Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

NCT05192434 | Active Not Recruiting DMC

• 2 other identifiers: 2105008584R01DA054543
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible for this study, participants must have been prescribed pre-exposure prophylaxis (PrEP), a medication taken to prevent HIV, at Prevention Point Philadelphia, a large harm reduction agency located in Philadelphia (PA, USA), or Courage Medicine, a nonprofit health services clinic located in Philadelphia (PA, USA). Enrollment in this study lasts for 12-months so that we can see if TIARAS reduces HIV risk immediately after the intervention ends and whether these effects last over time. During the first 3 months, participants engage in contingency management (CM), an evidenced-based intervention to reduce drug use and HIV risk. We will use CM to encourage engagement in PrEP care as well as stimulant/opioid abstinence. Also during the first 3-months, participants are randomly assigned to complete expressive writing exercises to address a previously undisclosed trauma or neutral writing exercises. Half of the participants will be assigned to the trauma writing group and the other half will be assigned to the neutral writing group. To understand the impact of TIARAS on HIV risk, we will collect and analyze data from surveys, interviews, and biological specimen during the 12-month study period. Our main questions are:

• Does participation in TIARAS reduce HIV risk among WWID?
• If observed, how long do beneficial effects last?
• How and why do WWID experience benefits from TIARAS?

Conditions

HIV Infections; Opioid Use; Trauma, Psychological

Keywords

PrEP; Preexposure Prophylaxis; WWID; Women who inject drugs

Outcome Measures

Primary Outcomes (1)

• HIV Acquisition Risk

  Our primary outcome will be a composite of two measures: self-reported behavioral HIV risk (syringe sharing or condomless sex) and objectively measured adherence to PrEP. To assess PrEP adherence in women initiating daily oral Tenofovir-based (TFV) PrEP products, we will collect scalp hair at baseline, 3, 6, and 12 months. Specimens will be tested using liquid chromatography/tandem mass spectrometry to quantify TFV concentrations levels. In primary analysis, and TFV level \>/= 0.025.ng, consistent with \>/= 6 doses per week, will be considered adherent. To assess PrEP adherence in women initiating cabotegravir PrEP products, we will extract the dates of LAI-CAB injections from participants' electronic medical records and will determine whether each follow-up LAI-CAB injection occurred within recommended dosing windows according to Apretude prescribing information (+/- 7 days). In primary analysis, any injection occurring within the recommended dosing window will be considered adherent.

  Participant duration (1 year)

Secondary Outcomes (6)

• Reductions in Drug Use

  Participation duration (1 year)

• Drug Abstinence

  Participation duration (1 year)

• Referrals for Drug Treatment

  Participation duration (1 year)

• Depression

  Participation duration (1 year)

• PTSD Symptoms

  Participation duration (1 year)

Study Arms (2)

Expressive Writing + Contingency Management

EXPERIMENTAL

A total of 120 WWID will be randomly assigned to the EW+CM (expressive writing + contingency management) intervention arm. To begin each session, participants will complete a brief battery of psychological measures. Then, in a private setting, they will be asked to write for 20 minutes about a major trauma that occurred three or more months in the past. WWID who prefer not to write (e.g., have lower literacy) will be provided the opportunity to talk aloud about the traumatic experience while being audio recorded, which yields comparable effects to writing. Next, women will respond to a prompt that encourages cognitive processing of the trauma for ten additional minutes. To complete the session, participants will answer the same brief battery of psychological measures for the purposes of identifying acute distress. Those exhibiting clinically elevated distress symptoms will engage in a brief de-escalation and evaluation session with study staff who will be trained.

Behavioral: Expressive Writing; Behavioral: Contingency Management

Neutral Writing + Contingency Management

PLACEBO COMPARATOR

A total of 120 WWID will be randomly assigned to the attention-control arm which includes neutral writing + CM. Women in this group will complete the same pre/post psychological measures as the intervention group for the purposes of time matching. During the writing session, they will be asked to describe their schedule from the preceding day as if they were reporting facts, without discussing personal thoughts and feelings (e.g., describe what you did from the time you got up until the time you went to bed). Those with lower literacy can opt to talk aloud while being audio recorded. This is the same attention-control used our previous work which balances contact time and study incentives.

Behavioral: Contingency Management

Interventions

Expressive Writing BEHAVIORAL

Expressive writing (EW) is a safe, acceptable, and effective intervention for improving psychological adjustment. Via brief directed writing sessions, EW facilitates disclosure of traumatic events. At a basic level, emotional expression and disclosure are important because they reduce the need to unconsciously direct psychological energy towards suppressing emotions from traumatic events.

Expressive Writing + Contingency Management

Contingency Management BEHAVIORAL

Contingency management (CM) is a proven strategy to reduce drug use and HIV risk behavior. Also known as a conditional cash transfer, CM reinforces positive behavior with tangible rewards. In the context of substance use treatment, monetary incentives are typically used to reinforce drug-negative urine specimens.

Expressive Writing + Contingency Management; Neutral Writing + Contingency Management

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender females eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Prevention Point Philadelphia

Philadelphia, Pennsylvania, 19143, United States

Location

Related Publications (13)

• Plotzker RE, Metzger DS, Holmes WC. Childhood sexual and physical abuse histories, PTSD, depression, and HIV risk outcomes in women injection drug users: a potential mediating pathway. Am J Addict. 2007 Nov-Dec;16(6):431-8. doi: 10.1080/10550490701643161.

  PMID: 18058406 BACKGROUND

• Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. doi: 10.1111/j.1360-0443.2006.01581.x.

  PMID: 17034434 BACKGROUND

• Haug NA, Sorensen JL. Contingency management interventions for HIV-related behaviors. Curr HIV/AIDS Rep. 2006 Nov;3(4):154-9. doi: 10.1007/s11904-006-0010-5.

  PMID: 17032574 BACKGROUND

• Rosen MI, Dieckhaus K, McMahon TJ, Valdes B, Petry NM, Cramer J, Rounsaville B. Improved adherence with contingency management. AIDS Patient Care STDS. 2007 Jan;21(1):30-40. doi: 10.1089/apc.2006.0028.

  PMID: 17263651 BACKGROUND

• Carrico AW, Nation A, Gomez W, Sundberg J, Dilworth SE, Johnson MO, Moskowitz JT, Rose CD. Pilot trial of an expressive writing intervention with HIV-positive methamphetamine-using men who have sex with men. Psychol Addict Behav. 2015 Jun;29(2):277-82. doi: 10.1037/adb0000031. Epub 2014 Dec 1.

  PMID: 25437153 BACKGROUND

• Baikie KA, Wilhelm K, Johnson B, Boskovic M, Wedgwood L, Finch A, Huon G. Expressive writing for high-risk drug dependent patients in a primary care clinic: a pilot study. Harm Reduct J. 2006 Nov 19;3:34. doi: 10.1186/1477-7517-3-34.

  PMID: 17112389 BACKGROUND

• Meshberg-Cohen S, Svikis D, McMahon TJ. Expressive writing as a therapeutic process for drug-dependent women. Subst Abus. 2014;35(1):80-8. doi: 10.1080/08897077.2013.805181.

  PMID: 24588298 BACKGROUND

• Koopman C, Ismailji T, Holmes D, Classen CC, Palesh O, Wales T. The effects of expressive writing on pain, depression and posttraumatic stress disorder symptoms in survivors of intimate partner violence. J Health Psychol. 2005 Mar;10(2):211-21. doi: 10.1177/1359105305049769.

  PMID: 15723891 BACKGROUND

• Ironson G, Bira L, Hylton E. Positive and negative emotional expression measured from a single written essay about trauma predicts survival 17 years later in people living with HIV. J Psychosom Res. 2020 Sep;136:110166. doi: 10.1016/j.jpsychores.2020.110166. Epub 2020 Jun 9.

  PMID: 32559504 BACKGROUND

• O'Cleirigh C, Ironson G, Antoni M, Fletcher MA, McGuffey L, Balbin E, Schneiderman N, Solomon G. Emotional expression and depth processing of trauma and their relation to long-term survival in patients with HIV/AIDS. J Psychosom Res. 2003 Mar;54(3):225-35. doi: 10.1016/s0022-3999(02)00524-x.

  PMID: 12614832 BACKGROUND

• Ironson G, O'Cleirigh C, Leserman J, Stuetzle R, Fordiani J, Fletcher M, Schneiderman N. Gender-specific effects of an augmented written emotional disclosure intervention on posttraumatic, depressive, and HIV-disease-related outcomes: a randomized, controlled trial. J Consult Clin Psychol. 2013 Apr;81(2):284-98. doi: 10.1037/a0030814. Epub 2012 Dec 17.

  PMID: 23244367 BACKGROUND

• Roth AM, Bartholomew TS, Ward KM, Groves A, Mazzella S, Bellamy S, Amico KR, Carrico AW, Ironson G, Krakower D. Preferential Initiation of Long-Acting Injectable Versus Oral HIV Pre-Exposure Prophylaxis Among Women Who Inject Drugs. Clin Infect Dis. 2025 Mar 17;80(3):621-625. doi: 10.1093/cid/ciae450.

  PMID: 39347705 RESULT

• Ward KM, Carrico AW, Vader D, Moore RH, Amico KR, Groves AK, Bellamy SL, Sherman SG, Krakower D, Mazzella S, Roth AM. Implementation of contingency management with women engaging in polysubstance use. Addict Sci Clin Pract. 2025 Aug 8;20(1):63. doi: 10.1186/s13722-025-00590-x.

  PMID: 40781335 DERIVED

MeSH Terms

Conditions

HIV Infections; Psychological Trauma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alexis M Roth, PhD, MPH

  Drexel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Study personnel who administer survey assessments will be blinded to study participants' assignment to the expressive writing group (treatment) or the neutral writing group (control).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Our concurrent nested mixed methods RCT will test the efficacy of addressing trauma as a potent trigger of substance use and psychological comorbidity through Expressive Writing (EW) among WWID receiving Contingency Management (CM). We will enroll 240 WWID who initiate PrEP. After a run-in period, participants will be randomized to either: 1) EW+CM (n=120); or 2) Neutral Writing+CM (n=120).

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 14, 2022
• Study Start: June 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)