model will have the OBGYN prioritize PrEP, while the other will shift the provider burden to a Nurse Practitioner.
Who is the study for?
This trial is for English or Spanish-speaking women over 18 who are patients at Montefiore Medical Center, Eastchester Professional Center. They must be able to consent and participate without cognitive impairments. Transgender women and those under 18, or not willing to have interviews recorded cannot join.Check my eligibility
What is being tested?
The study compares two ways of delivering PrEP (a medication that prevents HIV) in OBGYN clinics. One model trains OBGYNs on PrEP; the other uses Nurse Practitioners via telemedicine to reduce provider burden and promote a sex-positive approach.See study design
What are the potential side effects?
While specific side effects aren't listed here, common PrEP-related side effects can include nausea, headache, stomach pain, weight loss, and fatigue. These vary by individual and often decrease over time with continued use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mentally capable of understanding and participating in the trial.
Select...
I am a woman over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of intervention
Uptake of PrEP
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NP-PC PrEPExperimental Treatment1 Intervention
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 sex-positive approach to deliver PrEP services via telemedicine
Group II: OBGYN-PrEPPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,511 Total Patients Enrolled
New York State Psychiatric InstituteOTHER
474 Previous Clinical Trials
153,157 Total Patients Enrolled
Jessica Atrio, MD, MScPrincipal InvestigatorMontefiore Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there open slots for volunteers in the clinical trial?
"Per the clinicaltrials.gov website, this particular medical trial is not presently in need of participants - although it was first posted on September 14th 2021 and last updated August 19th 2022. Despite this study's status, 83 other trials are actively recruiting patients at present."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Montefiore Medical Center: < 48 hours
Average response time
- < 2 Days
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