HIV InfectionsTMPNCT03508908

Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission

A study testing HIV-1 RNA testing in people with HIV Infections, run by University of Oxford at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 39 years
Conditions the study is for: HIV Infections
What is being tested?: HIV-1 RNA testing
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,887 participants
Where: 1 siteKenya
Study dates: 1 Dec 2017to 31 Jul 2022
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 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

age from 18-39 years;
not previously diagnosed with HIV infection; and
a score ≥2 on our risk score algorithm to identify persons at higher risk for AHI, with scoring as follows:
age 18-29 years (1),
fever (1),
fatigue (1),

Show all 13Show fewer

body pains (1),
diarrhea (1),
sore throat (1), and
genital ulcer disease (GUD) (3).
Eligibility criteria for partners of newly diagnosed cases with prevalent or acute HIV include:
age over 18 years; and
not previously diagnosed HIV infection.

Who cannot join

Patients not meeting inclusion criteria or those who are not willing or able to participate (e.g., due to illness or time constraints, or at the discretion of the study clinician) will be excluded.
Individuals at high risk for Intimate Partner Violence (IPV) are excluded from the aPS intervention, but eligible for all other components of the study.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

KEMRI Mtwapa
Kilifi, 80108

Other trials in Kenya

About this study

Official title: Impact of a Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection and Reduce HIV Transmission - Tambua Mapema Plus

This study will assess the impact of an HIV-1 RNA testing intervention targeting adult patients aged 18-39 years who seek urgent care for symptoms at primary care facilities and meet specific risk criteria for acute HIV infection. All newly diagnosed HIV-infected patients in the intervention arm will be linked to care and offered both immediate treatment and assisted partner notification. Partners will also be tested using the HIV testing intervention, and pre-exposure prophylaxis will be offered to uninfected individuals with HIV-infected partners. The cost-effectiveness of this intervention will be evaluated.

Read the detailed description

This is a proof-of-concept study comparing outcomes of a health facility-based acute HIV infection (AHI) and prevalent HIV testing intervention using point of care HIV-1 RNA detection, combined with assisted partner services (aPS) and follow-up in an antiretroviral therapy (ART) cohort for all newly diagnosed individuals and follow-up in a pre-exposure prophylaxis (PrEP) cohort for the uninfected partners of newly diagnosed individuals, compared to standard care.

Study Design: Randomized stepped-wedge study with prospective cohort follow-up of all individuals newly diagnosed with acute or prevalent HIV infection and of up to 300 identified partners of these persons. Individuals enrolled in the observation phase will be compared to those enrolled in the intervention phase at each facility, after undergoing the following procedures in each phase.

Study Population: The study population will be recruited from among male and female adult patients who present for care at 6 public or private outpatient clinics in coastal Kenya. Eligibility criteria for the HIV-1 RNA testing intervention include: 1) age from 18-39 years; 2) not previously diagnosed with HIV infection; and 3) a score ≥2 on our AHI risk score algorithm. Eligibility criteria for partners of newly diagnosed cases with acute or prevalent HIV infection include: 1) age over 18 years; and 2) not previously diagnosed with HIV infection.

Sample Size: 3,175 study participants total, including 2,875 participants in the stepped-wedge study (1,375 in the observation period and 1,500 in the intervention period). We estimate that approximately 2% of participants in the observation period (n=28) and approximately 5% of participants in the intervention period (n=75) will test positive for HIV infection and continue in the study. We estimate that up to 300 partners of newly diagnosed individuals will be offered enrollment and tested for HIV using standard tests (observation period) or HIV-1 RNA testing (intervention period).

Participating Sites: Kenya Medical Research Institute (KEMRI)-Wellcome Trust Programme, Kilifi, Kenya with stepped wedge trial implementation at 6 community health facilities (2-4 public, 2-4 private) and ART and PrEP cohort follow-up at the KEMRI Research Clinic in Mtwapa, Kenya.

Schedule of Procedures: Individuals eligible for the HIV-1 RNA testing intervention will be offered enrollment when they seek care at one of the study facilities, with testing taking place on that same day. For individuals with negative test results for both acute and prevalent HIV infection, no further follow-up will occur. One 6-week follow-up visit will occur after testing for all individuals who are newly diagnosed with HIV. Procedures for the aPS intervention, the ART cohort, and the PrEP cohort are detailed in this protocol.

Study Duration: Study enrollment will occur over 24 months. Following enrollment and study procedures (1-2 hours of time), all participants who test negative for HIV infection will have no further visits. All participants newly diagnosed with HIV will have a 6-week follow-up visit. All participants who enroll in the ART or PrEP cohort will be followed for a total of 12 months.

