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Innovations in HIV Testing (TI)

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ClinicalTrials.gov Identifier: NCT03271424
Recruitment Status : Completed
First Posted : September 5, 2017
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
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

Study Description
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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 Diagnostic Test: Oraquick HIV Self Test - Choice Diagnostic Test: Atomo HIV Self Test - Choice Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both Not Applicable

Detailed Description:

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.

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, explained in this submission, 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Qualitative focus group discussions (FGDs) with male and female community members aged 18 - 24

In-clinic observation of HIV self-testing and completion of a brief CAPI/ACASI interview with male and female community members aged 18 - 24
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Focus Group Discussions
Focus group discussions (FGD) with young women (n=2 FGDs) and young men (n=2 FGDs) in the study area to determine the best way to offer self-testing to study participants.
Active Comparator: In Clinic Observation-Both
10 young women and 10 young men were assigned and conducted BOTH of the HIV self-tests. Participants tried two different self-testing kits, one that is oral fluid based (saliva), Oraquick HIV Self Test, and one that is blood based via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test and Atomo HIV Self Test - Both
 Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both
This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
Active Comparator: In Clinic Observation-Subject Choice
20 young women and 20 young men were assigned and conducted EITHER of the HIV self-tests. Investigators asked them to choose which test they would prefer to use, one that is oral fluid based (saliva), Oraquick HIV Self Test, or one that requires the use blood via a finger prick, Atomo HIV Self Test. Oraquick HIV Self Test - Choice; Atomo HIV Self Test - choice
 Diagnostic Test: Oraquick HIV Self Test - Choice
This is an oral swab in home HIV test.

Diagnostic Test: Atomo HIV Self Test - Choice
This is a blood finger prick in home HIV test.


Outcome Measures
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Primary Outcome Measures :
  1. Qualitative Summaries of Participant Experience in Focus Group Discussions [ Time Frame: 6 months post study start ]
    Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact

  2. Quantitative Summaries of Participants Experience in Observation Sessions [ Time Frame: 12 month post study start ]
    Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Enrolled participants need to self-identify as female or female for their respective data collection.
Accepts Healthy Volunteers:   Yes
Criteria

FGD Inclusion Criteria:

  • Females and males aged 18 - 24
  • Able and willing to provide informed consent
  • Residing in the selected villages

Observation Inclusion Criteria:

  • Females and males aged 18 -24
  • Able and willing to provide informed consent
  • Residing in the selected villages
  • Not known to be HIV positive (not reporting a previous positive test)
Contacts and Locations
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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): NCT03271424


Locations
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South Africa
Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit
Agincourt, 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
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03271424    
Other Study ID Numbers: 15-1361a
5R01HD083033 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2017    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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
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