Innovations in HIV Testing (TI)

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus

• Registration Number: NCT03271424
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Status Verified: 2017-09
• Study First Posted: 2017-09-05
• Results First Submitted: 2017-10-19
• Results First Submitted QC: 2017-12-18
• Last Update Submitted: 2017-12-18
• Results First Posted: 2018-01-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Qualitative Summaries of Participant Experience in Focus Group Discussions	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
Quantitative Summaries of Participants Experience in Observation Sessions	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

Trial Locations

Locations (1)

Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit; 🇿🇦 Agincourt, Mpumalanga, South Africa