Assisted Partner Services and HIVST in Western Kenya

Study Overview
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Brief Summary
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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.

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

Conditions
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Hiv

Intervention / Treatment
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* Diagnostic Test: HIVST
* Diagnostic Test: Standard aPS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard aPS<br>Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor. | Diagnostic Test: Standard aPS<br>* 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.<br>|
| Experimental: aPS + HIVST<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV self-testing, Assisted partner services, Acceptability, Implementation Science