InterventionNCT07113626
Adapting An Evidence-Based Intervention To Improve HIV Testing And PrEP Uptake In Vietnam
A study testing Mobile app in people with Intervention and Control Condition, run by Hanoi Medical University at 1 site in Vietnam.
Trial summary
Young men who have sex with men are experiencing an ongoing HIV epidemic in Vietnam, with an HIV prevalence of 12%. However, HIV testing and pre-exposure prophylaxis (PrEP) use among young men who have sex with men remain low. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention, Control Condition
- What is being tested?
- Mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jan 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young men who have sex with men (YMSM):
- Theater testing. YMSM are eligible if they (1) are 18-24 years old Vietnamese male; (2) report having anal intercourse with another man in the last 6 months; (3) are HIV negative or of unknown HIV status; (4) own a smartphone; (5) currently live in Hanoi, (6) are able to read and understand Vietnamese without assistance, and (7) are willing to provide informed consent.
- Beta testing. Eligibility is similar to theater testing. Randomized controlled trial (RCT). YMSM are eligible if they (1) are 18-24 years old Vietnamese male; (2) report having anal intercourse with another man in the last 6 months; (3) are HIV negative or of unknown HIV status; (4) own a smartphone; (5) currently live in Hanoi, (6) are able to read and understand Vietnamese without assistance, and (7) are willing to provide informed consent and (8) are not being currently on pre-exposure prophylaxis (PrEP).
- Other key stakeholders:
- Eligibility criteria of this group are (1) having worked with MSM-related health issues at an HIV/PrEP clinic or community-based organizations (CBO) for at least 6 months and (2) willingness to provide informed consent.
Who cannot join
- Young men who have sex with men (YMSM):
- Theater testing. None Beta testing. Participants will be deemed ineligible if they are unwilling to provide contact information.
- Randomized controlled trial. Exclusion criteria include (1) unwilling to provide contact information; (2) currently enrolled in other HIV testing or PrEP program/intervention.
- Other key stakeholders: None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Medical University
Hanoi, 100000
Yen Hoang, +842438523798, yenhoang@hmu.edu.vn
Xuan Binh Minh Nguyen, MD, PhD
About this study
Young men who have sex with men are experiencing an ongoing HIV epidemic in Vietnam, with an HIV prevalence of 12%. However, HIV testing and pre-exposure prophylaxis (PrEP) use among young men who have sex with men remain low. To improve HIV testing and PrEP use, mobile health (mHealth) interventions hold great promise to reach young men who have sex with men in low- and middle-income countries. HealthMindr, an evidence-based mHealth intervention developed in the United States for men who have sex with men, is an ideal option for adaptation for young men who have sex with men in Vietnam. The specific aims are to (1) Adapt the HealthMindr app to improve HIV testing and PrEP uptake among young men who have sex with men in Vietnam; (2) Examine acceptability, feasibility and preliminary effectiveness of the adapted app among young men who have sex with men in Vietnam and (3) Explore barriers and facilitators of implementing the adapted app among young men who have sex with men in Vietnam. In Aim 1, theater testing will be conducted through focus group discussions with young men who have sex with men and key other stakeholders, including health officials, clinic staff and community-based organizations. Theater testing data will be used to refine the app for beta testing. During beta testing, a small group of young men who have sex with men will use the app for 30 days, then complete an online survey and an exit interview to rate the app's usability, provide their perspectives of the app and report any other areas for improvement. App analytics will also be collected to understand whether and how the app is used. In Aim 2, the adapted app with be tested among young men who have sex with men through a randomized controlled design. Young men who have sex with men will be randomized into the intervention or control arm (1:1 ratio). The intervention arm will have full access to the app for 3 months, while the control group will receive standard-of-care HIV services. Key app features include HIV test planning, risk and PrEP eligibility assessment, ordering of free condoms and HIV test kits, information about PrEP, and PrEP provider and HIV testing locations. HIV testing and PrEP use will be assessed at baseline and 3 months and compared between groups. A mixed methods approach will be used to evaluate app acceptability and feasibility. Quantitative data on acceptability and feasibility will be collected through the 3-month online survey, while qualitative data will be collected through in-depth interviews with a subset of young men who have sex with men in the intervention arm and other key stakeholders. In Aim 3, through the same qualitative study as Aim 2, factors that influence the implementation of the app will be explored. Determinants from seven domains will be identified: condition, technology, value proposition, adopter system, health organization, wider system and embedding/adaption over time. Only when mHealth interventions are both effective and adopted can they maximize their potential to reduce HIV incidence among target populations. This proposal will generate data for designing a full-scale hybrid type 1 effectiveness-implementation trial to test the adapted app and identify implementation strategies to address the barriers of app implementation in low and middle-income countries.
- Conditions
- Intervention, Control Condition
- Being tested
- Mobile app
- Keywords
- young men who have sex with men, HIV/AIDS, HIV testing, PrEP, mHealth, Vietnam
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appBehavioural
The intervention will be a mobile app adapted from HealthMindr - an app based on Social Cognitive Theory - for young men who have sex with men in Vietnam. The app, which was developed and tested in the US, offers a range of testing and prevention services, including self-screening for HIV and sexually transmitted infection (STI) risk, a scheduling and reminder system for HIV/ STI testing, PrEP eligibility screener, an ordering platform for delivery of at-home test kits and condoms, and locators for HIV services. Additional features and contents might be revised and added depending on the needs of young men who have sex with men in Vietnam.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Those assigned to the intervention arm will receive access to the adapted HealthMindr app with key features, including HIV test planning, initial risk/PrEP eligibility assessment, ordering of free condoms and HIV test kits, information about PrEP, PrEP provider and HIV testing locations, and any additional features added through the adaptation process. The staff will help participants download the app and walk them through its use during the study visit. These participants will be encouraged to use the app for a period of 3 months. In addition, participants will be provided standard-of-care HIV prevention information upon enrollment at the study site by a study staff, which includes written prevention materials for HIV testing and referrals to local HIV prevention services. Anyone who seroconverts during the study period will be referred to appropriate HIV treatment services. Receives: Behavioral: Mobile app |
| Control | No intervention | Participants randomized to the control arm will be provided standard-of-care HIV prevention information upon enrollment at the study site by a study staff, which includes written prevention materials for HIV testing and referrals to local HIV prevention services. Anyone who seroconverts during the study period will be referred to appropriate HIV treatment services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Mean score on the 10-item System Usability Scale (for the app) of participants in the intervention arm. Data from this scale will be scored from 0 to 100, and a score of ≥50 indicates that the app is acceptable (higher score means better outcome).
Measured: 3 months
Feasibility (App usage)
The proportion of participants assigned to the intervention arm who open the app at least once during the follow-up period
Measured: 3 months
HIV testing
The proportion of participants who get tested for HIV in the last 3 months
Measured: Baseline; 3 months
PrEP uptake
The proportion of participants who initiate PrEP during the follow-up period
Measured: 3 months
Secondary outcomes (2)
STI testing
The proportion of participants who get tested for STI other than HIV in the last 3 months
Measured: Baseline; 3 months
PrEP clinic visit
Number of visit to a PrEP clinic in the last 3 months
Measured: Baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Jan 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of North Carolina, Chapel Hill, Emory University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113626
- Sponsor's protocol ID
- 1521
- Other IDs
- 1K43TW012850-01
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting An Evidence-Based Intervention To Improve HIV Testing And PrEP Uptake In Vietnam
- ClinicalTrials.gov ID
- NCT07113626
- Acronym / sponsor ID
- 1521
- Conditions
- Intervention, Control Condition
- Keywords
- young men who have sex with men, HIV/AIDS, HIV testing, PrEP, mHealth, Vietnam
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, University of North Carolina, Chapel Hill, Emory University
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 11 Aug 2025 (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.
Young men who have sex with men are experiencing an ongoing HIV epidemic in Vietnam, with an HIV prevalence of 12%. However, HIV testing and pre-exposure prophylaxis (PrEP) use among young men who have sex with men remain low. To improve HIV testing and PrEP use, mobile health (mHealth) interventions hold great promise to reach young men who have sex with men in low- and middle-income countries. HealthMindr, an evidence-based mHealth intervention developed in the United States for men who have sex with men, is an ideal option for adaptation for young men who have sex with men in Vietnam. The specific aims are to (1) Adapt the HealthMindr app to improve HIV testing and PrEP uptake among young men who have sex with men in Vietnam; (2) Examine acceptability, feasibility and preliminary effectiveness of the adapted app among young men who have sex with men in Vietnam and (3) Explore barriers and facilitators of implementing the adapted app among young men who have sex with men in Vietnam. In Aim 1, theater testing will be conducted through focus group discussions with young men who have sex with men and key other stakeholders, including health officials, clinic staff and community-based organizations. Theater testing data will be used to refine the app for beta testing. During beta testing, a small group of young men who have sex with men will use the app for 30 days, then complete an online survey and an exit interview to rate the app's usability, provide their perspectives of the app and report any other areas for improvement. App analytics will also be collected to understand whether and how the app is used. In Aim 2, the adapted app with be tested among young men who have sex with men through a randomized controlled design. Young men who have sex with men will be randomized into the intervention or control arm (1:1 ratio). The intervention arm will have full access to the app for 3 months, while the control group will receive standard-of-care HIV services. Key app features include HIV test planning, risk and PrEP