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

NCT03508908 | Completed Results

• 2 other identifiers: DAIDS-ES ID 381811R01AI124968-01A1
• Study Type: interventional
• Target: 2,887
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV testing; ART; partner notification; PrEP

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (4)

• Proportion of Newly Diagnosed Patients Linked to Care

  24 months

• Proportion of Named Partners Tested for HIV

  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)

  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)

  Data collected over 2 years, data is a predicted time point extrapolated to 10years

Study Arms (2)

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.

Diagnostic Test: HIV-1 RNA testing

Interventions

HIV-1 RNA testing DIAGNOSTIC_TEST

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.

Also known as: Xpert HIV-1 RNA testing

Intervention Period

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Individuals at high risk for Intimate Partner Violence (IPV) are excluded from the aPS intervention, but eligible for all other components of the study.

Sponsors & Collaborators

• University of Oxford: lead
• University of Washington: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

KEMRI Mtwapa

Kilifi, 80108, Kenya

Location

Related Publications (4)

• 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.

  PMID: 36175097 DERIVED

• 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.

  PMID: 35148720 DERIVED

• 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.

  PMID: 34431196 DERIVED

• 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.

  PMID: 32763882 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Eduard Sanders
• Organization: Aurum Institute

ESanders@auruminstitute.org

254723593762

Study Officials

• SUSAN M GRAHAM, MD MPH PHD

  University of Washington

  PRINCIPAL INVESTIGATOR

• EDUARD J SANDERS, MD MPH PHD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Public Health Physician and Epidemiologist

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 26, 2018
• Study Start: December 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)