An interventional study of Oraquick HIV Self Test - Choice and Atomo HIV Self Test - Choice in Human Immunodeficiency Virus, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in South Africa. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Other
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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.
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.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 95 is close to the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,373 studies on the registry; 134 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
FGD Inclusion Criteria:
Observation Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both
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
Diagnostic Test: Oraquick HIV Self Test - Choice · Diagnostic Test: Atomo HIV Self Test - Choice
This is an oral swab in home HIV test.
This is a blood finger prick in home HIV test.
This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
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
Time frame: 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
Time frame: 12 month post study start
| Milestone | In Clinic Observation-Both | Focus Group Discussions | In Clinic Observation-Subject Choice |
|---|---|---|---|
| Started | 20 | 0 | 0 |
| Completed | 20 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | In Clinic Observation-Both | Focus Group Discussions | In Clinic Observation-Subject Choice |
|---|---|---|---|
| Started | 0 | 35 | 0 |
| Completed | 0 | 35 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | In Clinic Observation-Both | Focus Group Discussions | In Clinic Observation-Subject Choice |
|---|---|---|---|
| Started | 0 | 0 | 40 |
| Completed | 0 | 0 | 40 |
| Not completed | 0 | 0 | 0 |
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
| number of times reported in FGD | Focus Group Discussions |
|---|---|
| HIV Self Test (HST) Acceptability | 100 |
| HST Context | 7 |
| HST Kit Preference | 26 |
| HST motivation | 10 |
| HST Recommendations | 29 |
| Supportive resources | 12 |
Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
| Participants | In Clinic Observation-Both (Oraquick Results) | In Clinic Observation - Both (Atomo Results) | In Clinic Observation-Subject Choice (Oraquick Results) | In Clinic Observation-Subject Choice (Atomo Results) |
|---|---|---|---|---|
| Found Instructions Clear | 19 | 19 | 30 | 8 |
| Were Very Comfortable Using the Test | 16 | 14 | 24 | 6 |
| Very Easy to use the Test | 18 | 13 | 27 | 7 |
| Very Easy to Interpret Results | 18 | 18 | 31 | 8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Focus Group Discussions | — | 0/35 (0%) | 0/35 (0%) |
| In Clinic Observation-Both | — | 0/20 (0%) | 0/20 (0%) |
| In Clinic Observation-Subject Choice | — | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Focus Group Discussions | In Clinic Observation-Both | In Clinic Observation-Subject Choice | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 20 | 40 | 95 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Focus Group Discussions | In Clinic Observation-Both | In Clinic Observation-Subject Choice | Total |
|---|---|---|---|---|
| Mean | 20 (18 to 24) | 20 (18 to 24) | 20 (18 to 24) | 20 (18 to 24) |
| Sex: Female, Male(Participants) | Focus Group Discussions | In Clinic Observation-Both | In Clinic Observation-Subject Choice | Total |
|---|---|---|---|---|
| Female | 16 | 10 | 20 | 46 |
| Male | 19 | 10 | 20 | 49 |
| Region of Enrollment(Participants) | Focus Group Discussions | In Clinic Observation-Both | In Clinic Observation-Subject Choice | Total |
|---|---|---|---|---|
| South Africa | 35 | 20 | 40 | 95 |
Ran from Oct 2015 to primary completion in Jun 2016, 8 months.
Results were first posted in Jan 2018, 1 year 7 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 8 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
University of North Carolina, Chapel Hill →