Innovations in HIV Testing (TI)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Diagnostic Test: Oraquick HIV Self Test - Choice
* Diagnostic Test: Atomo HIV Self Test - Choice
* Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Focus Group Discussions<br>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. | |
| Active Comparator: In Clinic Observation-Both<br>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<br>* This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.<br>|
| Active Comparator: In Clinic Observation-Subject Choice<br>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<br>* This is an oral swab in home HIV test.<br>Diagnostic Test: Atomo HIV Self Test - Choice<br>* This is a blood finger prick in home HIV test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |