Human Immunodeficiency VirusTINCT03162965
Innovations in HIV Testing
A study testing Oraquick HIV Self Test and Clinic Based HIV Counseling and Testing (HCT) 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 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Oraquick HIV Self Test and Clinic Based HIV Counseling and Testing (HCT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 898 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Dec 2016to 31 Oct 2018
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Eligibility Inclusion Criteria Index:
- Females ages 18-26
- Have had sex in the past 3 months and plan to have sex again in the next 3 months
- Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months
- Able and willing to provide informed consent
- Willing to comply with study procedures
- Not known to be HIV positive (not reporting a previous positive test)
Eligibility Inclusion Criteria Peer/Partner:
- Females and Males ages 18 and older
- Able and willing to provide informed consent
- Willing to comply with study procedures
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
Acornhoek, 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
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, previously completed, 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, Clinic Based HIV Counseling and Testing (HCT)
- 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 TestOther
This is an oral swab in home HIV test.
Clinic Based HIV Counseling and Testing (HCT)Other
Receiving Counseling and Testing for HIV at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Choice | Active comparator | Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT) Receives: Other: Oraquick HIV Self Test; Other: Clinic Based HIV Counseling and Testing (HCT) |
| HIV Counseling and Testing | Active comparator | Clinic Based HIV Counseling and Testing (HCT) Receives: Other: Clinic Based HIV Counseling and Testing (HCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of index reporting testing uptake
Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Measured: 3 months post randomization
Secondary outcomes (3)
Proportion of peer/partner referrals by the index
Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.
Measured: 12 months post randomization
Proportion of peer/partners reporting testing uptake
Compare between the two study arms the proportion of testing uptake by peers/partners. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Measured: 12 months post randomization
Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+
Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Dec 2016
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
- Masking
- None (open label)
- Enrolment
- 898 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
- NCT03162965
- Sponsor's protocol ID
- 15-1361b
- Other IDs
- 5R01HD083033
- Acronym
- TI
- Status last verified
- Aug 2019
- First submitted
- 19 May 2017
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pettifor A, Lippman SA, Kimaru L, Haber N, Mayakayaka Z, Selin A, Twine R, Gilmore H, Westreich D, Mdaka B, Wagner R, Gomez-Olive X, Tollman S, Kahn K. HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners. EClinicalMedicine. 2020 Apr 18;21:100327. doi: 10.1016/j.eclinm.2020.100327. eCollection 2020 Apr.
PubMed 32322811Ritchwood TD, Selin A, Pettifor A, Lippman SA, Gilmore H, Kimaru L, Hove J, Wagner R, Twine R, Kahn K. HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources. BMC Public Health. 2019 Jan 29;19(1):123. doi: 10.1186/s12889-019-6402-4.
PubMed 30696422
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. 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
- NCT03162965
- Acronym / sponsor ID
- TI / 15-1361b
- Conditions
- Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 898 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 Dec 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 22 May 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.
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, previously completed, 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
| Arm | Type | Receives |
|---|---|---|
| Choice | Active comparator | Other: Oraquick HIV Self Test, Other: Clinic Based HIV Counseling and Testing (HCT)Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT) |
| HIV Counseling and Testing | Active comparator | Other: Clinic Based HIV Counseling and Testing (HCT)Clinic Based HIV Counseling and Testing (HCT) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 TestThis is an oral swab in home HIV test. | Other | Choice |
| Clinic Based HIV Counseling and Testing (HCT)Receiving Counseling and Testing for HIV at the clinic. | Other | Choice, HIV Counseling and Testing |
Primary outcome
Proportion of index reporting testing uptake
Time frame: 3 months post randomization
Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
3 secondary outcomes
Proportion of peer/partner referrals by the index
Time frame: 12 months post randomization
Proportion of peer/partners reporting testing uptake
Time frame: 12 months post randomization
Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+
Time frame: 12 months post randomization
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 9 Aug 2019.
- Derived from this study: PubMed 32322811Pettifor A, Lippman SA, Kimaru L, Haber N, Mayakayaka Z, Selin A, Twine R, Gilmore H, Westreich D, Mdaka B, Wagner R, Gomez-Olive X, Tollman S, Kahn K. HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners. EClinicalMedicine. 2020 Apr 18;21:100327. doi: 10.1016/j.eclinm.2020.100327. eCollection 2020 Apr.
- Derived from this study: PubMed 30696422Ritchwood TD, Selin A, Pettifor A, Lippman SA, Gilmore H, Kimaru L, Hove J, Wagner R, Twine R, Kahn K. HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources. BMC Public Health. 2019 Jan 29;19(1):123. doi: 10.1186/s12889-019-6402-4.
- 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.
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 and Clinic Based HIV Counseling and Testing (HCT) 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 9 Aug 2019. 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?
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?
Proportion of index reporting testing uptake (time frame: 3 months post randomization). 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 NCT03162965, 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 9 Aug 2019.