HIV/AIDSYESNCT03665532
Youth Engagement Study: Intervention to Increase HIV Treatment Engagement and Adherence for Young People Living With HIV
A study testing Youth Engagement in Services in people with HIV/AIDS, run by University of Connecticut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Youth Engagement in Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Not HIV positive
- Younger than 16
- Older than 35 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast HIV/AIDS Research & Evaluation Project
Atlanta, Georgia, 30303
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Youth Engagement in Services
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Engagement in ServicesBehavioural
Brief phone coaching to enhance engagement, retention, and sustain adherence to HIV and substance use services for younger people living with HIV.
| Study group | Role | What they receive |
|---|---|---|
| Interactive 2-way texting | Experimental | Biweekly text message communications with counselors for problem solving Receives: Behavioral: Youth Engagement in Services |
| Passive text reminders | Active comparator | Automated weekly text message health care reminders Receives: Behavioral: Youth Engagement in Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV suppression
Blood plasma derived HIV RNA
Measured: up to 15 months after the baseline.
Secondary outcomes (1)
Medication Adherence
Antiretroviral medication adherence assessed by unannounced phone pill counts
Measured: up to 15 months after the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Jul 2017
- Primary completion1 Feb 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Mercer University
- Responsible party
- Principal investigator, Seth Kalichman, University of Connecticut
- Investigators
- Seth C Kalichman, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665532
- Sponsor's protocol ID
- H16-130
- Acronym
- YES
- Status last verified
- Sep 2021
- First submitted
- 27 May 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wiginton JM, Eaton LA, Earnshaw VA, Watson RJ, Kalichman SC. Socio-cognitive facilitators of ART-adherence among predominantly black sexual and gender minoritized persons living with HIV in Atlanta, Georgia: a latent profile analysis. J Behav Med. 2024 Dec;47(6):1012-1027. doi: 10.1007/s10865-024-00510-5. Epub 2024 Aug 31.
PubMed 39214949Kalichman SC, Kalichman MO, Eaton LA. Phone-Delivered Intervention to Improve HIV Care for Young People Living With HIV: Trial to Inform Implementation and Utility. J Acquir Immune Defic Syndr. 2023 Nov 1;94(3):227-234. doi: 10.1097/QAI.0000000000003279. Epub 2023 Oct 13.
PubMed 37643392Brousseau NM, Kalichman SC, Watson RJ, Eaton LA. Amphetamine use and its associations with antiretroviral adherence and viral load among sexual minority men and transgender women living with HIV. AIDS Care. 2023 Oct;35(10):1472-1479. doi: 10.1080/09540121.2023.2206096. Epub 2023 May 3.
PubMed 37139536Kalichman SC, Eaton LA, Kalichman MO. Believing That It Is Hazardous to Mix Alcohol With Medicines Predicts Intentional Nonadherence to Antiretrovirals. J Acquir Immune Defic Syndr. 2022 Jun 1;90(2):208-213. doi: 10.1097/QAI.0000000000002933.
PubMed 35125476
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Intervention to Impact HIV Care Continuum
- ClinicalTrials.gov ID
- NCT03665532
- Acronym / sponsor ID
- YES / H16-130
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Mercer University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive 2-way texting | Experimental | Behavioral: Youth Engagement in ServicesBiweekly text message communications with counselors for problem solving |
| Passive text reminders | Active comparator | Behavioral: Youth Engagement in ServicesAutomated weekly text message health care reminders |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age between 16 years and 35 years
- HIV positive
- At least one of the following:
Key exclusion criteria (3 listed)
- Not HIV positive
- Younger than 16
- Older than 35 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth Engagement in ServicesBrief phone coaching to enhance engagement, retention, and sustain adherence to HIV and substance use services for younger people living with HIV. | Behavioural | Interactive 2-way texting, Passive text reminders |
Primary outcome
HIV suppression
Time frame: up to 15 months after the baseline.
Blood plasma derived HIV RNA
1 secondary outcome
Medication Adherence
Time frame: up to 15 months after the baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 39214949Wiginton JM, Eaton LA, Earnshaw VA, Watson RJ, Kalichman SC. Socio-cognitive facilitators of ART-adherence among predominantly black sexual and gender minoritized persons living with HIV in Atlanta, Georgia: a latent profile analysis. J Behav Med. 2024 Dec;47(6):1012-1027. doi: 10.1007/s10865-024-00510-5. Epub 2024 Aug 31.
- Derived from this study: PubMed 37643392Kalichman SC, Kalichman MO, Eaton LA. Phone-Delivered Intervention to Improve HIV Care for Young People Living With HIV: Trial to Inform Implementation and Utility. J Acquir Immune Defic Syndr. 2023 Nov 1;94(3):227-234. doi: 10.1097/QAI.0000000000003279. Epub 2023 Oct 13.
- Derived from this study: PubMed 37139536Brousseau NM, Kalichman SC, Watson RJ, Eaton LA. Amphetamine use and its associations with antiretroviral adherence and viral load among sexual minority men and transgender women living with HIV. AIDS Care. 2023 Oct;35(10):1472-1479. doi: 10.1080/09540121.2023.2206096. Epub 2023 May 3.
- Derived from this study: PubMed 35125476Kalichman SC, Eaton LA, Kalichman MO. Believing That It Is Hazardous to Mix Alcohol With Medicines Predicts Intentional Nonadherence to Antiretrovirals. J Acquir Immune Defic Syndr. 2022 Jun 1;90(2):208-213. doi: 10.1097/QAI.0000000000002933.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth C Kalichman, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Engagement in Services in people with HIV/AIDS, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV suppression (time frame: up to 15 months after the baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665532, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.