Assisted Partner Services and HIVST in Western Kenya

University of Washington

Status: Completed

Conditions: Hiv

Treatments: Diagnostic Test: Standard aPS; Diagnostic Test: HIVST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04774835

R01AI134130 (U.S. NIH Grant/Contract)

STUDY00002420

Details and patient eligibility

About

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.

Enrollment: 4,941 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,941 participants in 2 patient groups

Standard aPS

Active Comparator group

Description:

Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor.

Treatment:

Diagnostic Test: Standard aPS

aPS + HIVST

Experimental group

Description:

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.

Treatment:

Diagnostic Test: HIVST