Innovations in HIV Testing (TI)

University of North Carolina (UNC) logo

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)

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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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