NCT03226379

Brief Summary

The DREAMM project is investigating whether the DREAMM interventions (1) Health system strengthening, 2) Co-designed education programs tailored to frontline healthcare workers, 3) Implementation of a diagnostic and treatment algorithm and, 4) Communities of practice in infectious diseases and laboratory capacity building) when combined reduce two week all-cause mortality of HIV-associated meningo-encephalitis in African LMICs.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
495

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4.9 years

First QC Date

May 31, 2017

Last Update Submit

May 3, 2022

Conditions

Keywords

HIV related MeningitisAIDS-Related Opportunistic InfectionsAdvanced HIV DiseaseHealth Systems StrengtheningEducation Programmes

Outcome Measures

Primary Outcomes (1)

  • 2-week all-cause mortality

    2-week all-cause mortality from enrolment

    2 weeks from enrolment

Secondary Outcomes (8)

  • 10-week all-cause mortality

    10 weeks from enrolment

  • 4-week all-cause mortality

    4 weeks from enrolment

  • 10-week and 6-month rate of death

    10 weeks and 6 months from enrolment

  • Time to appropriate investigation: lumbar puncture, brain imaging

    10 weeks from enrolment

  • Time to appropriate, microbiologically guided treatment

    10 weeks from enrolment

  • +3 more secondary outcomes

Study Arms (1)

DREAMM

OTHER

4 DREAMM interventions to reduce HIV-related meningoencephalitis mortality once access to essential diagnostic tests and medicines: 1. Health system strengthening 2. Delivery of a co-designed education program tailored to frontline healthcare workers 3. Implementation of an algorithm for HIV-related meningoencephalitis 4. Infectious diseases/AHD mentorship and laboratory capacity building

Other: DREAMM

Interventions

DREAMMOTHER

4 DREAMM interventions to reduce HIV-related meningoencephalitis mortality once access to essential diagnostic tests and medicines: 1. Health system strengthening 2. Delivery of a co-designed education program tailored to frontline healthcare workers 3. Implementation of an algorithm for HIV-related meningoencephalitis 4. Infectious diseases/AHD mentorship and laboratory capacity building

DREAMM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients \> 18 years with 1st episode of suspected meningo- encephalitis
  • Known to be HIV positive or willing to undertake an HIV test
  • Willing to agree to participate in the study

You may not qualify if:

  • Patients presenting with suspected relapse of HIV-associated meningo-encephalitis
  • HIV negative patients
  • Pregnant or lactating patients
  • Patients presenting with a known diagnosis of primary CNS Lymphoma or cerebral malaria
  • COVID-19 infected patients
  • Patients who are HIV negative or are diagnosed with cerebral malaria on hospital admission or after initial investigation will be excluded or withdrawn from the DREAMM study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Central Yaoundé

Yaoundé, Cameroon

Location

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Zomba Central Hospital

Zomba, Malawi

Location

Amana Hospital

Dar es Salaam, Tanzania

Location

Mwananyamala Hospital

Dar es Salaam, Tanzania

Location

Related Publications (1)

  • Mfinanga S, Kanyama C, Kouanfack C, Nyirenda S, Kivuyo SL, Boyer-Chammard T, Phiri S, Ngoma J, Shimwela M, Nkungu D, Fomete LN, Simbauranga R, Chawinga C, Ngakam N, Heller T, Lontsi SS, Aghakishiyeva E, Jalava K, Fuller S, Reid AM, Rajasingham R, Lawrence DS, Hosseinipour MC, Beaumont E, Bradley J, Jaffar S, Lortholary O, Harrison T, Molloy SF, Sturny-Leclere A, Loyse A; DREAMM Consortium. Reduction in mortality from HIV-related CNS infections in routine care in Africa (DREAMM): a before-and-after, implementation study. Lancet HIV. 2023 Oct;10(10):e663-e673. doi: 10.1016/S2352-3018(23)00182-0.

MeSH Terms

Conditions

AIDS-Related Opportunistic InfectionsMeningitis, CryptococcalMeningitis, BacterialTuberculosis, MeningealToxoplasmosis, Cerebral

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsOpportunistic InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMeningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesCryptococcosisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory DiseasesCentral Nervous System Bacterial InfectionsBacterial InfectionsTuberculosis, Central Nervous SystemTuberculosis, ExtrapulmonaryTuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBrain AbscessCentral Nervous System Protozoal InfectionsCentral Nervous System Parasitic InfectionsParasitic DiseasesToxoplasmosisCoccidiosisProtozoan InfectionsAbscessSuppurationBrain Diseases

Study Officials

  • Angela Loyse, MD

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Cohort study with a before and after design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

July 21, 2017

Study Start

April 23, 2016

Primary Completion

April 1, 2021

Study Completion

September 1, 2021

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations