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PrEP Implementation for HIV Prevention in Women Who Inject Drugs
N/A
Recruiting
Led By Laura Starbird, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will help reduce new HIV infections among women who inject drugs by considering the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP.
Who is the study for?
This trial is for primary care and reproductive health clinics that have had at least 50 visits from women who inject drugs in the past year, employ a minimum of three healthcare providers, and whose leadership agrees to participate. Clinics must also have completed previous surveys.Check my eligibility
What is being tested?
The study aims to improve how PrEP (a medication preventing HIV) is provided in these clinics to prevent new HIV infections among women who inject drugs by considering input from affected women, healthcare providers, and clinic leaders.See study design
What are the potential side effects?
Since this trial focuses on practice facilitation rather than direct medical intervention, it does not involve side effects related to medications or treatments. It's about improving service delivery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of intervention sessions completed by site champions
Proportion of clinics enrolled that complete the intervention
Proportion of providers who engage in Practice Facilitation training sessions
+2 moreSecondary outcome measures
Change in PrEP uptake among WWID
Incremental implementation cost
Trial Design
1Treatment groups
Experimental Treatment
Group I: Practice FacilitationExperimental Treatment1 Intervention
Practice Facilitation is an established evidence-based intervention to improve primary health care processes and outcomes, including the delivery of preventive services, through the creation of an ongoing, trusting relationship between an external Practice Facilitator (PF) and a clinical practice. In Practice Facilitation, a trained PF uses organization development, project management, quality improvement, and practice improvement approaches to build the internal capacity of a clinic to support it in reaching its goals for healthcare delivery, A PF's work includes relationship-building, helping to identify a clinic change champion, and facilitating change through logistical support, technical assistance, and external partnership building.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Practice Facilitation
2007
N/A
~17800
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,123 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,323 Total Patients Enrolled
Laura Starbird, PhDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Not applicable.
Research Study Groups:
This trial has the following groups:- Group 1: Practice Facilitation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a call for participants in this research project?
"Affirmative. Clinicaltrials.gov reveals that this investigation, which was originally posted on June 22nd 2021, is actively seeking patients for enrollment. 86 participants are required from 1 medical centre to complete the trial."
Answered by AI
To what extent are individuals being administered the experimental treatment?
"Affirmative. According to clinicaltrials.gov, this research is actively enrolling patients that were first notified of the study on June 22nd 2021 and updated most recently on April 29th 2022. 86 participants are being accepted at one location for participation in the trial."
Answered by AI
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