ASK-PrEP (Assistance Services Knowledge-PrEP)

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Weill Medical College of Cornell University

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Emory University

  collaborator OTHER

• Friends Research Institute, Inc.

  lead OTHER

Principal Investigators

• Cathy J Reback, PhD · Friends Research Institute, Inc.

• Sean M Murphy, PhD · Weill Medical College of Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-11

Primary Completion

2025-03-19

Completion

2025-03-19

Countries

• United States

Study Locations