Routine human immunodeficiency virus (HIV) screening for sexually transmitted infection (STI) patients in Cape Town, South Africa

ISRCTN	ISRCTN93692532
DOI	https://doi.org/10.1186/ISRCTN93692532
Protocol serial number	N/A
Sponsor	The Medical Research Council of South Africa (MRC) (South Africa)
Funder	Department of Science and Technology and The Medical Research Council of South Africa (MRC) (South Africa) - Health Systems Research Unit (ref: 3255)

Submission date: 14/05/2009
Registration date: 31/07/2009
Last edited: 18/12/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Natalie Leon
Scientific

Health Systems Research Unit
Medical Research Council of South Africa
P.O Box 19070
Tygerberg
Cape Town
7505
South Africa

Phone	+27 (0)21 938 0454
Email	natalie.leon@mrc.ac.za

Study information

Primary study design	Interventional
Study design	Non-randomised cluster controlled multicentre trial
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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
Key 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.
Completion date	30/12/2007

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	21
Key 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.
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	30/12/2007

Locations

Countries of recruitment

South Africa

Study participating centre

Health Systems Research Unit

Cape Town
7505
South Africa

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results on impact of provider-initiated (opt-out) HIV testing	30/01/2010		Yes	No
Results article	results on Implementing a provider-initiated testing and counselling (PITC) intervention	26/08/2013		Yes	No
Results article	results on A comparison of linkage to HIV care after provider-initiated HIV testing and counselling (PITC) versus voluntary HIV counselling and testing (VCT	18/08/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/12/2017: publication references added.