HIV-1-infectionNCT03593629
Kenya HIV Self-Testing in PrEP Delivery
A study testing 6-month PrEP + blood-based HIV self-test and 6-month PrEP + oral fluid HIV self-test in people with HIV-1-infection, run by University of Washington at 1 site in Kenya.
Trial summary
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- 6-month PrEP + blood-based HIV self-test and 6-month PrEP + oral fluid HIV self-test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 790 participants
- Where
- 1 siteKenya
- Study dates
- 28 May 2018to 25 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing
- Not currently enrolled in an HIV-1 prevention clinical trial
- Taking PrEP and planning to continue
- Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self-testing
- Note: Women who are pregnant at screening/enrollment are still eligible
Who cannot join
- Unable to provide written informed consent
- Contraindication to use Tenofovir (TDF)+/- Emtricitabine (FTC)/ Lamivudine (3TC)
- For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if:
- Age ≥18
- Able and willing to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIV Self-Testing to Improve the Efficiency of PrEP Delivery
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
Read the detailed description
Guidelines recommend HIV-1 testing quarterly for individuals on PrEP. Clinic-based HIV testing every three months is costly for both clinics and participants. The investigators propose using HIV self-testing to replace quarterly clinic-based HIV testing for participants on PrEP, eliminating half of clinic visits and saving staffing and participant costs. The investigators want to understand the effect that reduced clinic contact frequency (resulting from HIV self-testing) has on PrEP adherence or completion of HIV-1 testing, overall and in subgroups.
The investigators will enroll roughly 495 eligible individuals on PrEP: 165 men and 165 women in HIV-1 serodiscordant couples and 165 women at risk of HIV-1 infection (priority populations for PrEP delivery in Kenya and more generally in Africa).
In this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. Participants randomized to six-monthly clinic visits will receive a 6-month supply of PrEP and either two blood-based HIV self-tests (blood-based HIV self-testing arm) or two oral fluid HIV self-tests (oral fluid HIV self-testing arm). Participants randomized to quarterly clinic visits will receive a 3-month supply of PrEP and get tested for HIV by a healthcare professional at the clinic (standard of care arm)
Study outcomes, measured at Months 6 and 12, include PrEP adherence (defined as the detection of PrEP in dried blood spots as well as persistence in refilling PrEP), HIV-1 testing, and safety (including side effects and social harm).
- Conditions
- HIV-1-infection
- Being tested
- 6-month PrEP + blood-based HIV self-test, 6-month PrEP + oral fluid HIV self-test
- Keywords
- HIV, AIDS, PrEP, Truvada, Public Health, Global Health, Infectious Disease, Self-Testing, Kenya, Africa, Low and/or Middle Income Countries (LMIC), Cost-Effectiveness
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-month PrEP + blood-based HIV self-testCombination product
Participants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing.
6-month PrEP + oral fluid HIV self-testCombination product
Participants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months |
| Blood-based HIV self-testing | Experimental | Participants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing. Receives: Combination Product: 6-month PrEP + blood-based HIV self-test |
| Oral fluid HIV self-testing | Experimental | Participants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing. Receives: Combination Product: 6-month PrEP + oral fluid HIV self-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adherence to PrEP at 6 Months
Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
Measured: Month 6
Persistence in Refilling PrEP
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Measured: Month 6
HIV-1 Testing
Self-reported HIV-1 testing in the past 6 months
Measured: Month 6
Secondary outcomes (3)
PrEP Adherence
Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
Measured: Month 12
Persistence in Refilling PrEP
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
Measured: Month 12
HIV-1 Testing
Self-reported HIV-1 testing in the past 6 months
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start28 May 2018
- Primary completion10 Dec 2020
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 790 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jared Baeten, University of Washington
- Investigators
- Jared Baeten, MD, PhD, Principal investigator, University of WashingtonKenneth Ngure, PhD, MPH, Principal investigator, Jomo Kenyatta University of Agriculture and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593629
- Sponsor's protocol ID
- STUDY00003750
- Other IDs
- 1R01MH113572
- Status last verified
- May 2024
- First submitted
- 2 Jun 2018
- Last updated
- 4 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mangale DI, Heitner J, Ortblad KF, Mogere P, Kiptinness C, Mugo NR, Baeten JM, Ngure K, Barnabas R. Opportunity for cost savings with a novel differentiated model of PrEP delivery: a comparative costing analysis of six-month PrEP supported by interim HIV self-testing and standard of care PrEP dispensing in Kenya. BMC Health Serv Res. 2025 Jul 1;25(1):865. doi: 10.1186/s12913-025-12891-7.
