ASK-PrEP (Assistance Services Knowledge-PrEP)

NCT05934877 | Terminated DMC

• 1 other identifier: R01DA056888
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

ASK-PrEP is a two-arm randomized controlled trial (RCT), with a Stepped Care approach, among HIV-negative trans women and men who have sex with men with a substance use disorder (SUD). Participants will be randomized (3:1) to the ASK-PrEP Stepped Care arm or Standard of Care (SOC). Participants in the ASK-PrEP Stepped Care arm will receive 5 PrEP navigation sessions, with weekly text-messaging support, delivered over 3 months, at which point they will be assessed for intervention response. Responders will be maintained for an additional 3 months in ASK-PrEP to receive an additional 5 PrEP navigation session with weekly text-messaging support, while non-responders will receive added attention to their SUD via contingency management (CM). Non-responders will be re-randomized (1:1) to either a) receive ASK-PrEP + CM, or b) shift the primary focus to their SUD (CM alone) for an additional 3 months.

Conditions

Substance Use Disorders; HIV

Keywords

PrEP; HIV; MSM; transgender women; substance use disorder

Outcome Measures

Primary Outcomes (3)

• Rate of PrEP Persistence

  For those who initiate oral-daily PrEP, persistence is defined as a co-occurrence of ≥700fmol/punch and ongoing (i.e., minimum one every 3 months) confirmed PrEP care medical visits. At each time point, those who do not initiate PrEP, fail to attend a PrEP medical care visit in a given quarter, and/or evidence a Dried Blood Spot (DBS) of \<700 fmol/punch are coded "non-persistent;" participants who initiate PrEP, attend quarterly medical visits, and evidence a DBS ≥700 fmol/punch will be coded "PrEP persistent." For those who initiate long-acting injectable PrEP, persistence is defined as verified documentation of a Cabotegravir injection every 2 months. Participants that discontinue PrEP due to elimination of their illicit drug use and HIV sexual risk behaviors will be categorized as persistent.

  12 months

• Cost-effectiveness

  The primary outcome of the cost-effectiveness analysis is the incremental cost-effectiveness ratio (ICER), which will be calculated as the incremental mean cost of a given intervention relative to an alternative, divided by the incremental mean effectiveness of the two interventions. The primary measure of effectiveness for the economic evaluation will be the quality-adjusted life-year (QALY). The QALY is a measure that combines the health-related quality-of-life (HRQoL) associated with an individual's health state and their time spent in that state. All measures of mean cost and effectiveness will be adjusted for important covariates.

  12 months

• Average Cumulative Days of Substance Use

  The primary substance use outcome is cumulative days of the identified illicit substance use measured via timeline follow-back (TLFB), not contraindicated by urine drug screen results. Missing urine drug screens will be treated as positive. Treatment effects will be quantified in terms of the difference in average cumulative days of the identified substance use at 3-, 6-, 9-, and 12-month follow-up visits.

  12 months

Secondary Outcomes (1)

• Effects of substances, route of administration, severity of SUD, social and structural determinants of health, and differing individual-level characteristics as moderators.

  12 months

Study Arms (2)

ASK-PrEP

EXPERIMENTAL

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.

Behavioral: PrEP navigation + text messaging; Behavioral: Contingency Management

Education and Information

EXPERIMENTAL

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.

Behavioral: Standard of Care

Interventions

PrEP navigation + text messaging BEHAVIORAL

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.

ASK-PrEP

Standard of Care BEHAVIORAL

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.

Education and Information

Contingency Management BEHAVIORAL

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.

ASK-PrEP

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified as trans woman or trans feminine, trans masculine individuals who have a sexual identity of either gay or bisexual and identify as a man who has sex with men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identified transgender woman or MSM
• ≥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).

You may not qualify if:

• does not identify as a trans woman or male who has sex with men
• 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;

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• Weill Medical College of Cornell University: collaborator
• University of California, Los Angeles: collaborator
• Emory University: collaborator

Study Sites (1)

Friends Community Center

Los Angeles, California, 90038, United States

Location

Related Publications (1)

• 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.

  PMID: 39521970 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Cathy J Reback, PhD

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

• Sean M Murphy, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two randomly assigned arms (3:1) into ASK-PrEP Stepped Care (PrEP navigation) or Standard of Care (SOC).

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 7, 2023
• Study Start: May 11, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: February 11, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)