Implementing PrEP for Women Who Inject Drugs

NCT05360849 | Active Not Recruiting

• 2 other identifiers: 848579K01DA051348
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Women's Health; Intravenous Substance Abuse; Organization and Administration; Primary Prevention; Implementation Science

Outcome Measures

Primary Outcomes (5)

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

• 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.

  6 months

Secondary Outcomes (2)

• Change in PrEP uptake among WWID

  18 months

• Incremental implementation cost

  6 months

Study Arms (1)

Practice Facilitation

EXPERIMENTAL

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.

Behavioral: Practice Facilitation

Interventions

Practice Facilitation BEHAVIORAL

Participating clinics will work with a Practice Facilitator to modify clinic processes to improve delivery of PrEP to women who inject drugs

Practice Facilitation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals who identify as a woman (female sex at birth or transgender woman)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania School of Nursing

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Substance Abuse, Intravenous

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Laura Starbird, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: May 4, 2022
• Study Start: June 22, 2021
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): March 24, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)