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Clinical Trials/NCT04774835
NCT04774835
Completed
Not Applicable

Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya

University of Washington1 site in 1 country4,941 target enrollmentMarch 1, 2021
ConditionsHiv

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hiv
Sponsor
University of Washington
Enrollment
4941
Locations
1
Primary Endpoint
Number of newly diagnosed HIV-infected or known positive and not in care
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study includes different designs with Aim 1 being a cluster randomized controlled trial to investigate the use of HIV self-testing (HIVST) as a mode of HIV testing in Western Kenya in addition to the standard of care, assisted partner services (aPS). Aim 2 includes focus group discussions, in-depth interviews, semi-structured interviews, direct observation of facility infrastructure and clinic procedures, and data extraction from facility and county/national databases and expenditure reports to study acceptability, costs, and implementation aspects of HIVST within the aPS framework.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
October 12, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carey Farquhar

Professor, School of Medicine: Global Health

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Men and women
  • Tests HIV positive and is not in care or on treatment
  • ≥18 years old
  • Willing and able to provide informed consent
  • Able to provide locator information for sexual partners
  • ≥18 years old
  • Willing and able to provide informed consent

Exclusion Criteria

  • Pregnancy
  • Reports intimate partner violence during last month
  • \<18 years old
  • \<18 years old

Outcomes

Primary Outcomes

Number of newly diagnosed HIV-infected or known positive and not in care

Time Frame: 1 year

Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants newly being diagnosed with HIV after participation, or those known to be positive but not currently under care.

Number of participants testing for the first time

Time Frame: 1 year

Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants choosing to get HIV tested for the first time.

Linking a new positive or known positive not in care to a treatment center

Time Frame: 1 year

Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that are linked to care at a treatment center.

Initiating ART, or re-initiating ART if previously lost to follow-up

Time Frame: 1 year

Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that initiate (or re-initiate) ART.

Secondary Outcomes

  • Difficulty of using the HIVST kit(1 year)
  • Difficulty of interpreting the HIVST results(1 year)

Study Sites (1)

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