Condition category
Infections and Infestations
Date applied
26/04/2007
Date assigned
07/08/2007
Last edited
21/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lara Fairall

ORCID ID

Contact details

Knowledge Translation Unit
University of Cape Town Lung Institute
PO Box 34560
Groote Schuur
Cape Town
7937
South Africa
+27 21 406 6979
lfairall@uctgsh1.uct.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

STRETCH

Study hypothesis

That the decentralisation of antiretroviral treatment services from doctors at hospitals to nurses at clinics, supported by appropriate training and supervision, expands treatment access, reducing mortality among enrolled patients waiting for HAART (Highly Active AntiRetroviral Treatment), without compromising HAART treatment outcomes.

Ethics approval

1. Ethics Committee of the Faculty of Health Sciences, University of the Free State (South Africa) (ref: ETOVS NR 75/07)
2. Ethics Committee of the Faculty of Health Sciences, University of Cape Town (South Africa), approval pending as of 16/07/2007

Study design

Pragmatic, two-arm, cluster randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV/ AIDS

Intervention

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. Expanded prescribing provisions to permit trained nurse practitioners to prescribe ARVs
4. Re-defining roles of clinical staff:
4.1. Generalist nurses: pre-ARV HIV care
4.2. ARV nurses: monitoring of stable ARV patients, ARV initiation in selected adults
4.3. ARV doctors: review problem cases
5. Systems toolkit: a “guideline” for managers on how to implement STRETCH
6. Provincial STRETCH co-ordinators
7. STRETCH facility support teams - facilitate changes and provide support

Intervention type

Drug

Phase

Not Specified

Drug names

antiretroviral treatment (HAART)

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/07/2007

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Clinics: 31; Cohort 1: 7000 patients; Cohort 2: 4000 patients

Participant exclusion criteria

Clinics: None
Patients: Patients younger than 18 years

Recruitment start date

01/07/2007

Recruitment end date

30/06/2009

Locations

Countries of recruitment

South Africa

Trial participating centre

Knowledge Translation Unit
Cape Town
7937
South Africa

Sponsor information

Organisation

Development Cooperation Ireland (South Africa)

Sponsor details

Embassy of Ireland
1st Floor
Southern Life Plaza
1059 Schoeman Street
Arcadia
Pretoria
0083
South Africa
+27 12 342 5062
annalize.fourie@dfa.ie

Sponsor type

Government

Website

http://www.embassyireland.org.za/

Funders

Funder type

Government

Funder name

Canadian International Development Agency (02/2006) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Irish Aid (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22901955
2. 2012 process evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22800379

Publication citations

  1. Results

    Fairall L, Bachmann MO, Lombard C, Timmerman V, Uebel K, Zwarenstein M, Boulle A, Georgeu D, Colvin CJ, Lewin S, Faris G, Cornick R, Draper B, Tshabalala M, Kotze E, van Vuuren C, Steyn D, Chapman R, Bateman E, Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial., Lancet, 2012, 380, 9845, 889-898, doi: 10.1016/S0140-6736(12)60730-2.

  2. Process evaluation

    Georgeu D, Colvin CJ, Lewin S, Fairall L, Bachmann MO, Uebel K, Zwarenstein M, Draper B, Bateman ED, Implementing nurse-initiated and managed antiretroviral treatment (NIMART) in South Africa: a qualitative process evaluation of the STRETCH trial., Implement Sci, 2012, 7, 66, doi: 10.1186/1748-5908-7-66.

Additional files

Editorial Notes