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Clinical Trials/NCT03271424
NCT03271424
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 country95 target enrollmentOctober 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
University of North Carolina, Chapel Hill
Enrollment
95
Locations
1
Primary Endpoint
Qualitative Summaries of Participant Experience in Focus Group Discussions
Status
Completed
Last Updated
8 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

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2015
End Date
June 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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

Study Sites (1)

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