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Innovations in HIV Testing (TI)

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Oraquick HIV Self Test - Choice
Atomo HIV Self Test - Choice
Oraquick HIV Self Test and Atomo HIV Self Test - Both
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Focus Group Discussions

In Clinic Observation-Both

In Clinic Observation-Subject Choice

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2017
Last Updated
December 18, 2017
Sponsor
University of North Carolina, Chapel Hill
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)
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1. Study Identification

Unique Protocol Identification Number
NCT03271424
Brief Title
Innovations in HIV Testing (TI)
Official Title
Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
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)

4. Oversight

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
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focus Group Discussions
Arm Type
No Intervention
Arm Description
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.
Arm Title
In Clinic Observation-Both
Arm Type
Active Comparator
Arm Description
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
Arm Title
In Clinic Observation-Subject Choice
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Oraquick HIV Self Test - Choice
Intervention Description
This is an oral swab in home HIV test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Atomo HIV Self Test - Choice
Intervention Description
This is a blood finger prick in home HIV test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oraquick HIV Self Test and Atomo HIV Self Test - Both
Intervention Description
This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
Primary Outcome Measure Information:
Title
Qualitative Summaries of Participant Experience in Focus Group Discussions
Description
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
Time Frame
6 months post study start
Title
Quantitative Summaries of Participants Experience in Observation Sessions
Description
Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results
Time Frame
12 month post study start

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Enrolled participants need to self-identify as female or female for their respective data collection.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Pettifor
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit
City
Agincourt
State/Province
Mpumalanga
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Innovations in HIV Testing (TI)

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