Innovations in HIV Testing

NCT03162965 | Completed

• 2 other identifiers: 15-1361b5R01HD083033
• Study Type: interventional
• Target: 898
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Proportion of index reporting testing uptake

  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.

  3 months post randomization

Secondary Outcomes (3)

• Proportion of peer/partner referrals by the index

  12 months post randomization

• Proportion of peer/partners reporting testing uptake

  12 months post randomization

• 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+

  12 months post randomization

Study Arms (2)

Choice

ACTIVE COMPARATOR

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

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

HIV Counseling and Testing

ACTIVE COMPARATOR

Clinic Based HIV Counseling and Testing (HCT)

Other: Clinic Based HIV Counseling and Testing (HCT)

Interventions

Oraquick HIV Self Test OTHER

This is an oral swab in home HIV test.

Choice

Clinic Based HIV Counseling and Testing (HCT) OTHER

Receiving Counseling and Testing for HIV at the clinic.

Choice; HIV Counseling and Testing

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Enrolled participants need to self-identify as female. Peers and partners can be male and female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Witwatersrand, South Africa: collaborator
• University of California, San Francisco: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

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

Acornhoek, Mpumalanga, South Africa

Location

Related Publications (2)

• 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.

  PMID: 32322811 DERIVED

• 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.

  PMID: 30696422 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; 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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Audrey Pettifor

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: December 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)