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

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ClinicalTrials.gov Identifier: NCT03508908
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
DrEduard Sanders, University of Oxford

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Diagnostic Test: HIV-1 RNA testing Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2875 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
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 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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),
    • 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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

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


Contacts
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Contact: EDUARD J SANDERS, MD MPH PhD +254723593762 ESanders@kemri-wellcome.org
Contact: CLARA AGUTU, MBCHB MPH +254720735000 CAgutu@kemri-wellcome.org

Locations
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Kenya
KEMRI Mtwapa Recruiting
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         
Sponsors and Collaborators
University of Oxford
University of Washington
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: SUSAN M GRAHAM, MD MPH PHD University of Washington
Principal Investigator: EDUARD J SANDERS, MD MPH PHD University of Oxford
  Study Documents (Full-Text)

Documents provided by DrEduard Sanders, University of Oxford:
Study Protocol  [PDF] September 19, 2017


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Responsible Party: DrEduard Sanders, Public Health Physician and Epidemiologist, University of Oxford
ClinicalTrials.gov Identifier: NCT03508908     History of Changes
Other Study ID Numbers: DAIDS-ES ID 38181
1R01AI124968-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by DrEduard Sanders, University of Oxford:
HIV testing
ART
partner notification
PrEP

Additional relevant MeSH terms:
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Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes