Trauma intervention to improve HIV prevention for women who inject drugs
Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs
This study is testing a new program to see if helping women who inject drugs deal with trauma can lower their chances of getting HIV while also encouraging them to stick to their medication and avoid drug use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Drexel University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05192434 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a trauma intervention called TIARAS in reducing the risk of HIV acquisition among women who inject drugs (WWID). Participants will engage in a 12-month program that includes contingency management to encourage adherence to pre-exposure prophylaxis (PrEP) and abstinence from drug use. The study will randomly assign participants to receive either the trauma intervention combined with contingency management or an attention-control condition. The trial will assess both immediate and lasting effects of the intervention on HIV risk reduction.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-negative cisgender women aged 18 and older who have a history of non-prescription injection drug use and are either new or non-adherent PrEP patients.
Not a fit: Patients who are not women who inject drugs or those who are already adherent to PrEP may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly lower the risk of HIV among women who inject drugs, improving their overall health outcomes.
How similar studies have performed: Previous studies have shown success with similar trauma-informed approaches in HIV prevention, indicating potential for this intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Prevention Point Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Alexis M Roth, PhD, MPH — Drexel University
- Study coordinator: Alexis M Roth, PhD, MPH
- Email: amr395@drexel.edu
- Phone: 317-213-3960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.