HIV InfectionsTIARASNCT05192434
Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs
A study testing Expressive Writing and Contingency Management in people with HIV Infections and Opioid Use, run by Drexel University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Opioid Use, Trauma, Psychological
- What is being tested?
- Expressive Writing and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention Point Philadelphia
Philadelphia, Pennsylvania, 19143
About this study
Official title: Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs
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.
Read more
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?
Read the 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 partnership with Prevention Point Philadelphia (PPP), the largest syringe exchange in the mid-Atlantic, and Courage Medicine to recruit 240 WWID who will (re)initiate PrEP at PPP or Courage Medicine. 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=120) or Neutral Writing+CM (n=120). 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.
- Conditions
- HIV Infections, Opioid Use, Trauma, Psychological
- Being tested
- Expressive Writing, Contingency Management
- Keywords
- PrEP, Preexposure Prophylaxis, WWID, Women who inject drugs
- Medical subject headings
- HIV Infections, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
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.
Contingency ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participant duration (1 year)
Secondary outcomes (6)
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.
Measured: Participation duration (1 year)
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.
Measured: Participation duration (1 year)
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.
Measured: Participation duration (1 year)
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.
Measured: Participation duration (1 year)
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.
Measured: Participation duration (1 year)
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.
Measured: Participation duration (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start17 Jun 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Alexis Roth, Drexel University
- Investigators
- Alexis M Roth, PhD, MPH, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192434
- Sponsor's protocol ID
- 2105008584
- Other IDs
- R01DA054543
- Acronym
- TIARAS
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18058406Prendergast 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.
PubMed 17034434Haug 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.
PubMed 17032574Rosen 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.
PubMed 17263651Carrico 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.
PubMed 25437153Baikie 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.
PubMed 17112389Meshberg-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.
PubMed 24588298Koopman 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.
PubMed 15723891Ironson 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.
PubMed 32559504O'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.
PubMed 12614832Ironson 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.
PubMed 23244367Roth 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.
PubMed 39347705Ward 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.
PubMed 40781335
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Trauma Intervention for Affect Regulation, Adherence, and Substance Use to Optimize PrEP for Women Who Inject Drugs
- ClinicalTrials.gov ID
- NCT05192434
- Acronym / sponsor ID
- TIARAS / 2105008584
- Conditions
- HIV Infections, Opioid Use, Trauma, Psychological
- Keywords
- PrEP, Preexposure Prophylaxis, WWID, Women who inject drugs
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 partnership with Prevention Point Philadelphia (PPP), the largest syringe exchange in the mid-Atlantic, and Courage Medicine to recruit 240 WWID who will (re)initiate PrEP at PPP or Courage Medicine. 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=120) or Neutral Writing+CM (n=120). 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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 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).
| Arm | Type | Receives |
|---|---|---|
| Expressive Writing + Contingency Management | Experimental | Behavioral: Expressive Writing, Behavioral: Contingency ManagementA 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. |
| Neutral Writing + Contingency Management | Placebo comparator | Behavioral: Contingency ManagementA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive WritingExpressive 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. | Behavioural | Expressive Writing + Contingency Management |
| Contingency ManagementContingency 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. | Behavioural | Expressive Writing + Contingency Management, Neutral Writing + Contingency Management |
Primary outcome
HIV Acquisition Risk
Time frame: Participant duration (1 year)
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.
6 secondary outcomes
Reductions in Drug Use
Time frame: Participation duration (1 year)
Drug Abstinence
Time frame: Participation duration (1 year)
Referrals for Drug Treatment
Time frame: Participation duration (1 year)
Depression
Time frame: Participation duration (1 year)
PTSD Symptoms
Time frame: Participation duration (1 year)
Cost effectiveness
Time frame: Participation duration (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 18058406Plotzker 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.
- Background: PubMed 17034434Prendergast 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.
- Background: PubMed 17032574Haug 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.
- Background: PubMed 17263651Rosen 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.
- Background: PubMed 25437153Carrico 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.
- Background: PubMed 17112389Baikie 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.
- Background: PubMed 24588298Meshberg-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.
- Background: PubMed 15723891Koopman 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.
- Background: PubMed 32559504Ironson 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.
- Background: PubMed 12614832O'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.
- Background: PubMed 23244367Ironson 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.
- Results publication: PubMed 39347705Roth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis M Roth, PhD, MPH principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing and Contingency Management in people with HIV Infections and Opioid Use, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Acquisition Risk (time frame: Participant duration (1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192434, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.