search
Back to results

Implementing PrEP for Women Who Inject Drugs

Primary Purpose

HIV, Intravenous Substance Abuse, Women's Health

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Practice Facilitation
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

To be included in the pilot test of Practice Facilitation, clinics must:

  • Complete prior leadership and provider surveys
  • Have 50 or more clinic visits with women who inject drugs in the past year
  • Have 3 or more clinicians who provide primary and/or reproductive healthcare
  • Have leadership willing to participate

Exclusion Criteria:

  • None

Sites / Locations

  • University of Pennsylvania School of NursingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Practice Facilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of clinics enrolled that complete the intervention
The proportion of clinics who complete the intervention among those that enrolled is measured as part of determining feasibility of Practice Facilitation in primary and reproductive health settings. Feasibility is defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics.
Number of intervention sessions completed by site champions
The number of Practice facilitation sessions that the site champion completes with the Practice Facilitator is measured as part of determining feasibility of Practice Facilitation in primary and reproductive health clinics. Feasibility is defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics.
Proportion of providers who engage in Practice Facilitation training sessions
The proportion of providers at an enrolled clinic who attend Practice Facilitation training sessions is measured as part of determining feasibility of Practice Facilitation. Feasibility is defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics.
Proportion of providers who screen women who inject drugs for PrEP eligibility
The proportion of providers in enrolled clinics who screen their patients who identify as women who inject drugs for PrEP eligibility is measured as part of determining the acceptability of Practice Facilitation for PrEP among women who inject drugs. Acceptability is defined as the perception among clinic leaders and providers that Practice Facilitation to improve PrEP delivery among WWID is agreeable or satisfactory.
Proportion of providers who write a PrEP prescription to women who inject drugs
The proportion of providers in enrolled clinics who prescribe PrEP to patients who identify as women who inject drugs is measured as part of determining the acceptability of Practice Facilitation for PrEP among women who inject drugs. Acceptability is defined as the perception among clinic leaders and providers that Practice Facilitation to improve PrEP delivery among WWID is agreeable or satisfactory.

Secondary Outcome Measures

Change in PrEP uptake among WWID
Change in uptake of PrEP among WWID will be assessed as the difference in number of WWID who receive a PrEP prescription during the 6 months prior to baseline compared to the 6 months post-intervention.
Incremental implementation cost
Incremental implementation cost is the cost of adding Practice Facilitation for PrEP uptake from the healthcare sector perspective.

Full Information

First Posted
April 11, 2022
Last Updated
May 10, 2023
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05360849
Brief Title
Implementing PrEP for Women Who Inject Drugs
Official Title
Implementation of PrEP for Women Who Inject Drugs Through Practice Facilitation in Primary and Reproductive Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs, thereby reducing new HIV infections in this population.
Detailed Description
Women who inject drugs (WWID) are among the most vulnerable to acquiring HIV due to the dual effects of both unsafe injecting and sexual practices. Pre-exposure prophylaxis (PrEP) is both effective and recommended to prevent HIV infection among high-risk groups, including women who inject drugs. However, PrEP uptake among WWID is lagging - 92% of people who receive PrEP in New York State are men. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs to prevent women who inject drugs from getting HIV. The investigators plan to support primary care and reproductive health clinics in making organization-level changes to deliver PrEP to women who use drugs with a Practice Facilitation intervention. Practice Facilitation is an evidence-based strategy to support clinics' abilities to implement an intervention such as PrEP through technical assistance, logistical support, and external partnership building. The specific aims of this study are to 1) explore the opinions of women who inject drugs about how PrEP is delivered to them, 2) examine the provider- and organization-level barriers and facilitators to delivering PrEP to WWID, and 3) adapt and pilot test the feasibility and acceptability of Practice Facilitation to improve PrEP delivery to women who inject drugs in primary and reproductive healthcare settings. The objectives of the pilot study are: a) to adapt an evidence-based Practice Facilitation intervention based on WWID's opinions and provider and organization-level challenges reported in Aims 1 & 2; b) to assess potential barriers and facilitators to implementing Practice Facilitation for PrEP delivery, including cost of the intervention; and c) to assess in a pilot study change in uptake of PrEP among WWID following the delivery of Practice Facilitation. The outcomes for this pilot test are feasibility, defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics, and acceptability, defined as the perception among clinic leaders and providers that Practice Facilitation to improve PrEP delivery among WWID is agreeable or satisfactory. The investigators will also assess the change in PrEP uptake among WWID over the study period and the cost of implementing Practice Facilitation. This pilot will take place over 12 months. Pre-intervention baseline measures will include surveys with clinic leaders and providers on organizational capacity, organizational readiness to change, provider knowledge, experience, and willingness to prescribe PrEP and attitudes about WWID. The number of WWID who receive a PrEP prescription in the past 6 months will be extracted retrospectively from clinic electronic health records and/or clinic quality improvement data at baseline. During the 6-month intervention period, data on the implementation process including the feasibility, acceptability, and cost will be captured using standardized forms completed by the Practice Facilitator. In the 6-month period following the intervention, the investigators will assess the number of WWID who receive a PrEP prescription so that they can examine the outcome of change in uptake of PrEP among WWID. Change in uptake of PrEP among WWID will be assessed as the trend in number of WWID who receive a PrEP prescription over time to establish estimates needed for accurate sample size calculations for a full randomized study. This treatment effect will be assessed using logistic regression comparing the proportion of WWID who are prescribed PrEP over 6-months pre-intervention to the proportion during the 6-month intervention period and 6-months following the intervention using logistic regression. To examine potential biases resulting from clinics that discontinue participation, clinic dropouts will be compared to completers with respect to baseline PrEP prescription measures and other clinic characteristics. As a pilot study, this project will have a small sample size but will produce results that can support evaluation of feasibility and determination of effect size estimates for a subsequent large cluster randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Intravenous Substance Abuse, Women's Health, Organization and Administration, Primary Prevention, Implementation Science