eligibility assessment, ordering of free condoms and HIV test kits, information about PrEP, and PrEP provider and HIV testing locations. HIV testing and PrEP use will be assessed at baseline and 3 months and compared between groups. A mixed methods approach will be used to evaluate app acceptability and feasibility. Quantitative data on acceptability and feasibility will be collected through the 3-month online survey, while qualitative data will be collected through in-depth interviews with a subset of young men who have sex with men in the intervention arm and other key stakeholders. In Aim 3, through the same qualitative study as Aim 2, factors that influence the implementation of the app will be explored. Determinants from seven domains will be identified: condition, technology, value proposition, adopter system, health organization, wider system and embedding/adaption over time. Only when mHealth interventions are both effective and adopted can they maximize their potential to reduce HIV incidence among target populations. This proposal will generate data for designing a full-scale hybrid type 1 effectiveness-implementation trial to test the adapted app and identify implementation strategies to address the barriers of app implementation in low and middle-income countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mobile appThose assigned to the intervention arm will receive access to the adapted HealthMindr app with key features, including HIV test planning, initial risk/PrEP eligibility assessment, ordering of free condoms and HIV test kits, information about PrEP, PrEP provider and HIV testing locations, and any additional features added through the adaptation process. The staff will help participants download the app and walk them through its use during the study visit. These participants will be encouraged to use the app for a period of 3 months. In addition, participants will be provided standard-of-care HIV prevention information upon enrollment at the study site by a study staff, which includes written prevention materials for HIV testing and referrals to local HIV prevention services. Anyone who seroconverts during the study period will be referred to appropriate HIV treatment services. |
| Control | No intervention | –Participants randomized to the control arm will be provided standard-of-care HIV prevention information upon enrollment at the study site by a study staff, which includes written prevention materials for HIV testing and referrals to local HIV prevention services. Anyone who seroconverts during the study period will be referred to appropriate HIV treatment services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Young men who have sex with men (YMSM):
- Theater testing. YMSM are eligible if they (1) are 18-24 years old Vietnamese male; (2) report having anal intercourse with another man in the last 6 months; (3) are HIV negative or of unknown HIV status; (4) own a smartphone; (5) currently live in Hanoi, (6) are able to read and understand Vietnamese without assistance, and (7) are willing to provide informed consent.
- Beta testing. Eligibility is similar to theater testing. Randomized controlled trial (RCT). YMSM are eligible if they (1) are 18-24 years old Vietnamese male; (2) report having anal intercourse with another man in the last 6 months; (3) are HIV negative or of unknown HIV status; (4) own a smartphone; (5) currently live in Hanoi, (6) are able to read and understand Vietnamese without assistance, and (7) are willing to provide informed consent and (8) are not being currently on pre-exposure prophylaxis (PrEP).
- Other key stakeholders:
- Eligibility criteria of this group are (1) having worked with MSM-related health issues at an HIV/PrEP clinic or community-based organizations (CBO) for at least 6 months and (2) willingness to provide informed consent.
Key exclusion criteria (4 listed)
- Young men who have sex with men (YMSM):
- Theater testing. None Beta testing. Participants will be deemed ineligible if they are unwilling to provide contact information.
- Randomized controlled trial. Exclusion criteria include (1) unwilling to provide contact information; (2) currently enrolled in other HIV testing or PrEP program/intervention.
- Other key stakeholders: None
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 |
|---|---|---|
| Mobile appThe intervention will be a mobile app adapted from HealthMindr - an app based on Social Cognitive Theory - for young men who have sex with men in Vietnam. The app, which was developed and tested in the US, offers a range of testing and prevention services, including self-screening for HIV and sexually transmitted infection (STI) risk, a scheduling and reminder system for HIV/ STI testing, PrEP eligibility screener, an ordering platform for delivery of at-home test kits and condoms, and locators for HIV services. Additional features and contents might be revised and added depending on the needs of young men who have sex with men in Vietnam. | Behavioural | Intervention |
Primary outcome
Acceptability
Time frame: 3 months
Mean score on the 10-item System Usability Scale (for the app) of participants in the intervention arm. Data from this scale will be scored from 0 to 100, and a score of ≥50 indicates that the app is acceptable (higher score means better outcome).
Feasibility (App usage)
Time frame: 3 months
The proportion of participants assigned to the intervention arm who open the app at least once during the follow-up period
HIV testing
Time frame: Baseline; 3 months
The proportion of participants who get tested for HIV in the last 3 months
PrEP uptake
Time frame: 3 months
The proportion of participants who initiate PrEP during the follow-up period
2 secondary outcomes
STI testing
Time frame: Baseline; 3 months
PrEP clinic visit
Time frame: Baseline; 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app in people with Intervention and Control Condition, run by Hanoi Medical University at 1 site in Vietnam.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Aug 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.