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

NCT05044013 | Completed DMC

• 1 other identifier: K01DA051346
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Prevention Program

Keywords

mobile application; PrEP; mHealth

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure

  3 months

• Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure

  6 months

• Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence

  3 months

• Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence

  6 months

• Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP

  6 months

Study Arms (2)

JomPrEP App Group

EXPERIMENTAL

Participants in the JomPrEP group will be provided with full app access and will be encouraged to use all features of the app.

Other: Full access to JomPrEP app

Control Group

ACTIVE COMPARATOR

Participants in the control group will receive the JomPrEP app with major intervention features inactivated.

Other: inactivated JomPrEP app

Interventions

Full access to JomPrEP app OTHER

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.

JomPrEP App Group

inactivated JomPrEP app OTHER

Only information and resources for PrEP services will be available along with access to risk assessment tools.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Connecticut: lead
• University of Malaya: collaborator
• Yale University: collaborator

Study Sites (1)

Centre of Excellence For Research in AIDS (CERiA)

Kuala Lumpur, Malaysia

Location

Related Publications (8)

• 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.

  PMID: 19532070 BACKGROUND

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

  PMID: 16204405 BACKGROUND

• 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.

  PMID: 25973907 BACKGROUND

• 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.

  PMID: 15116282 BACKGROUND

• 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.

  PMID: 25065857 BACKGROUND

• 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.

  PMID: 22935078 BACKGROUND

• 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.

  PMID: 27572401 BACKGROUND

• 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.

  PMID: 26829517 BACKGROUND

Related Links

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

Study Officials

• Roman Shrestha, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 14, 2021
• Study Start: November 15, 2023
• Primary Completion: July 12, 2025
• Study Completion: July 12, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

MY (1)