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Practice Facilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Practice Facilitation
Intervention Description
Participating clinics will work with a Practice Facilitator to modify clinic processes to improve delivery of PrEP to women who inject drugs
Primary Outcome Measure Information:
Title
Proportion of clinics enrolled that complete the intervention
Description
The proportion of clinics who complete the intervention among those that enrolled is measured as part of determining feasibility of Practice Facilitation in primary and reproductive health settings. Feasibility is defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics.
Time Frame
6 months
Title
Number of intervention sessions completed by site champions
Description
The number of Practice facilitation sessions that the site champion completes with the Practice Facilitator is measured as part of determining feasibility of Practice Facilitation in primary and reproductive health clinics. Feasibility is defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics.
Time Frame
6 months
Title
Proportion of providers who engage in Practice Facilitation training sessions
Description
The proportion of providers at an enrolled clinic who attend Practice Facilitation training sessions is measured as part of determining feasibility of Practice Facilitation. Feasibility is defined as the extent to which Practice Facilitation of PrEP delivery for WWID can be successfully carried out in primary care and reproductive health clinics.
Time Frame
6 months
Title
Proportion of providers who screen women who inject drugs for PrEP eligibility
Description
The proportion of providers in enrolled clinics who screen their patients who identify as women who inject drugs for PrEP eligibility is measured as part of determining the acceptability of Practice Facilitation for PrEP among women who inject drugs. Acceptability is defined as the perception among clinic leaders and providers that Practice Facilitation to improve PrEP delivery among WWID is agreeable or satisfactory.
Time Frame
6 months
Title
Proportion of providers who write a PrEP prescription to women who inject drugs
Description
The proportion of providers in enrolled clinics who prescribe PrEP to patients who identify as women who inject drugs is measured as part of determining the acceptability of Practice Facilitation for PrEP among women who inject drugs. Acceptability is defined as the perception among clinic leaders and providers that Practice Facilitation to improve PrEP delivery among WWID is agreeable or satisfactory.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in PrEP uptake among WWID
Description
Change in uptake of PrEP among WWID will be assessed as the difference in number of WWID who receive a PrEP prescription during the 6 months prior to baseline compared to the 6 months post-intervention.
Time Frame
18 months
Title
Incremental implementation cost
Description
Incremental implementation cost is the cost of adding Practice Facilitation for PrEP uptake from the healthcare sector perspective.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Individuals who identify as a woman (female sex at birth or transgender woman)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be included in the pilot test of Practice Facilitation, clinics must: Complete prior leadership and provider surveys Have 50 or more clinic visits with women who inject drugs in the past year Have 3 or more clinicians who provide primary and/or reproductive healthcare Have leadership willing to participate Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Starbird, PhD
Phone
2157464188
Email
starbird@nursing.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Starbird, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania School of Nursing
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Starbird, PhD
Phone
215-746-4188
Email
starbird@nursing.upenn.edu
First Name & Middle Initial & Last Name & Degree
Laura Starbird, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Implementing PrEP for Women Who Inject Drugs

We'll reach out to this number within 24 hrs