Innovations in HIV Testing (TI)

University of North Carolina (UNC)

Status: Completed

Conditions: Human Immunodeficiency Virus

Treatments: Other: Oraquick HIV Self Test; Other: Clinic Based HIV Counseling and Testing (HCT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03162965

15-1361b

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

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, previously completed, 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: 898 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Inclusion Criteria Index:

• Females ages 18-26
• Have had sex in the past 3 months and plan to have sex again in the next 3 months
• Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months
• Able and willing to provide informed consent
• Willing to comply with study procedures
• Not known to be HIV positive (not reporting a previous positive test)

Eligibility Inclusion Criteria Peer/Partner:

• Females and Males ages 18 and older
• Able and willing to provide informed consent
• Willing to comply with study procedures

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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898 participants in 2 patient groups

Choice

Active Comparator group

Description:

Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)

Treatment:

Other: Clinic Based HIV Counseling and Testing (HCT)

Other: Oraquick HIV Self Test

HIV Counseling and Testing

Active Comparator group

Description:

Clinic Based HIV Counseling and Testing (HCT)

Treatment:

Other: Clinic Based HIV Counseling and Testing (HCT)