OA09.02
Background: When Madibeng Centre for Research (MCR) began its work on a Vaginal Microbicide Ring Phase III trial the surrounding community was peaceful. Wage negotiations in the surrounding mines became tense leading up to the Marikana massacre on 16 August 2012, just more than 4 months into the trial. The situation in the area remained tense and also led to male partner aggression towards their female partners. Partners viewed the trial and the ring with suspicion resulting in some participants being forced to stop using the ring and to withdraw from the trial.
Methods: With participant consent, MCR strategized on ways to reach out to the affected participants' partners and to engage the local community:
• Partners were visited personally and given appropriate information on the trial
• Partners were invited to attend the research centre (RC) to view procedures and interview the Principal Investigator
• Upscaled community engagement and education occurred in the communities close to Marikana
• Participants were educated and equipped to deal with partners who did not wish them to use the ring, or who wanted them to withdraw against their will
Results: Partners who accepted a visit from the Community Liaison Officer were in favour of the trial and their female partners' participation on the trial. Some partners visited the RC to observe all procedures before accepting that their female partners could continue on the trial. Women felt more equipped to deal with partner objections to the trial. Early trial withdrawal for partner related issues decreased substantially after the intervention.
Conclusions: The situation around a research centre could change dramatically overnight. Unrelated incidents could have a ripple effect on the clinical trials in the area. Partners may transfer their frustration and anger onto their female partners, affecting their compliance to the protocol. With appropriate intervention using a multi-pronged approach it is possible to turn such a situation around.
