STIs in CHIEDZA
Lead Research Organisation:
London School of Hygiene & Tropical Medicine
Department Name: Epidemiology and Population Health
Abstract
Sexually transmitted infections (STI), when acquired in adolescence, can jeopardize sexual and reproductive health later in life, and for women, the health of their babies. In developing countries, symptomatic STIs are treated by syndromic management (presumptive treatment of symptomatic patients without the use of laboratory tests). Syndromic management was developed because diagnostic tests for STIs were unavailable in developing countries. However, research has shown that the accuracy of syndromic management for treating common STIs, like chlamydia and gonorrhoea, is low - especially for women. This is because most women with chlamydia and gonorrhoea do not have any symptoms. Yet these infections can have devastating outcomes such as pregnancy complications, infertility, and enhanced HIV transmission. Thus, effective STI control in adolescents and young people is a key priority in developing countries where both HIV and STIs are prevalent. Newer STI diagnostics integrated into HIV prevention and testing services may provide a solution.
We plan to evaluate a STI screening intervention using newer STI diagnostic methods within a cluster randomised controlled trial among adolescents and young people (AYP) in Zimbabwe, called CHIEDZA. CHIEDZA is a community-based package of sexual reproductive health services incorporating HIV prevention, HIV testing, linkage to care for AYP aged 16 to 24 years. Our intervention will provide screening for the three most prevalent curable STIs (chlamydia, gonorrhoea and trichomoniasis) using point-of-care or near point-of-care tests.
This study is timely: WHO is in the process of updating their STI case management guidelines and revisiting syndromic case management. Robust evidence for integrating newer testing technologies for AYP is needed to inform these guidelines.
Our questions are
1. What is the uptake, prevalence and yield of community-based STI screening among AYP?
All CHIEDZA attendees will be offered chlamydia and gonorrhoea screening and young women will also be offered testing for trichomoniasis. The outcome will be uptake, prevalence (proportion positive for an STI of those screened) and yield (proportion positive for an STI of those eligible for screening).
2. What is the impact of community-based STI screening and comprehensive management on population level STI prevalence among AYP? A population-based cross-sectional survey is planned for the CHIEDZA trial following the intervention period. STI testing will be added for a random sub-sample of participants in the cross-sectional survey. The primary outcome will be a comparison of the percentage of individuals with a positive test for chlamydia, gonorrhoea or trichomoniasis between intervention and control clusters using the two-stage approach for analysis of CRTs.
3. Can a risk assessment tool predict STI positivity among asymptomatic AYP? During the STI screening intervention, data on risks and genital symptoms will be collected. A self-assessment tool will be developed using for k-fold cross validation methods. The outcome will be sensitivity, specificity, positive predictive value and negative predictive value of the assessment tool for STI positivity.
4. Is community-based STI screening and comprehensive management cost-effective? We will measure how cost-effective our intervention is compared to syndromic management.
5. Is community-based STI screening and comprehensive management acceptable and what factors need to be addressed to ensure that the intervention can be scaled-up and sustained at a national level if it is effective? We will conduct a process evaluation to understand how our intervention works, whether it is acceptable to clients and providers and specifically to understand the factors that would need to be considered to ensure the intervention could be delivered widely within the country if it was proven effective.
We plan to evaluate a STI screening intervention using newer STI diagnostic methods within a cluster randomised controlled trial among adolescents and young people (AYP) in Zimbabwe, called CHIEDZA. CHIEDZA is a community-based package of sexual reproductive health services incorporating HIV prevention, HIV testing, linkage to care for AYP aged 16 to 24 years. Our intervention will provide screening for the three most prevalent curable STIs (chlamydia, gonorrhoea and trichomoniasis) using point-of-care or near point-of-care tests.
This study is timely: WHO is in the process of updating their STI case management guidelines and revisiting syndromic case management. Robust evidence for integrating newer testing technologies for AYP is needed to inform these guidelines.
