Packaging PrEP to Prevent HIV Among WWID

Status Completed

Clinical Trial Summary

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. This observational study will evaluate a novel approach for the delivery of pre-exposure prophylaxis (PrEP) care: pairing PrEP with community-based syringe exchange program (SEP) services. 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. We will enroll a cohort of 125 women and follow-them over six months. At their first study visit, they will educated about and offered a prescription for PrEP. Those who indicate an interest in PrEP will be able to return to the SEP one week later to obtain a paper PrEP prescription or medication. All participants will be followed for six months using qualitative interviews and surveys to understand facilitators and barriers to PrEP uptake and engagement over time. In addition, we will collect urine and test it to detect the level of drug concentration among women who initiate PrEP. This will allow us to know whether their level of adherence translated to prevention effective drug levels.

Clinical Trial Description

This prospective mixed methods study will be initiated within the largest SEP in the mid-Atlantic region. Over six months, we will use semi-structured and in-depth interviews based on the Behavioral Model for Vulnerable Populations, and drug-level monitoring for emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) adherence, to address the following specific aims: (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 Behavioral Model for Vulnerable Populations 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. ;

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
HIV Infections
HIV/AIDS

Clinical Trial Details

NCT number	NCT03304912
Study type	Observational
Source	Drexel University
Contact
Status	Completed
Phase
Start date	April 3, 2018
Completion date	October 8, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03215901` - Life Plans Intervention Study	N/A
Completed	`NCT03289676` - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV	Phase 1
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting	`NCT04064567` - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK	N/A
Completed	`NCT04013295` - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya	N/A
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT03984136` - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM	N/A
Completed	`NCT02928900` - Patient Actor Training to Improve HIV Services for Adolescents in Kenya	N/A
Recruiting	`NCT03268109` - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed	`NCT02797262` - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System	N/A
Completed	`NCT02376582` - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS	Phase 1
Completed	`NCT01957865` - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda	N/A
Completed	`NCT01616940` - Minority AIDS Initiative Retention and Re-Engagement Project	N/A
Terminated	`NCT01443923` - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV	Phase 4
Completed	`NCT01910714` - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth	N/A
Completed	`NCT01084421` - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos	N/A
Completed	`NCT01596322` - International HIV Antiretroviral Adherence, Resistance and Survival	N/A
Completed	`NCT03643705` - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention	N/A
Completed	`NCT03923231` - Pharmacokinetics of Atazanavir in Special Populations

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.