Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

NCT01900236 | Completed DMC

• 1 other identifier: 1R01AI103661
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 4

Brief Summary

iENGAGE is a 4 session, in-clinic behavioral intervention that is delivered to new clinic patients during the first year of HIV care on a flexible delivery schedule, with intervention visits scheduled to coincide with HIV medical care visits. Interventionists from each participating collaborating site will be trained centrally to implement the iENGAGE protocol. Following study enrollment and baseline assessment, participants will be randomized to treatment as usual and intervention groups. For intervention-arm participants, each iENGAGE intervention session includes: interventionist-delivered educational content for managing HIV medical care appointment-keeping and information sessions for learning to manage HIV medications. The intervention will have a tailored, interactive agenda for each of the 4 sessions based on behavioral motivational interviewing (MI) techniques. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order to improve overall health.

Conditions

HIV

Keywords

Patients newly initiating outpatient HIV medical care

Outcome Measures

Primary Outcomes (1)

• Viral load (VL) suppression (<200c/ml) among patients newly initiating outpatient HIV medical care

  VL suppression is defined as \<200 copies/ml of blood

  48 weeks

Secondary Outcomes (4)

• Viremia Copy Years (VCY)

  96 weeks

• Visit adherence

  First provider visit to 48 weeks and 96 weeks

• 4 month visit constancy

  First provider visit to 48 weeks and 96 weeks

• Time to viral load (VL) suppression

  First provider visit to first VL suppression with administrative censoring at 12 months

Study Arms (2)

Control

NO INTERVENTION

Control arm participants will receive standard clinical care (i.e. receive usual clinic treatment)

Motivation Behavioral Technique

EXPERIMENTAL

Behavioral: 4 sessions of tailored, interactive agenda based on behavioral motivational interviewing (MI) techniques. Each iENGAGE intervention session includes: interventionist-delivered educational content for managing HIV medical care appointment-keeping and information sessions for learning to manage HIV medications. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order in order to achieve viral suppression and improve overall health.

Behavioral: Based on behavioral motivational interviewing (MI) technique

Interventions

Based on behavioral motivational interviewing (MI) technique BEHAVIORAL

In addition to receiving standard clinic care, the intervention will have a tailored, interactive agenda for each of the 4 sessions based on behavioral motivational interviewing (MI) technique. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order to in order to achieve viral suppression and improve overall health.

Motivation Behavioral Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented HIV infection
• Newly establishing HIV care at study site
• Age 18 years or older
• English speaking

You may not qualify if:

• Not willing or able to provide informed consent
• Received prior outpatient HIV care
• Completed \>1 primary care visits

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of North Carolina: collaborator
• University of Washington: collaborator
• Johns Hopkins University: collaborator
• University of Michigan: collaborator

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

The Johns Hopkins HIV Care Program

Baltimore, Maryland, 21205, United States

Location

UNC Infectious Diseases Clinic

Chapel Hill, North Carolina, 27599, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• Yigit I, Modi RA, Weiser SD, Johnson MO, Mugavero MJ, Turan JM, Turan B. Effects of an intervention on internalized HIV-related stigma for individuals newly entering HIV care. AIDS. 2020 Sep 1;34 Suppl 1(Suppl 1):S73-S82. doi: 10.1097/QAD.0000000000002566.

  PMID: 32881796 DERIVED

• Shaw S, Modi R, Mugavero M, Golin C, Quinlivan EB, Smith LR, Roytburd K, Crane H, Keruly J, Zinski A, Amico KR. HIV Standard of Care for ART Adherence and Retention in Care Among HIV Medical Care Providers Across Four CNICS Clinics in the US. AIDS Behav. 2019 Apr;23(4):947-956. doi: 10.1007/s10461-018-2320-1.

  PMID: 30377981 DERIVED

• Modi RA, Mugavero MJ, Amico RK, Keruly J, Quinlivan EB, Crane HM, Guzman A, Zinski A, Montue S, Roytburd K, Church A, Willig JH. A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey. JMIR Res Protoc. 2017 Jun 16;6(6):e115. doi: 10.2196/resprot.6768.

  PMID: 28623185 DERIVED

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Michael J Mugavero, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 16, 2013
• Study Start: December 1, 2013
• Primary Completion: June 30, 2017
• Study Completion: December 1, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (4)