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| ID | Type | Description | Link |
|---|---|---|---|
| MOST 108-2636-B-006-004 | Other Grant/Funding Number | Taiwan Ministry of Science and Technology |
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| Name | Class |
|---|---|
| National Cheng-Kung University Hospital | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| National Tsing Hua University | OTHER |
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This study is testing feasibility and acceptability of a theoretically based mobile application (app), UPrEPU, to increase adherence to pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) to prevent human immunodeficiency virus (HIV).
This study aims to develop an effective mobile application (app), UPrEPU to recognize the factors and decisions that affect PrEP adherence in high-risk populations to improve PrEP adherence. Key components of the app include a sex/PrEP diary using ecological momentary assessment to facilitate accurate data collection; PrEP taking reminder; HIV and sexually transmitted infections (STI) testing information and reminders; HIV and PrEP information and videos; geo-location.
After eligible PrEP candidates agree to participate in the study, we will ask participants to install the app. Then, we will begin to collect their sexual diary and PrEP taking log via ecological momentary assessment. Participants will also complete monthly assessments. The monthly follow-up will test HIV/STI and drug concentration. The participants will be interviewed for difficulties when they use our app and giving feedback on it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: the mobile App | Experimental | Participants in the intervention arm will receive access to all the app capabilities. The app features include information on HIV testing locations, sex and PrEP diary and reminder of taking PrEP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile app to improve adherence to PrEP self-management | Behavioral | Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Scores on system usability scale (SUS) for this app at the first month and the fourth month. | 4 months |
| Feasibility: data based on the app analytics |
| 4 months |
| Efficacy of adherence monitoring | Measuring the Tenofovir (TDF) and Emtricitabine (FTC) drug concentration in dried blood spot (DBS) samples to compare with self-report data | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: data from qualitative interviews |
| 4 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Strong, PhD | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Tainan | 701 | Taiwan | ||
| Taipei city hospital (Renai Branch) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33258793 | Derived | Strong C, Wu HJ, Tseng YC, Yuan CW, Yu YF, Liao JC, Chen YW, Hung YC, Li CW, Huang PH, Ko NY, Ku SW. Mobile App (UPrEPU) to Monitor Adherence to Pre-exposure Prophylaxis in Men Who Have Sex With Men: Protocol for a User-Centered Approach to Mobile App Design and Development. JMIR Res Protoc. 2020 Dec 1;9(12):e20360. doi: 10.2196/20360. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2020 |
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| Taipei |
| 10629 |
| Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Dec 28, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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