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Clinical Trials/NCT03162965
NCT03162965
Completed
Not 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 country898 target enrollmentDecember 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
University of North Carolina, Chapel Hill
Enrollment
898
Locations
1
Primary Endpoint
Proportion of index reporting testing uptake
Status
Completed
Last Updated
6 years ago

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

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2016
End Date
October 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proportion of index reporting testing uptake

Time Frame: 3 months post randomization

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 Outcomes

  • 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+(12 months post randomization)
  • Proportion of peer/partners reporting testing uptake(12 months post randomization)
  • Proportion of peer/partner referrals by the index(12 months post randomization)

Study Sites (1)

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