Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04633200

Enrollment

108

Registered

2020-11-18

Start date

2021-02-01

Completion date

2022-07-30

Last updated

2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Brief summary

This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men. The intervention will include: a) personalized PrEP pill reminders b) culturally- and developmentally-sensitive text messages targeting patient education, motivation, and stress c) a gamification avatar and d) a linked online community of peers. Effectively promoting PrEP adherence would reduce new HIV infections in this at-risk population, which is subject to health disparities

Detailed description

The project is to develop and test the effectiveness of an individually-tailored, developmentally- and culturally-sensitive, mobile health (mhealth) PrEP adherence intervention called DOT. The intervention will target culturally-diverse, young adult men, ages 18-35, who have sex with men (YMSM). The recent rise in HIV infection among young people, particularly minority YMSM, points to the value of PrEP uptake and adherence support for YMSM. In PrEP efficacy trials, younger age was the most consistent correlate with low PrEP adherence. Our DOT mhealth intervention reflects a developmental understanding of young adult decision-making, and is uniquely combined with principles from social cognitive theory, positive psychology and behavioral economics. The proposed project is based on Dr. Weitzman's successful Phase 1 trial of DOT, which led to significant improvements in PrEP adherence, PrEP treatment self-efficacy, and intention to follow PrEP treatment guidelines among the YMSM that used DOT for six weeks. Our proposed Phase 2 DOT mhealth intervention is directly responsive to Phase 1 findings by adding: 1) texts targeting motivation, patient education, and stress burden 2) online community for social support 3) linkage to the federal crisis text line 4) virtual avatar 5) cloud-based platform to view user engagement 7) calendar for clinic appointments and pharmacy refills 8) enhanced personalization of pill reminders and 9) enhanced adherence graphing. In Phase 2, we will test the effectiveness of DOT at improving PrEP adherence in a randomized controlled trial.

Interventions

OTHERDOT 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender

MALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

(self report) Individuals who self-identify as a male, age 18-35, who has sex with men or who self-identify as a bisexual male or a gay male; currently taking PrEP; own a smartphone and desirous of adherence support. \-

Exclusion criteria

(self report) Males who do not meet the above criteria and/or currently use I.V. drugs.

Design outcomes

Primary

Measure	Time frame	Description
Wilson Self-reported Medication Adherence Scale	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.

Secondary

Measure	Time frame	Description
PrEP Medication Adherence Self Efficacy Scale	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.
Intention to Follow PrEP Treatment Guidelines	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.
PrEP Medication Knowledge Measure	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.
Perceived Stress Scale	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	54
Control Participants in the control group will receive a 2-page PrEP patient education document based information about PrEP from on the CDC website.	46
Total	100

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	3	5

Baseline characteristics

Characteristic	Intervention	Total	Control
Age, Continuous	26.74 years STANDARD_DEVIATION 4.43	27.17 years STANDARD_DEVIATION 4.36	27.67 years STANDARD_DEVIATION 4.25
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants	27 Participants	14 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants	72 Participants	32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	7 Participants	11 Participants	4 Participants
Race (NIH/OMB) Black or African American	7 Participants	17 Participants	10 Participants
Race (NIH/OMB) More than one race	4 Participants	6 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	34 Participants	64 Participants	30 Participants
Region of Enrollment United States	54 participants	100 participants	46 participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	54 Participants	100 Participants	46 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 57	0 / 51
other Total, other adverse events	0 / 57	0 / 51
serious Total, serious adverse events	0 / 57	0 / 51

Arm	Measure	Value (MEAN)	Dispersion
Intervention	PrEP Medication Knowledge Measure	6.75 score on a scale	Standard Deviation 1.12
Control	PrEP Medication Knowledge Measure	6.92 score on a scale	Standard Deviation 1.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026