Study Results
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Basic Information
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RECRUITING
NA
152 participants
INTERVENTIONAL
2023-05-11
2026-07-30
Brief Summary
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Detailed Description
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ASK-PrEP is a PrEP navigation intervention with text-messaging support. The navigation component is based on mechanisms of the Reasoned Action Approach (RAA), and the text-messaging support component is based on Social Support Theory (SST). In Session 1, the PrEP navigator uses the Needs and Barriers Assessment (NBA) to identify needs and barriers to PrEP care, including substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. PrEP (Truvada, Descovy, Cabotegravir) and clinic options are discussed. Per current state-of-the-field recommendations, participants are guided to receive same-day PrEP linkage to their chosen clinic, with the goal of PrEP initiation within the first week of enrollment. In Sessions 2-5, PrEP navigators use the information from the NBA to help the participant overcome barriers to PrEP adherence, and work with participants to address their SUD and need for additional auxiliary services. A shorter version of the NBA (NBA-Lite) is administered at the beginning of Sessions 2-5 as a check-in, and to assess progress through the PrEP Care Continuum; client-centered treatment plans are reviewed and revised as needed. In the ASK-PrEP sessions, client-centered dialogical strategies premised on RAA: 1) identify barriers to PrEP, including substance use; 2) identify participants' readiness to address their SUD and link into other auxiliary needed services; and 3) increase participants' skills and self-efficacy in working with PrEP providers and other social service and treatment facilities. Using a client-centered approach, the PrEP navigator works to link participants into SUD treatment and other ancillary behavioral health and support services, according to their unique barriers, with the ultimate goal of PrEP initiation, adherence, and persistence; services may include mental healthcare, counseling for intimate partner violence, food insecurity, housing instability, hormone therapy. Discussions of PrEP adherence, reductions in substance use and/or substance use treatment, and other behavioral health concerns are discussed throughout the 5 sessions. A key feature of the study is the tailoring of PrEP navigation and text-messaging support to TW/MSM with a SUD.
The text-messaging support component of ASK-PrEP is based in SST. One PrEP support text message is transmitted weekly on Wednesday afternoon between 3:00 - 6:00, participants may choose to have the text messages delivered via cell phone or email. To maintain interest and enthusiasm for the intervention, participants receive TW- or MSM-specific messages, and never receive the same message twice.
Contingency Management is based on behavioral economics. Non-responders are stepped and re-randomized to CM, either in concert with ASK-PrEP, or alone. At the first CM session, a RA provides a 15-minute orientation to the CM procedures, which includes an explanation of the progressive contingency schedule. Thereafter, participants meet with the RA thrice weekly to provide a urine sample. Participants receive a voucher-based escalating reinforcement schedule. Successive urine samples that are nonreactive for the metabolites of their identified SUD will escalate their voucher point value. Each three consecutive nonreactive urine samples will receive bonus voucher points. A reactive urine sample will place the participant at the initial voucher point value; however, a rapid reset procedure allows participants to return to their place in the escalating schedule following three consecutive nonreactive urine samples. Voucher points can be redeemed at any time during the study for goods or services that promote a pro-social and healthy lifestyle.
Participants stepped and re-randomized into ASK-PrEP+CM receive the same ASK-PrEP and CM interventions (described above), but in concert to increase intensity and address both SUD and PrEP initiation, adherence and persistence.
The Standard of Care (SOC) arm provides PrEP education, information, and referrals. Those randomized to the SOC arm will receive an approximate 20-30-minute educational session on PrEP, and will be given a PrEP pamphlet and list of clinics that provide PrEP in Los Angeles County (LAC). The same educational session will be repeated following the 3-month follow-up assessment visit.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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ASK-PrEP
ASK-PrEP is a 5-session PrEP navigation intervention, with text-messaging support, to advance through the PrEP Care Continuum by identifying the individual needs and barriers to PrEP care, including substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence.
Intervention/treatment: PrEP navigation + text messaging Participants receive 5 PrEP navigation sessions within 3 months plus a weekly culturally specific, scripted text message. Participants that do not respond to the ASK-PrEP intervention at the 3-month assessment are re-randomized (1:1) and stepped up to receive ASK-PrEP plus CM or CM alone.
PrEP navigation + text messaging
Using a client-centered approach, the PrEP navigator works to link participants into SUD treatment and other ancillary behavioral health and support services, according to their unique barriers, with the ultimate goal of PrEP initiation, adherence, and persistence; services may include mental healthcare, counseling for intimate partner violence, food insecurity, housing instability, hormone therapy. Text-messaging support includes once weekly text message.
