NCT03665532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

May 27, 2017

Last Update Submit

September 28, 2021

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • HIV suppression

    Blood plasma derived HIV RNA

    up to 15 months after the baseline.

Secondary Outcomes (1)

  • Medication Adherence

    up to 15 months after the baseline.

Study Arms (2)

Interactive 2-way texting

EXPERIMENTAL

Biweekly text message communications with counselors for problem solving

Behavioral: Youth Engagement in Services

Passive text reminders

ACTIVE COMPARATOR

Automated weekly text message health care reminders

Behavioral: Youth Engagement in Services

Interventions

Youth Engagement in ServicesBEHAVIORAL

Brief phone coaching to enhance engagement, retention, and sustain adherence to HIV and substance use services for younger people living with HIV.

Interactive 2-way textingPassive text reminders

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Not HIV positive
  • Younger than 16
  • Older than 35 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast HIV/AIDS Research & Evaluation Project

Atlanta, Georgia, 30303, United States

Location

Related Publications (4)

  • 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.

    PMID: 39214949DERIVED

  • Kalichman 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.

    PMID: 37643392DERIVED

  • Brousseau 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.

    PMID: 37139536DERIVED

  • Kalichman 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.

    PMID: 35125476DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Seth C Kalichman, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2017

First Posted

September 11, 2018

Study Start

July 1, 2017

Primary Completion

February 1, 2020

Study Completion

June 30, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)