Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs (TIARAS)
HIV Infections, Opioid Use, Trauma, Psychological
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
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
Experimental
Placebo Comparator
Expressive Writing + Contingency Management
Neutral 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.
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.