Innovations in HIV Testing (TI)

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03271424
• Other study ID #: 15-1361a
• Secondary ID: 5R01HD083033
• Status: Completed
• Phase: N/A
• First received: August 31, 2017
• Last updated: December 18, 2017
• Start date: October 1, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: September 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Diagnostic Test:
• Oraquick HIV Self Test - Choice
This is an oral swab in home HIV test.
• Atomo HIV Self Test - Choice
This is a blood finger prick in home HIV 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.

Locations

Country	Name	City	State
South Africa	Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit	Agincourt	Mpumalanga

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	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

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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