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Youth Engagement Study: Intervention to Increase HIV Treatment Engagement and Adherence for Young People Living With HIV (YES)

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ClinicalTrials.gov Identifier: NCT03665532
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Mercer University
Information provided by (Responsible Party):
Seth Kalichman, University of Connecticut

Tracking Information
First Submitted Date  ICMJE May 27, 2017
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2018)
HIV suppression [ Time Frame: up to 15 months after the baseline. ]
Blood plasma derived HIV RNA
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2018)
Medication Adherence [ Time Frame: up to 15 months after the baseline. ]
Antiretroviral medication adherence assessed by unannounced phone pill counts
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Youth Engagement Study: Intervention to Increase HIV Treatment Engagement and Adherence for Young People Living With HIV
Official Title  ICMJE Unified Intervention to Impact HIV Care Continuum
Brief Summary This pragmatic adaptive clinical trial will test the effects of a Stigma-Motivational-Decision intervention designed to increase HIV treatment engagement, retention, and medication adherence for substance using adolescents and young adults (AYA) living with HIV who are not in clinical care. The intervention uses a uniquely unified counseling approach at multiple points along the HIV continuum of care. The trial will use multiple modes of outreach including social media, passive media, clinic records, and chain referrals to seek and identify HIV positive AYA who are HIV untreated, under-dosed, or unsuppressed (HIV-U3). Participants will receive phone-delivered Stigma-Motivational-Decision counseling intervention sessions to achieve engagement or re-engagement in HIV care, treatment adherence and control of their HIV infection. Once viral control is achieved, participants will receive a low-cost approach to sustaining long-term retention in care and medication adherence.
Detailed Description This pragmatic adaptive clinical trial will test the effects of a Stigma-Motivational-Decision intervention designed to increase HIV treatment engagement, retention, and antiretroviral (Art) medication adherence for substance using adolescents and young adults (AYA) living with HIV who are not in clinical care. The intervention uses a uniquely unified counseling approach at multiple points along the HIV continuum of care. In a first step, the study will use multiple modes of outreach including social media, passive media, clinic records, and chain referrals to seek and identify HIV positive AYA who are HIV untreated, under-dosed, or unsuppressed (HIV-U3). Identified AYA will be enrolled in a run-in to the trial to objectively confirm the following criteria for trial entry. In Step 2, Individuals who meet entry criteria -specifically - substance using HIV-U3 AYA - will be enrolled in a mobile health (mHealth) intervention to address substance use, HIV stigmas, medical care-related concerns, structural barriers, and other challenges to engaging youth in HIV care. Counseling will be provided weekly by cellphone until the time participants are receiving ART, adequately dosed on ART, and HIV suppressed within a maximum of 12 sessions (up to 3-months). The study will therefore determine the number of theory-based mHealth intervention sessions needed (minimally effective dose) for optimal treatment outcomes and the associated costs. Once engaged and optimally treated, Step 3 will conduct a randomized trial to test the comparative effects and cost effectiveness of two interventions to sustain long-term retention in care and medication adherence: (a) interactive text messaging with opportunities for ongoing supportive problem solving vs. (b) passive text message reminders. HIV positive AYA are likely to drop out of care because of known challenges such as substance use, social barriers such as stigma, and concerns regarding treatment. The 3-step study will use a single theory-based approach to determine the number of phone-delivered Stigma-Motivational-Decision counseling intervention sessions necessary to achieve engagement or re-engagement in HIV care, and will test the effects of a low-cost approach to sustaining long-term retention in care and medication adherence. The study will determine the minimally effective amount of counseling needed to engage substance using HIV positive AYA in care. The study will also test the effects of the counseling and text messaging interventions on maintaining HIV care retention, medication adherence, and HIV viral suppression over 18-months. The study will perform economic evaluations to determine the cost-effectiveness of the engagement-retention-adherence intervention and the effects of low-burden retention/adherence interventions to maintain retention in care and avoid relapse to non-adherence for AYA living with HIV.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV/AIDS
Intervention  ICMJE Behavioral: Youth Engagement in Services
Brief phone coaching to enhance engagement, retention, and sustain adherence to HIV and substance use services for younger people living with HIV.
Study Arms  ICMJE
  • Experimental: Interactive 2-way texting
    Biweekly text message communications with counselors for problem solving
    Intervention: Behavioral: Youth Engagement in Services
  • Active Comparator: Passive text reminders
    Automated weekly text message health care reminders
    Intervention: Behavioral: Youth Engagement in Services
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 16 years and 35 years
  • HIV positive
  • At least one of the following:

    • Active substance using
    • HIV untreated
    • Under-dosed with ART
    • HIV viral unsuppressed

Exclusion Criteria:

  • Not HIV positive
  • Younger than 16
  • Older than 35 years of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seth C Kalichman, PhD 860-208-3706 seth.k@uconn.edu
Contact: Lisa A Eaton, PhD 860-341-6802 lisa.eaton@uconn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665532
Other Study ID Numbers  ICMJE H16-130
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seth Kalichman, University of Connecticut
Study Sponsor  ICMJE University of Connecticut
Collaborators  ICMJE Mercer University
Investigators  ICMJE
Principal Investigator: Seth C Kalichman, PhD University of Connecticut
PRS Account University of Connecticut
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP