Trial no.:	PACTR201706002208408	Date of Approval:	14/04/2017
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

TRIP study

Official scientific title

Translating Research into Practice (TRIP): Evaluating and Speeding up the adoption of an evidenced based innovative REMSTART package to reduce mortality in advanced stage HIV patients starting antiretroviral therapy in Tanzania

Brief summary describing the background and objectives of the trial

Mortality from AIDS remains high in sub-Saharan Africa where HIV diagnosis and presentation to care are often delayed. UNAIDS and others estimates that 25% to 30% of HIV-infected persons in low and middle income countries present to care with a CD4<100 cells/µL with advanced disease and there is no suggestion that this is going to change in the foreseeable future. This group has a particularly high mortality after starting antiretroviral therapy (ART). Our recently EDCTP funded REMSTART trial published in the lancet, the findings showed that a simple relatively low-cost intervention, comprising a short period of home support for patients starting ART with advanced disease combined with screening for Cryptococcal meningitis reduced mortality substantially by 28%. Acceleration of the translation of these findings from research into policy and practice could reduce dramatically the mortality rates in African ART programs. The TRIP study aims to assess the effectiveness and feasibility of large-scale application of the proven package to reduce mortality in advanced HIV-infected patients starting on ART in routine health system in urban and rural settings. The principle objectives include: To determine cost-effectiveness of the TRIP intervention in reducing deaths in advanced HIV patients in a real health system setting when implemented on a large scale To determine feasibility of scaling up the TRIP intervention in routine health system To inform and refine guidelines on HIV/AIDS services for patients with advanced HIV/AIDS disease To describe differences in the effectiveness and costs of TRIP intervention package delivery between urban and rural settings

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

TRIP

Disease(s) or condition(s) being studied

Cryptococcal Meningitis,Infections and Infestations

Sub-Disease(s) or condition(s) being studied

HIV/AIDS

Purpose of the trial

Diagnosis / Prognosis

Anticipated trial start date

29/02/2016

Actual trial start date

05/12/2016

Anticipated date of last follow up

01/03/2020

Actual Last follow-up date

01/03/2020

Anticipated target sample size (number of participants)

5580

Actual target sample size (number of participants)

5243

Recruitment status

Completed

Publication URL

http://www.tripproject.org/

Secondary Ids	Issuing authority/Trial register
EDCTP-CSA-2014-279	EDCTP

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study	Randomised	After obtaining the list of all 18-study facilities, the randomisation was stratified by urban and rural and assumes intervention to deferred arm (control) ratio of 2:1 in each.	Central randomisation by phone/fax. An independent investigator did randomisation. At the central office, one row was pick randomly from the rural as well as one from the urban	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Cryptococcal serum antigen screening	once	At baseline	CrAg test will be used	620	Active-Treatment of Control Group
Experimental Group	Fluconazole	800mg	10 weeks	Fluconazole 800mg once daily for two weeks followed by 400mg daily dose for eight weeks.	620	Active-Treatment of Control Group
Experimental Group	M-health messaging	Weekly	Four (4) Months	weekly mobile telephone consultations for the first month then monthly for the next three months.	620	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
The inclusion criteria will be: - CD4<200 cells /¿l - Serum/plasma CrAg positive - Lumbar puncture negative - Adult: ¿18y or more. - Antiretroviral naïve (as reported by the patient) - Planning to remain in the study area for about 6 months (as reported by the patient)	The exclusion criteria will be: - requiring immediate in-patient care / admission - Pregnant or lactating - If ALT > 5 times upper limit of normal		18 Year(s)	100 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

16/10/2015

National Health Research Ethics Sub-Committee (NatHREC)

Ethics Committee Address
Street address	City	Postal code	Country
3 Barack Obama Drive, PO Box 9653	Dar es Salaam	255	Tanzania