Assisted Partner Services and HIVST in Western Kenya

NCT04774835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4941

Last updated 2022-10-19

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

HIVST

aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV self-testing by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.

DIAGNOSTIC_TEST

Standard aPS

aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV testing at their local HTS location by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • Kenyatta National Hospital

    collaborator OTHER_GOV
  • University of Nairobi

    collaborator OTHER
  • University of Washington

    lead OTHER

Principal Investigators

  • Carey Farquhar, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-07-01
Completion
2022-10-12

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04774835 on ClinicalTrials.gov