Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV (iENGAGE)

• ClinicalTrials.gov Identifier: NCT01900236
• Recruitment Status: Completed
• First Posted: July 16, 2013
• Last Update Posted: February 15, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborators: University of North Carolina; University of Washington; Johns Hopkins University; University of Michigan
• Information provided by (Responsible Party): Michael J Mugavero, MD, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV	Behavioral: Based on behavioral motivational interviewing (MI) technique	Not Applicable

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 Centers for AIDS Research (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.

Stigma Supplement (Michael J. Mugavero, Janet M. Turan, Bulent Turan)

As part of this supplement, the research team has incorporated multi-item questionnaire measures of stigma into baseline and final data collection for the iENGAGE trial. The goal of Aim 1 is to examine the longitudinal associations and potential causal mechanisms in the relationships between dimensions of HIV-related stigma and HIV visit adherence, antiretroviral therapy (ART) adherence, and viral load suppression, among control participants in the study. In addition, in Aim 2, we will examine the effects of the iENGAGE intervention on dimensions of stigma, by comparing changes in stigma in the two arms of the Randomized Controlled Trial (RCT).

For Aim 3, after participants have completed the 48-week iENGAGE intervention, we will conduct up to 40 individual in-depth face-to-face qualitative interviews with selected participants using a separate informed consent process. Topics to be explored in these interviews include qualitative exploration of how HIV-related stigma and other intersectional stigmas affect engagement in HIV care, as wells as exploring how participation in the iENGAGE intervention may have influenced the participant's experiences of anticipated, internalized, and experienced stigma; as well as disclosure concerns and actual disclosure behavior.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 371 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV
• Study Start Date: December 2013
• Actual Primary Completion Date: June 30, 2017
• Actual Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control; Control arm participants will receive standard clinical care (i.e. receive usual clinic treatment)
Experimental: Motivation Behavioral Technique; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Viral load (VL) suppression (<200c/ml) among patients newly initiating outpatient HIV medical care [ Time Frame: 48 weeks ]
   VL suppression is defined as <200 copies/ml of blood

Secondary Outcome Measures :

1. Viremia Copy Years (VCY) [ Time Frame: 96 weeks ]
   VCY is the area under the curve estimate of cumulative VL burden
2. Visit adherence [ Time Frame: First provider visit to 48 weeks and 96 weeks ]
   We will calculate visit adherence as a proportion that captures the number of "attended" visits in the numerator and the number of total scheduled visits ("attended" plus "no show") in the denominator during study period.
3. 4 month visit constancy [ Time Frame: First provider visit to 48 weeks and 96 weeks ]
   We will evaluate visit constancy as the proportion of pre-specified time intervals with at least 1 attended clinic visit during the study period. We will use 4 month time interval
4. Time to viral load (VL) suppression [ Time Frame: First provider visit to first VL suppression with administrative censoring at 12 months ]
   We will calculate time to VL suppression (defined as <200 copies/ml) as the time in days from the first medical provider visit to the first date with VL suppression. Kaplan-Meier analyses and Cox proportional hazards analyses will be used to generate survival curves and to estimate the median time to VL suppression.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Documented HIV infection
• Newly establishing HIV care at study site
• Age 18 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

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

United States, Maryland

The Johns Hopkins HIV Care Program

Baltimore, Maryland, United States, 21205

United States, North Carolina

UNC Infectious Diseases Clinic

Chapel Hill, North Carolina, United States, 27599

United States, Washington

University of Washington

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 Michigan

Investigators

• Principal Investigator: Michael J Mugavero, MD; University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Michael J Mugavero, MD, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01900236
• Other Study ID Numbers: 1R01AI103661 ( U.S. NIH Grant/Contract )
• First Posted: July 16, 2013
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

Keywords provided by Michael J Mugavero, MD, University of Alabama at Birmingham:

Patients newly initiating outpatient HIV medical care