A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV

NCT03154320 | Completed DMC

• 1 other identifier: AI131998
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.

Conditions

HIV/AIDS; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Retention in care with viral suppression

  Proportion of participants who are in care with HIV-1 RNA \<200 copies/ml

  48 weeks after HIV testing

Secondary Outcomes (17)

• Mortality

  48 weeks after HIV testing

• Mean treatment cost per participant

  48 weeks after HIV testing

• Viral suppression

  48 weeks after HIV testing

• Adherence by medication possession ratio

  48 weeks after HIV testing

• Adherence by 3-day self-report

  48 weeks after HIV testing

Study Arms (2)

Standard Group

ACTIVE COMPARATOR

On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and provide a sputum specimen for spot Xpert Ultra testing (48-hour results). Those with high clinical/radiographic suspicion for TB will start same-day TB treatment. On Day 2, participants will return for results of Xpert Ultra testing (spot specimen) and to provide a specimen for early morning Xpert Ultra testing. Those who are Xpert Ultra positive will start TB treatment. Those who are not diagnosed with TB will start ART on Day 7, after testing and treatment for other opportunistic infections. A liquid TB culture will be performed on both the spot and early morning specimens.

Other: Standard treatment

Same-Day Treatment Group

EXPERIMENTAL

On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and Xpert Ultra testing with same-day results. Based on clinical symptoms, Xpert Ultra results, and chest x-ray, physician will determine whether or not the participant has tuberculosis. Those who are diagnosed with TB will start same-day TB treatment. Those who are not diagnosed with TB will start same-day ART.

Other: Same-Day Treatment

Interventions

Same-Day Treatment OTHER

Treatment with ART or TB medication on day of HIV diagnosis

Same-Day Treatment Group

Standard treatment OTHER

Standard treatment

Standard Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of ≥18 years of age
• Presence of cough, fever, night sweats or weight loss
• Ability and willingness to give written informed consent
• Documentation of positive HIV status (test conducted at GHESKIO)
• Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".

You may not qualify if:

• Any use of ART in the past
• Treatment for TB in the year prior to screening visit
• Pregnancy or breastfeeding at the screening visit
• Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
• Score of \<3 for any of the 7 questions on the ART readiness survey
• Planning to transfer care to another clinic during the study period
• Symptoms consistent with WHO stage 4 neurologic disease (cryptococcal meningitis, TB meningitis; central nervous system toxoplasmosis; HIV encephalopathy; progressive multifocal leukoencephalopathy)
• Severe illness, classified as one of the WHO "danger signs" of temperature \>39 degrees Celsius, pulse \>120 beats/minutes, respiratory rate \>30, or inability to walk unaided.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• Weill Medical College of Cornell University: collaborator
• Florida International University: collaborator
• University of California, Davis: collaborator
• Analysis Group, Inc.: collaborator

Study Sites (1)

GHESKIO

Port-au-Prince, Haiti

Location

Related Publications (2)

• Dorvil N, Rivera VR, Riviere C, Berman R, Severe P, Bang H, Lavoile K, Devieux JG, Faustin M, Saintyl G, Mendicuti MD, Pierre S, Apollon A, Dumond E, Forestal GPL, Rouzier V, Marcelin A, McNairy ML, Walsh KF, Dupnik K, Reif LK, Byrne AL, Bousleiman S, Orvis E, Joseph P, Cremieux PY, Pape JW, Koenig SP. Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti. PLoS Med. 2023 Jun 9;20(6):e1004246. doi: 10.1371/journal.pmed.1004246. eCollection 2023 Jun.

  PMID: 37294843 DERIVED

• Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.

  PMID: 33616229 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Serena P Koenig, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Model Details: Patients will be randomized in a 1:1 ratio to standard or same-day treatment

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: May 16, 2017
• Study Start: November 6, 2017
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

HA (1)