NCT04868383

Brief Summary

This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

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

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

April 29, 2021

Last Update Submit

April 29, 2021

Conditions

HIV PreventionPrEPAdherence, Medication

Keywords

HIVPreventionAdherenceUptake

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Overall percentage of PrEP medication adherence

    6 months

Secondary Outcomes (1)

  • Usability

    6 months

Study Arms (1)

Single pilot arm

EXPERIMENTAL

In this single arm pilot study, all participants will receive access to a novel smartphone app designed to support PrEP uptake and adherence for a 6 month period.

Behavioral: Use of smart phone technology to support medication adherence and uptake

Interventions

Use of smart phone technology to support medication adherence and uptakeBEHAVIORAL

Use of smart phone technology to support medication adherence and uptake

Single pilot arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • one or considering being on PrEP for HIV prevention
  • Patient at a VDH or VDH funded clinic
  • ability to read at a 5th grade reading level

You may not qualify if:

  • HIV positive individuals
  • Persons under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Department of Health

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

April 29, 2021

First Posted

April 30, 2021

Study Start

January 1, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)