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Routine human immunodeficiency virus (HIV) screening for sexually transmitted infection (STI) patients in Cape Town, South Africa
ISRCTN ISRCTN93692532
DOI 10.1186/ISRCTN93692532
ClinicalTrials.gov identifier
EudraCT number
Public title Routine human immunodeficiency virus (HIV) screening for sexually transmitted infection (STI) patients in Cape Town, South Africa
Scientific title The impact of provider-initiated (opt-out) human immunodeficiency virus (HIV) testing and counselling of sexually transmitted infection (STI) patients in Cape Town, South Africa: a controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis Does provider-initiated human immunodeficiency virus (HIV) testing and counselling increase HIV test uptake amongst new sexually transmitted infection (STI) patients in an operational, primary health care setting?
Lay summary
Ethics approval 1. University of Cape Town, Health Sciences Faculty Research Ethics Committee approved on the 27th July 2007 (ref: 295/2007)
2. City Health Department letter of permission to do operational research dated 17th May 2007
Study design Non-randomised cluster controlled multicentre trial
Countries of recruitment South Africa
Disease/condition/study domain Human immunodeficiency virus (HIV)
Participants - inclusion criteria 1. Primary health care, public sector clinics
2. Geographical location-one clinic per sub-district in Cape Town
3. Clinics providing STI treatment for more than 30 new STI patients a month
4. Clinics with an average nurse:patient ratio
5. All patients assessed for a new episode of sexually transmitted disease at participating public sector primary care clinics. Male and female, mainly adults of reproductive age, but no age limit to who gets treated at the clinics.
Participants - exclusion criteria 1. Clinics providing an exclusive STI treatment service (not as part of a general primary health care package)
2. Clinics where other research is being conducted that may influence the outcome
Anticipated start date 01/04/2006
Anticipated end date 30/12/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 7 intervention and 14 control clinics
Interventions Provider-initiated (opt-out) HIV testing and counselling (PITC) provided by STI nurses as compared to the standard voluntary counselling and testing provided by lay counsellors. PITC was implemented for 18 months from April 2006 to Dec 2007. Routine data from the VCT register and the Routine Monthly Report was collected retrospectively for 6 months from April 2007 to December 2007.
Primary outcome measure(s) 1. HIV testing rates of new STI patients for a 6-month period from Jan 2007 to June 2007
2. Number of new STI patients who tested for HIV divided by total number of new STI patients treated
Secondary outcome measure(s) 1. The rate of providers offering the HIV test or pre-counselling patients (irrespective of whether they accept the test or not). Number of new STI patients offered the HIV test/counselled divided by the total number of STI patients treated.
2. The rate of patients declining the offer of testing. Number of new STI patients not tested for HIV divided by the total number of new STI patients treated.
3. The variability of outcome measures between the clinics. Statistical comparison of the range of clinic outcomes between the intervention and control groups to check for variance.
Sources of funding Department of Science and Technology and The Medical Research Council of South Africa (MRC) (South Africa) - Health Systems Research Unit (ref: 3255)
Trial website
Publications
Contact name Ms  Natalie  Leon
  Address Health Systems Research Unit
Medical Research Council of South Africa
P.O Box 19070
Tygerberg
  City/town Cape Town
  Zip/Postcode 7505
  Country South Africa
  Tel +27 (0)21 938 0454
  Fax +27 (0)21 938 0483
  Email natalie.leon@mrc.ac.za
Sponsor The Medical Research Council of South Africa (MRC) (South Africa)
  Address c/o Fransie Van Zyl Drive
Health Systems Research Unit
P.O Box 19070
Tygerberg
  City/town Cape Town
  Zip/Postcode 7505
  Country South Africa
  Email natalie.leon@mrc.ac.za
  Sponsor website: http://www.mrc.ac.za/healthsystems/healthsystems.htm
Date applied 14/05/2009
Last edited 31/07/2009
Date ISRCTN assigned 31/07/2009
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