Packaging PrEP to Prevent HIV Among WWID

NCT ID: NCT03304912

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2019-10-08

Brief 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.

Detailed 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.

Conditions

HIV/AIDS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women who inject drugs who are eligible for PrEP

Women who inject drugs who are eligible for PrEP are provided PrEP Education and option to accept a PrEP prescription.

PrEP Education and option to accept a PrEP prescription

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility 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 sexually transmitted infection (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Alexis Roth

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexis M Roth, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University Dornsife School of Public Health

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21DA043417-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link