TIARAS: Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

Sponsor

Drexel University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05192434

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

360

Enrollment

Location

Arms

38.9

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of TIARAS is to understand whether addressing trauma in the context of economic insecurity can produce durable reductions in HIV risk among women who inject drugs.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Opioid Use Trauma, Psychological	Behavioral: Expressive Writing Behavioral: Contingency Management	N/A

Detailed Description

TIARAS is a multi-component behavioral intervention designed to reduce HIV acquisition risk among women who inject drugs. All participants will receive contingency management, an evidenced-based intervention to reduce drug use and HIV risk will be utilized to incentivize daily directly observed pre-exposure prophylaxis doses doses and stimulant/opioid abstinence. Half of the participants will be randomized to receive expressive writing exercises, and evidenced-based intervention that addresses trauma while the other half will complete neutral writing exercises. During the course of twelve months, we will use surveys, interviews, and biological specimen collection to understand whether expressive writing can boost and extend the effects of contingency management for PrEP and stimulant/opioid abstinence on HIV acquisition risk among women who inject drugs.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 360 WWID who initiate PrEP. After a run-in period, participants will be randomized to either: 1) EW+CM (n=180); or 2) Neutral Writing+CM (n=180).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 360 WWID who initiate PrEP. After a run-in period, participants will be randomized to either: 1) EW+CM (n=180); or 2) Neutral Writing+CM (n=180).

Masking:

Single (Investigator)

Masking Description:

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).

Primary Purpose:

Prevention

Official Title:

Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs

Actual Study Start Date :

Jun 6, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Expressive Writing + Contingency Management A total of 180 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 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. Behavioral: Contingency Management 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.
Placebo Comparator: Neutral Writing + Contingency Management A total of 180 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 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.

Arm

Intervention/Treatment

Experimental: Expressive Writing + Contingency Management

A total of 180 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

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.

Behavioral: Contingency Management

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.

Placebo Comparator: Neutral Writing + Contingency Management

A total of 180 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

Outcome Measures

Primary Outcome Measures

HIV Acquisition Risk [Participant duration (1 year)]
HIV acquisition risk will be a composite of two measures of HIV risk: biologically confirmed PrEP non-adherence and at least one reported behavioral risk factor (either syringe sharing or condomless sex). Adherence will be measured by testing drug levels in scalp hair. Specimen will be tested using liquid chromatography/tandem mass spectrometry to quantify TFV levels. In primary analysis, any level ≥ 0.025/ng, consistent with ≥ 6 doses per week, will be considered adherent. Levels below this threshold will be considered non-adherent.

Secondary Outcome Measures

PrEP Persistence [Participation duration (1 year)]
PrEP persistence will be calculated as having PrEP appointments as well as days of coverage and medication possession ratios over the follow-up period.
Drug Abstinence [Participation duration (1 year)]
Drug abstinence will be defined using urine drug screens that do not screen positive for illicit stimulants/opioids.
Referrals for Drug Treatment [Participation duration (1 year)]
Referrals for drug treatment will be calculated from the number of participants requesting linkage.
Reductions in Drug Use [Participation duration (1 year)]
Reductions in drug use will be calculated from self-reports for each drug by route of administration.
Cost effectiveness [Participation duration (1 year)]
Cost effectiveness will be done using a micro-costing approach. Cost offsets will be collected using the Non-Study Medical and Other Services (NMOS) assessment tool along with the Patient Reported Outcomes Measurement Information System (PROMIS PROPr) assessment tool to determine QUALYs. Cost data collection and analysis will be informed by the Drug Abuse Treatment Cost Analysis Program (DATCAP), a standardized costing tool used in hundreds of clinical trials in past 3 decades.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 within 30 days. For injectable PrEP, they will be considered new if they have received a prescription but have not had their first injection. or NON-ADHERENT DAILY ORAL PrEP PATIENT: initiated PrEP at Prevention Point Philadelphia 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 but is outside of the window to receive their next injection (verified in participant's electronic medical record)

Exclusion Criteria:

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.