Mobile-Based Application "MyChoices"

• Sponsor: Fenway Community Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03179319
• Collaborator: University of North Carolina (Other), Montefiore Medical Center (Other), Emory University (Other), Brown University (Other)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Actual Duration (Months): 31
• Patients Per Site: 30
• Patients Per Site Per Month: 1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
HIV; Sexually Transmitted Diseases; Pre-exposure Prophylaxis; Risk Reduction	Behavioral: MyChoices	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Mobile-Based Application "MyChoices" to Increase Uptake of HIV Testing, Detection of New HIV Infections, and Linkage to Care and Prevention Services by Young Men Who Have Sex With Men
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Dec 28, 2019
• Actual Study Completion Date: Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Standard of Care Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Feasibility: Frequency of Logins [3 months]

   Number of individuals who logged into app at least one time after set up

Secondary Outcome Measures

1. Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV [6 months]

   Self-report having tested for HIV over follow up

2. Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP [6 months]

   Self-report of participants reporting PrEP initiation anytime over study follow up

3. 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

4. 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

5. Number of HIV Home Testing Kits Ordered [6 months]

   Number of Participants who ordered at least one HIV home testing kit over follow up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 24 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fenway Health Center	Boston	Massachusetts	United States	02215
2	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Fenway Community Health
• University of North Carolina
• Montefiore Medical Center
• Emory University
• Brown University

Investigators

• Principal Investigator: Katie B Biello, PhD, MPH, Protocol Co-Chair, Research Study MPI
• Principal Investigator: Kenneth H Mayer, MD, Fenway Health Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 8, 2019

More Information

Publications

None provided.

• Responsible Party: Kenneth H. Mayer, MD, Principal Investigator, Fenway Community Health
• ClinicalTrials.gov Identifier: NCT03179319
• Other Study ID Numbers: 1U19HD089881 (SubProject 8784); 1U19HD089881
• First Posted: Jun 7, 2017
• Last Update Posted: Dec 16, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kenneth H. Mayer, MD, Principal Investigator, Fenway Community Health: PrEP; HIV testing; Sexually transmitted disease (STD) testing; Mobile app; Young men who have sex with men; Technology
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

Participant Flow

Arm/Group Title	MyChoices	Standard of Care
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Period Title: Overall Study
STARTED	40	20
3 Month Visit	37	20
COMPLETED	34	20
NOT COMPLETED	6	0

Baseline Characteristics

Arm/Group Title	MyChoices	Standard of Care	Total
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.	Total of all reporting groups
Overall Participants	40	20	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.25 (2.08)	21.95 (2.26)	21.48 (2.15)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	40 100%	20 100%	60 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 15%	3 15%	9 15%
Not Hispanic or Latino	34 85%	17 85%	51 85%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 7.5%	4 20%	7 11.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 10%	1 5%	5 8.3%
White	29 72.5%	9 45%	38 63.3%
More than one race	3 7.5%	4 20%	7 11.7%
Unknown or Not Reported	1 2.5%	2 10%	3 5%
Region of Enrollment (Count of Participants)
Boston, MA	20 50%	10 50%	30 50%
Bronx, NY	6 15%	4 20%	10 16.7%
Chapel Hill, NC	14 35%	6 30%	20 33.3%

Outcome Measures

1. Primary Outcome

Title	Acceptability: System Usability Scale
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	MyChoices
Arm/Group Description	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.
Measure Participants	36
Mean (Standard Deviation) [score on a scale]	75.76 (10.72)

2. Primary Outcome

Title	Feasibility: Frequency of Logins
Description	Number of individuals who logged into app at least one time after set up
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Error in paradata collection resulted in missing app data for 7 participants

Arm/Group Title	MyChoices
Arm/Group Description	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.
Measure Participants	33
Count of Participants [Participants]	31 77.5%

3. Secondary Outcome

Title	Preliminary Efficacy: Number of Participants Self-reported Having Tested for HIV
Description	Self-report having tested for HIV over follow up
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MyChoices	Standard of Care
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	38	20
Count of Participants [Participants]	27 67.5%	13 65%

4. Secondary Outcome

Title	Preliminary Efficacy: Number of Participants Self-reported Having Initiated PrEP
Description	Self-report of participants reporting PrEP initiation anytime over study follow up
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MyChoices	Standard of Care
Arm/Group Description	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.	Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
Measure Participants	38	20
Count of Participants [Participants]	3 7.5%	3 15%

5. Secondary Outcome

Title	Number of Times Participants Used Distinct App Components
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	MyChoices
Arm/Group Description	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.
Measure Participants	33
Mean (Standard Deviation) [App components used]	100.58 (86.09)

6. Secondary Outcome

Title	App Content and Functionality Most Utilized
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	MyChoices
Arm/Group Description	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.
Measure Participants	33
HIV test plan	30 75%
Location search	26 65%
FAQs	22 55%
Ordering supplies	31 77.5%

7. Secondary Outcome

Title	Number of HIV Home Testing Kits Ordered
Description	Number of Participants who ordered at least one HIV home testing kit over follow up
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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/Group Title	MyChoices
Arm/Group Description	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.
Measure Participants	40
Count of Participants [Participants]	25 62.5%

Adverse Events

Time Frame	For each participant, adverse event data were collected for 6 months. Across the study, AE data was collected from 11/13/2018 through 11/05/2019.
Arm/Group Title	MyChoices		Standard of Care
Arm/Group Description	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.		Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.
All Cause Mortality
	MyChoices		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/20 (0%)
Serious Adverse Events
	MyChoices		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	MyChoices		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.