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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AI157857-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| treatment-as-usual (TAU) | Active Comparator | Participants in the TAU group will receive the MyLink2Care app with major intervention features inactivated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyLink2Care app full functionality | Other | Participants will be shown how to download the app and use the assessment tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Preliminary Efficacy of the MyLink2Care app through DBS testing as PrEP adherence measure |
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Inclusion Criteria:
Exclusion Criteria:
Transgender women
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Wickersham, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya | Kuala Lumpur | 50603 | Malaysia |
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| MyLink2Care app major intervention features inactivated | Other | Participants will be shown how to download the app and use the assessment tool. |
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| 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. | 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 | 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. | 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. | 6 months |
The investigators will measure PrEP adherence DBS at 6 months. DBS will quantify tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) in RBC |
| 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 | 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. | 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. | 6 months |