Our questions are
1. What is the uptake, prevalence and yield of community-based STI screening among AYP?
All CHIEDZA attendees will be offered chlamydia and gonorrhoea screening and young women will also be offered testing for trichomoniasis. The outcome will be uptake, prevalence (proportion positive for an STI of those screened) and yield (proportion positive for an STI of those eligible for screening).
2. What is the impact of community-based STI screening and comprehensive management on population level STI prevalence among AYP? A population-based cross-sectional survey is planned for the CHIEDZA trial following the intervention period. STI testing will be added for a random sub-sample of participants in the cross-sectional survey. The primary outcome will be a comparison of the percentage of individuals with a positive test for chlamydia, gonorrhoea or trichomoniasis between intervention and control clusters using the two-stage approach for analysis of CRTs.
3. Can a risk assessment tool predict STI positivity among asymptomatic AYP? During the STI screening intervention, data on risks and genital symptoms will be collected. A self-assessment tool will be developed using for k-fold cross validation methods. The outcome will be sensitivity, specificity, positive predictive value and negative predictive value of the assessment tool for STI positivity.
4. Is community-based STI screening and comprehensive management cost-effective? We will measure how cost-effective our intervention is compared to syndromic management.
5. Is community-based STI screening and comprehensive management acceptable and what factors need to be addressed to ensure that the intervention can be scaled-up and sustained at a national level if it is effective? We will conduct a process evaluation to understand how our intervention works, whether it is acceptable to clients and providers and specifically to understand the factors that would need to be considered to ensure the intervention could be delivered widely within the country if it was proven effective.
Technical Summary
Effective sexually transmitted infections (STI) control in adolescents and young people (AYP) is a key priority for low and middle-income countries where HIV and STIs are prevalent. In most low and middle-income countries, symptomatic STIs are treated by syndromic management, yet sensitivity and specificity of this approach for STIs are poor. We propose to evaluate the effectiveness of community-based screening for STIs using newer diagnostic technologies in a Wellcome Trust-funded community-based cluster randomised trial among AYP in Zimbabwe.
The aim of the study is to evaluate the effectiveness of community-based screening for and comprehensive management of curable STIs among AYP in reducing the population level prevalence of STIs in a high HIV-prevalence setting. Our objectives are to implement and measure the uptake and yield of STI screening and comprehensive case management offered to AYP aged 16-24 years in community settings in Zimbabwe; assess the impact of community-based STI screening and comprehensive case management on population level STI prevalence among AYP; develop and evaluate a risk assessment tool to predict STI positivity among asymptomatic AYP to inform targeted STI screening; measure the cost-effectiveness of community-based STI screening and comprehensive case management; and to conduct a process evaluation of the intervention's implementation to document its feasibility, mechanisms of action, and the role of local context to identify the key components required for effect, sustainability and scalability.
The study findings will help inform policy-makers on how to best integrate newer diagnostics into STI management guidelines for AYP.
The aim of the study is to evaluate the effectiveness of community-based screening for and comprehensive management of curable STIs among AYP in reducing the population level prevalence of STIs in a high HIV-prevalence setting. Our objectives are to implement and measure the uptake and yield of STI screening and comprehensive case management offered to AYP aged 16-24 years in community settings in Zimbabwe; assess the impact of community-based STI screening and comprehensive case management on population level STI prevalence among AYP; develop and evaluate a risk assessment tool to predict STI positivity among asymptomatic AYP to inform targeted STI screening; measure the cost-effectiveness of community-based STI screening and comprehensive case management; and to conduct a process evaluation of the intervention's implementation to document its feasibility, mechanisms of action, and the role of local context to identify the key components required for effect, sustainability and scalability.
The study findings will help inform policy-makers on how to best integrate newer diagnostics into STI management guidelines for AYP.