PubMed 40598383Thuo N, Bardon AR, Mogere P, Kiptinness C, Casmir E, Wairimu N, Owidi E, Okello P, Mugo NR, Baeten JM, Ngure K, Ortblad KF. Acceptability of six-monthly PrEP dispensing supported with interim HIV self-testing to simplify PrEP delivery in Kenya: findings from qualitative research. BMC Health Serv Res. 2024 Oct 24;24(1):1281. doi: 10.1186/s12913-024-11521-y.
PubMed 39448999Ortblad KF, Bardon AR, Mogere P, Kiptinness C, Gakuo S, Mbaire S, Thomas KK, Mugo NR, Baeten JM, Ngure K. Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2318590. doi: 10.1001/jamanetworkopen.2023.18590.
PubMed 37318803Ngure K, Ortblad KF, Mogere P, Bardon AR, Thomas KK, Mangale D, Kiptinness C, Gakuo S, Mbaire S, Nyokabi J, Mugo NR, Baeten JM. Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. Lancet HIV. 2022 Jul;9(7):e464-e473. doi: 10.1016/S2352-3018(22)00126-6.
PubMed 35777410Ortblad KF, Kearney JE, Mugwanya K, Irungu EM, Haberer JE, Barnabas RV, Donnell D, Mugo NR, Baeten JM, Ngure K. HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. Trials. 2019 Jul 4;20(1):396. doi: 10.1186/s13063-019-3521-2.
PubMed 31272495
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Self-Testing to Improve the Efficiency of PrEP Delivery
- ClinicalTrials.gov ID
- NCT03593629
- Acronym / sponsor ID
- STUDY00003750
- Conditions
- HIV-1-infection
- Keywords
- HIV, AIDS, PrEP, Truvada, Public Health, Global Health, Infectious Disease, Self-Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 27 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a three-arm, randomized trial, the investigators will test the use of HIV-1 self-testing to decrease the frequency and burden of clinic visits for PrEP while resulting in equivalent PrEP adherence and HIV testing.
Detailed description
Guidelines recommend HIV-1 testing quarterly for individuals on PrEP. Clinic-based HIV testing every three months is costly for both clinics and participants. The investigators propose using HIV self-testing to replace quarterly clinic-based HIV testing for participants on PrEP, eliminating half of clinic visits and saving staffing and participant costs. The investigators want to understand the effect that reduced clinic contact frequency (resulting from HIV self-testing) has on PrEP adherence or completion of HIV-1 testing, overall and in subgroups.
The investigators will enroll roughly 495 eligible individuals on PrEP: 165 men and 165 women in HIV-1 serodiscordant couples and 165 women at risk of HIV-1 infection (priority populations for PrEP delivery in Kenya and more generally in Africa).
In this study, participants will be randomly assigned in a 2:1 fashion to either six-monthly clinic visits or quarterly clinic visits. Participants randomized to six-monthly clinic visits will receive a 6-month supply of PrEP and either two blood-based HIV self-tests (blood-based HIV self-testing arm) or two oral fluid HIV self-tests (oral fluid HIV self-testing arm). Participants randomized to quarterly clinic visits will receive a 3-month supply of PrEP and get tested for HIV by a healthcare professional at the clinic (standard of care arm)
Study outcomes, measured at Months 6 and 12, include PrEP adherence (defined as the detection of PrEP in dried blood spots as well as persistence in refilling PrEP), HIV-1 testing, and safety (including side effects and social harm).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants receive standard of care for PrEP, including 3-months of PrEP supply and HIV testing at clinic every three months |
| Blood-based HIV self-testing | Experimental | Combination Product: 6-month PrEP + blood-based HIV self-testParticipants receive 6-months of PrEP supply and blood-based HIV self-tests for quarterly HIV testing. |
| Oral fluid HIV self-testing | Experimental | Combination Product: 6-month PrEP + oral fluid HIV self-testParticipants receive 6-months of PrEP supply and oral fluid HIV self-tests for quarterly HIV testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years HIV-1 uninfected based on negative HIV-1 rapid testing
- Not currently enrolled in an HIV-1 prevention clinical trial
- Taking PrEP and planning to continue
- Willing to be randomized to either clinic based HIV-1 testing or HIV-1 self-testing
- Note: Women who are pregnant at screening/enrollment are still eligible
Key exclusion criteria (5 listed)
- Unable to provide written informed consent
- Contraindication to use Tenofovir (TDF)+/- Emtricitabine (FTC)/ Lamivudine (3TC)
- For the HIV-1 serodiscordant couples, HIV-1 infected members of the couple will be enrolled for a single visit at baseline, if:
- Age ≥18
- Able and willing to provide written informed consent
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 |
|---|---|---|
| 6-month PrEP + blood-based HIV self-testParticipants receive 6-month PrEP supply plus two blood-based HIV self-tests (Atomo Diagnostics Blood-Based HIV-1 Self-Testing Kit) for quarterly HIV testing. | Combination product | Blood-based HIV self-testing |
| 6-month PrEP + oral fluid HIV self-testParticipants receive 6-month PrEP supply plus two oral fluid HIV self-tests (OraQuick Oral Fluid-based HIV-1 Self-Testing Kit) for quarterly HIV testing. | Combination product | Oral fluid HIV self-testing |
Primary outcome
Number of Participants With Adherence to PrEP at 6 Months
Time frame: Month 6
Laboratory tests will be conducted to measure adherence to PrEP medication by testing drug levels in the collected blood specimen. The detection of PrEP in blood will be considered as adherent to PrEP.
