Home care and routine: cryptococcal meningitis screening among patients starting antiretroviral therapy with advanced disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20410413

Enrollment

2500

Registered

2011-11-09

Start date

2012-02-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations Human immunodeficiency virus

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 05/07/2013: 1. CD4 < 200 cells /µl 2. Adult: = 18 years 3. Antiretroviral na?ve (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 na?ve (as reported by the patient) 4. Planning to remain in the study area for about six months (as reported by the patient)

Exclusion criteria

Exclusion criteria: 1. Requiring immediate in-patient care/admission 2. Living outside the catchment population of the hospital

Design outcomes

Primary

Measure	Time frame
All-cause mortality up to 12 months after enrolment	—

Secondary

Measure	Time frame
1. Costs of the two strategies to the health service 2. Patient retention 3. Rate of hospital admission 4. Frequency of outpatient attendances 5. Detection of TB among patients on antiretroviral therapy (ART) and their household members 6. Detection of cryptococcal meningitis among patients with ART 7. Uptake of HIV voluntary counselling and testing and of TB screening among household members 8. Adherence to ART	—

Measure

Time frame

1. Costs of the two strategies to the health service 2. Patient retention 3. Rate of hospital admission 4. Frequency of outpatient attendances 5. Detection of TB among patients on antiretroviral therapy (ART) and their household members 6. Detection of cryptococcal meningitis among patients with ART 7. Uptake of HIV voluntary counselling and testing and of TB screening among household members 8. Adherence to ART

—

Countries

Tanzania, Zambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026