Human Immunodeficiency VirusNCT03271424
Innovations in HIV Testing (TI)
A study testing Oraquick HIV Self Test - Choice, Atomo HIV Self Test - Choice and Oraquick HIV Self Test and Atomo HIV Self Test - Both in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
Trial summary
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Oraquick HIV Self Test - Choice, Atomo HIV Self Test - Choice and Oraquick HIV Self Test and Atomo HIV Self Test - Both
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Oct 2015to 1 Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
FGD Inclusion Criteria:
- Females and males aged 18 - 24
- Able and willing to provide informed consent
- Residing in the selected villages
Observation Inclusion Criteria:
- Females and males aged 18 -24
- Able and willing to provide informed consent
- Residing in the selected villages
- Not known to be HIV positive (not reporting a previous positive test)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit
Agincourt, Mpumalanga
About this study
Official title: Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
Read the detailed description
Study Description Brief Summary: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
Detailed Description: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, explained in this submission, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Oraquick HIV Self Test - Choice, Atomo HIV Self Test - Choice, Oraquick HIV Self Test and Atomo HIV Self Test - Both
- 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.
Oraquick HIV Self Test - ChoiceDiagnostic test
This is an oral swab in home HIV test.
Atomo HIV Self Test - ChoiceDiagnostic test
This is a blood finger prick in home HIV test.
Oraquick HIV Self Test and Atomo HIV Self Test - BothDiagnostic test
This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
| Study group | Role | What they receive |
|---|---|---|
| Focus Group Discussions | No intervention | Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants. |
| In Clinic Observation-Both | Active comparator | 10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both Receives: Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both |
| In Clinic Observation-Subject Choice | Active comparator | 20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice Receives: Diagnostic Test: Oraquick HIV Self Test - Choice; Diagnostic Test: Atomo HIV Self Test - Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Summaries of Participant Experience in Focus Group Discussions
Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact
Measured: 6 months post study start
Quantitative Summaries of Participants Experience in Observation Sessions
Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
Measured: 12 month post study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Oct 2015
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24 In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, University of California, San Francisco, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Audrey Pettifor, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271424
- Sponsor's protocol ID
- 15-1361a
- Other IDs
- 5R01HD083033
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
- ClinicalTrials.gov ID
- NCT03271424
- Acronym / sponsor ID
- 15-1361a
- Conditions
- Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, University of California, San Francisco, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Posted 19 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
Detailed description
Study Description Brief Summary: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care.
Detailed Description: The investigators propose to improve HIV prevention and care through expanding HIV testing options to include self-testing for young women, their peers and their sex partners, and by facilitating linkage to care. In this study the investigators proposed two phases. The first phase, explained in this submission, is formative and involved two parts: 1) conducting formative qualitative research to understand perceptions of HIV testing and HIV self-testing in the study population and 2) conducting observed HIV self-testing to better understand any challenges with self-testing and the materials needed to make the process clear. The second phase of the study is a randomized controlled trial where the investigators will randomize approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized, they will be asked to recruit up to 4 peers or male sex partners to test with the method of their randomization group.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24 In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
| Arm | Type | Receives |
|---|---|---|
| Focus Group Discussions | No intervention | –Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants. |
| In Clinic Observation-Both | Active comparator | Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both |
| In Clinic Observation-Subject Choice | Active comparator | Diagnostic Test: Oraquick HIV Self Test - Choice, Diagnostic Test: Atomo HIV Self Test - Choice20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Oraquick HIV Self Test - ChoiceThis is an oral swab in home HIV test. | Diagnostic test | In Clinic Observation-Subject Choice |
| Atomo HIV Self Test - ChoiceThis is a blood finger prick in home HIV test. | Diagnostic test | In Clinic Observation-Subject Choice |
| Oraquick HIV Self Test and Atomo HIV Self Test - BothThis is an oral swab in home HIV test and this is a blood finger prick in home HIV test. | Diagnostic test | In Clinic Observation-Both |
Primary outcome
Qualitative Summaries of Participant Experience in Focus Group Discussions
Time frame: 6 months post study start
Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact
Quantitative Summaries of Participants Experience in Observation Sessions
Time frame: 12 month post study start
Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Audrey Pettifor principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oraquick HIV Self Test - Choice, Atomo HIV Self Test - Choice and Oraquick HIV Self Test and Atomo HIV Self Test - Both in people with Human Immunodeficiency Virus, run by University of North Carolina, Chapel Hill at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Jan 2018. 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 South Africa. 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?
Yes. Results are posted in the registry (first posted 19 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Qualitative Summaries of Participant Experience in Focus Group Discussions (time frame: 6 months post study start). 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?
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 19 Jan 2018.