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Clinical Trials/NCT03584282
NCT03584282
Completed
Not Applicable

Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

University of Washington2 sites in 1 country21 target enrollmentJuly 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
University of Washington
Enrollment
21
Locations
2
Primary Endpoint
Acceptability of Text Messaging
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2018
End Date
June 30, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joanne Stekler, MD MPH

Associate Professor, School of Medicine: Allergy and Infectious Diseases

University of Washington

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.

Outcomes

Primary Outcomes

Acceptability of Text Messaging

Time Frame: 6 months

Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.

Acceptability of Peer Navigation

Time Frame: 6 months

Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.

Secondary Outcomes

  • PrEP Persistence(6 months)
  • PrEP Adherence(6 months)

Study Sites (2)

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