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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

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Youth Engagement in Services Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Unified Intervention to Impact HIV Care Continuum
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Interactive 2-way texting
Biweekly text message communications with counselors for problem solving
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.

Active Comparator: Passive text reminders
Automated weekly text message health care reminders
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.




Primary Outcome Measures :
  1. HIV suppression [ Time Frame: up to 15 months after the baseline. ]
    Blood plasma derived HIV RNA


Secondary Outcome Measures :
  1. Medication Adherence [ Time Frame: up to 15 months after the baseline. ]
    Antiretroviral medication adherence assessed by unannounced phone pill counts



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03665532


Contacts
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Contact: Seth C Kalichman, PhD 860-208-3706 seth.k@uconn.edu
Contact: Lisa A Eaton, PhD 860-341-6802 lisa.eaton@uconn.edu

Locations
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United States, Georgia
Southeast HIV/AIDS Research & Evaluation Project Recruiting
Atlanta, Georgia, United States, 30303
Contact: Seth C Kalichman, PhD    860-208-3706    seth.k@uconn.edu   
Contact: Lisa A Eaton, PhD    860-341-6802    lisa.eaton@uconn.edu   
Sponsors and Collaborators
University of Connecticut
Mercer University
Investigators
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Principal Investigator: Seth C Kalichman, PhD University of Connecticut

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Responsible Party: Seth Kalichman, Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT03665532     History of Changes
Other Study ID Numbers: H16-130
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No