Clinical Trials

MainTitle

Packaging PrEP to Prevent HIV Among WWID

This study has been completed
Sponsor
Drexel University


Information provided by (Responsible Party)
Alexis Roth, Drexel University

ClinicalTrials.gov Identifier
NCT03304912

First received: September 29, 2017
Last updated: October 22, 2019
Last Verified: October 2019
History of Changes
Purpose

Purpose

Pre-exposure prophylaxis (PrEP) is a promising bio-medical HIV prevention strategy that involves the use of single daily dose of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) by HIV-negative individuals to reduce risk of acquiring HIV. Evidence suggests women who inject drugs (WWID) are disproportionately vulnerable to HIV. If HIV incidence continues unchecked, 1 in 23 WWID in the United States will acquire HIV. One concern regarding PrEP implementation for WWID is that they will face a number of challenges to engaging in PrEP care. To reduce barriers and thereby increase the individual and public health benefits of PrEP, alternative approaches based outside of traditional clinical settings are needed. The proposed research is significant, because PrEP could reduce HIV acquisition among WWID. However, at present, there is little knowledge to help address PrEP implementation challenges for this understudied group. The proposed research is highly innovative, because it will address this knowledge gap by evaluating a novel approach for the delivery of PrEP care: pairing PrEP with community-based syringe exchange program (SEP) services. This approach may represent a paradigm shift that enables and encourages women in this highly vulnerable population to engage in effective biomedical HIV prevention strategies. The rationale is that (1) SEPs may currently provide prescription medications and long-term monitoring for other conditions such as buprenorphine for opioid dependence, so providing PrEP care is a natural extension of what is already being done successfully; (2) SEPs are a viable access point for many HIV-uninfected WWID who would be considered eligible for PrEP under current clinical guidelines; and (3) PrEP interventions, delivered in settings already utilized and trusted by WWID, will increase uptake, adherence and retention in PrEP. To evaluate this approach, a prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Through semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for FTC/TDF adherence, the following specific aims will be addressed: (1) Describe WWID's engagement in the PrEP care continuum (focusing on critical moments when women could disengage or need additional support to remain in care). (2) Identify factors from the BVMP that are associated with WWID's engagement in the PrEP care continuum. (3) Explore how and why model factors are associated with WWID's decisions and ability to engage in PrEP care. A paired model of PrEP and SEP services has yet to be tested. This is exploratory study will provide preliminary data to generate hypotheses for future intervention studies. The long-term outcome of this research program will be a reduction in HIV among WWID through the delivery of HIV prevention interventions that include PrEP. The reproducibility of this approach, resulting from utilization of an already functional service delivery system, significantly increases the potential for translation to other settings and PWID populations, including men who inject drugs, in domestic and global contexts.

Condition Intervention
HIV/AIDS

Behavioral : PrEP Education and option to accept a PrEP prescription

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs

Further study details as provided by Alexis Roth, Drexel University:

Primary Outcome Measures

  • PrEP Uptake: Receiving a Prescription [ Time Frame: 3 months ]
    We will operationalize PrEP uptake in two ways: First, as receiving a PrEP prescription assessed through medical chart review
  • PrEP Uptake: Filling a Prescription [ Time Frame: 3 months ]
    We will operationalize PrEP uptake in two ways: Second, receiving the prescription and filling the prescription verified through pharmacy fill data
Secondary Outcome Measures:
  • PrEP adherence based on urinalysis [ Time Frame: 3 months ]
    We will operationalize PrEP adherence in two ways: First, based on the concentration of FTC in urine
  • PrEP adherence based on self-report [ Time Frame: 3 months ]
    We will operationalize PrEP adherence in two ways: Second, using a validated self-report measure

Enrollment: 105
Study Start Date: April 3, 2018
Study Completion Date: October 8, 2019
Primary Completion Date: October 8, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Cohort
The cohort will be comprised of women who inject drugs who are eligible for PrEP.
Behavioral: PrEP Education and option to accept a PrEP prescription

Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  
Sampling Method: Non-Probability Sample  

Study Population

Community sample to be recruited from a syringe exchange program.

Criteria

Inclusion Criteria:

  • HIV sero-negative
  • Females
  • Age ≥18 years
  • Reporting non-prescription injection drug use and any of the following:
    1. Syringe sharing
    2. Injecting drugs with a HIV-positive partner
    3. Recent opioid agonist treatment but still injecting drugs
    4. Sex exchange
    5. Inconsistent condom use
    6. Recent bacterial STI
    7. and/or sex with a HIV-positive partner


Exclusion Criteria:
  • HIV seropositivity
  • Currently taking PrEP
  • Pregnant, breastfeeding or trying to become pregnant
  • Previous enrollment in the study

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03304912

Locations

United States, Pennsylvania
Drexel University Dornsife School of Public Health
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Drexel University
More Information

More Information


Responsible Party: Alexis Roth, Assistant Professor, Drexel University  
ClinicalTrials.gov Identifier: NCT03304912   History of Changes  
Other Study ID Numbers: 1R21DA043417-01A1  
Study First Received: September 29, 2017  
Last Updated: October 22, 2019  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Alexis Roth, Drexel University:

Pre-Exposure Prophylaxis
Injection Drug Use

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on August 07, 2020
This information is provided by ClinicalTrials.gov.