NCT04546061

Brief Summary

This study provides substance use and mental health treatment for young sexual and gender minority adults in Durham and Charlotte, NC and seeks to provide intensive wraparound services that address factors that influence substance use and mental health among this population such as minority stressors and lack of social support, housing instability, lack of access to affirmative health care, and limited job opportunities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

September 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

September 4, 2020

Last Update Submit

March 2, 2023

Conditions

Substance UseMental Health

Keywords

Sexual and Gender MinoritiesSubstance Use and Mental Health TreatmentMental HealthSubstance UseMinority StressYoung AdultsIntensive Case ManagementPeer Support

Outcome Measures

Primary Outcomes (2)

  • Change in substance use from baseline to 6-month follow-up

    Addiction Severity Index collected via a computer assisted self-interviewing survey

    Baseline and 6-months

  • Change in mental health status from baseline to 6-month follow-up

    Brief Symptom Inventory collected via a computer assisted self-interviewing survey

    Baseline and 6-months

Study Arms (1)

Project Uplift Intervention

EXPERIMENTAL

A 6-month long intervention for young adult sexual and gender minorities, ages 18-35.

Behavioral: Project Uplift

Interventions

Project UpliftBEHAVIORAL

Substance use and mental health treatment for young sexual and gender minorities in Durham and Charlotte, NC in conjunction with intensive wraparound services that address factors that influence substance use and mental health among this population.

Project Uplift Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mecklenburg County Community Support Services

Charlotte, North Carolina, 28207, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-BeingCoitus

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehaviorSexual Behavior

Study Officials

  • Sara H LeGrand, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Susan Reif, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 11, 2020

Study Start

September 15, 2020

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)