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Clinical Trials/NCT03271424
NCT03271424CompletedNot Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country95 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions

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

No Intervention

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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