Innovations in HIV Testing (TI)

University of North Carolina (UNC)

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Diagnostic Test: Atomo HIV Self Test - Choice; Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both; Diagnostic Test: Oraquick HIV Self Test - Choice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03271424

15-1361a

5R01HD083033 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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95 participants in 3 patient groups

Focus Group Discussions

No Intervention group

Description:

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 group

Description:

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

Treatment:

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

In Clinic Observation-Subject Choice

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Atomo HIV Self Test - Choice

Diagnostic Test: Oraquick HIV Self Test - Choice