Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

Conditions
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HIV/AIDS, Adherence, Medication, Drug Use

Intervention / Treatment
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* Behavioral: Text Messaging
* Behavioral: Peer Navigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions. | |
| Active Comparator: Text Messaging<br>Participants in this group will receive the text messaging intervention. | Behavioral: Text Messaging<br>* 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.<br>|
| Active Comparator: Peer Navigation<br>Participants in this group will receive the peer navigator intervention. | Behavioral: Peer Navigation<br>* 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.<br>|
| Active Comparator: Text Messaging and Peer Navigation<br>Participants in this group will receive both the text messaging and peer navigation interventions. | Behavioral: Text Messaging<br>* 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.<br>Behavioral: Peer Navigation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP persistence | Persistence on PrEP comparing standard of care vs text messaging vs peer navigation vs both interventions. | 6 months | 
| PrEP adherence | PrEP adherence measured in dried blood spots comparing standard of care vs text messaging vs peer navigation vs both interventions. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-Exposure Prophylaxis (PrEP), Methamphetamine