HIV, Pre-exposure Prophylaxis, Risk Reduction, Sexually Transmitted Diseases
Conditions
Keywords
PrEP, HIV testing, Sexually transmitted disease (STD) testing, Mobile app, Young men who have sex with men, Technology
Brief summary
This study is testing the acceptability and feasibility of MyChoices, a mobile application (app), to promote HIV testing and pre-exposure prophylaxis (PrEP) uptake among young men who have sex with men (YMSM).
Detailed description
MyChoices, an app adapted from HealthMindr and developed using iterative feedback from youth, is being refined to to maximize acceptability among YMSM. MyChoices was guided by the Social Cognitive Theory (SCT) model and includes three major functions that are designed to promote self-efficacy, self-regulation, goal-setting and environmental influences in order to impact behavior change. (1) Tracking and Self-Monitoring HIV Risk: In order to target self-regulation, brief surveys within the app are used to assess behavioral patterns of YMSM, particularly around sexual relationships, which are then used to help customize the app for each user. (2) HIV and sexually transmitted infection (STI) Prevention Information: In order to improve self-efficacy for HIV testing and HIV prevention overall, quizzes and infographics that appeal to YMSM have been incorporated into the app, focusing on promotion of HIV prevention and regular HIV testing. The app also allows users to order OraQuick HIV home testing kits and STI home collection kits (for rectal and urethral gonorrhea and Chlamydia and syphilis). Additionally, the app includes information on testing sites and local PrEP clinics (e.g., telephone, address, hours of testing, etc), and external links to specific site webpages that are near the user (determined using GPS technology). (3) HIV Testing Plan: Acknowledging the central role of goal setting and environmental influences on health behavior, the app allows users to create a HIV testing plan by allowing them to compare and choose different screening options (e.g., home self-testing, antigen, rapid). Questions about HIV transmission behaviors and testing history are then asked to create a tailored testing plan. After a HIV testing plan is developed, users have the option to customize reminders for the timeframe selected (e.g., user is pinged every 3 months as a reminder to get tested). Users are able to select from a list of phrases or create their own to ensure privacy. Moreover, geofencing technology allows users to be notified when in the vicinity of testing locations, based on the Geo Positioning System (GPS) location, during the testing timeframe. This study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.
Interventions
BEHAVIORALMyChoices
Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Sponsors
University of North Carolina
Montefiore Medical Center
Emory University
Brown University
Fenway Community Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* No HIV test in the past 3 months (self-reported). * Not known to be HIV-infected (self-reported). * Not currently taking PrEP (self-report). * Owns or leases a phone with Android platform (for Aims 2 and 3) or iOS platform (Aim 3 only), has an active data plan, and willing to download the MyChoices application. * Willing to attend an in-person baseline study visit in Boston or the Bronx and complete online follow-up visits. * Able to understand, read, and speak English. * Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months. * Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following: 1. at least one episode of condomless anal intercourse with an HIV-infected or unknown HIV status male or transfemale partner during the last 6 months; or 2. anal intercourse with 2 or more male or transfemale sex partners during the last 6 months; or 3. exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or 4. sex with a male or transfemale partner and has had an STI during the last 6 months.
Exclusion criteria
* Any health condition that may interfere with participation or the ability to provide informed consent, including any debilitating or life-threatening conditions. * Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product and evidence of vaccine-induced seropositivity. * Known to be HIV-infected. * Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: System Usability Scale | 3 months | System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average. |
| Feasibility: Frequency of Logins | 3 months | Number of individuals who logged into app at least one time after set up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Times Participants Used Distinct App Components | 3 months | The total number of times that participants selected distinct components (e.g., testing plan, ordering, FAQs) of the app were summed |
| Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV | 6 months | Self-report having tested for HIV over follow up |
| Number of HIV Home Testing Kits Ordered | 6 months | Number of Participants who ordered at least one HIV home testing kit over follow up |
| App Content and Functionality Most Utilized | 3 months | We a priori identified the primary app components (i.e., HIV test plan, location search, ordering supplies, FAQs) and report the number of participants using these app components at least once over follow up |
| Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP | 6 months | Self-report of participants reporting PrEP initiation anytime over study follow up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MyChoices Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Participants in this study arm will also receive local standard of care for linkage to PrEP and HIV/STI testing. | 40 |
| Standard of Care Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 0 |
Baseline characteristics
| Characteristic | Standard of Care | Total | MyChoices |
|---|---|---|---|
| Age, Continuous | 21.95 years STANDARD_DEVIATION 2.26 | 21.48 years STANDARD_DEVIATION 2.15 | 21.25 years STANDARD_DEVIATION 2.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 51 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 38 Participants | 29 Participants |
| Region of Enrollment United States Boston, MA | 10 Participants | 30 Participants | 20 Participants |
| Region of Enrollment United States Bronx, NY | 4 Participants | 10 Participants | 6 Participants |
| Region of Enrollment United States Chapel Hill, NC | 6 Participants | 20 Participants | 14 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 60 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 20 |
| other Total, other adverse events | 0 / 40 | 0 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 20 |
Outcome results
Primary
Acceptability: System Usability Scale
System Usability Scale: a validated scale that assesses subjective usability of a system, or, in this case, an app. The System Usability Scale consists of a 10 item questionnaire with five response options; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the app is acceptable, and a score above 68 is considered above average.
Time frame: 3 months
Population: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome; One person had missing data for this item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyChoices | Acceptability: System Usability Scale | 75.76 score on a scale | Standard Deviation 10.72 |
Primary
Feasibility: Frequency of Logins
Number of individuals who logged into app at least one time after set up
Time frame: 3 months
Population: Error in paradata collection resulted in missing app data for 7 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChoices | Feasibility: Frequency of Logins | 31 Participants |
Secondary
App Content and Functionality Most Utilized
We a priori identified the primary app components (i.e., HIV test plan, location search, ordering supplies, FAQs) and report the number of participants using these app components at least once over follow up
Time frame: 3 months
Population: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. Due to data collection error in the app (which was subsequently fixed), we are missing data from 7 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MyChoices | App Content and Functionality Most Utilized | HIV test plan | 30 Participants |
| MyChoices | App Content and Functionality Most Utilized | Location search | 26 Participants |
| MyChoices | App Content and Functionality Most Utilized | FAQs | 22 Participants |
| MyChoices | App Content and Functionality Most Utilized | Ordering supplies | 31 Participants |
Secondary
Number of HIV Home Testing Kits Ordered
Number of Participants who ordered at least one HIV home testing kit over follow up
Time frame: 6 months
Population: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChoices | Number of HIV Home Testing Kits Ordered | 25 Participants |
Secondary
Number of Times Participants Used Distinct App Components
The total number of times that participants selected distinct components (e.g., testing plan, ordering, FAQs) of the app were summed
Time frame: 3 months
Population: Given that this measure is directly related to the MyChoices app, only those who were randomized to the MyChoices app arm were eligible to respond to this outcome. Due to data collection error in the app (which was subsequently fixed), we are missing data from 7 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyChoices | Number of Times Participants Used Distinct App Components | 100.58 App components used | Standard Deviation 86.09 |
Secondary
Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
Self-report of participants reporting PrEP initiation anytime over study follow up
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChoices | Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP | 3 Participants |
| Standard of Care | Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP | 3 Participants |
Secondary
Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
Self-report having tested for HIV over follow up
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MyChoices | Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV | 27 Participants |
| Standard of Care | Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV | 13 Participants |