Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Alabama at Birmingham
Sponsor:
Collaborators:
University of North Carolina
University of Washington
Johns Hopkins University
University of Connecticut
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01900236
First received: July 2, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
HIV
Behavioral: 4 sessions of tailored, interactive agenda based on behavioral motivational interviewing (MI) techniques

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Viral load suppression (<200c/ml)among patients newly initiating outpatient HIV medical care [ Time Frame: 48 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viremia copy years (VCY) [ Time Frame: 96 week ] [ Designated as safety issue: No ]
    VCY is the area under the curve estimate of cumulative VL burden


Estimated Enrollment: 400
Study Start Date: December 2013
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Motivation Behavioral Technique
Behavioral: 4 sessions of tailored, interactive agenda based on behavioral motivational interviewing (MI) techniques
Behavioral: 4 sessions of tailored, interactive agenda based on behavioral motivational interviewing (MI) techniques
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.

Detailed Description:

The Centers for Disease Control's Retention In Care (CDC RIC) and the Participating and Communicating Together (PACT) antiretroviral therapy (ART) adherence interventions have shown success in the literature, and they are well suited to target the two essential HIV adherence behaviors needed to achieve better overall health: HIV medical visit adherence and ART adherence. While these original interventions target each of these behaviors separately, the comprehensive iENGAGE intervention combines these two approaches to address the experience of an individual who is initiating HIV care. Upon entry to care, knowledge, motivation, and skills for adherence to HIV medical visits and ART must be learned rapidly. Jointly targeting these behaviors offers a distinct advantage over addressing them separately.

iENGAGE integrates CDC RIC and PACT through their common intervention targets with the assistance of trained interventionists, who will maintain contact with the new patient to educate and assist with reinforcing the importance of adherence to care. While the actions required to attend HIV medical care appointments and take medications properly are distinct, each is influenced by an individual's personal motivation and skills for self-management of HIV infection and overall health; these principles are the focus of the intervention sessions for this protocol .

During this intervention, our team will make every effort to protect all participants' confidential and private information in order to minimize possible study-associated risks. In addition, the follow up measurement plan for this study is unique, as it aims to utilize the X060831001: Unsolicited R24 for the CFAR Network of Integrated Clinical Sciences, CNICS, PI Michael Saag) secure electronic data infrastructure, which has existing defined protocols for the protection of human subjects data, including a data management core that is housed at the collaborating site at the University of Washington.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented HIV infection
  • Newly establishing HIV care at study site
  • Age 19 years or older
  • English speaking

Exclusion Criteria:

  • Not willing or able to provide informed consent
  • Received prior outpatient HIV care
  • Completed >1 primary care visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900236

Contacts
Contact: Modi 2059341284 Rmodi@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: Michael J Mugavero, MD, MHSc         
United States, Maryland
The Johns Hopkins HIV Care Program Recruiting
Baltimore, Maryland, United States, 21205
United States, North Carolina
UNC Infectious Diseases Clinic Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Washington
• University of Washington Recruiting
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Alabama at Birmingham
University of North Carolina
University of Washington
Johns Hopkins University
University of Connecticut
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01900236     History of Changes
Other Study ID Numbers: 1R01AI103661
Study First Received: July 2, 2013
Last Updated: April 15, 2014
Health Authority: United States: National Institutes of Health

Keywords provided by University of Alabama at Birmingham:
Patients newly initiating outpatient HIV medical care

ClinicalTrials.gov processed this record on July 23, 2014