Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial

BackgroundAlthough pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce sub...

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Main Authors: Leah Davis-Ewart, Christian Grov, Rachel Verhagen, Jennifer Manuel, Michael Viamonte, Samantha Dilworth, Nicole O'Dell, Omar Valentin, Sidney Carr, Emily Cherenack, Chelsea Henderson, Susanne Doblecki-Lewis, Inbal Nahum-Shani, Adam W Carrico
Format: Article
Language:English
Published: JMIR Publications 2023-10-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2023/1/e48459
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author Leah Davis-Ewart
Christian Grov
Rachel Verhagen
Jennifer Manuel
Michael Viamonte
Samantha Dilworth
Nicole O'Dell
Omar Valentin
Sidney Carr
Emily Cherenack
Chelsea Henderson
Susanne Doblecki-Lewis
Inbal Nahum-Shani
Adam W Carrico
author_facet Leah Davis-Ewart
Christian Grov
Rachel Verhagen
Jennifer Manuel
Michael Viamonte
Samantha Dilworth
Nicole O'Dell
Omar Valentin
Sidney Carr
Emily Cherenack
Chelsea Henderson
Susanne Doblecki-Lewis
Inbal Nahum-Shani
Adam W Carrico
author_sort Leah Davis-Ewart
collection DOAJ
description BackgroundAlthough pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. ObjectivePrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. MethodsA national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US $50) and filling a PrEP prescription (US $50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. ResultsImplementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. ConclusionsLessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. Trial RegistrationClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487 International Registered Report Identifier (IRRID)DERR1-10.2196/48459
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spelling doaj.art-ff0a3fb453914d8097ecc180b4a570bb2023-10-13T12:45:41ZengJMIR PublicationsJMIR Research Protocols1929-07482023-10-0112e4845910.2196/48459Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized TrialLeah Davis-Ewarthttps://orcid.org/0000-0002-8143-4630Christian Grovhttps://orcid.org/0000-0001-6871-3531Rachel Verhagenhttps://orcid.org/0009-0001-4721-7480Jennifer Manuelhttps://orcid.org/0000-0001-7457-3408Michael Viamontehttps://orcid.org/0009-0006-1669-7764Samantha Dilworthhttps://orcid.org/0000-0002-5451-5486Nicole O'Dellhttps://orcid.org/0000-0001-7268-2176Omar Valentinhttps://orcid.org/0000-0003-3474-8984Sidney Carrhttps://orcid.org/0009-0004-6886-4654Emily Cherenackhttps://orcid.org/0000-0002-8762-2050Chelsea Hendersonhttps://orcid.org/0009-0004-1356-4531Susanne Doblecki-Lewishttps://orcid.org/0000-0001-6535-6698Inbal Nahum-Shanihttps://orcid.org/0000-0001-6138-9089Adam W Carricohttps://orcid.org/0000-0002-0209-8844 BackgroundAlthough pre-exposure prophylaxis (PrEP) could substantially mitigate HIV risk, sexual minority men who use stimulants commonly experience difficulties with engaging in PrEP clinical services. Motivational interviewing (MI) and contingency management (CM) reduce substance use and condomless anal sex (CAS) in this population, but these motivational enhancement interventions require modifications to promote engagement along the PrEP care continuum. ObjectivePrEP Readiness Interventions for Supporting Motivation (PRISM) is a pilot sequential multiple assignment randomized trial testing the feasibility, acceptability, and preliminary effectiveness of distinct combinations of telehealth MI and CM in 70 cisgender sexual minority men who use stimulants that are not currently taking PrEP. MethodsA national sample was recruited via social networking applications to complete a baseline assessment and mail-in HIV testing. Those with nonreactive HIV results were randomized to receive either (1) a 2-session MI intervention focusing on PrEP use (session 1) and concomitant stimulant use or CAS (session 2) or (2) a CM intervention with financial incentives for documented evidence of PrEP clinical evaluation by a medical provider (US $50) and filling a PrEP prescription (US $50). At the 3-month follow-up assessment, participants who reported they had not filled a prescription for PrEP were randomized a second time to either (1) switch to a second-stage intervention (ie, MI+CM or CM+MI) or (2) continue with assessments only. Outcomes for both responders and nonresponders were reassessed at a 6-month follow-up. The primary outcome is documented evidence of filling a PrEP prescription over 6 months. Self-reported secondary outcomes include PrEP clinical evaluation by a medical provider, stimulant use, and CAS. Qualitative exit interviews were conducted with a subgroup of responders and nonresponders to characterize their experiences with the MI and CM interventions. ResultsImplementation of PRISM underscores challenges in reaching sexual minority men who use stimulants to optimize HIV prevention efforts. Approximately 1 in 10 (104/1060) eligible participants have enrolled. Of the 104 who enrolled, 87 (84%) completed mail-in HIV testing. We delivered 5 preliminary HIV-positive results, including posttest counseling with referrals to confirmatory testing. ConclusionsLessons learned from PRISM underscore the central importance of a flexible, participant-centered approach to support the engagement of sexual minority men who use stimulants. Leveraging telehealth platforms to deliver motivational enhancement interventions also expanded their reach and potential public health impact with this high-priority population. Further research is needed to determine the effectiveness of telehealth MI and CM for supporting PrEP use in sexual minority men who use stimulants. Trial RegistrationClinicalTrials.gov NCT04205487; https://clinicaltrials.gov/study/NCT04205487 International Registered Report Identifier (IRRID)DERR1-10.2196/48459https://www.researchprotocols.org/2023/1/e48459
spellingShingle Leah Davis-Ewart
Christian Grov
Rachel Verhagen
Jennifer Manuel
Michael Viamonte
Samantha Dilworth
Nicole O'Dell
Omar Valentin
Sidney Carr
Emily Cherenack
Chelsea Henderson
Susanne Doblecki-Lewis
Inbal Nahum-Shani
Adam W Carrico
Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial
JMIR Research Protocols
title Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial
title_full Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial
title_fullStr Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial
title_full_unstemmed Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial
title_short Motivational Enhancement Interventions to Increase Pre-Exposure Prophylaxis Use in Sexual Minority Men Who Use Stimulants: Protocol for a Pilot Sequential Multiple Assignment Randomized Trial
title_sort motivational enhancement interventions to increase pre exposure prophylaxis use in sexual minority men who use stimulants protocol for a pilot sequential multiple assignment randomized trial
url https://www.researchprotocols.org/2023/1/e48459
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