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Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

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ClinicalTrials.gov Identifier: NCT03584282
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joanne Stekler, University of Washington

Brief Summary:
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.

Condition or disease Intervention/treatment Phase
HIV/AIDS Adherence, Medication Drug Use Behavioral: Text Messaging Behavioral: Peer Navigation Not Applicable

Detailed Description:
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The investigators will randomly assign 10 participants to each arm: 1) standard of care, 2) text messaging only, 3) peer navigation only, and 4) text messaging and peer navigation.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : June 18, 2020
Estimated Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard of Care
Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions.
Active Comparator: Text Messaging
Participants in this group will receive the text messaging intervention.
Behavioral: Text Messaging
The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.

Active Comparator: Peer Navigation
Participants in this group will receive the peer navigator intervention.
Behavioral: Peer Navigation
The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.

Active Comparator: Text Messaging and Peer Navigation
Participants in this group will receive both the text messaging and peer navigation interventions.
Behavioral: Text Messaging
The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.

Behavioral: Peer Navigation
The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.




Primary Outcome Measures :
  1. Acceptability of text messaging intervention [ Time Frame: 6 months ]
    Self-reported acceptability via surveys and interviews

  2. Acceptability and impact of text messaging intervention. [ Time Frame: 6 months ]
    Self-reported acceptability via surveys and interviews


Secondary Outcome Measures :
  1. PrEP persistence [ Time Frame: 6 months ]
    Persistence on PrEP comparing standard of care vs text messaging vs peer navigation vs both interventions.

  2. PrEP adherence [ Time Frame: 6 months ]
    PrEP adherence measured in dried blood spots comparing standard of care vs text messaging vs peer navigation vs both interventions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   cisgender men, transgender women, transgender men, and genderqueer individuals
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets the clinic's eligibility criteria for PrEP
  • 18 years of age or older
  • HIV-negative
  • Cisgender man or individual on the trans gender variant spectrum who has sex with men
  • Ability to understand, read, and speak English
  • Reports meth use in the past 3 months
  • Has a cell phone able to send and receive text messages

Exclusion Criteria:

  • PrEP use in the prior month,
  • Discomfort or anxiety with regards to text messaging.
  • Has any circumstances that, based on the study staff's opinion, would preclude provision of informed consent, make participation unsafe, or make it unlikely the participant would be able to participate for 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584282


Contacts
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Contact: Vanessa M McMahan 206-616-5234 vmcmahan@uw.edu

Locations
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United States, Washington
Kelley-Ross One-Step PrEP Recruiting
Seattle, Washington, United States, 98104
Contact: Elyse Tung    206-324-6990    prep@kelley-ross.com   
Gay City Recruiting
Seattle, Washington, United States, 98122
Contact: Luis Viquez    206-860-6969    prep@gaycity.org   
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Joanne Stekler, MD University of Washington

Publications:
Mera R, McCallister S, Palmer B, Mayer G, Magnuson D, Rawlings K. Truvada (TVD) for HIV pre-exposure prophylaxis (PrEP) utilization in the United States (2013-2015). 21st International AIDS Conference; Durban, South Africa; July 18-22, 2016 [abstract TUAX0105LB]. In.
Pitasi M, Llata E, Stenger M, Kerani R, Kohn R, Murphy R, et al. HIV prevalence among transgender women and men: results from the STD Surveillance Network, 2010-2013. 2015 National HIV Prevention Conference; Atlanta, GA; December 6-9, 2015 [abstract #1193]. In.
Buskin S, Hood J, Katz DA. Estimating the population-level impact of methamphetamine use on HIV acquisition among men who have sex with men using population attributable risk percent - a powerful and underused planning tool. International AIDS Society Conference 2015. July 19-22, 2015. Vancouver. Abstract MOPEC491. In.
McMahan V, Martin A, Garske L, Baeten JM, Banta-Green C, Stekler J. Knowledge about PrEP among MSM and Trans* Methamphetamine Users in Seattle. 24th Conference on Retroviruses and Opportunistic Infections; Seattle, WA; February 13-16, 2017 [#2063]. In.
Liu A, Stojanovski K, Lester R. Developing and Implementing a Mobile Health (mHealth) Adherence Support System for HIV- Uninfected Men who have Sex with Men (MSM) Taking Pre-Exposure Prophylaxis (PrEP): The iText Study. 8th International Conference on HIV Treatment and Prevention Adherence; Miami, FL; June 2-4, 2013 [Abstract #165]. In.

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Responsible Party: Joanne Stekler, Associate Professor, School of Medicine: Allergy and Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT03584282     History of Changes
Other Study ID Numbers: STUDY00004760
1R34DA045620-01 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joanne Stekler, University of Washington:
Pre-Exposure Prophylaxis (PrEP)
Methamphetamine

Additional relevant MeSH terms:
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Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors