Condition category
Infections and Infestations
Date applied
14/05/2009
Date assigned
31/07/2009
Last edited
31/07/2009
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

Ms Natalie Leon

ORCID ID

Contact details

Health Systems Research Unit
Medical Research Council of South Africa
P.O Box 19070
Tygerberg
Cape Town
7505
South Africa
+27 (0)21 938 0454
natalie.leon@mrc.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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?

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

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Human immunodeficiency virus (HIV)

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/04/2006

Overall trial end date

30/12/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

7 intervention and 14 control clinics

Participant 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

Recruitment start date

01/04/2006

Recruitment end date

30/12/2007

Locations

Countries of recruitment

South Africa

Trial participating centre

Health Systems Research Unit
Cape Town
7505
South Africa

Sponsor information

Organisation

The Medical Research Council of South Africa (MRC) (South Africa)

Sponsor details

c/o Fransie Van Zyl Drive
Health Systems Research Unit
P.O Box 19070
Tygerberg
Cape Town
7505
South Africa
natalie.leon@mrc.ac.za

Sponsor type

Research council

Website

http://www.mrc.ac.za/healthsystems/healthsystems.htm

Funders

Funder type

Research council

Funder name

Department of Science and Technology and The Medical Research Council of South Africa (MRC) (South Africa) - Health Systems Research Unit (ref: 3255)

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

Publication citations

Additional files

Editorial Notes