HIV Prevention ProgramNCT05044013
Testing of the Smartphone App to Enhance HIV Prevention Cascade Among Malaysian MSM
A study testing Full access to JomPrEP app and inactivated JomPrEP app in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention Program
- What is being tested?
- Full access to JomPrEP app and inactivated JomPrEP app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Nov 2023to 12 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-negative MSM
- Age more than or equal to 18
- Cis-gender men
- Condomless sex in the last 30 days
- Own a smartphone
Who cannot join
- Unable to provide informed consent
- Unable to read and understand English or Bahasa Malaysia
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Centre of Excellence For Research in AIDS (CERiA)
Kuala Lumpur
About this study
Official title: Training in mHealth Prevention With MSM
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.
Read the detailed 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.
- Conditions
- HIV Prevention Program
- Being tested
- Full access to JomPrEP app, inactivated JomPrEP app
- Keywords
- mobile application, PrEP, mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full access to JomPrEP appOther
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 appOther
Only information and resources for PrEP services will be available along with access to risk assessment tools.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: inactivated JomPrEP app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 3 months
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
Measured: 6 months
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start15 Nov 2023
- Primary completion12 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV Prevention ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, Yale University
- Responsible party
- Principal investigator, Roman Shrestha, University of Connecticut
- Investigators
- Roman Shrestha, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044013
- Sponsor's protocol ID
- K01DA051346
- Status last verified
- Jul 2025
- First submitted
- 25 Aug 2021
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19532070Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Guadamuz 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.
PubMed 25973907Giordano 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.
PubMed 15116282Grant 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.
PubMed 25065857Castillo-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.
PubMed 22935078Castillo-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.
PubMed 27572401Zheng 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.
PubMed 26829517
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in mHealth Prevention With MSM
- ClinicalTrials.gov ID
- NCT05044013
- Acronym / sponsor ID
- K01DA051346
- Conditions
- HIV Prevention Program
- Keywords
- mobile application, PrEP, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- University of Malaya, Yale University
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JomPrEP App Group | Experimental | Other: Full access to JomPrEP appParticipants in the JomPrEP group will be provided with full app access and will be encouraged to use all features of the app. |
| Control Group | Active comparator | Other: inactivated JomPrEP appParticipants in the control group will receive the JomPrEP app with major intervention features inactivated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-negative MSM
- Age more than or equal to 18
- Cis-gender men
- Condomless sex in the last 30 days
- Own a smartphone
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Unable to read and understand English or Bahasa Malaysia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full access to JomPrEP appAll 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. | Other | JomPrEP App Group |
| inactivated JomPrEP appOnly information and resources for PrEP services will be available along with access to risk assessment tools. | Other | Control Group |
Primary outcome
Feasibility of the JomPrEP app using percentages of individuals screened
Time frame: 6 months
The investigators will use the percentage of individuals screened to determine the feasibility of the JomPrEP app
Feasibility of the JomPrEP app using percentages of individuals eligible
Time frame: 6 months
The investigators will use the percentage of individuals eligible to determine the feasibility of the JomPrEP app
Feasibility of the JomPrEP app using percentages of individuals enrolled
Time frame: 6 months
The investigators will use the percentage of individuals enrolled to determine the feasibility of the JomPrEP app
Feasibility of the JomPrEP app using percentages of individuals retained
Time frame: 6 months
The investigators will use the percentage of individuals retained to determine the feasibility of the JomPrEP app
Feasibility of the JomPrEP app using the percentage of participants that accessed the app
Time frame: 6 months
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.
Acceptability of the JomPrEP app based on the subjective usability measure
Time frame: 6 months
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.
Acceptability of the JomPrEP app based on perceived usefulness of participants assessed in qualitative interviews
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes specific areas of perceived usefulness of the app.
Acceptability of the JomPrEP app based on barriers and facilitators identifies by participants in qualitative interviews
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes barriers and facilitators.
Acceptability of the JomPrEP app based on usability concerns identified by participants in qualitative interviews
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes usability concerns.
Acceptability of the JomPrEP app based on refinement feedback identified by participants in qualitative data interviews
Time frame: 6 months
Acceptability will be based on analysis of qualitative data which includes refinement needed to maximize future implementation.
5 secondary outcomes
Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure
Time frame: 3 months
Preliminary Efficacy of the JomPrEP app through dried blood spot testing as PrEP adherence measure
Time frame: 6 months
Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence
Time frame: 3 months
Preliminary Efficacy of the JomPrEP app using the visual analog scale (VAS) to measure PrEP adherence
Time frame: 6 months
Preliminary Efficacy of the JomPrEP app using proportion of participants who persist on PrEP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 19532070Van 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.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Background: PubMed 25973907Guadamuz 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.
- Background: PubMed 15116282Giordano 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.
- Background: PubMed 25065857Grant 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.
- Background: PubMed 22935078Castillo-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.
- Background: PubMed 27572401Castillo-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.
- Background: PubMed 26829517Zheng 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.
- Transforming Qualitative Information Thematic Analysis and Code Development. By Richard E. BoyatzisLink provided by the sponsor.
- Handbook of data analysis. By Roberto P. Franzosi.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Shrestha, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full access to JomPrEP app and inactivated JomPrEP app in people with HIV Prevention Program, run by University of Connecticut at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the JomPrEP app using percentages of individuals screened (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044013, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.