Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

HIV Clinical Trial

— iENGAGE  

Official title:

Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900236
• Other study ID #: 1R01AI103661
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	The Johns Hopkins HIV Care Program	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UNC Infectious Diseases Clinic	Chapel Hill	North Carolina
United States	University of Washington	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Johns Hopkins University, University of Michigan, University of North Carolina, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Viremia Copy Years (VCY)	VCY is the area under the curve estimate of cumulative VL burden	96 weeks
Secondary	Visit adherence	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.	First provider visit to 48 weeks and 96 weeks
Secondary	4 month visit constancy	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	First provider visit to 48 weeks and 96 weeks
Secondary	Time to viral load (VL) suppression	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.	First provider visit to first VL suppression with administrative censoring at 12 months