Packaging PrEP to Prevent HIV Among WWID

NCT03304912 | Completed Results DMC

• 1 other identifier: 1R21DA043417-01A1
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

Pre-Exposure Prophylaxis; Injection Drug Use

Outcome Measures

Primary Outcomes (1)

• PrEP Uptake at Week 1

  Number of WWID accepting a paper Truvada prescription to fill at their preferred pharmacy or obtaining Truvada from the SSP among those who returned to care as verified in electronic medical records.

  1 week

Secondary Outcomes (4)

• PrEP Uptake at Week 12

  12 weeks

• PrEP Adherence Based on Urinalysis at 12 Weeks

  12 weeks

• PrEP Adherence Based on Self-report at 12 Weeks

  12 weeks

• PrEP Uptake at Week 24

  24 weeks

Study Arms (1)

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.

Behavioral: PrEP Education and option to accept a PrEP prescription

Interventions

PrEP Education and option to accept a PrEP prescription 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).

Women who inject drugs who are eligible for PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample to be recruited from a syringe exchange program.

You may qualify if:

• HIV sero-negative
• Females
• Age ≥18 years
• Reporting non-prescription injection drug use and any of the following:
• Syringe sharing
• Injecting drugs with a HIV-positive partner
• Recent opioid agonist treatment but still injecting drugs
• Sex exchange
• Inconsistent condom use
• Recent bacterial sexually transmitted infection (STI)
• and/or sex with a HIV-positive partner

You may not qualify if:

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

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University Dornsife School of Public Health

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Alexis Roth, PhD, MPH
• Organization: Drexel University

alexisroth@drexel.edu

267.359.6123

Study Officials

• Alexis M Roth, PhD, MPH

  Drexel University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 9, 2017
• Study Start: April 3, 2018
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: July 12, 2023
• Results First Posted: July 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)