NCT03238586

Brief Summary

A clinical study for patients with HIV that investigates the best way to reduce HIV transmission risk, and to improve the overall health of people living with HIV/AIDS. Participants will complete four assessments over the course of one year and will be randomly assigned to a five-week treatment program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

6.7 years

First QC Date

July 31, 2017

Last Update Submit

February 18, 2020

Conditions

HIV/AIDS

Keywords

hivaidsalcoholhealthknowledgemotivationskillsbehavior

Outcome Measures

Primary Outcomes (1)

  • Viral load

    The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.

    Change from baseline at 3 months, 6 months and 1 year

Study Arms (2)

WELL Program

EXPERIMENTAL

Five-week treatment program that aims to improve knowledge, motivation, and skills. It is designed to motivate participants to take their medications routinely, improve the quality of life for those living with HIV, and decrease risky behaviors that may lead to HIV transmission.

Behavioral: WELL Program

Standard of Care

NO INTERVENTION

Five-week standard of care program.

Interventions

WELL ProgramBEHAVIORAL
WELL Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • Recent alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center New Orleans Infectious Disease Services

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeBehavior

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

  • Patricia Molina, MD, PhD

    Louisiana State University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Richard Ashman, PhD Professor and Head Department of Physiology; Director Alcohol and Drug Abuse Center of Excellence

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 3, 2017

Study Start

November 1, 2012

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)