YATHU YATHU ("For us by us"): A Cluster Randomised Trial of community-based SRH and HIV services for adolescents and young people in Zambia

There are more than 1.8 billion adolescents and young people (aged 10-24) alive today, more than ever before in world history. Most of these live in developing countries, with many countries in Africa having 50% of the population less than 18 years old. HIV is the second leading cause of death in this age group and the number of new infections continues to rise. HIV infection, unwanted pregnancies and early marriage limit the potential of millions of young women yet services to prevent these are often not accessible to young people.
In Zambia, adolescents (10-19 years old) represent 25% of the total population. Zambia has the 5th highest adolescent birth rate in sub-Saharan Africa (the region with the highest rates in the world) and 44.7% of women under 20 reported an unplanned pregnancy. HIV prevalence rates in the Lusaka communities chosen for this study are 6.4% among 15-24 year old women and 1.6% amongst young men of the same age, rising rapidly thereafter. The Zambian Adolescent Health Strategy 2017-2021 recognises sexual and reproductive health (SRH) and HIV as the two leading priorities for health service planning with a mission "to ensure equity of access to appropriate, quality and cost-effective adolescent-friendly health platforms and an adolescent responsive health system as close to the people as possible."
When we ask young people in Zambia what SRH services they want they unequivocally tell us that they want services specifically designed for them, provided with them ("Yathu Yathu; For us by us") away from traditional health facilities where attitudes of health providers can still be stigmatising towards young people. In response, we have designed a community-based, peer-led intervention that makes use of innovative technology, including prevention points "loyalty card" to incentivise and measure service access and use, and support for uptake and adherence to services using virtual support groups. At the start of the study period, we will continue discussion with adolescent community advisory boards to refine the location, content and delivery of the community-based peer-led services.
This study aims to evaluate the process of establishing and delivering community-based peer-led SRH services, including HIV testing, treatment and prevention, in two urban communities in Lusaka, Zambia. The study will compare the uptake of SRH services by adolescents and young people aged 15-24 living in areas of the ten communities which were randomly allocated to have access to these community-based, peer-led services, compared to ten areas randomly allocated to have services provided via traditional health facilities. The study will measure whether the community-based peer-led services increased knowledge of HIV status and coverage of SRH services relative to standard of care areas. To measure knowledge of HIV status, we will conduct a cross-sectional survey in all sites 18-months after the intervention implementation and compare these outcomes between the intervention and standard of care sites. To measure coverage, we will use the data routinely collected at point of service access and use by the innovative prevention points cards system. The innovative chip-enabled prevention points "Yathu card" will enable service users to collect of SRH "prevention" points, which can be exchanged for goods and services, to encourage uptake of services and measure access. The study will also evaluate the use of mobile phone based support groups to enable adolescents and young people to adhere to medication such as anti-retroviral therapy used either as treatment for HIV or as pre-exposure prophylaxis (PreP).
The research will be carried out by Zambart a Zambian research organisation in collaboration with researchers from the London School of Hygiene and Tropical Medicine and Imperial College in the UK in partnership with the Zambian Ministry of Health, Society for Family Health and the SHM foundation.

Yathu Yathu ("For us by us") is a two-arm cluster-randomised trial that will evaluate community-based, peer-led sexual and reproductive health services (SRH), including HIV prevention and treatment for adolescents and young people (AYP), in 2 urban communities in Lusaka, Zambia.
SRH services will be established in community spaces in collaboration with adolescent community advisory boards who will advise on the location, content and running of the services. Services offered will include contraception, condoms, HIV testing, STI screening and treatment, VMMC information and referral, ART support groups (face-to-face and via mobile phone), PEP/PrEP services and support groups (by mobile phone), menstrual hygiene products as well as information and support on a range of other subjects requested by young people.
The 2 communities are divided into 20 clusters that will be randomized to intervention or control arms. Each intervention cluster will have one community centre with services accessed either at the centre or the health facility. In the control clusters, services can be accessed at the health facility as per the national standard of care. The primary outcomes will be knowledge of HIV status, measured via a cross-sectional survey, and an indicator of coverage measured using an electronic prevention points "Yathu card" provided to all AYP, aged 15-24 years, living in the study communities. Secondary outcomes will include uptake and adherence of specific services such as ART, PreP, or modern contraceptives. In addition economic and qualitative enquiry will provide data on the costs and inputs required to establish the services, barriers and enablers to the use of the services and the experience of AYP in both control and intervention arms.
The study findings will help inform policy-makers on how to best provide SRH services for AYP.

This research will directly benefit the communities where it is being conducted in Lusaka, Zambia. As highlighted in the Pathways to Impact, engaging adolescents and young people has been a critical part of this application from the outset. Over the past four years, the Yathu Yathu team has established a presence within the communities, developing a relationship through and with adolescent community advisory boards. The communities will continue to be engaged throughout the study, including in developing and conducting the intervention and the research, with some important employment opportunities, as well as benefitting from improved access to services. If the intervention has the desired effect, more adolescents and young people will be able to make important decisions in their lives to avoid HIV infection and unplanned pregnancies, both of which will improve the quality of their lives and their economic and social productivity in the communities where they live. Adolescents and young people who are engaged in the research process will gain important skills from the process and this may enable them to access employment and other educational opportunities in the future.
All services delivered through the Yathu Yathu intervention will be linked to and delivered in collaboration with existing Ministry of Health health facilities, including HIV treatment, prevention. The research will directly affect these health facilities, and health management professionals in Lusaka district and province, who will be able to observe the operations of the Yathu Yathu centres and learn lessons for the provision of services both within the health facilities as well as possibly in communities in the future. The research teams will gain important skills in community based research as well as new knowledge from the electronic and mobile phone based systems.
We plan to build on the existing relationships with national and regional authorities, international funders and agencies, to rapidly translate our findings into a comprehensive evidence base that supports decision making within and outside of Zambia. National and Regional policy makers will benefit from lessons learned from the implementation of the intervention and also the results of the trial. Through the P-ART-Y study, we have shown that rapid changes have been adopted by participating Ministry of Health health-care facilities following initial consultations, for example to implement adolescent corners in existing health facilities. We would anticipate that, should the implementation of the intervention be successful and coverage of services increase in a cost effective manner, then policy makers would adopt this model of adolescent-responsive services. This would be directly in line with the Zambian adolescent strategic framework with the results of the trial being available within the time frame of this framework (2017-2021) such that the intervention could be scaled up and introduced as policy in the next version of the guidelines.
Internationally, WHO and UN agencies have commissioned reviews of what works for adolescent SRH and have reached the conclusion that more rigorous evidence of high quality interventions is needed. The combined UN agencies have launched the Global Accelerated Action for the Health of Adolescents (AA-HA!) initiative in 2017 and so robust and rigorous evidence from a well-designed cluster randomised trial that incorporates many of the recommendations from this process and fully engages with adolescents and young people will be important to feed into this process and achieve the development goals by 2030. Funders, including PEPFAR and the Bill & Melinda Gates Foundation, with whom we already have an established relationships with, will benefit from the findings as it will provide information on what research is still required and direction on how to target their investments.