Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

September 24, 2020 updated by: Joanne Stekler, MD MPH, University of Washington
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Vanessa M McMahan
  • Phone Number: 206-616-5234
  • Email: vmcmahan@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Kelley-Ross One-Step PrEP
        • Contact:
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Gay City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of text messaging intervention
Time Frame: 6 months
Self-reported acceptability via surveys and interviews
6 months
Acceptability and impact of text messaging intervention.
Time Frame: 6 months
Self-reported acceptability via surveys and interviews
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PrEP persistence
Time Frame: 6 months
Persistence on PrEP comparing standard of care vs text messaging vs peer navigation vs both interventions.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004760
  • 1R34DA045620-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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