Innovations in HIV Testing (TI)
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|ClinicalTrials.gov Identifier: NCT03271424|
Recruitment Status : Completed
First Posted : September 5, 2017
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Diagnostic Test: Oraquick HIV Self Test - Choice Diagnostic Test: Atomo HIV Self Test - Choice Diagnostic Test: Oraquick HIV Self Test and Atomo HIV Self Test - Both||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Sequential Assignment|
|Intervention 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)|
|Official Title:||Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners|
|Actual Study Start Date :||October 1, 2015|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||June 1, 2016|
No Intervention: Focus Group Discussions
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.
Active Comparator: In Clinic Observation-Both
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
Diagnostic 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.
Active Comparator: In Clinic Observation-Subject Choice
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
Diagnostic Test: Oraquick HIV Self Test - Choice
This is an oral swab in home HIV test.
Diagnostic Test: Atomo HIV Self Test - Choice
This is a blood finger prick in home HIV test.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271424
|Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit|
|Agincourt, Mpumalanga, South Africa|
|Principal Investigator:||Audrey Pettifor||University of North Carolina, Chapel Hill|