Contingency Management
Non-responders in the ASK-PrEP arm will be stepped and re-randomized (1:1) to Contingency Management (CM), either in concert with ASK-PrEP or alone. CM is a progressive contingency schedule. Participants submit a thrice weekly urine sample. Participants will receive a voucher-based escalating reinforcement schedule. Successive urine samples that are nonreactive for the metabolites of their identified SUD will escalate their voucher point value. Each three consecutive nonreactive urine samples will receive bonus voucher points. A reactive urine sample will place the participant at the initial voucher point value; however, a rapid reset procedure allows participants to return to their place in the escalating schedule following three consecutive nonreactive urine samples. Voucher points can be redeemed at any time during the study for goods or services that promote a pro-social and healthy lifestyle.
Education and Information
The Standard of Care (SOC) intervention includes a 20-30-minute session of PrEP information and where to access PrEP in Los Angeles. The same session is repeated at the 3-month assessment.
Participants randomized to the SOC arm receive 2 educational/informational sessions on PrEP misconceptions, uptake, and adherence. The sessions occur at baseline and the 3-month assessment.
Standard of Care
The SOC arm provides PrEP education, information, and referrals. Those randomized to the SOC arm receive an approximate 20-30-minute educational session on PrEP, and will be given a PrEP pamphlet and list of clinics that provide PrEP in LAC.
Interventions
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PrEP navigation + text messaging
Using a client-centered approach, the PrEP navigator works to link participants into SUD treatment and other ancillary behavioral health and support services, according to their unique barriers, with the ultimate goal of PrEP initiation, adherence, and persistence; services may include mental healthcare, counseling for intimate partner violence, food insecurity, housing instability, hormone therapy. Text-messaging support includes once weekly text message.
Standard of Care
The SOC arm provides PrEP education, information, and referrals. Those randomized to the SOC arm receive an approximate 20-30-minute educational session on PrEP, and will be given a PrEP pamphlet and list of clinics that provide PrEP in LAC.
Contingency Management
Non-responders in the ASK-PrEP arm will be stepped and re-randomized (1:1) to Contingency Management (CM), either in concert with ASK-PrEP or alone. CM is a progressive contingency schedule. Participants submit a thrice weekly urine sample. Participants will receive a voucher-based escalating reinforcement schedule. Successive urine samples that are nonreactive for the metabolites of their identified SUD will escalate their voucher point value. Each three consecutive nonreactive urine samples will receive bonus voucher points. A reactive urine sample will place the participant at the initial voucher point value; however, a rapid reset procedure allows participants to return to their place in the escalating schedule following three consecutive nonreactive urine samples. Voucher points can be redeemed at any time during the study for goods or services that promote a pro-social and healthy lifestyle.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* verified HIV negative
* identified as high risk for HIV based on the Los Angeles County criteria
* SUD (injection and non-injection; excluding cannabis (CUD) only
For those who have already initiated PrEP there is an additional eligibility criterion:
* non-protective prophylaxis defined as missed ≥4 doses of PrEP/week during any week in the previous 30 days
* no PrEP care visits in the past 3 months
* willing to provide informed consent; and
* willing to comply with study requirements.
Should a participant be identified as having kidney or liver dysfunction sufficient to contraindicate PrEP use (creatinine clearance \<60 mL/min), that individual will be withdrawn from study participation but may re-screen for eligibility once adequate renal and/or liver function has been established and medically documented (≥60 mL/min).
Exclusion Criteria
* under 18 years of age
* HIV positive status
* not identified as high risk for HIV based on the Los Angeles County criteria
* no verified SUD or only CUD
* if already initiated PrEP: PrEP adherent and PrEP care visits in the past 3 months
* unwilling to provide informed consent
* unwilling to comply with study requirements;
18 Years
MALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
University of California, Los Angeles
OTHER
Emory University
OTHER
Friends Research Institute, Inc.
OTHER
Responsible Party
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Principal Investigators
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Cathy J Reback, PhD
Role: PRINCIPAL_INVESTIGATOR
Friends Research Institute, Inc.
Sean M Murphy, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Friends Community Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Reback CJ, Landovitz RJ, Benkeser D, Jalali A, Shoptaw S, Li MJ, Mata RP, Ryan D, Jeng PJ, Murphy SM. Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services Knowledge-PrEP (A.S.K.-PrEP). Addict Sci Clin Pract. 2024 Nov 9;19(1):79. doi: 10.1186/s13722-024-00482-6.
Other Identifiers
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