Home care and routine: cryptococcal meningitis screening among patients starting antiretroviral therapy with advanced disease
| ISRCTN | ISRCTN20410413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20410413 |
| Protocol serial number | N/A |
| Sponsor | London School of Hygiene and Tropical Medicine (UK) |
| Funder | European and Developing Countries Clinical Trials Partnership |
- Submission date
- 10/10/2011
- Registration date
- 09/11/2011
- Last edited
- 19/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
HIV is a virus that attacks the immune system, weakening its ability to fight infections and disease. It is treated with antiretroviral therapy – drugs that stop the virus replicating in the body, allowing the immune system to repair itself and preventing further damage. Mortality (death rate) is high among people in Africa with HIV who are starting antiretroviral therapy, particularly in those with advanced disease. The aim of this study is to assess the effect of a short period of community support to supplement clinic-based services, combined with testing for cryptococcal meningitis (a fungal infection of the tissues covering the brain and spinal cord).
Who can participate?
HIV-infected adults with a CD4 count of less than 200 cells per microlitre
What does the study involve?
Participants are randomly allocated to either the intervention or the control group. The intervention group receive antiretroviral therapy in a short time frame (following first presentation with HIV), home-based monitoring and adherence support (for about 6 weeks), testing for cryptococcal meningitis (and treatment if needed). All patients (both groups) are tested for tuberculosis (a bacterial infection of the lungs). An additional test for tuberculosis is carried out about 4 weeks after the start of antiretroviral therapy among patients in the intervention group. The control group receive standard care. Both groups are followed up for 12 months after the start of antiretroviral therapy.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Dar es Salaam in Tanzania and Lusaka in Zambia
When is the study starting and how long is it expected to run for?
February 2012 to December 2014
Who is funding the study?
European and Developing Countries Clinical Trials Partnership (Netherlands)
Who is the main contact?
Dr Saidi Egwaga
Contact information
Scientific
Ministry of Health and Social Welfare
PO Box 9083
Dar es Salaam
N/A
Tanzania
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-arm individually randomised open-label trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Reduction of Early Mortality among HIV-infected Subjects sTarting AntiRetroviral Therapy (REMSTART) in Zambia and Tanzania with CD4 count <200 cells per microlitre: a randomised trial involving home support and routine screening for cryptococcal meningitis |
| Study acronym | REMSTART |
| Study objectives | Current hypothesis as of 09/07/2013 The intervention will reduce the high early mortality among HIV-infected patients presenting with CD4 count <200 cells per microlitre and will be cost effective in achieving this. Previous hypothesis The intervention will reduce the high early mortality among HIV-infected patients presenting with CD4 count <100 cells per microlitre and will be cost effective in achieving this. |
| Ethics approval(s) | 1. National Institute of Medical Research Ethics Committee, Tanzania, 10/08/2011 2. ERES Converge Local Ethics Committee, Zambia, 29/08/2011 3. London School of Hygiene and Tropical Medicine ethics committee, 17/11/2011 |
| Health condition(s) or problem(s) studied | Human immunodeficiency virus (HIV) |
| Intervention | The intervention is a complex health care delivery strategy. It comprises initiation of antiretroviral therapy in a short time frame (following first presentation with HIV), home-based monitoring and adherence support (for about 6 weeks), screening of cryptococcal meningitis using a point of care antigen test (and treatment as indicated). All patients (both arms) will be tested for tuberculosis (TB) using GeneXpert as well as classical methods (symptom history using standard questionnaire followed by smear and culture if indicated). An additional screening for tuberculosis will be done about 4 weeks after initiation of antiretroviral therapy among patients in the intervention arm. The trial will be integrated into normal health care delivery with study patients managed according to national guidelines. Services for hypertension and diabetes will be strengthened for all patients and a buffer supply of drugs will be made available to ensure continued drug supply. The control arm is the standard of care. We will ensure that care is functional to reasonably good standards. Thus, for example, we will monitor availability of clinical staff (and arrange clinic support if necessary), ensure essential drugs supplies and antiretrovirals are available (we will purchase buffer supplies for the health service), ensure generally procedures are in line with guidelines and provide feedback of observations to the health service. This will result in a standard of care that is better than normal health service delivery and will narrow the size of our effects. However, it is important that we compare our intervention with functional care to ensure that the results can be generalised widely. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
All-cause mortality up to 12 months after enrolment |
| Key secondary outcome measure(s) |
1. Costs of the two strategies to the health service |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 2500 |
| Key inclusion criteria | Current inclusion criteria as of 05/07/2013: 1. CD4 < 200 cells /µl 2. Adult: ≥ 18 years 3. Antiretroviral naїve (as reported by the patient) 4. Planning to remain in the study area for about six months (as reported by the patient) Previous inclusion criteria: 1. CD4 < 100 cells /µl 2. Adult: ≥ 18 years 3. Antiretroviral naїve (as reported by the patient) 4. Planning to remain in the study area for about six months (as reported by the patient) |
| Key exclusion criteria | 1. Requiring immediate in-patient care/admission 2. Living outside the catchment population of the hospital |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- Tanzania
- Zambia
Study participating centre
N/A
Tanzania
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/05/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/07/2016: Plain English summary added.
09/07/2013: the overall trial start date was changed from 01/12/2011 to 01/02/2012. The scientific title was also changed; the original title was "Reduction of Early Mortality among HIV-infected Subjects sTarting AntiRetroviral Therapy (REMSTART) in Zambia and Tanzania with CD4 count <100 cells per microlitre: a randomised trial involving home support and routine screening for cryptococcal meningitis."
