HIVGLADLYNCT02562092
The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project
A study testing Reducing Risk Behavior and Support and Guidance in people with HIV, run by Emory University at 2 sites in United States.
Trial summary
This study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults. This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Reducing Risk Behavior and Support and Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to Aug 2017
- 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 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sexually active
- HIV positive or negative
- Latino youth ages 18-24 years
- Residents of the state of Georgia and can understand spoken and written English or Spanish.
Who cannot join
- Unmet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Health System
Atlanta, Georgia, 30303
Ponce De Leon Center
Atlanta, Georgia, 30308
About this study
This study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults. This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting.
Read the detailed description
This study aims to identify factors that can facilitate or impede the use of non-clinical HIV testing venues as well as identify potential testing sites and assess acceptability of an HIV prevention intervention. In addition, the study will implement a pilot intervention to test the feasibility non-clinical HIV testing and follow up events for HIV positive youth.
- Conditions
- HIV
- Being tested
- Reducing Risk Behavior, Support and Guidance
- Keywords
- AIDS, Health Promotion
- 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.
Reducing Risk BehaviorBehavioural
A small survey will be conducted to identify risk factors and assess demographics. Participants will receive psychological support and counseling on reducing risk behavior for one year.
Support and GuidanceBehavioural
A small survey will be conducted to identify risk factors and assess demographics. Participants with a positive HIV test will receive standard HIV care, support, and guidance from a psychologist and case manager including an assessment of basic needs (food, clothing, shelter), and counseling on risk taking behaviors for one year.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group | No intervention | Participants will complete a questionnaire and will be involved in a group discussion regarding good sites within the community to perform HIV testing. |
| Venue Testing Group- Negative Test | Other | Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. No followup is needed for a negative HIV test. Receives: Behavioral: Reducing Risk Behavior |
| Venue Testing Group- Positive Test | Other | Participants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. Participants with a positive HIV test will receive care from a psychologist and case manager for one year. Receives: Behavioral: Support and Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to Linkage to Care
For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.
Measured: Post Diagnosis (Up to 3 months)
Secondary outcomes (7)
Number of medical care visits
For participants who test positive, engagement to care is measured as the number of medical care visits in a six month period after diagnosis. One HIV medical care visit every six months is considered engaged.
Measured: Post Diagnosis (Up to one year)
Change in CD4 count
A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a blood sample. A very low CD4 count (less than 200 cells/mm3) is a way to determine whether an HIV infection has progressed. Change is measured as the difference in CD4 count from baseline to the end of the study period.
Measured: Baseline (Post Diagnosis), One year assessment (Up to one year)
Change in viral load
A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A high viral load indicates the presence of more HIV within the body. Change is measured as the difference in viral load from baseline to the end of the study period.
Measured: Baseline (Post Diagnosis), One year assessment (Up to one year)
Rate of venue acceptance
The rate of venue acceptance is measured as the number of venues that allow rapid HIV testing over he number of venues approached.
Measured: One year assessment (Up to one year)
Rate of study subject acceptance
The rate of study subject acceptance is measured as the number of participants who agree to participate in rapid HIV testing over the number of people approached.
Measured: One year assessment (Up to one year)
Change in HIV stigma scale score
The HIV stigma scale is a ten question self report measure that assesses perceived feelings of being stigmatized. Answers are reported on a scale from 0 (not at all) to 4 (extremely). A higher score indicates feelings of greater stigmatization.
Measured: Baseline (Post Diagnosis), One year assessment (Up to one year)
Change in HIV-AIDS stress scale score
The HIV-AIDS stress scale is a self report measure that assesses perceived emotional stress related to HIV. Answers are reported on a scale from 0 (not at all) to 4 (extremely). A higher score indicates more emotional stress.
Measured: Baseline (Post Diagnosis), One year assessment (Up to one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: The study was not able to be completed due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Camacho-Gonzalez, Emory University
- Investigators
- Andres Camacho-Gonzalez, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562092
- Sponsor's protocol ID
- IRB00080817
- Acronym
- GLADLY
- Status last verified
- Jan 2021
- First submitted
- 24 Sep 2015
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Georgia Latino AIDS/HIV Diagnosis and Linkage in Youth (GLADLY) Project
- ClinicalTrials.gov ID
- NCT02562092
- Acronym / sponsor ID
- GLADLY / IRB00080817
- Conditions
- HIV
- Keywords
- AIDS, Health Promotion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was not able to be completed due to the COVID-19 pandemic.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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 study aims to understand the barriers to receiving HIV testing and retention of care for at risk and HIV positive young adults. This study also seeks to determine the feasibility and acceptability of HIV testing in a non-clinical setting.
Detailed description
This study aims to identify factors that can facilitate or impede the use of non-clinical HIV testing venues as well as identify potential testing sites and assess acceptability of an HIV prevention intervention. In addition, the study will implement a pilot intervention to test the feasibility non-clinical HIV testing and follow up events for HIV positive youth.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus Group | No intervention | –Participants will complete a questionnaire and will be involved in a group discussion regarding good sites within the community to perform HIV testing. |
| Venue Testing Group- Negative Test | Other | Behavioral: Reducing Risk BehaviorParticipants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. No followup is needed for a negative HIV test. |
| Venue Testing Group- Positive Test | Other | Behavioral: Support and GuidanceParticipants will perform a rapid HIV test and will be asked to answer questions about their sexual life and living situation. Participants with a positive HIV test will receive care from a psychologist and case manager for one year. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sexually active
- HIV positive or negative
- Latino youth ages 18-24 years
- Residents of the state of Georgia and can understand spoken and written English or Spanish.
Key exclusion criteria (1 listed)
- Unmet inclusion criteria
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 |
|---|---|---|
| Reducing Risk BehaviorA small survey will be conducted to identify risk factors and assess demographics. Participants will receive psychological support and counseling on reducing risk behavior for one year. | Behavioural | Venue Testing Group- Negative Test |
| Support and GuidanceA small survey will be conducted to identify risk factors and assess demographics. Participants with a positive HIV test will receive standard HIV care, support, and guidance from a psychologist and case manager including an assessment of basic needs (food, clothing, shelter), and counseling on risk taking behaviors for one year. | Behavioural | Venue Testing Group- Positive Test |
Primary outcome
Days to Linkage to Care
Time frame: Post Diagnosis (Up to 3 months)
For participants who test positive, linkage to care is measured as the number of days to seek HIV treatment.
7 secondary outcomes
Number of medical care visits
Time frame: Post Diagnosis (Up to one year)
Change in CD4 count
Time frame: Baseline (Post Diagnosis), One year assessment (Up to one year)
Change in viral load
Time frame: Baseline (Post Diagnosis), One year assessment (Up to one year)
Rate of venue acceptance
Time frame: One year assessment (Up to one year)
Rate of study subject acceptance
Time frame: One year assessment (Up to one year)
Change in HIV stigma scale score
Time frame: Baseline (Post Diagnosis), One year assessment (Up to one year)
Change in HIV-AIDS stress scale score
Time frame: Baseline (Post Diagnosis), One year assessment (Up to one year)
Results and safety
The study was stopped early (reason given: The study was not able to be completed due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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.
Andres Camacho-Gonzalez principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing Risk Behavior and Support and Guidance in people with HIV, run by Emory University at 2 sites 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 4 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: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The study was not able to be completed due to the COVID-19 pandemic.). Results are not available in the source record.
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?
Days to Linkage to Care (time frame: Post Diagnosis (Up to 3 months)). 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 22 Jan 2021.