Innovations in HIV Testing to Enhance Care for Young Women and Their Peers and Partners
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 95
- Locations
- 1
- Primary Endpoint
- Qualitative Summaries of Participant Experience in Focus Group Discussions
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 24 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
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
Intervention: Oraquick HIV Self Test and Atomo HIV Self Test - Both (Diagnostic Test)
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
Intervention: Oraquick HIV Self Test - Choice (Diagnostic Test)
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
Intervention: Atomo HIV Self Test - Choice (Diagnostic Test)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
