Innovations in HIV Testing (TI)

Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Other: Oraquick HIV Self Test; Other: Clinic Based HIV Counseling and Testing (HCT)

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 Type: Interventional
• Enrollment (Actual): 898
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Mpumalanga
    • Acornhoek, Mpumalanga, South Africa
      • Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of peer/partner referrals by the index	Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.	12 months post randomization
Proportion of peer/partners reporting testing uptake	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.	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+	Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.	12 months post randomization

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 15-1361b; 5R01HD083033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: Yes