Planned Impact
There is an urgent need to improve STI diagnosis in low and middle-income countries. A key impact of this research is the development of effective and scalable interventions to reduce the incidence and prevalence of STIs in adolescents and young people in HIV-endemic communities in southern Africa. In addition, outputs from this study will benefit the communities where it is being conducted in Zimbabwe, BRTI, national and international health programmes. We have outlined the impact at each level below
Impact for AYP, their parents and community members: Engaging adolescents and young people has been critical for the development of CHIEDZA, and this community engagement will be crucial for integrating STI testing within the CHIEDZA intervention. Sexually transmitted infections are stigmatised, and feelings of embarrassment and shame are barriers to STI testing, treatment and partner notification. Yet, our research in South Africa has shown that young people, their parents and community members prioritise reproductive health and future fertility. Reframing STI testing towards testing to protect one's future reproductive health is a powerful message of personal responsibility and aligns with community priorities. We found that young people want to have the opportunity to take action to protect their future reproductive health. Engaging the three Youth Advisory Groups (YAG) - one per province - will be important for messaging STI testing correctly in this population. If successful, up to 8,000 young people could benefit from STI testing in the CHIEDZA intervention.
Impact for BRTI: BRTI has carried out major research projects that have impacted adolescent health. BRTI will have strengthened capacity in laboratory diagnosis of STIs as well as expertise in STI research gained by training study staff in the diagnosis and management of STIs.
Impact for the Zimbabwean Ministry of Health and Child Care (MOHCC), and other national organisations: This study will provide data on efficacy, cost and a process evaluation for the delivery of community-based STI screening and comprehensive case management in Zimbabwe. In addition, the cross-sectional survey will provide population-based prevalence data. These data are essential to advocate, fund, plan, and implement interventions for STI prevention and control at a national level. The MOHCC has written a letter of support for this study, and a policy brief is a planned output from this study.
Impact for the WHO and other international organisations: WHO is in the process of updating the WHO STI case management guidelines and revisiting syndromic case management. Dr Teodora Wi, WHO Medical Officer, has written a letter of support for this study as evidence is urgently needed to inform the integration of newer testing technologies in the STI management guidelines. Once newer STI testing technologies (near point-of-care tests and rapid and affordable point-of-care tests) are integrated into the WHO guidelines, demand for affordable point-of-care tests will be created, motivating WHO and others to negotiate costs and facilitate the development of point-of-care tests that meet WHO ASSURED benchmarking.
Lastly, understanding how to engage with communities through understanding community priorities is key to implementing effective public health interventions. Lessons learned from this study will impact sexual and reproductive health programmes and policies.
Impact for AYP, their parents and community members: Engaging adolescents and young people has been critical for the development of CHIEDZA, and this community engagement will be crucial for integrating STI testing within the CHIEDZA intervention. Sexually transmitted infections are stigmatised, and feelings of embarrassment and shame are barriers to STI testing, treatment and partner notification. Yet, our research in South Africa has shown that young people, their parents and community members prioritise reproductive health and future fertility. Reframing STI testing towards testing to protect one's future reproductive health is a powerful message of personal responsibility and aligns with community priorities. We found that young people want to have the opportunity to take action to protect their future reproductive health. Engaging the three Youth Advisory Groups (YAG) - one per province - will be important for messaging STI testing correctly in this population. If successful, up to 8,000 young people could benefit from STI testing in the CHIEDZA intervention.
Impact for BRTI: BRTI has carried out major research projects that have impacted adolescent health. BRTI will have strengthened capacity in laboratory diagnosis of STIs as well as expertise in STI research gained by training study staff in the diagnosis and management of STIs.
Impact for the Zimbabwean Ministry of Health and Child Care (MOHCC), and other national organisations: This study will provide data on efficacy, cost and a process evaluation for the delivery of community-based STI screening and comprehensive case management in Zimbabwe. In addition, the cross-sectional survey will provide population-based prevalence data. These data are essential to advocate, fund, plan, and implement interventions for STI prevention and control at a national level. The MOHCC has written a letter of support for this study, and a policy brief is a planned output from this study.
Impact for the WHO and other international organisations: WHO is in the process of updating the WHO STI case management guidelines and revisiting syndromic case management. Dr Teodora Wi, WHO Medical Officer, has written a letter of support for this study as evidence is urgently needed to inform the integration of newer testing technologies in the STI management guidelines. Once newer STI testing technologies (near point-of-care tests and rapid and affordable point-of-care tests) are integrated into the WHO guidelines, demand for affordable point-of-care tests will be created, motivating WHO and others to negotiate costs and facilitate the development of point-of-care tests that meet WHO ASSURED benchmarking.
Lastly, understanding how to engage with communities through understanding community priorities is key to implementing effective public health interventions. Lessons learned from this study will impact sexual and reproductive health programmes and policies.
Publications
Kranzer K
(2021)
Identifying youth at high risk for sexually transmitted infections in community-based settings using a risk prediction tool: a validation study.
in BMC infectious diseases
Mackworth-Young C
(2022)
Putting youth at the centre: co-design of a community-based intervention to improve HIV outcomes among youth in Zimbabwe
in Wellcome Open Research
Mackworth-Young C
(2022)
Putting youth at the centre: co-design of a community-based intervention to improve HIV outcomes among youth in Zimbabwe
in Wellcome Open Research
Mackworth-Young CRS
(2022)
"Other risks don't stop": adapting a youth sexual and reproductive health intervention in Zimbabwe during COVID-19.
in Sexual and reproductive health matters
Martin K
(2021)
Uptake of and factors associated with testing for sexually transmitted infections in community-based settings among youth in Zimbabwe: a mixed-methods study.
in The Lancet. Child & adolescent health
Martin K
(2022)
"It was difficult to offer same day results": evaluation of community-based point-of-care testing for sexually transmitted infections among youth using the GeneXpert platform in Zimbabwe.
in BMC health services research
Rochford H
(2023)
Acceptability of self-collected vaginal swabs for sexually transmitted infection testing among youth in a community-based setting in Zimbabwe.
in International journal of STD & AIDS
Description | Contribution to Global Fund/ PEPFAR Application for HIV programming |
Geographic Reach | National |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | Provision of integrated HIV and sexual and reproducitve health service and a shift away from syndromic to aetiological testing - this aligns strongly to the WHO GHSS 2023-2030 strategy |
Description | Participation in Zimbabwe MoHCC STI Advisory Group |
Geographic Reach | National |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | Changes anticipated through inclusion on STI testing in Zimbabwe Management guidance should Global Fund cycle include STIs - a key output from this meeting. |
Description | Presentation of findings to the Ministry of Health AIDS and TB Unit |
Geographic Reach | National |
Policy Influence Type | Contribution to new or improved professional practice |
Impact | MoHCC is actively discussing modalities through which STI testing can be incorporated into routine practice within Zimbabwe. |
Description | Presentation to WHO Guidelines Development Group |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | Impact anticipated in new WHO guidelines for Partner Notification. |
Description | WHO Asymptomatic STI Management smaller advisory group (for Guidelines Development) |
Geographic Reach | Multiple continents/international |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | This will inform the upcoming WHO guidelines on STI management which are planned to incorporate STI testing for key population groups. |
Description | EDCTP Research and Innovation Action (RIA) |
Amount | € 3,508,462 (EUR) |
Funding ID | RIA2020I-3297 |
Organisation | European Commission |
Sector | Public |
Country | European Union (EU) |
Start | 04/2021 |
End | 03/2024 |
Title | STICH trial dataset |
Description | Dataset of STICH cluster randomised trial |
Type Of Material | Database/Collection of data |
Year Produced | 2023 |
Provided To Others? | Yes |
Impact | None yet |
URL | http://www.datacompass.lshtm.ac.uk |
Description | BRTI and LSHTM |
Organisation | Biomedical Research and Training Institute (BRTI) |
Country | Zimbabwe |
Sector | Charity/Non Profit |
PI Contribution | We are collaborators on the grant. |
Collaborator Contribution | Professor Rashida Ferrand is head of the Zimbabwe-LSHTM research partnership hosted at BRTI and provides leadership on the implementation of the study. |
Impact | We are collecting data |
Start Year | 2020 |
Description | Blog Post in Springer Nature Community |
Form Of Engagement Activity | Engagement focused website, blog or social media channel |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Media (as a channel to the public) |
Results and Impact | CDC wrote a blog post about the study which was shared on the Springer Nature web page. It resulted in wide engagement about the project and was also shared widely on social media including Twitter thus raising awareness about the research and challenges in STI management in Zimbabwe. |
Year(s) Of Engagement Activity | 2023 |
URL | https://go.nature.com/3YABzdY |
Description | Dissemination to Implementers |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | PResented and discussed how to implement SRH and HIV integrated services to Teeres des Hommes (service implementers in communities) and UNESCO (implementers in Universities) |
Year(s) Of Engagement Activity | 2022 |
Description | Presentation at International Statistics & Epidemiology Group (ISEG), LSHTM symposium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Presentation of the principles of service integration at ISEG symposium- to celebrate the 30th Anniversary of ISEG. |
Year(s) Of Engagement Activity | 2022 |
Description | Presentation at the National AIDS Council Symposium |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Professional Practitioners |
Results and Impact | Presented findings at a symposium organsied by the National AIDS Council presenting on the findings relate dto integration of HIV and SRH services |
Year(s) Of Engagement Activity | 2022 |
Description | Presentation of Study findings to the Zimbabwe National Network of People Living with HIV (ZNNP+) |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Patients, carers and/or patient groups |
Results and Impact | CDC was asked to present findings at a national meeting for the Zimbabwe National Network of People Living with HIV (ZNNP+). STIs are a topic not usually included in these meetings and this sparked a lot of interest in the challenges as well as possible implication for people living with HIV as well as the need for further research and advocacy. |
Year(s) Of Engagement Activity | 2022 |
Description | Presentation of trial findings to Directorate of Public Health at Ministry of Health and Care |
Form Of Engagement Activity | A formal working group, expert panel or dialogue |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Policymakers/politicians |
Results and Impact | We presented the findings to the Ministry of Health and Care for our trial findigs to feed into national policy on programming for SRH and hIV testing and care service delivery |
Year(s) Of Engagement Activity | 2023 |
Description | Presentation to LSHTM Sexually Transmitted Infections Research Interest Group |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Postgraduate students |
Results and Impact | Over 40 researchers attended a webinar on STI research in Zimbabwe which was followed by questions and discussions about the high prevalence of STIs in this setting and the need for improved diagnostics. |
Year(s) Of Engagement Activity | 2022 |
Description | Wellcome Trust - Bloomsbury Centre for Global Health Research Scientific Meeting |
Form Of Engagement Activity | A talk or presentation |
Part Of Official Scheme? | No |
Geographic Reach | International |
Primary Audience | Professional Practitioners |
Results and Impact | Preliminary findings from this study were presented at the Wellcome Trust - Bloomsbury Centre for Global Health Research Scientific Meeting which was attended by approximately 100 participants in Zimbabwe and The Gambia. After the presentation discussions on STI management in Zimbabwe we conducted with researchers present including representatives from Ministries of Health. |
Year(s) Of Engagement Activity | 2022 |
Description | Youth Researcher academy for PZAT |
Form Of Engagement Activity | Participation in an activity, workshop or similar |
Part Of Official Scheme? | No |
Geographic Reach | National |
Primary Audience | Other audiences |
Results and Impact | Training of youth in conducting researchers in partnership with PZAT (NGO) |
Year(s) Of Engagement Activity | 2022 |