STIs in CHIEDZA

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.

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.

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.