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
Clinic Based HIV Counseling and Testing (HCT)
Sponsored by
About this trial
This is an interventional screening trial for Human Immunodeficiency Virus
Eligibility Criteria
Eligibility Inclusion Criteria Index:
- Females ages 18-26
- Have had sex in the past 3 months and plan to have sex again in the next 3 months
- Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months
- Able and willing to provide informed consent
- Willing to comply with study procedures
- Not known to be HIV positive (not reporting a previous positive test)
Eligibility Inclusion Criteria Peer/Partner:
- Females and Males ages 18 and older
- Able and willing to provide informed consent
- Willing to comply with study procedures
Sites / Locations
- Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Choice
HIV Counseling and Testing
Arm Description
Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)
Clinic Based HIV Counseling and Testing (HCT)
Outcomes
Primary Outcome Measures
Proportion of index reporting testing uptake
Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Secondary Outcome Measures
Proportion of peer/partner referrals by the index
Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.
Proportion of peer/partners reporting testing uptake
Compare between the two study arms the proportion of testing uptake by peers/partners. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+
Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.
Full Information
NCT ID
NCT03162965
First Posted
May 19, 2017
Last Updated
August 6, 2019
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)
1. Study Identification
Unique Protocol Identification Number
NCT03162965
Brief Title
Innovations in HIV Testing
Acronym
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
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (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
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
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, previously completed, 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
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
898 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choice
Arm Type
Active Comparator
Arm Description
Oraquick HIV Self Test or Clinic Based HIV Counseling and Testing (HCT)
Arm Title
HIV Counseling and Testing
Arm Type
Active Comparator
Arm Description
Clinic Based HIV Counseling and Testing (HCT)
Intervention Type
Other
Intervention Name(s)
Oraquick HIV Self Test
Intervention Description
This is an oral swab in home HIV test.
Intervention Type
Other
Intervention Name(s)
Clinic Based HIV Counseling and Testing (HCT)
Intervention Description
Receiving Counseling and Testing for HIV at the clinic.
Primary Outcome Measure Information:
Title
Proportion of index reporting testing uptake
Description
Compare between the two study arms the proportion of testing uptake at 3 months post-randomization. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Time Frame
3 months post randomization
Secondary Outcome Measure Information:
Title
Proportion of peer/partner referrals by the index
Description
Compare between the two studies arms the number of self test kits and HCT cards distributed by the index.
Time Frame
12 months post randomization
Title
Proportion of peer/partners reporting testing uptake
Description
Compare between the two study arms the proportion of testing uptake by peers/partners. Testing uptake is defined for HCT as self-report of going to the clinic and testing; and for self-test as self-report of using a self-test kit.
Time Frame
12 months post randomization
Title
Proportion of index and peer/partners who obtain a confirmatory test, start Antiretroviral Treatment (ART) if HIV+, and obtain their Cluster of Differentiation 4 (CD4) count if HIV+
Description
Among participants who test positive (young women, peers and sex partners), the investigators will examine uptake of linkage to care.
Time Frame
12 months post randomization
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Enrolled participants need to self-identify as female. Peers and partners can be male and female.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Eligibility Inclusion Criteria Index:
Females ages 18-26
Have had sex in the past 3 months and plan to have sex again in the next 3 months
Planning on staying in the Agincourt Health and Demographic Surveillance System (AHDSS) area for the next nine months
Able and willing to provide informed consent
Willing to comply with study procedures
Not known to be HIV positive (not reporting a previous positive test)
Eligibility Inclusion Criteria Peer/Partner:
Females and Males ages 18 and older
Able and willing to provide informed consent
Willing to comply with study procedures
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
Acornhoek
State/Province
Mpumalanga
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32322811
Citation
Pettifor A, Lippman SA, Kimaru L, Haber N, Mayakayaka Z, Selin A, Twine R, Gilmore H, Westreich D, Mdaka B, Wagner R, Gomez-Olive X, Tollman S, Kahn K. HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners. EClinicalMedicine. 2020 Apr 18;21:100327. doi: 10.1016/j.eclinm.2020.100327. eCollection 2020 Apr.
Results Reference
derived
PubMed Identifier
30696422
Citation
Ritchwood TD, Selin A, Pettifor A, Lippman SA, Gilmore H, Kimaru L, Hove J, Wagner R, Twine R, Kahn K. HIV self-testing: South African young adults' recommendations for ease of use, test kit contents, accessibility, and supportive resources. BMC Public Health. 2019 Jan 29;19(1):123. doi: 10.1186/s12889-019-6402-4.
Results Reference
derived
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Innovations in HIV Testing
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