- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01900236
Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV (iENGAGE)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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Maryland
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Baltimore, Maryland, Forenede Stater, 21205
- The Johns Hopkins HIV Care Program
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Infectious Diseases Clinic
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Washington
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Seattle, Washington, Forenede Stater, 98104
- University of Washington
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Control
Control arm participants will receive standard clinical care (i.e.
receive usual clinic treatment)
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Eksperimentel: 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.
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Viral load (VL) suppression (<200c/ml) among patients newly initiating outpatient HIV medical care
Tidsramme: 48 weeks
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VL suppression is defined as <200 copies/ml of blood
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48 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Viremia Copy Years (VCY)
Tidsramme: 96 weeks
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VCY is the area under the curve estimate of cumulative VL burden
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96 weeks
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Visit adherence
Tidsramme: First provider visit to 48 weeks and 96 weeks
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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.
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First provider visit to 48 weeks and 96 weeks
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4 month visit constancy
Tidsramme: First provider visit to 48 weeks and 96 weeks
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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
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First provider visit to 48 weeks and 96 weeks
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Time to viral load (VL) suppression
Tidsramme: First provider visit to first VL suppression with administrative censoring at 12 months
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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.
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First provider visit to first VL suppression with administrative censoring at 12 months
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael J Mugavero, MD, University of Alabama at Birmingham
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1R01AI103661 (U.S. NIH-bevilling/kontrakt)
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