Assessment of a nutrition care and support intervention to prevent wasting in people living with human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) not yet on antiretroviral treatment

Completed

• Conditions: Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS); Infections and Infestations; Human immunodeficiency virus [HIV] disease resulting in other specified diseases

• Registration Number: ISRCTN93858860
• Lead Sponsor: Valid International (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-02
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

The study targets both female and male adults aged between 18 years and 59 years of age, already registered by one HIV positive living group. Participants will be recruited among the positive living group members who fulfill the following criteria:
1. Confirmed HIV status (HIV positive)
2. World Health Organization (WHO) stage: no clinical event compatible with stage 3 or 4
3. CD4 count greater than or equal to 350 cells/µL
4. Good nutritional status: absence of oedema, mid-upper arm circumference [MUAC] greater than 220 mm for women and greater than 230 mm for men, body mass index (BMI) greater than 18.5 kg/m^2 and no history of weight loss above 5% of usual weight
5. Physically active (Karnofsky score above 80%)
6. Permanent resident of the catchment area of the positive living group
7. Willingness to participate (signed consent form)

Exclusion Criteria

1. CD4 less than 350 cells/µL
2. Malnutrition (MUAC less than 220 mm for female and less than 230 mm for male, BMI less than or equal to 18.5 kg/m^2, presence of bilateral oedema)
3. On ART
4. Hypertension
5. Diabetes
6. Kidney disease
7. HIV clinical stage 3 or 4
8. Karnofsky score less than 80%

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be assessed at 12 and 24 months after admission in the programme:<br>1. Mean monthly CD4 count decrease <br>2. Mean monthly viral load change <br>3. Incidence of CD4 count less than 350 cells/ml <br>4. Incidence of WHO HIV stage 3 or 4 defining event <br>5. Time to commencing ART <br>6. Three-monthly MUAC change

Secondary Outcome Measures

Name	Time	Method
The following will be assessed at 12 and 24 months after admission in the programme:<br>1. Incidence of short period and long period of weight loss <br>2. Incidence of wasting defined as a MUAC less than 22 cm for women and less than 23 cm for men <br>3. Three-monthly weight change <br>4. Incidence of opportunistic infection <br>5. Probability of dying within the two years <br>6. Incidence of WHO clinical stage defining illnesses <br><br>Outcomes of interest after discharged from the study for secondary end-point of interest: <br>7. Probability of dying within the two years <br>8. Mortality during the first trimester of ART treatment