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Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs (TIARAS)

Primary Purpose

HIV Infections, Opioid Use, Trauma, Psychological

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive Writing
Contingency Management
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring PrEP, Preexposure Prophylaxis, WWID, Women who inject drugs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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:

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.

Sites / Locations

  • Prevention Point PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Expressive Writing + Contingency Management

Neutral Writing + Contingency Management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reductions in Drug Use
At each study visit, participants will complete The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), which assesses lifetime and recent (past 90 day) drug use. We will describe recent substance use and determine whether there are clinically meaningful decreases in illicit stimulant and/or opioid use over time.
Drug Abstinence
Participants will provide urine samples for oon-site toxicology screening of methamphetamine, cocaine, and opioid metabolites. Reactive urine toxicology results are indicative of stimulant/opioid use within the past 72 hours. Results of urine drug screens will be extracted from electronic medical records.
Referrals for Drug Treatment
Participant requests for a referral for drug treatment will be captured during study visits and logged into the study database. To calculate the number of referrals, we will extract data from the study database.
Depression
We will use the Beck Depression Inventory (BDI). This validated 21 item scale has a score range of 0 to 63. A cutoff score of 19 will be used to classify moderate/severe depressive symptoms.
PTSD Symptoms
We will use the PTSD checklist from DSM 5 (PCL-5). This is a 20 item validated scale with a score range 0 to 80. This generates 5 sub-scales symptom scores, which will be assessed for particular patterns of symptomology. A total cutoff score ≥ 33 will be used to classify moderate/severe PTSD.
Cost effectiveness
Cost effectiveness will be estimated 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 over the past 3 decades.

Full Information

First Posted
January 5, 2022
Last Updated
April 25, 2023
Sponsor
Drexel University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05192434
Brief Title
Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs
Acronym
TIARAS
Official Title
Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 for Prevention Point Philadelphia, a large harm reduction agency 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?
Detailed Description
In the United States, recent outbreaks coast-to-coast forewarn of a possible resurgence of HIV, especially among women who inject drugs (WWID), particularly if access, uptake, and adherence to effective harm reduction tools remain sub-optimal. Pre-exposure prophylaxis (PrEP) is a user-driven method that safely and effectively prevents HIV. While we have shown that cisgender WWID consider PrEP beneficial and are willing to accept a prescription, consistent with the well-known SAVA syndemic framework, social stigma, economic insecurity, traumatic experiences (or the threat of violence), and drug use greatly undermined their agency to prioritize and adhere to PrEP. This trauma-informed randomized control trial (RCT) will address the urgent need for HIV prevention interventions, informed by the SAVA framework, that produce durable reductions in HIV risk among WWID. We will integrate contingency management (CM), a proven strategy to reduce drug use and HIV risk, and expressive writing (EW), a safe and effective approach for addressing trauma symptoms, in order to test whether EW delivered during CM (EW+CM) produces durable reductions in HIV acquisition risk compared to an attention-control condition. We will leverage our longstanding partnership with Prevention Point Philadelphia (PPP), the largest syringe exchange in the mid-Atlantic, to recruit 360 WWID who will (re)initiate PrEP at PPP. Once enrolled they will immediately begin a 3-month CM period that provides incentives for directly observed daily oral PrEP doses or confirmed injectable PrEP doses, stimulant/opioid abstinence (measured thrice weekly through urine screening), and completion of four writing sessions. After a run-in period, WWID will be randomized to either EW+CM (n=180) or Neutral Writing+CM (n=180). Follow-up assessments will occur at 3-, 6-, and 12-months post-randomization and will include objective measures of PrEP adherence over time. A subset of WWID from both arms will complete qualitative interviews at 3- and 12-months. All study activities and daily PrEP dispensing will occur at PPP. The specific aims are to: (1) Determine the efficacy of EW+CM for improving the proportion of participants achieving reductions in HIV acquisition risk (operationalized as the proportion of WWID reporting syringe sharing or condomless sex during objectively measured periods of PrEP non-adherence) at 12 months. (2) Examine key secondary outcomes such as greater PrEP persistence, reductions in substance use, PTSD symptoms, and depression, as well as entry into drug treatment over 12 months. (3) Evaluate the pathways through which the intervention operates using qualitative interviews, mediation analysis (e.g., emotional expression and processing in EW essays), and moderation analysis (e.g., more pronounced among those with higher PTSD severity at baseline). This RCT could have an exceptional impact by yielding one of the first evidence-based interventions to address HIV acquisition risk in the era of PrEP among WWID.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Opioid Use, Trauma, Psychological
Keywords
PrEP, Preexposure Prophylaxis, WWID, Women who inject drugs

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
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).
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expressive Writing + Contingency Management
Arm Type
Experimental
Arm Description
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.
Arm Title
Neutral Writing + Contingency Management
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV Acquisition Risk
Description
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.
Time Frame
Participant duration (1 year)
Secondary Outcome Measure Information:
Title
Reductions in Drug Use
Description
At each study visit, participants will complete The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), which assesses lifetime and recent (past 90 day) drug use. We will describe recent substance use and determine whether there are clinically meaningful decreases in illicit stimulant and/or opioid use over time.
Time Frame
Participation duration (1 year)
Title
Drug Abstinence
Description
Participants will provide urine samples for oon-site toxicology screening of methamphetamine, cocaine, and opioid metabolites. Reactive urine toxicology results are indicative of stimulant/opioid use within the past 72 hours. Results of urine drug screens will be extracted from electronic medical records.
Time Frame
Participation duration (1 year)
Title
Referrals for Drug Treatment
Description
Participant requests for a referral for drug treatment will be captured during study visits and logged into the study database. To calculate the number of referrals, we will extract data from the study database.
Time Frame
Participation duration (1 year)
Title
Depression
Description
We will use the Beck Depression Inventory (BDI). This validated 21 item scale has a score range of 0 to 63. A cutoff score of 19 will be used to classify moderate/severe depressive symptoms.
Time Frame
Participation duration (1 year)
Title
PTSD Symptoms
Description
We will use the PTSD checklist from DSM 5 (PCL-5). This is a 20 item validated scale with a score range 0 to 80. This generates 5 sub-scales symptom scores, which will be assessed for particular patterns of symptomology. A total cutoff score ≥ 33 will be used to classify moderate/severe PTSD.
Time Frame
Participation duration (1 year)
Title
Cost effectiveness
Description
Cost effectiveness will be estimated 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 over the past 3 decades.
Time Frame
Participation duration (1 year)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Cisgender females eligible
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis M Roth, PhD, MPH
Phone
317-213-3960
Email
amr395@drexel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Ward, MSPH, CHES
Phone
201.707.6747
Email
kmw444@drexel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis M Roth, PhD, MPH
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prevention Point Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Jessop, MD
Phone
610-220-7473
Email
amy@ppponline.org
First Name & Middle Initial & Last Name & Degree
Rachel Holbert, MPH
Phone
215.510.3599
Email
rholbert@ppponline.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18058406
Citation
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.
Results Reference
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PubMed Identifier
17034434
Citation
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Results Reference
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PubMed Identifier
17032574
Citation
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.
Results Reference
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PubMed Identifier
17263651
Citation
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.
Results Reference
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PubMed Identifier
25437153
Citation
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.
Results Reference
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PubMed Identifier
17112389
Citation
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Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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.
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Citation
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.
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Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs

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