Innovations in HIV Testing (TI)

NCT03271424 | Completed Results FDA Device

• 2 other identifiers: 15-1361a5R01HD083033
• Study Type: interventional
• Target: 95
• 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 (2)

• Qualitative Summaries of Participant Experience in Focus Group Discussions

  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

  6 months post study start

• Quantitative Summaries of Participants Experience in Observation Sessions

  Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results

  12 month post study start

Study Arms (3)

Focus Group Discussions

NO INTERVENTION

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.

In Clinic Observation-Both

ACTIVE COMPARATOR

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

In Clinic Observation-Subject Choice

ACTIVE COMPARATOR

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; Diagnostic Test: Atomo HIV Self Test - Choice

Interventions

Oraquick HIV Self Test - Choice DIAGNOSTIC_TEST

This is an oral swab in home HIV test.

In Clinic Observation-Subject Choice

Atomo HIV Self Test - Choice DIAGNOSTIC_TEST

This is a blood finger prick in home HIV test.

In Clinic Observation-Subject Choice

Oraquick HIV Self Test and Atomo HIV Self Test - Both DIAGNOSTIC_TEST

This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.

In Clinic Observation-Both

Eligibility Criteria

• Age: 18 Years - 24 Years
• Gender Eligibility Details: Enrolled participants need to self-identify as female or female for their respective data collection.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

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

Agincourt, Mpumalanga, South Africa

Location

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

Results Point of Contact

• Title: Dr. Audrey Pettifor
• Organization: University of North Carolina Chapel Hill

apettif@email.unc.edu

919-966-7439

Study Officials

• Audrey Pettifor

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 19, 2018
• Results First Posted: January 19, 2018

Record last verified: 2017-09

Locations

ZA (1)