Assisted Partner Services and HIVST in Western Kenya

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

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.

Study Overview

• Status: Completed
• Conditions: Hiv
• Intervention / Treatment: Diagnostic test: Standard aPS; Diagnostic test: HIVST

• Study Type: Interventional
• Enrollment (Actual): 4941
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Aim 1:

• 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

Aim 2:

• ≥18 years old
• Willing and able to provide informed consent

Exclusion Criteria:

Aim 1:

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

Aim 2:

• <18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard aPS; Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor.	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.
Experimental: aPS + HIVST; Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor as well as the option to do HIV self-testing (HIVST) instead of testing at the local HTS location.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants testing for the first time	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.	1 year
Number of newly diagnosed HIV-infected or known positive and not in care	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.	1 year
Linking a new positive or known positive not in care to a treatment center	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.	1 year
Initiating ART, or re-initiating ART if previously lost to follow-up	Identify if there's a difference between standard aPS and aPS+HIVST in the number of participants that initiate (or re-initiate) ART.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty of using the HIVST kit	Understand the ease of using HIV self-testing kits in this population and setting, via a survey question with a 4 point Likert scale ranging from "very easy" to "very "hard".	1 year
Difficulty of interpreting the HIVST results	Understand the readability of HIV self-testing results in this population and setting, via a survey question.	1 year

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); University of Nairobi; Kenyatta National Hospital
• Investigators: Principal Investigator: Carey Farquhar, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Acceptability; HIV self-testing; Implementation Science; Assisted partner services
• Other Study ID Numbers: STUDY00002420; R01AI134130 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No