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Trial Outcomes & Findings for Mhealth for PrEP Adherence by Young Adult MSM, Phase 2 (NCT NCT04633200)

NCT ID: NCT04633200

Last Updated: 2023-12-28

Results Overview

The self-reported medication adherence scale, developed by Wilson et al. (2016), is designed to assess self-reported medication adherence to HIV-related and other types of medications. In this study, it was used to assess self-reported PrEP medication adherence. Minimum score=0, maximum=299.9. Higher score means better adherence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

108 participants

Primary outcome timeframe

90 days

Results posted on

2023-12-28

Participant Flow

Participant milestones

Participant milestones
Measure
Intervention
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
Overall Study
STARTED
57
51
Overall Study
COMPLETED
54
46
Overall Study
NOT COMPLETED
3
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Intervention
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
Overall Study
Lost to Follow-up
3
5

Baseline Characteristics

Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=54 Participants
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
n=46 Participants
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
Total
n=100 Participants
Total of all reporting groups
Age, Continuous
26.74 years
STANDARD_DEVIATION 4.43 • n=5 Participants
27.67 years
STANDARD_DEVIATION 4.25 • n=7 Participants
27.17 years
STANDARD_DEVIATION 4.36 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
54 Participants
n=5 Participants
46 Participants
n=7 Participants
100 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants
n=5 Participants
14 Participants
n=7 Participants
27 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
40 Participants
n=5 Participants
32 Participants
n=7 Participants
72 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
7 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
10 Participants
n=7 Participants
17 Participants
n=5 Participants
Race (NIH/OMB)
White
34 Participants
n=5 Participants
30 Participants
n=7 Participants
64 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
54 participants
n=5 Participants
46 participants
n=7 Participants
100 participants
n=5 Participants

PRIMARY outcome

Timeframe: 90 days

The self-reported medication adherence scale, developed by Wilson et al. (2016), is designed to assess self-reported medication adherence to HIV-related and other types of medications. In this study, it was used to assess self-reported PrEP medication adherence. Minimum score=0, maximum=299.9. Higher score means better adherence.

Outcome measures

Outcome measures
Measure
Intervention
n=54 Participants
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
n=46 Participants
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
Wilson Self-reported Medication Adherence Scale
77.48 score on a scale
Standard Deviation 13.68
71.59 score on a scale
Standard Deviation 17.07

SECONDARY outcome

Timeframe: 90 days

This scale was adapted by Kogelman and Weitzman from the Johnson HIV Adherence Self-Efficacy Scale. The PrEP medication adherence self efficacy scale was developed to assess one's confidence in one's ability to adhere to their PrEP medication treatment plan. The minimum score = 0, maximum score =80. Higher score indicates greater PrEP medication adherence self efficacy.

Outcome measures

Outcome measures
Measure
Intervention
n=54 Participants
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
n=46 Participants
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
PrEP Medication Adherence Self Efficacy Scale
8.26 score on a scale
Standard Deviation 1.55
7.63 score on a scale
Standard Deviation 1.82

SECONDARY outcome

Timeframe: 90 days

This measure was developed by Kogelman and Weitzman to assess an individual's intention to engage in key behaviors that are recommended while on PrEP treatment, e.g. concomitant use of condoms and testing for HIV every 3 months. The minimum score=0, the maximum score=16. Higher score means greater intention to follow PrEP treatment guidelines.

Outcome measures

Outcome measures
Measure
Intervention
n=54 Participants
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
n=46 Participants
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
Intention to Follow PrEP Treatment Guidelines
4.26 score on a scale
Standard Deviation 0.72
3.93 score on a scale
Standard Deviation 0.95

SECONDARY outcome

Timeframe: 90 days

This measure was developed by Kogelman and Weitzman to assess an individual's knowledge of PrEP medication through questions about medication purpose, side effects, etc. Minimum score =0, maximum score = 8. Higher score means greater knowledge about PrEP medication.

Outcome measures

Outcome measures
Measure
Intervention
n=54 Participants
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
n=46 Participants
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
PrEP Medication Knowledge Measure
6.75 score on a scale
Standard Deviation 1.12
6.92 score on a scale
Standard Deviation 1.11

SECONDARY outcome

Timeframe: 90 days

The Perceived Stress Scale, developed by Cohen et al. (1983), is designed to measure the degree to which one perceives situations in one's life as stressful. The minimum score=0, maximum score=40. Higher score indicates higher perceived stress.

Outcome measures

Outcome measures
Measure
Intervention
n=54 Participants
Participants in the intervention arm will receive a mobile app to support their daily PrEP adherence. DOT mobile app: DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
Control
n=46 Participants
Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.
Perceived Stress Scale
2.19 score on a scale
Standard Deviation 0.54
2.28 score on a scale
Standard Deviation 0.59

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patricia Flynn Weitzman

Environment and Health Group

Phone: 617-455-5976

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place