Adapting the Stepping Stones intervention to strengthen HIV-related outcomes, and enable scale- up, for young men in South Africa

South Africa (SA) has an estimated 7.2 million people living with HIV - the highest in the world and HIV remains the leading cause of death, with 110,000 deaths per annum. Men continue to have a higher HIV related mortality than women, whilst HIV incidence has remained stubbornly high, especially in KwaZulu-Natal (KZN) where we have shown an annual incidence of 8% amongst females aged 20-24. There has been considerable progress in developing efficacious and cost-effective HIV prevention tools. These include HIV point of care tests (POCT) and HIV self-tests; voluntary medical male circumcision (VMMC), condoms, and the use of daily oral tenofovir/emtricitabine for Pre-Exposure Prophylaxis (PrEP) which can reduce the risk of acquiring HIV by up to 90%; and HIV treatment with antiretroviral therapy (ART) that, when taken consistently, reduces mortality and eliminates onward transmission of HIV to sexual partners to zero. However, the promise of eliminating HIV in young people has not materialised in part due to the fact that young men still have poor use of these technologies. This undermines our efforts to end AIDS.

In this project we propose to take interventions that have previously been used successfully with young men to reduce their use of violence in relationships and alcohol use, and adapt them to strengthen HIV-related outcomes. This will be done in a district of South Africa with one of the highest HIV-prevalence globally.

The adaptation process will comprise a mixture of working with other academics, non-governmental organisations (NGOs) and the young men themselves to co-develop a framework and intervention. Over a period of five months we will then pilot this intervention. The intervention will have two versions: the first version will be delivered over approximately 8 weeks, with sessions run twice a week, while the second version will be delivered over a one week period. We will follow up men to see whether after attending the intervention they will attend an HIV-test at a clinic, and then engage in a discussion about HIV-treatment (if positive) or HIV-prevention options if HIV-negative. We will collect a mixture of data on service uptake, and service users, service providers and the community experience, and adverse events and our ability to follow participants up for three months. We will also talk to men about their experience of the intervention and to those who are delivering the intervention about what it was like.

By the end of the study period we anticipate that we will have an acceptable and scalable scalable group-based participatory intervention that will improve men's health through transforming masculinities and strengthening livelihoods After this process we will revise the manual and it will be ready for a larger evaluation in a formal trial to see whether it has impact on men's lives and HIV-prevention and treatment.

Our experienced multidisciplinary team of clinical researcher, social scientists, and biostatisticians together with the implementing partner Project Empower, will conduct the study over 16 months. We believe that we will be able to help provide answers to the important scientific question: Can a scalable group-based participatory intervention improve men's health and reduce their high HIV related mortality through the pathways of transforming men's masculinities and strengthening livelihoods in rural South Africa?

Background: In South Africa, men's HIV-prevention and treatment outcomes are poor, driven by gender inequitable masculinities, poverty, and health services that do not respond to men's needs. The African Health Research Institute's (AHRI) recently completed Treatment As Prevention Trial, showed young men (aged 16-29) had the worst engagement in the treatment cascade; less than 80% knew their HIV-status, 25% on treatment, and 18% virally suppressed. And young men's HIV-prevention is similarly poor.
Aim: To strengthen approaches to improve HIV testing, care and prevention for young men in rural South Africa. To achieve this we will work with young (18-30) men in rural South Africa to enhance scalable interventions which have been shown to transform men's masculinities and strengthen livelihoods, to improve these interventions effectiveness on HIV-related outcomes.
Methods: To achieve this we will use participatory methods to co-adapt and refine a theoretical framework for an intervention, with researchers, practitioners and end users (men 18-30) and then deliver a small pre-test of the intervention (n=30), using the African Health Research Institute Health Demographic Surveillance System as a sampling frame to determine acceptability and feasibility at the population level. We will assess acceptability through qualitative research with men in the intervention, and quantitative process data. We will also confirm that our outcome - attendance at a confirmatory HIV test and discussion about HIV-treatment/prevention - is measurable using the structures available within the study site.
Outcome: At the end of the project we will have an intervention that is ready for a larger scale evaluation.
Timetable: 16 months
Expertise: An experienced multidisciplinary team of clinical researchers and implementers, epidemiologists, social scientists, biostatisticians and trial-ists.

Despite the availability of effective treatment and prevention HIV remains one of the gravest health problems facing young people living in sub-Saharan Africa, in part because of the challenge of engaging men in effective HIV care and prevention. Moreover, young men's health is further impacted upon through violence, alcohol and lack of employment opportunities. The study seeks to address this by determining whether adapting a scalable group-based participatory intervention that aims to improve engagement of men in HIV testing, prevention and treatment through the pathways of transforming men's masculinities and strengthening livelihoods is acceptable, feasible and scalable in a poor and high HIV burden area of rural area of South Africa (SA).

This innovative intervention will build on a widely used group intervention, stepping stones. Nesting this within an existing HIV surveillance platform will allows the resulting trial to understand the effectiveness of this intervention on reducing HIV incidence in all young people offered it. Through our participatory intervention development, specifically engaging an expert advisory group, beneficieries (youth advisors) and implementers (Project Empower) in adapting the intervention we embed the pathways to impact from the outset

The potential beneficiaries of this study are:
1. Patients and young men who will benefit from a more patient-centred approach to HIV prevention and treatment that tackles wider issues of masculinity, livelihoods, mental health, violence and alcohol use. By adapting the intervention with young men we will ensure that the health concerns of young men remain at the heart of the intervention.
2. Public and communities: Widening access to HIV testing, treatment and prevention will reduce morbidity or mortality, and improve quality of life. Our social science work has highlighted the concern communities have about the impact of HIV on the young men and the barriers that they face in equitable access and retention in care. This intervention explicitly tackles these barriers and will work with communities to refine the intervention and ensure it is adapted to the context.
3. Policy makers who have called for innovations in engaging young men in HIV care and prevention (our research team work closely with the SA government and Project Empower (an NGO) and the results will feed iteratively into their recommendations).
4. The MoH and SA government who have started scaling up Universial Test and Treat. The study will provide evidence for the acceptability and feasibility of interventions to improve young men's engagegment in HIV testing, care and prevention. The synergies with existing health plans will support scalability.
5. Academic beneficiaries: Our research programme will directly benefit researchers in masculinities, HIV, gender based violence, participatory methods and complex intervention design and evaluation. We have a strong track record of supporting the translation of research into practice.
AHRI's Wellcome Trust funded public engagement unit is supporting our communication strategy. We have already engaged stakeholders in the development of the research plan and will engage them in our dissemination, through our community advisory board; SAMRC; Project Empower; close links to the directorate of health in KZN, the SA MoH; international partners in the WHO and UNAIDS; funders (Global Fund, Bill and Melinda Gates Foundation and PePFAR) and the scientific community.