Testing of the Smartphone App to Enhance HIV Prevention Cascade Among Malaysian MSM

HIV Prevention Program Clinical Trial

Official title:

Training in mHealth Prevention With MSM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044013
• Other study ID #: K01DA051346
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: University of Connecticut
• Contact: Roman Shrestha, PhD
• Phone: +1(903)407-0387
• Email: roman.shrestha[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group.

Description:

mHealth is a promising and cost-effective strategy to reach stigmatized and hard-to-reach populations and link them to care. Leveraging mHealth reduces individuals' discomfort and distrust of disclosing risk behaviors to providers, providers' low cultural competency for working with individuals of diverse sexual identities, and bypasses barriers to care for marginalized populations, - all features crucial for HIV prevention in MSM in Malaysia. Results from the investigators' studies show Malaysian MSM often do not get HIV tested or initiate PrEP. Mixed methods suggest MSM want these services but prefer a streamlined system to access them that reduces interaction with clinicians where disclosure and perceived judgment occurs. mHealth may overcome these barriers by facilitating prevention services delivery and health decision-making in a confidential, less-stigmatizing, and convenient manner. Overall smartphone growth in Malaysia (63% in 2015 to 89% in 2017), and the investigators' parallel work with MSM indicates that nearly all (>97%) MSM own a smartphone. Findings from qualitative interviews with MSM further indicate preferences for interfacing with 'apps' rather than health professionals as well as local stakeholders indicating strong interest in using such platform to deliver HIV prevention services align with developing culturally tailored mHealth strategies and to engage MSM in virtual communication with providers - all embedded within one app. To the investigators' knowledge however, no mHealth intervention has been developed to improve access to HIV prevention services in Malaysia. The investigators, therefore, propose to pilot test their new clinic-affiliated app (JomPrEP) to promote HIV testing and PrEP uptake in Malaysian MSM. They will conduct a pilot RCT to evaluate the feasibility and acceptability of the JomPrEP app and examine its preliminary efficacy in improving PrEP cascade compared with the control group. The investigators will enroll 90 participants who will be randomized (1:1) to receive either the JomPrEP app or the control group and assessed at 3- and 6-months. Randomization will be stratified by ATS use (16% to 24%) and age. They will conduct exit interviews with participants and clinical staff to examine the barriers and facilitators to the app and obtain feedback to further optimize the app.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: MSM

• HIV-negative MSM
• Age more than or equal to 18
• Cis-gender men
• Condomless sex in the last 30 days
• Own a smartphone

Exclusion Criteria:

• Unable to provide informed consent
• Unable to read and understand English or Bahasa Malaysia

Related Conditions & MeSH terms

• HIV Prevention Program

Intervention

Other:
• Full access to JomPrEP app
All participants will receive the JomPrEP app with access to all of its features which include: customizable page (using avatars and pseudonyms); visual dashboard (track and visualize progress); HIV testing plan (create plan for HIV testing, order self-testing kits, testing site locator); PrEP Care Plan (PrEPxpress, automated reminders for follow-up care, labs, delivery); chat function and discussion forum; tailored messages and reminders; assessment center (weekly assessment on adherence to PrEP, HIV risk, mood); knowledge center (resources on HIV testing and PrEP); Mental health support (screen for P/SUD, counseling feedback, referral to support services); Integration of provider locator (provides users with a GPS enabled map for PrEP and mental health support providers in Malaysia) and Gamification (offers extrinsic motivation by rewarding points/milestones for doing activities within the app). Participants can also contact the RA using the chat function for support.
• inactivated JomPrEP app
Only information and resources for PrEP services will be available along with access to risk assessment tools.

Locations

Country	Name	City	State
Malaysia	Centre of Excellence For Research in AIDS (CERiA)	Kuala Lumpur

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	University of Malaya, Yale University

Country where clinical trial is conducted

Malaysia, 

References & Publications (8)

Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov. — View Citation

Castillo-Mancilla JR, Zheng JH, Rower JE, Meditz A, Gardner EM, Predhomme J, Fernandez C, Langness J, Kiser JJ, Bushman LR, Anderson PL. Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure. AIDS Res Hum Retroviruses. 2013 Feb;29(2):384-90. doi: 10.1089/AID.2012.0089. Epub 2012 Oct 10. — View Citation

