A cluster randomised controlled trial of an educational and organisational intervention to expand antiretroviral treatment access in public-sector primary care clinics in South Africa: the STRETCH (Streamlining Tasks and Roles to Expand Treatment and Care for HIV) trial

Completed

Conditions: HIV/ AIDS
Infections and Infestations
Unspecified human immunodeficiency virus [HIV] disease

Registration Number: ISRCTN46836853

Lead Sponsor: Development Cooperation Ireland (South Africa)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 11000

Inclusion Criteria

Clinics: All 31 public sector clinics currently offering antiretroviral treatment in the Free State province, South Africa.
Patients:
Cohort 1: All patients enrolled at the 31 facilities with a CD4 count of 350 cells/ul or less not yet on HAART.
Cohort 2: All patients enrolled at the 31 facilities already on HAART for 6 months or longer, and alive and in care at the start of the trial.

Exclusion Criteria

Clinics: None
Patients: Patients younger than 18 years

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be analysed at 1 year (interim analysis) and 2 years (final analysis): <br>Cohort 1: Survival<br>Cohort 2: Viral load suppression rates

Secondary Outcome Measures

Name	Time	Method
The following will be measured at 2 years (or 1 year if the trial should be discontinued):<br>Cohort 1: <br>1. Viral load suppression rates<br>2. Duration between enrolment and starting HAART<br>3. Proportion of patients with CD4 count <=350 who start HAART during the study period<br>4. Median baseline CD4 count of patients starting HAART<br>5. Tuberculosis (TB) case detection<br>6. Screening for TB (sputum tests)<br>7. Cotrimoxazole prophylaxis provision<br>8. Changes in CD4 and weight, hospital admissions<br>9. Number of nurse and doctor visits <br>Cohort 2: <br>1. Survival<br>2. Programme retention (the proportion of patients remaining alive and in care)<br>3. Duration of viraemia prior to switch to second-line treatment<br>4. TB case detection<br>5. Screening for TB (sputum tests)<br>6. Cotrimoxazole prophylaxis provision<br>7. Changes in CD4 and weight<br>8. Hospital admissions<br>9. Number of nurse and doctor visits