Innovations in HIV Testing

NCT ID: NCT03162965

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 898 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2018-10-31

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, 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.

Conditions

Human Immunodeficiency Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Choice

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

Group Type: ACTIVE_COMPARATOR

Oraquick HIV Self Test

Intervention Type: OTHER

This is an oral swab in home HIV test.

Clinic Based HIV Counseling and Testing (HCT)

Intervention Type: OTHER

Receiving Counseling and Testing for HIV at the clinic.

HIV Counseling and Testing

Clinic Based HIV Counseling and Testing (HCT)

Group Type: ACTIVE_COMPARATOR

Clinic Based HIV Counseling and Testing (HCT)

Intervention Type: OTHER

Receiving Counseling and Testing for HIV at the clinic.

Interventions

Oraquick HIV Self Test

This is an oral swab in home HIV test.

Intervention Type: OTHER

Clinic Based HIV Counseling and Testing (HCT)

Receiving Counseling and Testing for HIV at the clinic.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Audrey Pettifor

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit

Acornhoek, Mpumalanga, South Africa

Countries

South Africa

References

Pettifor A, Lippman SA, Kimaru L, Haber N, Mayakayaka Z, Selin A, Twine R, Gilmore H, Westreich D, Mdaka B, Wagner R, Gomez-Olive X, Tollman S, Kahn K. HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners. EClinicalMedicine. 2020 Apr 18;21:100327. doi: 10.1016/j.eclinm.2020.100327. eCollection 2020 Apr.

Reference Type: DERIVED

PMID: 32322811 (View on PubMed)

Ritchwood TD, Selin A, Pettifor A, Lippman SA, Gilmore H, Kimaru L, Hove J, Wagner R, Twine R, Kahn K. HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources. BMC Public Health. 2019 Jan 29;19(1):123. doi: 10.1186/s12889-019-6402-4.

Reference Type: DERIVED

PMID: 30696422 (View on PubMed)

Other Identifiers

5R01HD083033

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-1361b

Identifier Type: -

Identifier Source: org_study_id