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Innovations in HIV Testing (TI)

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ClinicalTrials.gov Identifier: NCT03162965
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : August 9, 2019
Sponsor:
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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162965


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03162965     History of Changes
Other Study ID Numbers: 15-1361b
5R01HD083033 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases