Trial Outcomes & Findings for DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence (NCT NCT03387462)

Last Updated: 2021-10-27

Results Overview

System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-10-27

Participant Flow

Participants were recruited online and via social media, as well as through in-person community outreach.

Participant milestones

Participant milestones
Measure	DOT Diary Optimization Intervention DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
Overall Study STARTED	20
Overall Study 4 Weeks	20
Overall Study 8 Weeks	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DOT Diary Optimization Intervention DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
Overall Study Lost to Follow-up	1

Baseline Characteristics

DOT Diary Optimization Pilot: A Pilot Study to Optimize the DOT Diary App to Measure PrEP Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DOT Diary Optimization Intervention n=20 Participants DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
Age, Continuous	27.4 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: MSM eligible for or taking PrEP

Outcome measures

Outcome measures
Measure	DOT Diary Optimization Intervention n=19 Participants DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
DOT Diary Mobile App Acceptability	79.8 Score on scale Standard Deviation 15.0

PRIMARY outcome

Timeframe: 8 weeks

Population: Participants answering the ease of use question at 8 weeks.

5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP.

Outcome measures

Outcome measures
Measure	DOT Diary Optimization Intervention n=19 Participants DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
DOT Diary Mobile App Ease of Use	4 Score on a scale (Likert) Interval 4.0 to 5.0

PRIMARY outcome

Timeframe: 8 weeks

Population: MSM eligible for or taking PrEP

Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion

Outcome measures

Outcome measures
Measure	DOT Diary Optimization Intervention n=19 Participants DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP	93 Percentage of doses taken

SECONDARY outcome

Timeframe: 8 weeks

Population: MSM eligible for or taking PrEP

Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization

Outcome measures

Outcome measures
Measure	DOT Diary Optimization Intervention n=19 Participants DOT Diary mobile app and Emtricitabine / Tenofovir Disoproxil Oral Tablet Emtricitabine / Tenofovir Disoproxil Oral Tablet: Open label daily emtricitabine/tenofovir disoproxil oral tablet DOT Diary mobile app: DOT Diary mobile application for tracking medication adherence and sexual activities.
Assessment of Situations and Reasons for Sub-optimal Use of the App Technical problems	8 Count of participants for each reason
Assessment of Situations and Reasons for Sub-optimal Use of the App Away from home	6 Count of participants for each reason

Adverse Events

DOT Diary Optimization Intervention

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

Dr. Susan Buchbinder

Bridge HIV, San Francisco Department of Public Health

Phone: 628-217-7479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place