Giordano TP, Guzman D, Clark R, Charlebois ED, Bangsberg DR. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials. 2004 Mar-Apr;5(2):74-9. doi: 10.1310/JFXH-G3X2-EYM6-D6UG. — View Citation

Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, Hosek S, Mosquera C, Casapia M, Montoya O, Buchbinder S, Veloso VG, Mayer K, Chariyalertsak S, Bekker LG, Kallas EG, Schechter M, Guanira J, Bushman L, Burns DN, Rooney JF, Glidden DV; iPrEx study team. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014 Sep;14(9):820-9. doi: 10.1016/S1473-3099(14)70847-3. Epub 2014 Jul 22. — View Citation

Guadamuz TE, Cheung DH, Wei C, Koe S, Lim SH. Young, Online and in the Dark: Scaling Up HIV Testing among MSM in ASEAN. PLoS One. 2015 May 14;10(5):e0126658. doi: 10.1371/journal.pone.0126658. eCollection 2015. — View Citation

Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. — View Citation

Van Tieu H, Koblin BA. HIV, alcohol, and noninjection drug use. Curr Opin HIV AIDS. 2009 Jul;4(4):314-8. doi: 10.1097/COH.0b013e32832aa902. — View Citation

Zheng JH, Rower C, McAllister K, Castillo-Mancilla J, Klein B, Meditz A, Guida LA, Kiser JJ, Bushman LR, Anderson PL. Application of an intracellular assay for determination of tenofovir-diphosphate and emtricitabine-triphosphate from erythrocytes using dried blood spots. J Pharm Biomed Anal. 2016 Apr 15;122:16-20. doi: 10.1016/j.jpba.2016.01.038. Epub 2016 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the JomPrEP app using percentages of individuals screened	The investigators will use the percentage of individuals screened to determine the feasibility of the JomPrEP app	6 months
Primary	Feasibility of the JomPrEP app using percentages of individuals eligible	The investigators will use the percentage of individuals eligible to determine the feasibility of the JomPrEP app	6 months
Primary	Feasibility of the JomPrEP app using percentages of individuals enrolled	The investigators will use the percentage of individuals enrolled to determine the feasibility of the JomPrEP app	6 months
Primary	Feasibility of the JomPrEP app using percentages of individuals retained	The investigators will use the percentage of individuals retained to determine the feasibility of the JomPrEP app	6 months
Primary	Feasibility of the JomPrEP app using the percentage of participants that accessed the app	The investigators will determine the percentage of participants that accessed the app, with =60% of participants accessing app as lower threshold. The higher the percentage, the higher the feasibility.	6 months
Primary	Acceptability of the JomPrEP app based on the subjective usability measure	Acceptability will be based on descriptive statistics from the subjective usability measure, with a target mean score of = 50. The higher the score, the higher the acceptability. Minimum score for the scale is 0, highest is 100.	6 months
Primary	Acceptability of the JomPrEP app based on perceived usefulness of participants assessed in qualitative interviews	Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.	6 months
Primary	Acceptability of the JomPrEP app based on barriers and facilitators identifies by participants in qualitative interviews	Acceptability will be based on analysis of qualitative data which includes barriers and facilitators.	6 months
Primary	Acceptability of the JomPrEP app based on usability concerns identified by participants in qualitative interviews	Acceptability will be based on analysis of qualitative data which includes usability concerns.	6 months
Primary	Acceptability of the JomPrEP app based on refinement feedback identified by participants in qualitative data interviews	Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.	6 months
Secondary	Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure	The investigators will measure PrEP adherence (using dried blood spots) at 3 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC.	3 months
Secondary	Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure	The investigators will measure PrEP adherence (using dried blood spots) at 6 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC	6 months
Secondary	Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence	The investigators will measure PrEP adherence using the visual analogue scale at 3 months.	3 months
Secondary	Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence	The investigators will measure PrEP adherence using the visual analogue scale at 6 months.	6 months
Secondary	Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP	Preliminary Efficacy of the app will be calculated using the proportion of participants who persist on PrEP. Persistence on PrEP is measured on the app when completing PrEP care.	6 months

External Links

•   Determining What Individual SUS Scores Mean: Adding an Adjective Rating Scale by Aaron Bangor, PhD, CHFP, Philip Kortum, PhD, James Miller, PhD
•   Handbook of data analysis. By Roberto P. Franzosi.
•   Transforming Qualitative Information Thematic Analysis and Code Development. By Richard E. Boyatzis