HIV/AIDSWELLNCT03238586
HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
A study testing WELL Program in people with HIV/AIDS, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- WELL Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- Recent alcohol use
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center New Orleans Infectious Disease Services
New Orleans, Louisiana, 70112
About this study
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.
Read the detailed description
The main purpose of this research study is to investigate the best way to reduce HIV transmission risk and to improve the overall health of people living with HIV/AIDS. This study tests an intervention program that aims to improve knowledge, motivation, and skills. The intervention program 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.
- Conditions
- HIV/AIDS
- Being tested
- WELL Program
- Keywords
- hiv, aids, alcohol, health, knowledge, motivation, skills, behavior
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WELL ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: WELL Program |
| Standard of Care | No intervention | Five-week standard of care program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.
Measured: Change from baseline at 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study startNov 2012
- Primary completionJul 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Patricia Molina, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Patricia Molina, MD, PhD, Principal investigator, Louisiana State University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238586
- Sponsor's protocol ID
- WELL
- Other IDs
- 1U01AA021995-01
- Acronym
- WELL
- Status last verified
- Feb 2020
- First submitted
- 31 Jul 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV/AIDS & Alcohol-Related Outcomes: Translational Evidence-Based Interventions
- ClinicalTrials.gov ID
- NCT03238586
- Acronym / sponsor ID
- WELL / WELL
- Conditions
- HIV/AIDS
- Keywords
- hiv, aids, alcohol, health, knowledge, motivation, skills, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2012 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 3 Aug 2017 (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.
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.
Detailed description
The main purpose of this research study is to investigate the best way to reduce HIV transmission risk and to improve the overall health of people living with HIV/AIDS. This study tests an intervention program that aims to improve knowledge, motivation, and skills. The intervention program 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WELL Program | Experimental | Behavioral: WELL ProgramFive-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. |
| Standard of Care | No intervention | –Five-week standard of care program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV positive
- Recent alcohol use
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| WELL Program | Behavioural | WELL Program |
Primary outcome
Viral load
Time frame: Change from baseline at 3 months, 6 months and 1 year
The primary outcome measure will be disease progression or more specifically, the proportion of patients achieving viral suppression.
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 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Patricia Molina, MD, PhD principal investigator
Louisiana State University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WELL Program in people with HIV/AIDS, run by Louisiana State University Health Sciences Center in New Orleans 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 2 inclusion and 1 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 20 Feb 2020. 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?
Viral load (time frame: Change from baseline at 3 months, 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2020.