Studies
| Study First Submitted Date | 2021-08-25 |
| Study First Posted Date | 2021-09-14 |
| Last Update Posted Date | 2023-05-23 |
| Start Month Year | October 2023 |
| Primary Completion Month Year | January 2025 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-23 |
Detailed Descriptions
| Sequence: | 20779499 |
| 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. |
Facilities
| Sequence: | 200580916 |
| Name | Centre of Excellence For Research in AIDS (CERiA) |
| City | Kuala Lumpur |
| Country | Malaysia |
Conditions
| Sequence: | 52319165 |
| Name | HIV Prevention Program |
| Downcase Name | hiv prevention program |
Id Information
| Sequence: | 40264391 |
| Id Source | org_study_id |
| Id Value | K01DA051346 |
| Id Type | U.S. NIH Grant/Contract |
| Id Link | https://reporter.nih.gov/quickSearch/K01DA051346 |
Countries
| Sequence: | 42683598 |
| Name | Malaysia |
| Removed | False |
Design Groups
| Sequence: | 55757947 | Sequence: | 55757948 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | JomPrEP App Group | Title | Control Group |
| Description | Participants in the JomPrEP group will be provided with full app access and will be encouraged to use all features of the app. | Description | Participants in the control group will receive the JomPrEP app with major intervention features inactivated. |
Interventions
| Sequence: | 52630137 | Sequence: | 52630138 |
| Intervention Type | Other | Intervention Type | Other |
| Name | Full access to JomPrEP app | Name | inactivated JomPrEP app |
| Description | 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. | Description | Only information and resources for PrEP services will be available along with access to risk assessment tools. |
Keywords
| Sequence: | 80073083 | Sequence: | 80073084 | Sequence: | 80073085 |
| Name | mobile application | Name | PrEP | Name | mHealth |
| Downcase Name | mobile application | Downcase Name | prep | Downcase Name | mhealth |
Design Outcomes
| Sequence: | 177925652 | Sequence: | 177925653 | Sequence: | 177925654 | Sequence: | 177925655 | Sequence: | 177925656 | Sequence: | 177925657 | Sequence: | 177925658 | Sequence: | 177925659 | Sequence: | 177925660 | Sequence: | 177925661 | Sequence: | 177925662 | Sequence: | 177925663 | Sequence: | 177925664 | Sequence: | 177925665 | Sequence: | 177925666 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Feasibility of the JomPrEP app using percentages of individuals screened | Measure | Feasibility of the JomPrEP app using percentages of individuals eligible | Measure | Feasibility of the JomPrEP app using percentages of individuals enrolled | Measure | Feasibility of the JomPrEP app using percentages of individuals retained | Measure | Feasibility of the JomPrEP app using the percentage of participants that accessed the app | Measure | Acceptability of the JomPrEP app based on the subjective usability measure | Measure | Acceptability of the JomPrEP app based on perceived usefulness of participants assessed in qualitative interviews | Measure | Acceptability of the JomPrEP app based on barriers and facilitators identifies by participants in qualitative interviews | Measure | Acceptability of the JomPrEP app based on usability concerns identified by participants in qualitative interviews | Measure | Acceptability of the JomPrEP app based on refinement feedback identified by participants in qualitative data interviews | Measure | Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure | Measure | Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure | Measure | Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence | Measure | Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence | Measure | Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP |
| Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 6 months | Time Frame | 3 months | Time Frame | 6 months | Time Frame | 3 months | Time Frame | 6 months | Time Frame | 6 months |
| Description | The investigators will use the percentage of individuals screened to determine the feasibility of the JomPrEP app | Description | The investigators will use the percentage of individuals eligible to determine the feasibility of the JomPrEP app | Description | The investigators will use the percentage of individuals enrolled to determine the feasibility of the JomPrEP app | Description | The investigators will use the percentage of individuals retained to determine the feasibility of the JomPrEP app | Description | 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. | Description | 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. | Description | Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app. | Description | Acceptability will be based on analysis of qualitative data which includes barriers and facilitators. | Description | Acceptability will be based on analysis of qualitative data which includes usability concerns. | Description | Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation. | Description | 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. | Description | 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 | Description | The investigators will measure PrEP adherence using the visual analogue scale at 3 months. | Description | The investigators will measure PrEP adherence using the visual analogue scale at 6 months. | Description | 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. |
Sponsors
| Sequence: | 48457887 | Sequence: | 48457888 | Sequence: | 48457889 |
| Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | University of Connecticut | Name | University of Malaya | Name | Yale University |
Overall Officials
| Sequence: | 29364154 |
| Role | Principal Investigator |
| Name | Roman Shrestha, PhD |
| Affiliation | University of Connecticut |
Central Contacts
| Sequence: | 12045633 | Sequence: | 12045634 |
| Contact Type | primary | Contact Type | backup |
| Name | Roman Shrestha, PhD | Name | Antoine Khati, MD |
| Phone | +1(903)407-0387 | ||
| roman.shrestha@uconn.edu | antoine.khati@uconn.edu | ||
| Role | Contact | Role | Contact |
Design Group Interventions
| Sequence: | 68348449 | Sequence: | 68348450 |
| Design Group Id | 55757947 | Design Group Id | 55757948 |
| Intervention Id | 52630137 | Intervention Id | 52630138 |
Eligibilities
| Sequence: | 30851083 |
| Gender | Male |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | 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 |
| Gender Description | Cis-gender men |
| Gender Based | True |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254267174 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 10 |
| Number Of Secondary Outcomes To Measure | 5 |
Designs
| Sequence: | 30596941 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Prevention |
| Time Perspective | |
| Masking | None (Open Label) |
Links
| Sequence: | 4399606 | Sequence: | 4399607 | Sequence: | 4399608 |
| Url | https://uxpajournal.org/determining-what-individual-sus-scores-mean-adding-an-adjective-rating-scale/ | Url | https://us.sagepub.com/en-us/nam/transforming-qualitative-information/book7714 | Url | https://dokumen.pub/the-handbook-of-data-analysis-7-1nbsped-1848601166-978-1-84860-116-1.html |
| Description | Determining What Individual SUS Scores Mean: Adding an Adjective Rating Scale by Aaron Bangor, PhD, CHFP, Philip Kortum, PhD, James Miller, PhD | Description | Transforming Qualitative Information Thematic Analysis and Code Development. By Richard E. Boyatzis | Description | Handbook of data analysis. By Roberto P. Franzosi. |
Responsible Parties
| Sequence: | 28963421 |
| Responsible Party Type | Principal Investigator |
| Name | Roman Shrestha |
| Title | Assistant Professor |
| Affiliation | University of Connecticut |
Study References
| Sequence: | 52223551 | Sequence: | 52223552 | Sequence: | 52223553 | Sequence: | 52223554 | Sequence: | 52223555 | Sequence: | 52223556 | Sequence: | 52223557 | Sequence: | 52223558 |
| Pmid | 19532070 | Pmid | 16204405 | Pmid | 25973907 | Pmid | 15116282 | Pmid | 25065857 | Pmid | 22935078 | Pmid | 27572401 | Pmid | 26829517 |
| Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background | Reference Type | background |
| 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. | Citation | Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. | 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. | 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. | 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. | 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. | Citation | 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. | 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. |