HIVNCT02869776
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
A study testing Questionnaire, Rapid finger stick and Venipuncture in people with HIV and Hepatitis C, run by Boston Medical Center at 1 site in United States.
Trial summary
The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in high prevalence settings, such as detoxification centers with a large proportion of young injection drug users. The latest venipuncture testing will be compared to rapid finger stick testing for HCV and HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C
- What is being tested?
- Questionnaire, Rapid finger stick and Venipuncture
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 26 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater or equal to 18
- All clients admitted to BTC with a history of drug or alcohol use
- Individuals who self-report as being HIV and HCV non-infected within the past 6 months or having unknown status
- Participants providing contact information of two family members or friends
- Individuals signing a medical records release form for the referral site (Boston Medical Center)
- English speaking
Who cannot join
- Individuals unable to provide informed consent
- Individuals with a known history of HCV and/or HIV
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in high prevalence settings, such as detoxification centers with a large proportion of young injection drug users. The latest venipuncture testing will be compared to rapid finger stick testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a short-term drug detoxification center will be determined.
- Conditions
- HIV, Hepatitis C
- Being tested
- Questionnaire, Rapid finger stick, Venipuncture
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Behavioral questionnaires
Rapid finger stickProcedure or surgery
HIV and HCV testing through rapid finger stick
VenipunctureProcedure or surgery
HIV and HCV testing through venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Rapid finger stick | Experimental | HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered. Receives: Behavioral: Questionnaire; Procedure: Rapid finger stick |
| Standard venipuncture | Experimental | HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered. Receives: Behavioral: Questionnaire; Procedure: Venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who receive HCV test results
The number of participants who receive HCV test results by the time they are discharged from the detoxification center
Measured: within 5 days (by the time of discharge from the detoxification center)
Number of participants who receive HIV test results
The number of participants who receive HIV test results by the time they are discharged from the detoxification center
Measured: within 5 days (by the time of discharge from the detoxification center)
Secondary outcomes (10)
Number of participants who link to HCV care
The number of participants who are seen for an HCV visit
Measured: by three months
Number of participants who have HCV RNA testing
The number of participants who have HCV RNA testing performed
Measured: by three months
Number of participants who have fibrosis staging performed
The number participants who have fibrosis staging performed
Measured: by three months
Number of participants who have HCV treatment initiated
The number participants who have HCV treatment initiated
Measured: by six months
Number of participants who reach sustained virologic response
The number participants who reach sustained virologic response
Measured: by twelve months
Number of participants who link to HIV care
The number participants who are seen for an HIV visit
Measured: by 3 months
Number of participants who HIV RNA testing
The number participants who have HIV RNA testing
Measured: by 3 months
Number of participants who have CD4 testing
The number participants who have CD4 testing
Measured: by 3 months
Number of participants who have antiretroviral treatment initiated
The number participants who initiated antiretroviral treatment
Measured: by 3 months
Number of participants who achieve HIV viral suppression
The number participants who achieve HIV viral suppression
Measured: by 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Assoumou, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869776
- Sponsor's protocol ID
- H-35271
- Other IDs
- RA25035163 -01A 1, 5P30AI042853-18
- Status last verified
- Dec 2020
- First submitted
- 10 Aug 2016
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Assoumou SA, Paniagua SM, Gonzalez P, Wang J, Beckwith CG, White LF, Taylor JL, Coogan K, Samet JH, Linas BP. HIV Pre-exposure Prophylaxis and Buprenorphine at a Drug Detoxification Center During the Opioid Epidemic: Opportunities and Challenges. AIDS Behav. 2021 Aug;25(8):2591-2598. doi: 10.1007/s10461-021-03220-0. Epub 2021 Mar 22.
PubMed 33751315Assoumou SA, Paniagua SM, Linas BP, Wang J, Samet JH, Hall J, White LF, Beckwith CG. Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial. J Infect Dis. 2020 Sep 2;222(Suppl 5):S376-S383. doi: 10.1093/infdis/jiaa162.
