Clinical trial NCT05360849: 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
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Intravenous Substance Abuse
Women's Health
Organization and Administration
Primary Prevention
Implementation Science
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-05-04
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proportion of clinics enrolled that complete the intervention
timeFrame: 6 months
measure: Number of intervention sessions completed by site champions
timeFrame: 6 months
measure: Proportion of providers who engage in Practice Facilitation training sessions
timeFrame: 6 months
measure: Proportion of providers who screen women who inject drugs for PrEP eligibility
timeFrame: 6 months
measure: Proportion of providers who write a PrEP prescription to women who inject drugs
timeFrame: 6 months
Secondary outcomes:
measure: Change in PrEP uptake among WWID
timeFrame: 18 months
measure: Incremental implementation cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Nursing
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Laura Starbird, PhD
role: PRINCIPAL_INVESTIGATOR
References: