Acceptability, feasibility and cost of point-of-care testing for sexually transmitted infections in adolescent health services in Cape Town, South Africa
| ISRCTN | ISRCTN10275700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10275700 |
- Submission date
- 06/08/2023
- Registration date
- 09/01/2024
- Last edited
- 16/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Young people (YP) in southern Africa are at substantial risk of HIV and sexually transmitted infections (STIs). Despite the epidemiological and biological link between STIs and HIV transmission and acquisition, infections such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) remain widely undiagnosed. Syndromic STI management classifies STIs into easily identifiable groups of symptoms and signs and provides treatment for the most common organisms causing the syndrome and is the standard of care in low- and middle-income countries (LMICs) despite a high prevalence of asymptomatic infections. The study team conducted a prospective study to explore the acceptability, feasibility, and cost of an STI test-and-treat service for YP in Cape Town.
Who can participate?
YP aged between 15 and 23 years old who are service users at two adolescent-specific community health services
What does the study involve?
YP attending a mobile clinic (MC) and a youth centre clinic will be offered STI screening. Urine testing for CT and NG using a 90-minute molecular point-of-care (POC) test on the GeneXpert platform will be conducted and treatment provided. Data will be collated on demographics, sexual behaviour, presence of symptoms, uptake of same-day treatment, prevalence of CT/NG, and service acceptability.
What are the possible benefits and risks of participating?
STI testing services are not available in the public health sector in South Africa. As such, participants may benefit from free testing services that they would otherwise have to pay for privately to access. Participations with asymptomatic infections will benefit from access to direct testing options.
Participants are required to be sexually active to participate in the study and may be at risk of sexually transmitted infections, including HIV, and unintended pregnancy. As participants are adolescents, they may experience external or internal stigma around sexual activities and may feel distress, embarrassed, or uncomfortable while testing and waiting for the STI test results. All participants will receive risk reduction counselling to promote sexual health at every point of contact. All counselling related to sexual health or test procedures will be youth-orientated and youth-friendly. Participants are informed that their participation is voluntary and that they have the right to withdraw from the study at any time, without the risk of stigmatisation or victimisation.
Receiving a positive STI test has potential to cause distress. Participants will receive pre- and post-test counselling and are informed that they will receive access to treatment if they test positive for chlamydia or gonorrhoea.
Where is the study run from?
The Alexander Pringle Centre, North Middlesex Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2016 to March 2019
Who is funding the study?
The Desmond Tutu Health Foundation (formerly Desmond Tutu HIV Foundation) (South Africa), with GeneXpert modules and tests provided by Cepheid (USA)
Who is the main contact?
Dr Rebecca Marcus, rebeccamarcus@nhs.net (UK)
Contact information
Public
Desmond Tutu Health Foundation
P.O. Box 13801
Mowbray
Cape Town
7705
South Africa
| Phone | +27 (0) 21 301 2020 |
|---|---|
| carey.pike@hiv-research.org.za |
Scientific, Principal Investigator
Alexander Pringle Centre
North Middlesex Hospital
Sterling Way
London
N18 1QX
United Kingdom
 ORCID ID |
0000-0003-1058-0654 |
|---|---|
| Phone | +44 (0)208 887 3236 |
| rebeccamarcus@nhs.net |
Study information
| Study design | Prospective test-and-treat sexually transmitted infection programme study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Diagnostic, Screening, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participation information sheet |
| Scientific title | Acceptability, feasibility and cost of point-of-care testing for sexually transmitted infections in adolescent health services in Cape Town, South Africa |
| Study acronym | STAX |
| Study hypothesis | Point of care testing for sexually transmitted infections in adolescent health services in Cape Town is acceptable, feasible and cost-effective |
| Ethics approval(s) |
Approved 27/01/2017, Human Research Ethics Committee, University of Cape Town (E52-24 Old Main Building Groote Schuur Hospital Observatory, Cape Town, 7925, South Africa; +27 21 406 6338; hrec-enquiries@uct.ac.za), ref: HREC 339/2016 |
| Condition | Testing and treatment of chlamydia and gonorrhoea using molecular point of care testing |
| Intervention | Background Young people (YP) in southern Africa are at substantial risk of HIV and sexually transmitted infections (STIs). Despite the epidemiological and biological link between STIs and HIV transmission and acquisition, infections such as Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) remain widely undiagnosed. Syndromic STI management is the standard of care in low- and middle-income settings (LMICs) despite a high prevalence of asymptomatic infections. This observational cross-sectional study will explore the acceptability, feasibility, and cost of an STI test-and-treat service for YP in Cape Town. Participants will be offered STI screening and treatment for chlamydia (CT) and gonorrhoea (NG) using the Gene Xpert platform, molecular point-of-care technology that can detect CT/NG from a first-catch urine sample in under 90 minutes. If participants test positive for either infection, they will receive same-day treatment and contact tracing. Those who would like to participate will give informed consent. Prior to STI testing, study staff will administer a sexual risk behaviour and symptom questionnaire. Risk reduction counselling and condom provision will be performed at every visit. Participants will be offered the option to re-test after a 3-month period. Study groups 15-23 year old adolescents living in Cape Town, South Africa. Two study cohorts were considered: adolescents receiving care from a clinic situated within a peri-urban youth centre (YC) in the southern peninsula of Cape Town and adolescents receiving care from a mobile clinic (MC) on rotation at different low-income, high-density locations in the Cape Town area. Intervention provider • Healthcare providers at the clinic and mobile service were registered nurses trained in adolescent-friendly healthcare delivery and HIV counselling. • Medical doctors, which comprised a team of medical officers and infectious disease specialists, provided clinical oversight at both sites. Modes of delivery Services were provided face-to-face on an individual basis. Locations • Youth clinic: the youth clinic is a free-standing building located within a Youth Centre. It is situated in a peri-urban township area in the Southern peninsula of Cape Town. • Mobile clinic: the mobile clinic is an established service provider run by the Desmond Tutu Health Foundation. The mobile clinic is equipped to conduct screening and testing related to sexual reproductive health as well as a range of HIV prevention and treatment options. The mobile operates on a schedule whereby it rotates across different low-income, high-density locations in the Cape Town area. There is no overlap between the areas served by the youth clinic and the mobile clinic. All staff at each site are trained healthcare providers with experience in conducting clinical and socio-behavioural research studies. Infrastructure for the collection and safe storage of research data are available at each site. |
| Intervention type | Mixed |
| Primary outcome measure | 1. To evaluate the uptake of an STI test and treat programme for adolescents (aged 15-23 years) at a stand-alone youth clinic compared to a mobile clinic serving two peri-urban areas in Cape Town, South Africa. Participants will be offered free STI testing for chlamydia (CT) and gonorrhoea (NG) using a GeneXpert, a molecular point-of-care test that can detect CT/NG within 90 minutes. 2. To assess the acceptability of an STI test and treat programme amongst adolescents (aged 15-23 years) using a self-administrated paper-based questionnaire where participants rate the STI test and treat services by answering Likert-type scale questions (including how helpful the service was, whether they would use this service if it were more widely available and if participants experienced any negative consequences as a result of using the service). 3. To establish participant characteristics and site of testing associated with uptake of STI testing and treatment though a descriptive analysis of participant demographic details, disaggregated by site. |
| Secondary outcome measures | Establish the proportion of participants testing positive for chlamydia and/or gonorrhoea and the participant and site characteristics associated with positivity measured using the recorded results after the intervention |
| Overall study start date | 05/10/2016 |
| Overall study end date | 08/03/2019 |
Eligibility
| Participant type(s) | Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 15 Years |
| Upper age limit | 23 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 366 |
| Participant inclusion criteria | 1. Aged between 15 and 23 years old 2. Willing and able to provide signed informed consent/assent for the study 3. Sexual activity within the past two years 4. Willing to wait for results, receive results by text/phone call, or return the following day for results |
| Participant exclusion criteria | 1. Treatment for STI or presumed STI in the past 21 days 2. Has any condition that, in the opinion of the investigator, would preclude informed consent or make study participation unsafe 3. Appears psychologically unstable, intoxicated or under the influence of alcohol or other drugs at the time of informed consent |
| Recruitment start date | 23/02/2017 |
| Recruitment end date | 28/08/2018 |
Locations
Countries of recruitment
- South Africa
Study participating centre
Mowbray
Cape Town
7705
South Africa
Sponsor information
Research organisation
Desmond Tutu Health Foundation (formerly Desmond Tutu HIV Foundation)
P.O. Box 13801
Mowbray
Cape Town
7705
South Africa
| Phone | +27 (0) 21 301 2020 |
|---|---|
| carey.pike@hiv-research.org.za | |
| Website | https://desmondtutuhealthfoundation.org.za/ |
"ROR" |
https://ror.org/02asra118 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 14/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal, such as BMC Health Services Research |
| IPD sharing plan | The datasets generated during and analysed from this study will be available on request from Carey Pike, carey.pike@hiv-research.org.za Anonymised, de-linked databases have been shared on the University of Cape Town ZivaHub: https://zivahub.uct.ac.za/projects/The_STAX_Study/151755. These are available for review by interested parties. Consent from participants for participation in the study and the use of the data collected for research purposes was obtained. |
Editorial Notes
16/11/2023: Study's existence confirmed by the Human Research Ethics Committee, University of Cape Town.
