Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

NCT03584282 | Completed Results

• 2 other identifiers: STUDY000047601R34DA045620-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV/AIDS; Adherence, Medication; Drug Use

Keywords

Pre-Exposure Prophylaxis (PrEP); Methamphetamine

Outcome Measures

Primary Outcomes (2)

• Acceptability of Text Messaging

  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.

  6 months

• Acceptability of Peer Navigation

  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.

  6 months

Secondary Outcomes (2)

• PrEP Persistence

  6 months

• PrEP Adherence

  6 months

Study Arms (4)

Standard of Care

NO INTERVENTION

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

Text Messaging

ACTIVE COMPARATOR

Participants in this group will receive the text messaging intervention.

Behavioral: Text Messaging

Peer Navigation

ACTIVE COMPARATOR

Participants in this group will receive the peer navigator intervention.

Behavioral: Peer Navigation

Text Messaging and Peer Navigation

ACTIVE COMPARATOR

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

Behavioral: Text Messaging; Behavioral: Peer Navigation

Interventions

Text Messaging BEHAVIORAL

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.

Text Messaging; Text Messaging and Peer Navigation

Peer Navigation BEHAVIORAL

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.

Peer Navigation; Text Messaging and Peer Navigation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: cisgender men, transgender women, transgender men, and genderqueer individuals
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the clinic's eligibility criteria for PrEP
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Kelley-Ross One-Step PrEP

Seattle, Washington, 98104, United States

Location

Gay City

Seattle, Washington, 98122, United States

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  PMID: 26562845 BACKGROUND

• 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.

  PMID: 22819660 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26180964 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Simoni JM, Huh D, Frick PA, Pearson CR, Andrasik MP, Dunbar PJ, Hooton TM. Peer support and pager messaging to promote antiretroviral modifying therapy in Seattle: a randomized controlled trial. J Acquir Immune Defic Syndr. 2009 Dec 1;52(4):465-473. doi: 10.1097/qai.0b013e3181b9300c.

  PMID: 19911481 BACKGROUND

• 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.

  PMID: 21071074 BACKGROUND

• Dowshen N, Kuhns LM, Johnson A, Holoyda BJ, Garofalo R. Improving adherence to antiretroviral therapy for youth living with HIV/AIDS: a pilot study using personalized, interactive, daily text message reminders. J Med Internet Res. 2012 Apr 5;14(2):e51. doi: 10.2196/jmir.2015.

  PMID: 22481246 BACKGROUND

• Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 5;9(2):e88166. doi: 10.1371/journal.pone.0088166. eCollection 2014.

  PMID: 24505411 BACKGROUND

• 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.

  BACKGROUND

• Frank N, McMahan VM, Violette LR, Martin A, Glick SN, Stekler JD. Efficient Expansion of a Behavioral Survey to Assess Sex, Gender, and Behavioral Risk Among Transgender and Nonbinary Individuals: HMU! (HIV Prevention for Methamphetamine Users). Transgend Health. 2023 Oct 4;8(5):472-476. doi: 10.1089/trgh.2021.0082. eCollection 2023 Oct.

  PMID: 37810934 DERIVED

• McMahan VM, Frank N, Buckler S, Violette LR, Baeten JM, Banta-Green CJ, Barnabas RV, Simoni J, Stekler JD. Protocol Development for HMU! (HIV Prevention for Methamphetamine Users), a Study of Peer Navigation and Text Messaging to Promote Pre-Exposure Prophylaxis Adherence and Persistence Among People Who Use Methamphetamine: Qualitative Focus Group and Interview Study. JMIR Form Res. 2020 Sep 14;4(9):e18118. doi: 10.2196/18118.

  PMID: 32924952 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Data collected via surveys may have been impacted by social desirability bias. While the HMU! cohort represented some populations disproportionately impacted by methamphetamine and HIV, there were key populations we did not reach. Alaskan Native and Native American and Hispanic/Latinx MSM were under represented in our study, as were individuals who were not cisgender.

Results Point of Contact

• Title: Dr. Joanne Stekler, Primary Investigator
• Organization: University of Washington

jstekler@uw.edu

(206) 744-8312

Study Officials

• Joanne Stekler, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Allergy and Infectious Diseases

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 12, 2018
• Study Start: July 11, 2018
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-05

Locations

US (2)