Tambua Mapema Plus - to Discover HIV Infection Early and Prevent Onward Transmission (TMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03508908|
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Diagnostic Test: HIV-1 RNA testing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2875 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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)|
|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|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
No Intervention: Observation Period
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.
Active Comparator: Intervention Period
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.
Diagnostic Test: 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.
Other Name: Xpert HIV-1 RNA testing
- 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.
- Proportion of newly diagnosed patients linked to care [ Time Frame: 24 months ]Secondary endpoints for the linkage to care intervention include the proportion of newly diagnosed patients captured in the HIV care cascade.
- Proportion of partners engaged in HIV care and prevention cascade [ Time Frame: 24 months ]Secondary endpoints for the assisted partner notification intervention include the proportion of newly diagnosed partners engaged in HIV care, and HIV-uninfected partners in HIV prevention.
- Cost effectiveness of novel RNA testing intervention [ Time Frame: 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508908
|Contact: EDUARD J SANDERS, MD MPH PhD||+254723593762||ESanders@kemri-wellcome.org|
|Contact: CLARA AGUTU, MBCHB MPH||+254720735000||CAgutu@kemri-wellcome.org|
|Kilifi, Kenya, 80108|
|Contact: Eduard J Sanders, PhD +254723593762 ESanders@kemri-wellcome.org|
|Contact: Clara A Agutu, MPH +254720735000 CAgutu@kemri-wellcome.org|
|Principal Investigator: Eduard J Sanders, MD MPH PhD|
|Principal Investigator: Susan M Graham, MD MPH PhD|
|Sub-Investigator: Amin Hassan, BSc MSc PhD|
|Sub-Investigator: Clara A Agutu, MBChB MPH|
|Sub-Investigator: Elise van der Elst, MA PhD|
|Sub-Investigator: Carey Farquhar|
|Sub-Investigator: Steve Goodreau|
|Sub-Investigator: Joseph Babigumira|
|Sub-Investigator: Deven Hamilton|
|Sub-Investigator: Peter Mugo, BPharm PhD|
|Principal Investigator:||SUSAN M GRAHAM, MD MPH PHD||University of Washington|
|Principal Investigator:||EDUARD J SANDERS, MD MPH PHD||University of Oxford|