NCT04233931

Brief Summary

The proposed project involves the development and testing of an mhealth intervention to increase adherence to PrEP treatment using texts providing tailored pill reminders, motivational messages, and health education messages. The intervention targets culturally-diverse young adult men who have sex with men (YMSM), who are at high risk for both HIV and non-adherence to PrEP medication. Supporting PrEP adherence would help reduce new HIV infections in this group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

January 15, 2020

Last Update Submit

January 16, 2020

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

  • PrEP medication adherence tool

    A 3-item HIV medication adherence tool developed by Segeral was adapted for use with PrEP/Truvada to assess PrEP adherence

    6 weeks

Secondary Outcomes (3)

  • PrEP treatment self-efficacy scale

    6 weeks

  • PrEP knowledge Tool

    6 weeks

  • Intention to practice safe sex and adhere to 3-month follow-up HIV testing Tool

    6 weeks

Study Arms (1)

participant

EXPERIMENTAL

all participants in the study receive the mobile app.

Behavioral: PrEP medication adherence mobile app

Interventions

PrEP medication adherence mobile appBEHAVIORAL

Participants use a PrEP medication adherence mobile app for six weeks.

participant

Eligibility Criteria

Age20 Years - 29 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-identify as male
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age 20-29
  • Currently taking PrEP
  • Own smartphone

You may not qualify if:

  • Current participation in PrEP or other HIV-related study
  • Uncomfortable with potential privacy loss risks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Environment and Health Group

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • patricia f weitzman, PhD

    Environment and Health Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: pre-post test evaluation of the impact of a mobile app on PrEP treatment adherence
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

June 21, 2017

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

We have no plan to make data available.

Locations

US(1)