HIVNCT02043041
Evaluation of the Quality of Self-collected Blood Spot Specimens for Laboratory HIV Testing - An InvolveMENt Sub Study
An observational study of HIV, run by Emory University at 1 site in United States.
Trial summary
We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV
- What is being tested?
- Number of DBS Spots
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2015
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be enrolled or previously enrolled in the InvolveMENt Study through Emory University. They will be assesed for study interest either at the end of their scheduled appointment with InvolveMENt, or will be contacted if consent to contact them for future studies was previously obtained through InvolveMENt.
Who may be able to join
- Must be either currently enrolled or previously enrolled in the InvolveMENt Study through Emory University
- Over 18 years old
- HIV Negative
Who cannot join
- Not enrolled or previously enrolled in the InvolveMENt Study through Emory University
- Under 18 years old
- HIV Positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explaining the Differences in HIV Prevalence and Incidence Between Black and White Men Who Have Sex With Men in Atlanta
We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.
Read the detailed description
Participants will be recruited to this one-time assessment during their follow-up visits. After completing a consent procedure specific to this study component, participants will be provided with instructions on how to fully self-administer the procedure of a finger stick and also blotting to collect a blood specimen using a 1, 3 or 5 blood spot specimen collection card. These specimens will be labeled with the participant's unique identification number, and no other identifying information. The dried blood spots will be evaluated by a laboratorian to assess quality, but will not be tested for HIV. This evaluation will help determine what number of self-collected dried blood spots yields the highest usable quantity of sample for HIV testing. There will be a separate monetary incentive of $30 for this procedure.
- Conditions
- HIV
- Being tested
- Number of DBS Spots
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Number of DBS SpotsOther
The number of DBS spots on the card constitutes the experimental condition.
| Study group | Role | What they receive |
|---|---|---|
| 1 Dried Blood Spot (DBS) | Number of DBS Spots Participants will be asked to fill one spot on a dried blood spot collection card. Receives: Other: Number of DBS Spots | |
| 3 DBS Spots | Number of DBS Spots Participants will be asked to fill three spots on a dried blood spot collection card. Receives: Other: Number of DBS Spots | |
| 5 DBS Sports | Number of DBS Spots Participants will be asked to fill five spots on a dried blood spot collection card. Receives: Other: Number of DBS Spots |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viable sample for HIV Testing
Samples will be examined and not tested by a lab technician for acceptability for HIV testing.
Measured: Outcome measure will be assessed with in two weeks of all samples being collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- AD McNaghten, PHD, MHSA, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043041
- Sponsor's protocol ID
- IRB00042405
- Other IDs
- P30AI050409
- Status last verified
- Jun 2015
- First submitted
- 21 Jan 2014
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explaining the Differences in HIV Prevalence and Incidence Between Black and White Men Who Have Sex With Men in Atlanta
- ClinicalTrials.gov ID
- NCT02043041
- Acronym / sponsor ID
- IRB00042405
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jan 2014 (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.
We will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.
Detailed description
Participants will be recruited to this one-time assessment during their follow-up visits. After completing a consent procedure specific to this study component, participants will be provided with instructions on how to fully self-administer the procedure of a finger stick and also blotting to collect a blood specimen using a 1, 3 or 5 blood spot specimen collection card. These specimens will be labeled with the participant's unique identification number, and no other identifying information. The dried blood spots will be evaluated by a laboratorian to assess quality, but will not be tested for HIV. This evaluation will help determine what number of self-collected dried blood spots yields the highest usable quantity of sample for HIV testing. There will be a separate monetary incentive of $30 for this procedure.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Dried Blood Spot (DBS) | – | Other: Number of DBS SpotsNumber of DBS Spots Participants will be asked to fill one spot on a dried blood spot collection card. |
| 3 DBS Spots | – | Other: Number of DBS SpotsNumber of DBS Spots Participants will be asked to fill three spots on a dried blood spot collection card. |
| 5 DBS Sports | – | Other: Number of DBS SpotsNumber of DBS Spots Participants will be asked to fill five spots on a dried blood spot collection card. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled or previously enrolled in the InvolveMENt Study through Emory University. They will be assesed for study interest either at the end of their scheduled appointment with InvolveMENt, or will be contacted if consent to contact them for future studies was previously obtained through InvolveMENt.
Key inclusion criteria (3 listed)
- Must be either currently enrolled or previously enrolled in the InvolveMENt Study through Emory University
- Over 18 years old
- HIV Negative
Key exclusion criteria (3 listed)
- Not enrolled or previously enrolled in the InvolveMENt Study through Emory University
- Under 18 years old
- HIV Positive
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 |
|---|---|---|
| Number of DBS SpotsThe number of DBS spots on the card constitutes the experimental condition. | Other | 1 Dried Blood Spot (DBS), 3 DBS Spots, 5 DBS Sports |
Primary outcome
Viable sample for HIV Testing
Time frame: Outcome measure will be assessed with in two weeks of all samples being collected
Samples will be examined and not tested by a lab technician for acceptability for HIV testing.
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 25 Jun 2015.
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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.
AD McNaghten, PHD, MHSA principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Emory University 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 3 inclusion and 3 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 25 Jun 2015. 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?
Viable sample for HIV Testing (time frame: Outcome measure will be assessed with in two weeks of all samples being collected). 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 25 Jun 2015.