Hiv
Conditions
Keywords
HIV self-testing, Assisted partner services, Acceptability, Implementation Science
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.
Interventions
DIAGNOSTIC_TESTHIVST
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.
DIAGNOSTIC_TESTStandard 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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Kenyatta National Hospital
University of Nairobi
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed