Assisted Partner Services and HIVST in Western Kenya

Not Applicable

Completed

• Conditions: Hiv
• Interventions: Diagnostic Test: Standard aPS; Diagnostic Test: HIVST

• Registration Number: NCT04774835
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-24
• Study Start: 2021-03-01
• Study First Posted: 2021-03-01
• Primary Completion: 2022-07-01
• Status Verified: 2022-10
• Study Completion: 2022-10-12
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4941

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

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Exclusion Criteria

Aim 1:

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

Aim 2:

• <18 years old

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard aPS	Standard aPS	Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor.
aPS + HIVST	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.

Primary Outcome Measures

Name	Time	Method
Number of newly diagnosed HIV-infected or known positive and not in care	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	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	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	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 Outcome Measures

Name	Time	Method
Difficulty of using the HIVST kit	1 year	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".
Difficulty of interpreting the HIVST results	1 year	Understand the readability of HIV self-testing results in this population and setting, via a survey question.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States