An interventional study of HIVST and Standard aPS in Hiv, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-19.
Sponsored by University of Washington · Not applicable, Interventional, and Screening
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.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Aim 1:
Aim 2:
Exclusion Criteria:
Aim 1:
Aim 2:
Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor.
Diagnostic Test: Standard aPS
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
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 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
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".
Time frame: 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.
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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