Intervention: Testing for acute and prevalent HIV infection, followed by partner notification services and immediate ART (provided by the Kenyan Ministry of Health) for newly diagnosed individuals and PrEP (provided by Gilead) for uninfected partners in serodiscordant relationships.

Conditions: HIV Infections
Being tested: HIV-1 RNA testing
Keywords: HIV testing, ART, partner notification, PrEP
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIV-1 RNA testingDiagnostic test
Also called Xpert HIV-1 RNA testing
During the intervention period, a blood sample will be obtained and tested for AHI using point-of-care Xpert® HIV Qual assay (Cepheid, Sunnyvale, California, USA). Individuals who test positive will undergo rapid tests to differentiate acute from prevalent HIV infection. Newly diagnosed individuals will be offered immediate ART and assisted partner notification with the HIV-1 RNA testing intervention delivered to partners following the same approach.

Study groups in NCT03508908
Study group	Role	What they receive
Observation Period	No intervention	HIV testing will only be done if ordered by the primary care clinician. Individuals diagnosed with HIV who have not yet notified partners will be offered assisted partner notification at a 6-week visit.
Intervention Period	Active comparator	Combination intervention with HIV-1 RNA testing followed by rapid tests if positive for HIV diagnosis, immediate ART if diagnosed, assisted partner notification with HIV-1 RNA testing of partners, and PrEP for uninfected partners in discordant relationships. Receives: Diagnostic Test: HIV-1 RNA testing

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking
Primary endpoints for the HIV-1 RNA testing intervention include the proportion of participants with newly diagnosed prevalent or AHI at care seeking.
Measured: 24 months

Secondary outcomes (4)

Proportion of Newly Diagnosed Patients Linked to Care
Secondary endpoints for the linkage to care intervention include the proportion of newly diagnosed patients captured in the HIV care cascade.
Measured: 24 months
Proportion of Named Partners Tested for HIV
Proportion of named partners tested for HIV in each period
Measured: 24 months
Cost Effectiveness of Novel RNA Testing Intervention: Total Cost (Including Both Testing and HIV-positive Patient Management) Per Participant (Base Case Patient Modeled)
Model outputs will include an analysis of the cost effectiveness of the novel testing intervention assessing several parameters of the HIV prevention and care cascade using stochastic, agent-based mathematical modelling. The population of interest modeled was 18- to 39-year-old heterosexuals in Kenya. The age range coincides with the sampled population in this study (NCT03508908) which provided the majority of the parameters for the networks and behavioral modules in the simulation. The observations from this study were weighted to match the sex and age composition reported in the Kenya Fact and Figures 2015 published by the Kenya National Bureau of Statistics. Additional model parameters were drawn from the literature on HIV infection, prevention, and treatment in Kenya.The analysis was conducted over a time horizon of 10 years, consistent with the mathematical model. 10,000 base-case patients (simulations) were run.
Measured: Data collected over 2 years, data is a predicted time point extrapolated to 10 years
Cost Effectiveness of Novel RNA Testing Intervention: Disability-Adjusted Life Years (Base Case Patient Modeled)
Disability-adjusted Life Year (DALY) is an index calculated as the sum of years of life lost (YLL) plus the years lost due to disability (YLD), where 1 DALY represents one lost year of healthy life. The higher the DALY index value, the worse the outcome, where there is no theoretical minimum ore maximum index value. the sampled population in this study (NCT03508908) which provided the majority of the parameters for the networks and behavioral modules in the simulation. The observations from this study were weighted to match the sex and age composition reported in the Kenya Fact and Figures 2015 published by the Kenya National Bureau of Statistics. Additional model parameters were drawn from the literature on HIV infection, prevention, and treatment in Kenya. The analysis was conducted over a time horizon of 10 years, consistent with the mathematical model. 10,000 base-case patients (simulations) were run.
Measured: Data collected over 2 years, data is a predicted time point extrapolated to 10years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201731 Jul 2022

First posted26 Apr 2018
Study start1 Dec 2017
Primary completion31 Jul 2020
Study completion31 Jul 2022

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 (4)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of OxfordThe 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Model description: This trial will use a modified stepped wedge design to evaluate the yield of the HIV-1 RNA testing intervention at 6 public or private health facilities in Kenya, before (1,375 patients) and after (1,500 patients) intervention delivery. This study will be conducted in two phases (observation phase and intervention phase) at each site.
Masking: None (open label)
Enrolment: 2,887 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03508908
Sponsor's protocol ID: DAIDS-ES ID 38181
Other IDs: 1R01AI124968-01A1
Acronym: TMP
Status last verified: Nov 2023
First submitted: 7 Mar 2018
Last updated: 13 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Babigumira JB, Agutu CA, Hamilton DT, van der Elst E, Hassan A, Gichuru E, Mugo PM, Farquhar C, Ndung'u T, Sirengo M, Chege W, Goodreau SM, Sanders EJ, M Graham S. Testing strategies to detect acute and prevalent HIV infection in adult outpatients seeking healthcare for symptoms compatible with acute HIV infection in Kenya: a cost-effectiveness analysis. BMJ Open. 2022 Sep 29;12(9):e058636. doi: 10.1136/bmjopen-2021-058636.
PubMed 36175097
Agutu CA, Oduor TH, Hassan AS, Mugo PM, Chege W, de Wit TFR, Sanders EJ, Graham SM. Predictors of testing history and new HIV diagnosis among adult outpatients seeking care for symptoms of acute HIV infection in coastal Kenya: a cross-sectional analysis of intervention participants in a stepped-wedge HIV testing trial. BMC Public Health. 2022 Feb 11;22(1):280. doi: 10.1186/s12889-022-12711-1.
PubMed 35148720
Sanders EJ, Agutu C, van der Elst E, Hassan A, Gichuru E, Mugo P, Farquhar C, Babigumira JB, Goodreau SM, Hamilton DT, Ndung'u T, Sirengo M, Chege W, Graham SM. Effect of an opt-out point-of-care HIV-1 nucleic acid testing intervention to detect acute and prevalent HIV infection in symptomatic adult outpatients and reduce HIV transmission in Kenya: a randomized controlled trial. HIV Med. 2022 Jan;23(1):16-28. doi: 10.1111/hiv.13157. Epub 2021 Aug 25.
PubMed 34431196
Graham SM, Agutu C, van der Elst E, Hassan AS, Gichuru E, Mugo PM, Farquhar C, Babigumira JB, Goodreau SM, Hamilton DT, Ndung'u T, Sirengo M, Chege W, Sanders EJ. A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 7;9(8):e16198. doi: 10.2196/16198.
PubMed 32763882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection and Reduce HIV Transmission - Tambua Mapema Plus
ClinicalTrials.gov ID: NCT03508908
Acronym / sponsor ID: TMP / DAIDS-ES ID 38181
Conditions: HIV Infections
Keywords: HIV testing, ART, partner notification, PrEP
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,887 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: University of Washington, National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 1 Dec 2017 (actual)
Primary completion: 31 Jul 2020 (actual)
Study completion: 31 Jul 2022 (actual)
First posted: 26 Apr 2018 (actual)
Results: Posted 13 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This trial will use a modified stepped wedge design to evaluate the yield of the HIV-1 RNA testing intervention at 6 public or private health facilities in Kenya, before (1,375 patients) and after (1,500 patients) intervention delivery. This study will be conducted in two phases (observation phase and intervention phase) at each site.

Arm	Type	Receives
Observation Period	No intervention	–HIV testing will only be done if ordered by the primary care clinician. Individuals diagnosed with HIV who have not yet notified partners will be offered assisted partner notification at a 6-week visit.
Intervention Period	Active comparator	Diagnostic Test: HIV-1 RNA testingCombination intervention with HIV-1 RNA testing followed by rapid tests if positive for HIV diagnosis, immediate ART if diagnosed, assisted partner notification with HIV-1 RNA testing of partners, and PrEP for uninfected partners in discordant relationships.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (13 listed)

age from 18-39 years;
not previously diagnosed with HIV infection; and
a score ≥2 on our risk score algorithm to identify persons at higher risk for AHI, with scoring as follows:
Eligibility criteria for partners of newly diagnosed cases with prevalent or acute HIV include:
age over 18 years; and

Key exclusion criteria (2 listed)

Patients not meeting inclusion criteria or those who are not willing or able to participate (e.g., due to illness or time constraints, or at the discretion of the study clinician) will be excluded.
Individuals at high risk for Intimate Partner Violence (IPV) are excluded from the aPS intervention, but eligible for all other components of the study.

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
HIV-1 RNA testingAlso: Xpert HIV-1 RNA testingDuring the intervention period, a blood sample will be obtained and tested for AHI using point-of-care Xpert® HIV Qual assay (Cepheid, Sunnyvale, California, USA). Individuals who test positive will undergo rapid tests to differentiate acute from prevalent HIV infection. Newly diagnosed individuals will be offered immediate ART and assisted partner notification with the HIV-1 RNA testing intervention delivered to partners following the same approach.	Diagnostic test	Intervention Period

Primary outcome

Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking
Time frame: 24 months
Primary endpoints for the HIV-1 RNA testing intervention include the proportion of participants with newly diagnosed prevalent or AHI at care seeking.

4 secondary outcomes

Proportion of Newly Diagnosed Patients Linked to Care
Time frame: 24 months
Proportion of Named Partners Tested for HIV
Time frame: 24 months
Cost Effectiveness of Novel RNA Testing Intervention: Total Cost (Including Both Testing and HIV-positive Patient Management) Per Participant (Base Case Patient Modeled)
Time frame: Data collected over 2 years, data is a predicted time point extrapolated to 10 years
Cost Effectiveness of Novel RNA Testing Intervention: Disability-Adjusted Life Years (Base Case Patient Modeled)
Time frame: Data collected over 2 years, data is a predicted time point extrapolated to 10years

Results and safety

Results posted to the registry on 13 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observation Period	249	249
Intervention Period	0	0
Observation Period Partners	0	0
Intervention Period Partners	0	0

Primary outcome: Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Adult Outpatients With Symptoms of Acute HIV Infection n = 2874	Observation Phase n = 1374	Intervention Phase n = 1500
HIV-positive	50	13	37
Acute HIV infection	2	0	2
HIV-negative	2822	1361	1461

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events for those tested at a single clinic visit but not diagnosed with HIV were evaluated on that same day. Adverse events for those diagnosed with HIV were evaluated over the subsequent 6 weeks. Adverse events for those in cohort follow-up were evaluated over the entire 12-month follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observation Period	0 of 1,374 (0%)	0 of 1,374 (0%)	0 of 1,374
Intervention Period	0 of 1,500 (0%)	0 of 1,500 (0%)	0 of 1,500
Observation Period Partners	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Intervention Period Partners	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36175097Babigumira JB, Agutu CA, Hamilton DT, van der Elst E, Hassan A, Gichuru E, Mugo PM, Farquhar C, Ndung'u T, Sirengo M, Chege W, Goodreau SM, Sanders EJ, M Graham S. Testing strategies to detect acute and prevalent HIV infection in adult outpatients seeking healthcare for symptoms compatible with acute HIV infection in Kenya: a cost-effectiveness analysis. BMJ Open. 2022 Sep 29;12(9):e058636. doi: 10.1136/bmjopen-2021-058636.
Derived from this study: PubMed 35148720Agutu CA, Oduor TH, Hassan AS, Mugo PM, Chege W, de Wit TFR, Sanders EJ, Graham SM. Predictors of testing history and new HIV diagnosis among adult outpatients seeking care for symptoms of acute HIV infection in coastal Kenya: a cross-sectional analysis of intervention participants in a stepped-wedge HIV testing trial. BMC Public Health. 2022 Feb 11;22(1):280. doi: 10.1186/s12889-022-12711-1.
Derived from this study: PubMed 34431196Sanders EJ, Agutu C, van der Elst E, Hassan A, Gichuru E, Mugo P, Farquhar C, Babigumira JB, Goodreau SM, Hamilton DT, Ndung'u T, Sirengo M, Chege W, Graham SM. Effect of an opt-out point-of-care HIV-1 nucleic acid testing intervention to detect acute and prevalent HIV infection in symptomatic adult outpatients and reduce HIV transmission in Kenya: a randomized controlled trial. HIV Med. 2022 Jan;23(1):16-28. doi: 10.1111/hiv.13157. Epub 2021 Aug 25.
Derived from this study: PubMed 32763882Graham SM, Agutu C, van der Elst E, Hassan AS, Gichuru E, Mugo PM, Farquhar C, Babigumira JB, Goodreau SM, Hamilton DT, Ndung'u T, Sirengo M, Chege W, Sanders EJ. A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 7;9(8):e16198. doi: 10.2196/16198.
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.

SUSAN M GRAHAM, MD MPH PHD principal investigator

University of Washington

EDUARD J SANDERS, MD MPH PHD principal investigator

University of Oxford

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HIV-1 RNA testing in people with HIV Infections, run by University of Oxford 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 13 inclusion and 2 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 13 Nov 2023. 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 13 Nov 2023). 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?

Proportion of Patients With Newly Diagnosed HIV Infection at Care Seeking (time frame: 24 months). 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 NCT03508908, which also lists 4 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 13 Nov 2023.