NCT04774835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,941

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

February 14, 2021

Last Update Submit

October 17, 2022

Conditions

Hiv

Keywords

HIV self-testingAssisted partner servicesAcceptabilityImplementation Science

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Difficulty of using the HIVST kit

    1 year

  • Difficulty of interpreting the HIVST results

    1 year

Study Arms (2)

Standard aPS

ACTIVE COMPARATOR

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

Diagnostic Test: Standard aPS

aPS + HIVST

EXPERIMENTAL

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

Interventions

HIVSTDIAGNOSTIC_TEST

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.

aPS + HIVST
Standard aPSDIAGNOSTIC_TEST

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.

Standard aPS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Aim 1:
  • Pregnancy
  • Reports intimate partner violence during last month
  • \<18 years old
  • Aim 2:
  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Roy Paladhi U, Katz DA, Otieno G, Hughes JP, Lagat H, Masyuko S, Sharma M, Macharia P, Bosire R, Mugambi M, Kariithi E, Farquhar C. Effectiveness of HIV self-testing when offered within assisted partner services in Western Kenya (APS-HIVST Study): a cluster randomized controlled trial. J Int AIDS Soc. 2024 Jul;27 Suppl 1(Suppl 1):e26298. doi: 10.1002/jia2.26298.

    PMID: 38965976DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Carey Farquhar, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine: Global Health

Study Record Dates

First Submitted

February 14, 2021

First Posted

March 1, 2021

Study Start

March 1, 2021

Primary Completion

July 1, 2022

Study Completion

October 12, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)