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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46836853
Enrollment
11000
Registered
2007-08-07
Start date
2007-07-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

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

Interventions

Complex health systems intervention comprising: 1. Clinical algorithm to triage AntiRetroViral (ARV) patients for nurse- or doctor-managed care 2. Educational outreach training to nurses 3. Expande

Sponsors

Development Cooperation Ireland (South Africa)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Clinics: None Patients: Patients younger than 18 years

Design outcomes

Primary

MeasureTime frame
The following will be analysed at 1 year (interim analysis) and 2 years (final analysis): Cohort 1: Survival Cohort 2: Viral load suppression rates

Secondary

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

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026