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Completed

NCT Number: NCT03271424

Innovations in HIV Testing (TI)

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.

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Key information

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit

Agincourt, Mpumalanga, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oraquick HIV Self Test - Choice

Diagnostic Test

This is an oral swab in home HIV test.

Atomo HIV Self Test - Choice

Diagnostic Test

This is a blood finger prick in home HIV test.

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2017
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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