Clinical trial NCT03584282: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Adherence, Medication
Drug Use
Keywords: Pre-Exposure Prophylaxis (PrEP)
Methamphetamine
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-07-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Acceptability of Text Messaging
timeFrame: 6 months
measure: Acceptability of Peer Navigation
timeFrame: 6 months
Secondary outcomes:
measure: PrEP Persistence
timeFrame: 6 months
measure: PrEP Adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kelley-Ross One-Step PrEP
state: Washington
city: Seattle
country: United States
facility: Gay City
state: Washington
Study officials:
affiliation: University of Washington
name: Joanne Stekler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.