Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

Launched by DREXEL UNIVERSITY · Jan 5, 2022

Keywords

ClinConnect Summary

This clinical trial, called "TIARAS," aims to find out if a special program can help reduce the risk of HIV among women who inject drugs. The program includes support for managing trauma and encourages healthy behaviors, like staying on a medication called PrEP, which helps prevent HIV. Women eligible for the study must be HIV-negative, at least 18 years old, and have recently been prescribed PrEP at a local harm reduction agency in Philadelphia. They should also have a history of using injection drugs in the past six months.

Participants will take part in the study for 12 months. In the first three months, they will either write about past traumatic experiences or do neutral writing, while also receiving support to reduce drug use and improve their adherence to PrEP. Throughout the study, researchers will gather information from surveys, interviews, and health tests to see if the program helps lower the risk of HIV and how long those benefits might last. This trial is important because it focuses on understanding how to better support women in staying healthy and reducing their risk of HIV.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • a) HIV-negative cisgender female, b) age ≥ 18 years, c) speaks/reads English d) reporting past 6 months day non-prescription injection drug use and any of the following: NEW PrEP PATIENT: prescribed daily oral or injectable PrEP at Prevention Point Philadelphia or Courage Medicine within 30 days. For injectable PrEP, they will be considered new if they have received a prescription but are within two weeks of receiving their first injection. or NON-ADHERENT DAILY ORAL PrEP PATIENT: initiated PrEP at Prevention Point Philadelphia or Courage Medicine 30 or more days ago who reports any non-adherence or reports consistent adherence but has PrEP-related drug levels indicating non-adherence (verified with urine-based tenofovir testing) or NON-ADHERENT INJECTABLE PrEP PATIENT: initiated injectable PrEP at Prevention Point Philadelphia or Courage Medicine but is 8 or more days late to receive their next injection (verified in participant's electronic medical record)
• Exclusion Criteria:
• • a) Unable to provide informed consent; b); unwilling or unable to return to the SSP daily for the next 90 days; c) unwilling to provide specimen for PrEP-related clinical monitoring and adherence monitoring; d) pregnant.