HIVNCT05271097
MHealth HIV Prevention for Transgender Women
A study testing MyLink2Care app full functionality and MyLink2Care app major intervention features inactivated in people with HIV, run by Yale University at 1 site in Malaysia.
Trial summary
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual. 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
- What is being tested?
- MyLink2Care app full functionality and MyLink2Care app major intervention features inactivated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 12 Jul 2023to Mar 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-negative
- Identify as a transgender woman
- 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.
About this study
Official title: Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.
Read the detailed description
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis (PrEP) compared to treatment as usual.
A new clinic-affiliated app (to be called MyLink2Care) will be developed (by adapting an existing app) and tested to deliver an integrated HIV prevention intervention that incorporates tailored HIV prevention and gender affirming care (GAC) services to TGW in Malaysia. The specific aims of the study include:
- Aim 1: Guided by the modified IM Adapt model, an existing mobile app will be adapted, expanded, and refined. Focus groups will be conducted with TGW (n=20) and clinical stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the MyLink2Care app (alpha version), which will undergo usability testing (N=10), followed by full development of the app (beta version).
- Aim 2 Conduct beta testing of the fully developed version of the MyLink2Care app (N=15) to assess its usability and acceptability.
- Aim 3: Assess preliminary feasibility and acceptability of the MyLink2Care app within a pilot, randomized controlled trial, compared with treatment as usual for engagement in the HIV prevention cascade (N=50).
Together, these aims will address multilevel barriers to HIV testing and PrEP uptake in Malaysian TGW. Feasibility is high based on the investigators extensive experience with HIV prevention in TGW, theory-guided behavioral interventions, mHealth expertise, and longstanding work in Malaysia.
- Conditions
- HIV
- Being tested
- MyLink2Care app full functionality, MyLink2Care app major intervention features inactivated
- Keywords
- transgender, HIV prevention, HIV intervention, transgender woman
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyLink2Care app full functionalityOther
Participants will be shown how to download the app and use the assessment tool.
MyLink2Care app major intervention features inactivatedOther
Participants will be shown how to download the app and use the assessment tool.
| Study group | Role | What they receive |
|---|---|---|
| MyLink2Care app | Experimental | Participants in the MyLink2Care group will be provided with full app access and will be encouraged to use all features of the app. Receives: Other: MyLink2Care app full functionality |
| treatment-as-usual (TAU) | Active comparator | Participants in the TAU group will receive the MyLink2Care app with major intervention features inactivated. Receives: Other: MyLink2Care app major intervention features inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the MyLink2Care app using percentages of individuals screened
The investigators will use the percentage of individuals screened to determine the feasibility of the MyLink2Care app
Measured: 6 months
Feasibility of the MyLink2Care app using percentages of individuals eligible
The investigators will use the percentage of individuals eligible to determine the feasibility of the MyLink2Care app
Measured: 6 months
Feasibility of the MyLink2Care app using percentages of individuals enrolled
The investigators will use the percentage of individuals enrolled to determine the feasibility of the MyLink2Care app
Measured: 6 months
Feasibility of the MyLink2Care app using percentages of individuals retained
The investigators will use the percentage of individuals retained to determine the feasibility of the MyLink2Care app
Measured: 6 months
Feasibility of the MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care app through dried blood spot (DBS) testing as PrEP adherence measure
The investigators will measure PrEP adherence DBS at 3 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in red blood cells (RBC).
Measured: 3 months
Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure
The investigators will measure PrEP adherence DBS at 6 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC
Measured: 6 months
Preliminary Efficacy of the MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 posted8 Mar 2022
- Study start12 Jul 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Wickersham, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271097
- Sponsor's protocol ID
- 2000030146
- Other IDs
- 1R21AI157857-01A1
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2022
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a MHealth HIV Prevention Intervention for Transgender Women (Phase 1 and 2)
- ClinicalTrials.gov ID
- NCT05271097
- Acronym / sponsor ID
- 2000030146
- Conditions
- HIV
- Keywords
- transgender, HIV prevention, HIV intervention, transgender woman
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Mar 2022 (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.
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis compared to treatment as usual.
Detailed description
This study aims to inform the development of an acceptable and usable smartphone app for transgender women (TGW) in Malaysia to deliver an integrated HIV prevention intervention that incorporates screening and guidance for HIV testing and pre-exposure prophylaxis (PrEP) compared to treatment as usual.
A new clinic-affiliated app (to be called MyLink2Care) will be developed (by adapting an existing app) and tested to deliver an integrated HIV prevention intervention that incorporates tailored HIV prevention and gender affirming care (GAC) services to TGW in Malaysia. The specific aims of the study include:
- Aim 1: Guided by the modified IM Adapt model, an existing mobile app will be adapted, expanded, and refined. Focus groups will be conducted with TGW (n=20) and clinical stakeholders (n=10) to theater test the existing app to develop an interactive prototype of the MyLink2Care app (alpha version), which will undergo usability testing (N=10), followed by full development of the app (beta version).
- Aim 2 Conduct beta testing of the fully developed version of the MyLink2Care app (N=15) to assess its usability and acceptability.
- Aim 3: Assess preliminary feasibility and acceptability of the MyLink2Care app within a pilot, randomized controlled trial, compared with treatment as usual for engagement in the HIV prevention cascade (N=50).
Together, these aims will address multilevel barriers to HIV testing and PrEP uptake in Malaysian TGW. Feasibility is high based on the investigators extensive experience with HIV prevention in TGW, theory-guided behavioral interventions, mHealth expertise, and longstanding work in Malaysia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyLink2Care app | Experimental | Other: MyLink2Care app full functionalityParticipants in the MyLink2Care group will be provided with full app access and will be encouraged to use all features of the app. |
| treatment-as-usual (TAU) | Active comparator | Other: MyLink2Care app major intervention features inactivatedParticipants in the TAU group will receive the MyLink2Care 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 (4 listed)
- HIV-negative
- Identify as a transgender woman
- 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 |
|---|---|---|
| MyLink2Care app full functionalityParticipants will be shown how to download the app and use the assessment tool. | Other | MyLink2Care app |
| MyLink2Care app major intervention features inactivatedParticipants will be shown how to download the app and use the assessment tool. | Other | treatment-as-usual (TAU) |
Primary outcome
Feasibility of the MyLink2Care 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 MyLink2Care app
Feasibility of the MyLink2Care 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 MyLink2Care app
Feasibility of the MyLink2Care 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 MyLink2Care app
Feasibility of the MyLink2Care 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 MyLink2Care app
Feasibility of the MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care 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 MyLink2Care app through dried blood spot (DBS) testing as PrEP adherence measure
Time frame: 3 months
Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure
Time frame: 6 months
Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence
Time frame: 3 months
Preliminary Efficacy of the MyLink2Care app using the visual analog scale (VAS) to measure PrEP adherence
Time frame: 6 months
Preliminary Efficacy of the MyLink2Care app using proportion of participants who persist on PrEP
Time frame: 6 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 18 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Jeffrey Wickersham, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyLink2Care app full functionality and MyLink2Care app major intervention features inactivated in people with HIV, run by Yale University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 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?
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?
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 MyLink2Care 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?
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 18 Mar 2025.