Innovations in HIV Testing (TI)

• ClinicalTrials.gov Identifier: NCT03162965
• Recruitment Status: Completed
• First Posted: May 22, 2017
• Last Update Posted: August 9, 2019
• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of Witwatersrand, South Africa; University of California, San Francisco; National Institutes of Health (NIH); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus	Other: Oraquick HIV Self Test; Other: Clinic Based HIV Counseling and Testing (HCT)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 898 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
• Actual Study Start Date: December 1, 2016
• Actual Primary Completion Date: October 31, 2018
• Actual Study Completion Date: October 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Choice; Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)	Other: Oraquick HIV Self Test; This is an oral swab in home HIV test.; Other: Clinic Based HIV Counseling and Testing (HCT); Receiving Counseling and Testing for HIV at the clinic.
Active Comparator: HIV Counseling and Testing; Clinic Based HIV Counseling and Testing (HCT)	Other: Clinic Based HIV Counseling and Testing (HCT); Receiving Counseling and Testing for HIV at the clinic.

Outcome Measures

Primary Outcome Measures :

1. Proportion of index reporting testing uptake [ Time Frame: 3 months post randomization ]
   Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.

Secondary Outcome Measures :

1. Proportion of peer/partner referrals by the index [ Time Frame: 12 months post randomization ]
   Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.
2. Proportion of peer/partners reporting testing uptake [ Time Frame: 12 months post randomization ]
   Compare between the two study arms the proportion of testing uptake by peers/partners. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
3. Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+ [ Time Frame: 12 months post randomization ]
   Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Enrolled participants need to self-identify as female. Peers and partners can be male and female.
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

South Africa

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

Acornhoek, Mpumalanga, South Africa

Sponsors and Collaborators

University of North Carolina, Chapel Hill

University of Witwatersrand, South Africa

University of California, San Francisco

National Institutes of Health (NIH)

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

Investigators

• Principal Investigator: Audrey Pettifor; University of North Carolina, Chapel Hill

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03162965
• Other Study ID Numbers: 15-1361b; 5R01HD083033 ( U.S. NIH Grant/Contract )
• First Posted: May 22, 2017
• Last Update Posted: August 9, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases