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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD083033 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Witwatersrand, South Africa | OTHER |
| University of California, San Francisco | OTHER |
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oraquick HIV Self Test - Choice | Diagnostic Test | This is an oral swab in home HIV test. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 month post study start |
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FGD Inclusion Criteria:
Observation Inclusion Criteria:
Enrolled participants need to self-identify as female or female for their respective data collection.
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| Name | Affiliation | Role |
|---|---|---|
| Audrey Pettifor | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit | Agincourt | Mpumalanga | South Africa |
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| ID | Title | Description |
|---|---|---|
| FG000 | In Clinic Observation-Both | 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 Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test. |
| FG001 | Focus Group Discussions | 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. |
| FG002 | In Clinic Observation-Subject Choice | 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 Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test. Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| November 2015 |
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| December 2015 |
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| April-May 2016 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Focus Group Discussions | 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. |
| BG001 | In Clinic Observation-Both |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | number of times reported in FGD | 6 months post study start |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Focus Group Discussions | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Audrey Pettifor | University of North Carolina Chapel Hill | 919-966-7439 | apettif@email.unc.edu |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| NIH |
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
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| Atomo HIV Self Test - Choice | Diagnostic Test | This is a blood finger prick in home HIV test. |
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| Oraquick HIV Self Test and Atomo HIV Self Test - Both | Diagnostic Test | This is an oral swab in home HIV test and this is a blood finger prick in home HIV test. |
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| NOT COMPLETED |
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| NOT COMPLETED |
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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
Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
| BG002 | In Clinic Observation-Subject Choice | 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 Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test. Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | 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 | Posted | Count of Participants | Participants | 12 month post study start |
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|
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| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | In Clinic Observation-Both | 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 Oraquick HIV Self Test and Atomo HIV Self Test - Both: This is an oral swab in home HIV test and this is a blood finger prick in home HIV test. | 0 | 20 | 0 | 20 |
| EG002 | In Clinic Observation-Subject Choice | 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 Oraquick HIV Self Test - Choice: This is an oral swab in home HIV test. Atomo HIV Self Test - Choice: This is a blood finger prick in home HIV test. | 0 | 40 | 0 | 40 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Were Very Comfortable Using the Test |
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| Very Easy to use the Test |
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| Very Easy to Interpret Results |
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