PrEP Implementation for HIV Prevention in Women Who Inject Drugs

Overseen By Laura Starbird, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how healthcare clinics deliver PrEP (a medication to prevent HIV) to women who inject drugs. It focuses on understanding the needs and barriers faced by these women, healthcare providers, and clinic leaders to reduce new HIV infections. The trial employs a method called Practice Facilitation, where a trained facilitator assists clinics in enhancing their services and support systems. Clinics with at least 50 visits from women who inject drugs each year and willing leadership are well-suited for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative healthcare solutions for preventing HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this practice facilitation is safe for improving healthcare delivery?

Research has shown that Practice Facilitation safely improves healthcare services. This method involves a trained helper working with clinics to enhance services such as HIV prevention. No reports of medical side effects or physical harm exist because Practice Facilitation focuses on improving clinic procedures, not on using new medications or devices.

The World Health Organization and other studies have found that this approach effectively enhances clinic performance and service delivery. The goal is to ensure clinics provide better care, including easier access to HIV prevention services like PrEP (pre-exposure prophylaxis) for women who inject drugs.

In summary, Practice Facilitation helps clinics operate more efficiently. It is considered safe because it does not involve direct medical treatments or drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Practice Facilitation for HIV prevention in women who inject drugs because it offers a unique approach to improving healthcare delivery. Unlike standard medical treatments that focus solely on medication, Practice Facilitation enhances the clinic's internal processes through a collaborative relationship with an external Practice Facilitator. This method aims to build the clinic's capacity for delivering preventive services effectively by fostering organizational change and partnership building. By emphasizing relationship-building and continuous support, Practice Facilitation has the potential to significantly improve the implementation of preventive measures like PrEP, offering a promising new angle for tackling HIV prevention in this vulnerable population.

What evidence suggests that Practice Facilitation is effective for improving PrEP delivery to women who inject drugs?

Research shows that pre-exposure prophylaxis (PrEP) effectively prevents HIV infection. Studies have found that regular use of PrEP can reduce the risk of contracting HIV by over 90%. However, women who use drugs often face challenges in accessing PrEP. This trial examines Practice Facilitation as a method to help clinics enhance their PrEP offerings, with support and guidance from trained facilitators. This approach can simplify PrEP provision for those in need, potentially reducing new HIV infections in this at-risk group. ^{3 6 7 8 9}

Who Is on the Research Team?

Laura Starbird, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Clinics must have 3 or more clinicians who provide primary and/or reproductive healthcare

Clinics must complete prior leadership and provider surveys

Clinics must have had 50 or more clinic visits with women who inject drugs in the past year

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Baseline

Surveys with clinic leaders and providers on organizational capacity, readiness to change, and provider knowledge about PrEP

6 months

Data collection from clinic records

Intervention

Practice Facilitation intervention to improve PrEP delivery to women who inject drugs

6 months

Ongoing facilitation sessions

Post-intervention Follow-up

Assessment of PrEP uptake among women who inject drugs and evaluation of intervention outcomes

6 months

Data collection from clinic records

What Are the Treatments Tested in This Trial?

Interventions

• Practice Facilitation

Trial Overview

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.

How Is the Trial Designed?

Group I: Practice Facilitation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Women who inject drugs (WWID) with accurate beliefs about PrEP were more likely to intend to use it, recognizing its benefits in preventing HIV and empowering them, compared to those with inaccurate beliefs.

Inaccurate beliefs about PrEP were linked to significant perceived barriers, such as fear of partner reprisal and concerns about theft, highlighting the need for targeted interventions to improve understanding and increase PrEP uptake among WWID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of PrEP beliefs to perceived personal, interpersonal and structural benefits and barriers to PrEP use in women who inject drugs. Paulus, K., Kelly, PJA., Brajuha, J., et al.[2023]

A qualitative study involving 33 HIV-uninfected people who inject drugs (PWID) revealed high interest in PrEP for HIV prevention, but significant barriers to its use were identified at individual, interpersonal, clinical, and structural levels.

Barriers included low knowledge about PrEP, stigma, negative healthcare experiences, and logistical issues like homelessness and lack of access to prescriptions, highlighting the need for targeted interventions to improve PrEP delivery and uptake among PWID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. Biello, KB., Bazzi, AR., Mimiaga, MJ., et al.[2019]

A study involving 24 semi-structured interviews and 4 focus groups with people who inject drugs (PWID) revealed that nearly half of the participants had little concern about acquiring HIV, indicating a significant gap in awareness and risk perception.

The research identified key barriers to PrEP uptake among PWID, including limited knowledge about PrEP, a focus on sexual behaviors rather than injection drug use as a risk factor, and various individual and environmental obstacles, highlighting the need for targeted public health education efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative inquiry into perceptions of HIV pre-exposure prophylaxis among people who inject drugs living with hepatitis C in Seattle, WA, USA. Barry, MP., Austin, EJ., Bhatraju, EP., et al.[2023]

The study involved 31 women (15 female sex workers and 16 women who inject drugs) in Baltimore, exploring their attitudes towards different PrEP delivery methods, including pills, injections, and implants.

Participants expressed concerns about side effects and privacy, highlighting that while longer-lasting PrEP options could improve adherence, issues like perceptibility of the implant could hinder uptake, indicating the need for tailored interventions for these high-risk groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring new and existing PrEP modalities among female sex workers and women who inject drugs in a U.S. city. Footer, KHA., Lim, S., Rael, CT., et al.[2020]

A demonstration project in Philadelphia showed that integrating preexposure prophylaxis (PrEP) with syringe services programs (SSP) is feasible and acceptable for women who inject drugs (WWID), with 63 out of 136 participants accepting a PrEP prescription within the first week.

