Innovations in HIV Testing (TI)

Not Applicable

Completed

Interventions: Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both
Diagnostic Test: Oraquick HIV Self Test - Choice
Diagnostic Test: Atomo HIV Self Test - Choice

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: 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.

Recruitment & Eligibility

Inclusion Criteria

Observation Inclusion Criteria:

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
In Clinic Observation-Both	Oraquick HIV Self Test and Atomo HIV Self Test - 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
In Clinic Observation-Subject Choice	Oraquick HIV Self Test - 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
In Clinic Observation-Subject Choice	Atomo HIV Self Test - 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

Primary Outcome Measures

Name	Time	Method
Qualitative Summaries of Participant Experience in Focus Group Discussions	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	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

Secondary Outcome Measures

Name	Time	Method

Locations (1): Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit
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Agincourt, Mpumalanga, South Africa