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| Name | Class |
|---|---|
| Healing, Empowerment, Recovery of Chemsex (HERO) integrated care clinic | UNKNOWN |
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This study is examining the usability and effectiveness of an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for individuals and communities.
The practice of sexualized drug use is historical and has been noted across a diversity of genders and people of various sexual orientations. The term "chemsex" has been used to specifically describe the use of psychoactive substances in sexualized settings among gay, bisexual, and other men who have sex with men (GBMSM), particularly stimulants like methamphetamine and mephedrone, or other drugs like γ-hydroxybutyrate (GHB), γ-butyrolactone (GBL). Chemsex among GBMSM has coincided with the emergence of sexual-networking mobile apps, creating new opportunities for finding new partners with the intention to engage in chemsex.
Harm reduction strategies for GBMSM engaging in chemsex are needed because the use of these drugs can have negative consequences for the physical and mental health of the people who use them. One of the main risks associated with chemsex is the possibility of overdose. In addition to the risk of overdose, chemsex may also increase the risk of sexually transmitted infections (STIs) and HIV transmission due to the higher possibility to engage in risky sexual behaviors.
Seeking help can be difficult for GBMSM who engage in chemsex due to stigma, making the harm reduction approach equally important as clinical treatment or intervention that emphasized an abstinence approach. Harm reduction strategies recognize that drug use is a complex issue and that it is not always possible or desirable for people to stop using drugs completely. Instead, harm reduction approaches aim to reduce the harm that can result from drug use and to support people in making healthier choices.
Considering also that mobile applications are another way to provide help to hard to reach population, this study aims to develop an innovative mobile app that integrates harm reduction strategies into the existing pre-exposure prophylaxis (PrEP) intake and adherence app. PrEP is a medication that can be taken daily to reduce the risk of HIV transmission. The aim of including PrEP adherence in the self-help harm reduction strategy is to ensure that participants have access to and are using an effective HIV prevention method. Behavior regulation strategies such as providing education about the risks of drug use, overdose prevention and management, and HIV prevention through correct PrEP intake, can be integrated into a mobile app that aims to minimize the negative consequences of drug use and reduce the risks associated with it, with an overarching goal to reduce the potentially negative consequences of problematics chemsex behavior for individuals and communities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The harm reduction mobile app | Experimental | Participants in the intervention arm will receive access to all the app functions. The primary features of the app include PrEP taking diary, setting harm reduction goals, providing location of needle and syringe services program, providing accurate information on chemsex urban legends, and sending alerts to emergency contact in case of intoxication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile app to reduce harm of chemsex | Behavioral | Access to the mobile app which includes PrEP diary, demistification of chemsex urban legends, information on the location of needle and syringe services program, and alert sending to emergency contact. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the App | Scores on the translated version of the mHealth App Usability questionnaire (MAUQ) was used to assess usability. Responses to the statements on the questionnaire ranged from 1(strongly agree) to 7 (strongly disagree). The questionnaire is the total score of each item divided by the number of items. The closer the mean value is to 1, the higher the app's usability will be. | 1 month |
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Inclusion Criteria:
Exclusion criteria:
chemsex engaging individuals aged 18 years or older that are cisgender men or transgender female who have sex with men are eligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Carol Strong, PhD | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NationalCKU | Tainan | Taiwan |
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No significant events occurred between enrollment and participation. Eligible participants were directly onboarded to the UPrEPU app and completed baseline assessments. No washout, run-in period, or pre-assignment exclusions were reported.
Participants were recruited from an integrated care clinic specializing in sexual health and chemsex, from current UPrEPU users, and through online channels and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Harm Reduction Mobile App | Participants in the intervention arm will receive access to all the app functions. The primary features of the app include PrEP taking diary, setting harm reduction goals, providing location of needle and syringe services program, providing accurate information on chemsex urban legends, and sending alerts to emergency contact in case of intoxication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty-five eligible participants were enrolled and completed the baseline survey, of whom twenty completed the follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | The Harm Reduction Mobile App | Participants in the intervention arm will receive access to all the app functions. The primary features of the app include PrEP taking diary, setting harm reduction goals, providing location of needle and syringe services program, providing accurate information on chemsex urban legends, and sending alerts to emergency contact in case of intoxication. Mobile app to reduce harm of chemsex: Access to the mobile app which includes PrEP diary, demistification of chemsex urban legends, information on the location of needle and syringe services program, and alert sending to emergency contact. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants were categorized as below 35 years or 35 years and above. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of the App | Scores on the translated version of the mHealth App Usability questionnaire (MAUQ) was used to assess usability. Responses to the statements on the questionnaire ranged from 1(strongly agree) to 7 (strongly disagree). The questionnaire is the total score of each item divided by the number of items. The closer the mean value is to 1, the higher the app's usability will be. | Posted | Mean | Standard Deviation | Scores on the MAUQ | 1 month |
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From enrollment until the day of interview, up to 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Harm Reduction Mobile App | Participants in the intervention arm will receive access to all the app functions. The primary features of the app include PrEP taking diary, setting harm reduction goals, providing location of needle and syringe services program, providing accurate information on chemsex urban legends, and sending alerts to emergency contact in case of intoxication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Carol Strong | National Cheng Kung University | +886-6-2353535 | 5963 | Carol.chiajung@gmail.com |
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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 | May 31, 2023 | Apr 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Education | Education was categorized as having a bachelor's degree or higher versus lower educational attainment. | Count of Participants | Participants |
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| Employment Status | Employment status was recorded as employed versus not employed. | Count of Participants | Participants |
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| Type of substance used for chemsex | Participants reported use of specific substances for chemsex in the past 3 months. Multiple responses were allowed. | Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item. | Number | Participants |
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| Sexual behaviors | Sexual behaviors were assessed based on self-reported sexual risk indicators, including partner HIV status, number of sexual partners, condomless anal intercourse, and lifetime STI history. | Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item. | Number | Participants |
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| Preventive behaviors | Preventive behaviors included HIV status and PrEP use, vaccination uptake (Mpox and HPV), and use of doxycycline post-exposure prophylaxis (Doxy-PEP). | Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item. | Number | Participants |
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| Chemsex services utilization in the past three months | Chemsex service utilization was assessed based on self-reported use of recovery counseling, mental health services, NGO-affiliated programs, and needle and syringe programs | Multiple-response variables allowed participants to be counted in more than one category; therefore, category totals may exceed the overall number of participants analyzed. All other variables used complete available data per item. | Number | Participants |
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| Self-efficacy for sexual safety | Self-efficacy for sexual safety was measured using seven items rated on a five-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (5). Example items include "I can choose safer sex with a man I have sex with regularly" and "I am confident that I can have safer sex even if my partner really doesn't want to" (Cron bach's alpha = 0.72). Total scores ranged from 7 to 35, with higher scores indicating greater self-efficacy for safe sex . Higher scores indicate greater self-efficacy. | Mean | Standard Deviation | Scale scores |
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| Sexual satisfaction | Sexual satisfaction was assessed using four questions rated on a seven-point scale ranging from "not at all" (1) to "extremely" (7). Participants responded to statements reflecting their sexual lives, such as "In most ways, my sexual life is close to my ideal" (Cronbach's alpha = 0.97) Higher scores indicate greater satisfaction | Mean | Standard Deviation | Scale scores |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 20 |
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| 20 |
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| 20 |
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