HivNCT04774835
Assisted Partner Services and HIVST in Western Kenya
A study testing HIVST and Standard aPS in people with Hiv, run by University of Washington at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- What is being tested?
- HIVST and Standard aPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,941 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Aim 2:
- ≥18 years old
- Willing and able to provide informed consent
Who cannot join
- Aim 1:
- Pregnancy
- Reports intimate partner violence during last month
- <18 years old
- Aim 2:
- <18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya
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.
- Conditions
- Hiv
- Being tested
- HIVST, Standard aPS
- Keywords
- HIV self-testing, Assisted partner services, Acceptability, Implementation Science
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard aPS | Active comparator | Subjects receive standard assisted partner services from their local HIV testing services (HTS) counselor. Receives: 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. Receives: Diagnostic Test: HIVST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Secondary outcomes (2)
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".
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Jul 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 4,941 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Kenyatta National Hospital, University of Nairobi
- Responsible party
- Principal investigator, Carey Farquhar, University of Washington
- Investigators
- Carey Farquhar, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774835
- Sponsor's protocol ID
- STUDY00002420
- Other IDs
- R01AI134130
- Status last verified
- Oct 2022
- First submitted
- 14 Feb 2021
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38965976
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Assisted Partner Services for HIV Testing and Treatment in Western Kenya
- ClinicalTrials.gov ID
- NCT04774835
- Acronym / sponsor ID
- STUDY00002420
- Conditions
- Hiv
- Keywords
- HIV self-testing, Assisted partner services, Acceptability, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,941 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Kenyatta National Hospital, University of Nairobi
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard aPS | Active comparator | Diagnostic Test: Standard aPSSubjects receive standard assisted partner services from their local HIV testing services (HTS) counselor. |
| aPS + HIVST | Experimental | Diagnostic Test: HIVSTSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnancy
- Reports intimate partner violence during last month
- <18 years old
- <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIVSTaPS 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 test | aPS + HIVST |
| Standard aPSaPS 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. | Diagnostic test | Standard aPS |
Primary outcome
Number of participants testing for the first time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Difficulty of using the HIVST kit
Time frame: 1 year
Difficulty of interpreting the HIVST results
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 38965976Roy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carey Farquhar, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIVST and Standard aPS in people with Hiv, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants testing for the first time (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04774835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.