Persistence in Refilling PrEP
Time frame: Month 6
The percentage of participants that return to clinic to refill their PrEP medication. An alternative measure of PrEP adherence.
HIV-1 Testing
Time frame: Month 6
Self-reported HIV-1 testing in the past 6 months
3 secondary outcomes
PrEP Adherence
Time frame: Month 12
Persistence in Refilling PrEP
Time frame: Month 12
HIV-1 Testing
Time frame: Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40598383Mangale DI, Heitner J, Ortblad KF, Mogere P, Kiptinness C, Mugo NR, Baeten JM, Ngure K, Barnabas R. Opportunity for cost savings with a novel differentiated model of PrEP delivery: a comparative costing analysis of six-month PrEP supported by interim HIV self-testing and standard of care PrEP dispensing in Kenya. BMC Health Serv Res. 2025 Jul 1;25(1):865. doi: 10.1186/s12913-025-12891-7.
- Derived from this study: PubMed 39448999Thuo N, Bardon AR, Mogere P, Kiptinness C, Casmir E, Wairimu N, Owidi E, Okello P, Mugo NR, Baeten JM, Ngure K, Ortblad KF. Acceptability of six-monthly PrEP dispensing supported with interim HIV self-testing to simplify PrEP delivery in Kenya: findings from qualitative research. BMC Health Serv Res. 2024 Oct 24;24(1):1281. doi: 10.1186/s12913-024-11521-y.
- Derived from this study: PubMed 37318803Ortblad KF, Bardon AR, Mogere P, Kiptinness C, Gakuo S, Mbaire S, Thomas KK, Mugo NR, Baeten JM, Ngure K. Effect of 6-Month HIV Preexposure Prophylaxis Dispensing With Interim Self-testing on Preexposure Prophylaxis Continuation at 12 Months: A Randomized Noninferiority Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2318590. doi: 10.1001/jamanetworkopen.2023.18590.
- Derived from this study: PubMed 35777410Ngure K, Ortblad KF, Mogere P, Bardon AR, Thomas KK, Mangale D, Kiptinness C, Gakuo S, Mbaire S, Nyokabi J, Mugo NR, Baeten JM. Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomised, non-inferiority, implementation trial. Lancet HIV. 2022 Jul;9(7):e464-e473. doi: 10.1016/S2352-3018(22)00126-6.
- Derived from this study: PubMed 31272495Ortblad KF, Kearney JE, Mugwanya K, Irungu EM, Haberer JE, Barnabas RV, Donnell D, Mugo NR, Baeten JM, Ngure K. HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya. Trials. 2019 Jul 4;20(1):396. doi: 10.1186/s13063-019-3521-2.
- 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.
Jared Baeten, MD, PhD principal investigator
University of Washington
Kenneth Ngure, PhD, MPH principal investigator
Jomo Kenyatta University of Agriculture and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-month PrEP + blood-based HIV self-test and 6-month PrEP + oral fluid HIV self-test in people with HIV-1-infection, run by University of Washington at 1 site in Kenya.
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 5 inclusion and 5 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 4 Jun 2024. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Adherence to PrEP at 6 Months (time frame: Month 6). The study lists 3 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 NCT03593629, which also lists 5 linked publications.
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 4 Jun 2024.