Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV (iENGAGE)
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|ClinicalTrials.gov Identifier: NCT01900236|
Recruitment Status : Active, not recruiting
First Posted : July 16, 2013
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Based on behavioral motivational interviewing (MI) technique||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Completion Date :||December 2018|
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.
- 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
- Viremia Copy Years (VCY) [ Time Frame: 96 weeks ]VCY is the area under the curve estimate of cumulative VL burden
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900236
|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|
|Principal Investigator:||Michael J Mugavero, MD||University of Alabama at Birmingham|