PubMed 32877557
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
- ClinicalTrials.gov ID
- NCT02869776
- Acronym / sponsor ID
- H-35271
- Conditions
- HIV, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2016 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 17 Aug 2016 (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.
The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in high prevalence settings, such as detoxification centers with a large proportion of young injection drug users. The latest venipuncture testing will be compared to rapid finger stick testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a short-term drug detoxification center will be determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid finger stick | Experimental | Behavioral: Questionnaire, Procedure: Rapid finger stickHIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered. |
| Standard venipuncture | Experimental | Behavioral: Questionnaire, Procedure: VenipunctureHIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater or equal to 18
- All clients admitted to BTC with a history of drug or alcohol use
- Individuals who self-report as being HIV and HCV non-infected within the past 6 months or having unknown status
- Participants providing contact information of two family members or friends
- Individuals signing a medical records release form for the referral site (Boston Medical Center)
Key exclusion criteria (2 listed)
- Individuals unable to provide informed consent
- Individuals with a known history of HCV and/or HIV
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 |
|---|---|---|
| QuestionnaireBehavioral questionnaires | Behavioural | Rapid finger stick, Standard venipuncture |
| Rapid finger stickHIV and HCV testing through rapid finger stick | Procedure or surgery | Rapid finger stick |
| VenipunctureHIV and HCV testing through venipuncture | Procedure or surgery | Standard venipuncture |
Primary outcome
Number of participants who receive HCV test results
Time frame: within 5 days (by the time of discharge from the detoxification center)
The number of participants who receive HCV test results by the time they are discharged from the detoxification center
Number of participants who receive HIV test results
Time frame: within 5 days (by the time of discharge from the detoxification center)
The number of participants who receive HIV test results by the time they are discharged from the detoxification center
10 secondary outcomes
Number of participants who link to HCV care
Time frame: by three months
Number of participants who have HCV RNA testing
Time frame: by three months
Number of participants who have fibrosis staging performed
Time frame: by three months
Number of participants who have HCV treatment initiated
Time frame: by six months
Number of participants who reach sustained virologic response
Time frame: by twelve months
Number of participants who link to HIV care
Time frame: by 3 months
Number of participants who HIV RNA testing
Time frame: by 3 months
Number of participants who have CD4 testing
Time frame: by 3 months
Number of participants who have antiretroviral treatment initiated
Time frame: by 3 months
Number of participants who achieve HIV viral suppression
Time frame: by 6 months
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 11 Dec 2020.
- Derived from this study: PubMed 33751315Assoumou SA, Paniagua SM, Gonzalez P, Wang J, Beckwith CG, White LF, Taylor JL, Coogan K, Samet JH, Linas BP. HIV Pre-exposure Prophylaxis and Buprenorphine at a Drug Detoxification Center During the Opioid Epidemic: Opportunities and Challenges. AIDS Behav. 2021 Aug;25(8):2591-2598. doi: 10.1007/s10461-021-03220-0. Epub 2021 Mar 22.
- Derived from this study: PubMed 32877557Assoumou SA, Paniagua SM, Linas BP, Wang J, Samet JH, Hall J, White LF, Beckwith CG. Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial. J Infect Dis. 2020 Sep 2;222(Suppl 5):S376-S383. doi: 10.1093/infdis/jiaa162.
- Individual participant dataSharing planned: No
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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.
Sabrina Assoumou, MD, MPH principal investigator
Boston Medical 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 Questionnaire, Rapid finger stick and Venipuncture in people with HIV and Hepatitis C, run by Boston Medical Center 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 6 inclusion and 2 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 11 Dec 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?
Number of participants who receive HCV test results (time frame: within 5 days (by the time of discharge from the detoxification center)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869776, which also lists 2 linked publications.
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 11 Dec 2020.