Standard of care for social harms in HIV prevention trials: A South African perspective.

BACKGROUND: The prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports. METHODOLOGY: This paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such reports. RESULTS: This review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal. CONCLUSION: Social harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence-based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials.

Risk of Sexual Violence: Perspectives and Experiences of Women in a Hospital in the Democratic Republic of Congo.

Sexual violence in conflict situations is gaining worldwide recognition as a human rights issue. There is growing awareness and concern about the risks associated with sexual violence against women. This study was conducted in order to explore the perceptions and experiences of the risk of sexual violence in the Democratic Republic of Congo. The study draws on qualitative, in-depth interviews with women at a hospital in Bukavu. The findings show that women suffered humiliation, torture and beatings during their rape. Most women were raped by a number of men and others were forced to have sex with close family members. The rapist often used extreme brutality against the women which had major long-term consequences for women including unwanted pregnancies and/or HIV/AIDS. Many of the women experienced great uncertainty about their future and that of their children.

Development, feasibility, acceptability and potential effectiveness of a healthy lifestyle programme delivered in churches in urban and rural South Africa.

Rising levels of obesity in South Africa require innovation in community-level lifestyle change programmes. Our aim was to co-develop Impilo neZenkolo ('Health through Faith'), a healthy lifestyle programme for low-income, black South Africans delivered through churches, and evaluate its feasibility, acceptability and potential effectiveness. In the first phase we developed programme materials with church members. In the second phase we trained lay leaders to deliver the programme and assessed feasibility, acceptability (observation, focus groups and interviews) and potential effectiveness (pre and post measurement of weight, hip and waist circumferences, blood pressure, self-reported physical activity, dietary habits, health status, self-esteem, psychological distress). The study was conducted in four churches in urban and rural South Africa. The development workshops led to increased focus on positive benefits of participation, widening inclusion criteria to all adults and greater emphasis on Christian ethos. Challenges to feasibility included: recruitment of churches; scheduling of programme sessions (leading to one church not delivering the programme); attendance at the programme (63% attended more than half of the 12 weekly sessions); and poor programme fidelity (in particular in teaching behaviour change techniques). Aspects of the programme were acceptable, particularly the way in which the programme was aligned with a Christian ethos. There was some indication that amongst the 42/68 (62%) for whom we were obtained pre- and post-programme measurements the programme has potential to support weight loss. We conclude that a healthy lifestyle programme for low-income, black South Africans, delivered through churches, may be viable with extensive re-development of delivery strategies. These include finding external funding for the programme, endorsement from national level denominational organisations and the professionalization of programme leadership, including paid rather than volunteer leaders to ensure sufficient time can be spent in training.