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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Practice Facilitation for HIV prevention in women who inject drugs?

The research highlights that PrEP (pre-exposure prophylaxis) is effective for HIV prevention, and using coordinators to manage PrEP programs can improve access and service delivery. This suggests that structured support, like Practice Facilitation, could enhance the implementation of PrEP among women who inject drugs. ^{1 2 3 4 5}

Is PrEP safe for women who inject drugs?

PrEP (Pre-Exposure Prophylaxis) is generally considered safe for preventing HIV in various populations, including people who inject drugs. However, concerns about side effects, especially with new forms like injections, have been noted, and more information may be needed to address these concerns. ^{3 5 6 7 8}

How is the drug PrEP unique for HIV prevention in women who inject drugs?

PrEP (Pre-Exposure Prophylaxis) is unique for HIV prevention in women who inject drugs because it is specifically designed to be taken before potential exposure to HIV, offering a proactive approach to prevention. Unlike other treatments that may be used after exposure, PrEP provides a preventive measure, which is particularly important for women who face biological, behavioral, and gender-based barriers to accessing traditional HIV prevention services. ^{3 5 9 10 11}

Research Team

Laura Starbird, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

PrEParing for long-acting injectable PrEP in the South: perspectives from healthcare providers in Georgia. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Lessons Learned from an HIV Pre-Exposure Prophylaxis Coordination Program in San Francisco Primary Care Clinics. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Perspectives on HIV pre-exposure prophylaxis (PrEP) utilization and related intervention needs among people who inject drugs. [2019]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. [2020]

6. England 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. [2020]

7. United States 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. [2019]

8. United States 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. [2023]

9. England 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. [2023]

10. United States 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. [2023]

11. England 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. [2023]