Assisted Partner Services and HIVST in Western Kenya

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774835
• Other study ID #: STUDY00002420
• Secondary ID: R01AI134130
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: October 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4941
• Est. completion date: October 12, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Kenyatta National Hospital, National Institute of Allergy and Infectious Diseases (NIAID), University of Nairobi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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