Retention in the PrEP program was notably higher among women who frequently accessed SSP services, indicating that consistent engagement with these services may enhance the effectiveness of PrEP in preventing HIV among this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating HIV Preexposure Prophylaxis With Community-Based Syringe Services for Women Who Inject Drugs: Results From the Project SHE Demonstration Study. Roth, AM., Tran, NK., Felsher, M., et al.[2023]

HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV, yet many eligible individuals are not receiving it, highlighting a gap in access to this important preventive measure.

Recommendations from PrEP Coordinators in San Francisco emphasize the need for better training, integration of PrEP into routine care, and proactive strategies to improve patient retention and communication, particularly for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. Shrestha, I., Ming, K., Jimenez, V., et al.[2023]

A systematic review of 76 peer-reviewed articles and 28 conference abstracts revealed that while awareness of daily oral PrEP among at-risk populations is low, most individuals expressed a willingness to use it once informed about its benefits.

Concerns regarding safety, side effects, cost, and effectiveness were the main barriers to PrEP adoption, indicating a need for better education and resources for both potential users and healthcare providers before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Values and Preferences on the Use of Oral Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Multiple Populations: A Systematic Review of the Literature. Koechlin, FM., Fonner, VA., Dalglish, SL., et al.[2023]

In a survey of 407 people who inject drugs (PWID) in rural West Virginia, only 32.6% had heard of oral PrEP, but 58.3% expressed interest in using it, indicating a significant gap in awareness and potential for uptake.

Half of the participants (55.7%) showed interest in injectable forms of PrEP, suggesting that both oral and injectable options could effectively enhance HIV prevention strategies in rural areas, especially among those comfortable discussing sexual health with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness of and interest in oral pre-exposure prophylaxis (PrEP) for HIV prevention and interest in hypothetical forms of PrEP among people who inject drugs in rural West Virginia. Schneider, KE., White, RH., O'Rourke, A., et al.[2022]

A study involving 33 people who inject drugs (PWID) revealed that their knowledge about pre-exposure prophylaxis (PrEP) was low, primarily due to inadequate marketing targeting this group and healthcare providers' reluctance to discuss PrEP with them.

To improve PrEP uptake among high-risk PWID, it is essential to enhance education about PrEP, address misconceptions about HIV risk, and develop targeted outreach strategies that effectively communicate the benefits of PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. Bazzi, AR., Biancarelli, DL., Childs, E., et al.[2020]

A focus group study with 36 young men and transgender individuals in major U.S. cities revealed that while there is knowledge about oral PrEP, barriers such as stigma and access to information hinder its broader use.

Participants expressed mixed preferences for injectable versus oral PrEP, noting that quarterly injections could be beneficial for those with adherence challenges, but raised concerns about side effects, pain, and trust in the medical system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for Injectable PrEP Among Young U.S. Cisgender Men and Transgender Women and Men Who Have Sex with Men. Biello, KB., Hosek, S., Drucker, MT., et al.[2019]

Healthcare providers are generally interested in prescribing long-acting injectable PrEP (LAI-PrEP) and believe that some patients will be receptive to this new prevention method for HIV.

Successful implementation of LAI-PrEP will depend on addressing structural challenges such as cost and access to healthcare services, as identified by clinicians in the South during in-depth interviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEParing for long-acting injectable PrEP in the South: perspectives from healthcare providers in Georgia. Xavier Hall, CD., Smith, JC., Driggers, RA., et al.[2023]

Citations

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cureus.com

cureus.com/articles/279455-barriers-and-facilitators-that-influence-hiv-pre-exposure-prophylaxis-prep-prescribing-behaviors-among-primary-care-providers-in-the-southern-united-states

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sciencedirect.com

sciencedirect.com/science/article/pii/S2211335519301834

Results from a survey of primary care providers

Among 240 participants, the majority (85%) favored integrating PrEP into primary care, either by training all providers (“all trained”) (42%) or having an ...

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ajpmonline.org

ajpmonline.org/article/S0749-3797(21)00358-5/fulltext

Pre-exposure Prophylaxis Uptake, Adherence, and ...

In MSM, ≥4 doses per week has been shown to reduce the risk of HIV infection by 90%. Data are less robust in women, although modeling analyses suggest that as ...

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pmc.ncbi.nlm.nih.gov/articles/PMC12258332/

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In this case, HIV PrEP has been proven as an effective strategy to prevent HIV infection.

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viivhealthcare.com

viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

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CAB LA for PrEP was effective in 99.7% of individuals (762 of 764 were not diagnosed with HIV during the follow-up period). There were two ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11863588/

Investigating facilitators and barriers to the routine provision of ...

The WHO systemic review and analysis of studies, updated in 2016, found that PrEP is effective at reducing the risk of acquiring HIV regardless ...

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academic.oup.com

academic.oup.com/ofid/article/12/4/ofaf124/8052655

Internal Medicine Resident Perceptions of the Barriers to and ...

We conducted a mixed methods study to characterize internal medicine resident (IMR) perceptions of harm reduction and HIV prevention services among PWID.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2667321523001415

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Daily oral pre-exposure prophylaxis (PrEP) is highly safe and effective for HIV prevention, yet barriers to PrEP access and adherence persist among key ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11399752/

Barriers and Facilitators That Influence HIV Pre-exposure ...

A cross-sectional survey was conducted among PCPs in 10 Southern states to assess their PrEP-prescribing practices, barriers, and facilitators. The results ...