NCT03271424

Innovations in HIV Testing (TI)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oraquick HIV Self Test - Choice	This is an oral swab in home HIV test.
DIAGNOSTIC_TEST	Atomo HIV Self Test - Choice	This is a blood finger prick in home HIV test.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2017-09-05
• Last updated: 2018-01-19
• Results posted: 2018-01-19

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated device study