Packaging PrEP to Prevent HIV Among WWID

HIV/AIDS Clinical Trial

Official title:

Packaging Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Transmission Among Women Who Inject Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304912
• Other study ID #: 1R21DA043417-01A1
• Status: Completed
• Start date: April 3, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: June 2023
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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).

Locations

Country	Name	City	State
United States	Drexel University Dornsife School of Public Health	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PrEP Uptake at Week 12	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.	12 weeks
Secondary	PrEP Adherence Based on Urinalysis at 12 Weeks	Protection effective emtricitabine (FTC) concentration (>1000 ng/ml) in urine. Analyzed only among women with available urine-analysis data that self-reported PrEP use at 12 weeks	12 weeks
Secondary	PrEP Adherence Based on Self-report at 12 Weeks	Self-reported adherence was assessed with a single item administered on a computer assisted self-interview. The item, "How many PrEP pills have you missed in the past 7 days?," had numerical response options ranging from zero to seven. Responses were recoded into: took zero doses within 7 days (operationalized as non-adherent), took 1-5 doses within 7 days defined as inconsistent operationalized), and took 6-7 doses within 7 days (operationalized as consistent adherence).	12 weeks
Secondary	PrEP Uptake at Week 24	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.	24 weeks