Youth Engagement Study: Intervention to Increase HIV Treatment Engagement and Adherence for Young People Living With HIV
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 16 - 35 |
| Updated: | 9/13/2018 |
| Start Date: | July 1, 2017 |
| End Date: | June 30, 2021 |
| Contact: | Seth C Kalichman, PhD |
| Email: | seth.k@uconn.edu |
| Phone: | 860-208-3706 |
Unified Intervention to Impact HIV Care Continuum
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.
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.
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.
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.
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
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