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 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Ms Natalie Leon
Scientific
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 |
|---|---|
| natalie.leon@mrc.ac.za |
Study information
| Study design | Non-randomised cluster controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(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 |
| 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 |
| Primary outcome measure | 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 study start date | 01/04/2006 |
| Overall study end date | 30/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 7 intervention and 14 control clinics |
| 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 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
Study participating centre
Health Systems Research Unit
Cape Town
7505
South Africa
7505
South Africa
Sponsor information
The Medical Research Council of South Africa (MRC) (South Africa)
Research council
Research council
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 | |
| Website | http://www.mrc.ac.za/healthsystems/healthsystems.htm |
"ROR" |
https://ror.org/05q60vz69 |
Funders
Funder type
Research council
Department of Science and Technology and The Medical Research Council of South Africa (MRC) (South Africa) - Health Systems Research Unit (ref: 3255)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
18/12/2017: publication references added.
