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Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

Primary Purpose

HIV/AIDS, Adherence, Medication, Drug Use

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging
Peer Navigation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring Pre-Exposure Prophylaxis (PrEP), Methamphetamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kelley-Ross One-Step PrEPRecruiting
  • Gay CityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard of Care

Text Messaging

Peer Navigation

Text Messaging and Peer Navigation

Arm Description

Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions.

Participants in this group will receive the text messaging intervention.

Participants in this group will receive the peer navigator intervention.

Participants in this group will receive both the text messaging and peer navigation interventions.

Outcomes

Primary Outcome Measures

Acceptability of text messaging intervention
Self-reported acceptability via surveys and interviews
Acceptability and impact of text messaging intervention.
Self-reported acceptability via surveys and interviews

Secondary Outcome Measures

PrEP persistence
Persistence on PrEP comparing standard of care vs text messaging vs peer navigation vs both interventions.
PrEP adherence
PrEP adherence measured in dried blood spots comparing standard of care vs text messaging vs peer navigation vs both interventions.

Full Information

First Posted
June 19, 2018
Last Updated
September 24, 2020
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03584282
Brief Title
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Official Title
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Adherence, Medication, Drug Use
Keywords
Pre-Exposure Prophylaxis (PrEP), Methamphetamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions.
Arm Title
Text Messaging
Arm Type
Active Comparator
Arm Description
Participants in this group will receive the text messaging intervention.
Arm Title
Peer Navigation
Arm Type
Active Comparator
Arm Description
Participants in this group will receive the peer navigator intervention.
Arm Title
Text Messaging and Peer Navigation
Arm Type
Active Comparator
Arm Description
Participants in this group will receive both the text messaging and peer navigation interventions.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Peer Navigation
Intervention Description
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 Measure Information:
Title
Acceptability of text messaging intervention
Description
Self-reported acceptability via surveys and interviews
Time Frame
6 months
Title
Acceptability and impact of text messaging intervention.
Description
Self-reported acceptability via surveys and interviews
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PrEP persistence
Description
Persistence on PrEP comparing standard of care vs text messaging vs peer navigation vs both interventions.
Time Frame
6 months
Title
PrEP adherence
Description
PrEP adherence measured in dried blood spots comparing standard of care vs text messaging vs peer navigation vs both interventions.
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
cisgender men, transgender women, transgender men, and genderqueer individuals
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa M McMahan
Phone
206-616-5234
Email
vmcmahan@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Stekler, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kelley-Ross One-Step PrEP
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyse Tung
Phone
206-324-6990
Email
prep@kelley-ross.com
Facility Name
Gay City
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Viquez
Phone
206-860-6969
Email
prep@gaycity.org

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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PubMed Identifier
26562845
Citation
Hood JE, Buskin SE, Dombrowski JC, Kern DA, Barash EA, Katz DA, Golden MR. Dramatic increase in preexposure prophylaxis use among MSM in Washington state. AIDS. 2016 Jan 28;30(3):515-9. doi: 10.1097/QAD.0000000000000937. Erratum In: AIDS. 2016 Jun 19;30(10 ):1689.
Results Reference
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PubMed Identifier
22819660
Citation
Beyrer C, Baral SD, van Griensven F, Goodreau SM, Chariyalertsak S, Wirtz AL, Brookmeyer R. Global epidemiology of HIV infection in men who have sex with men. Lancet. 2012 Jul 28;380(9839):367-77. doi: 10.1016/S0140-6736(12)60821-6. Epub 2012 Jul 20.
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Citation
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.
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PubMed Identifier
26180964
Citation
Habarta N, Wang G, Mulatu MS, Larish N. HIV Testing by Transgender Status at Centers for Disease Control and Prevention-Funded Sites in the United States, Puerto Rico, and US Virgin Islands, 2009-2011. Am J Public Health. 2015 Sep;105(9):1917-25. doi: 10.2105/AJPH.2015.302659. Epub 2015 Jul 16.
Results Reference
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Citation
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.
Results Reference
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Citation
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.
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Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, Jack W, Habyarimana J, Sadatsafavi M, Najafzadeh M, Marra CA, Estambale B, Ngugi E, Ball TB, Thabane L, Gelmon LJ, Kimani J, Ackers M, Plummer FA. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010 Nov 27;376(9755):1838-45. doi: 10.1016/S0140-6736(10)61997-6. Epub 2010 Nov 9.
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Results Reference
derived

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Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

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