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Impact of partner-related social harms on women's adherence to the dapivirine vaginal ring during a phase III trial
Palanee-Phillips, T., Roberts, S. T., Reddy, K., Vaneshree Govender, Naidoo, L., Siva, S., Gafoor, Z., Pather, A., Matovu, F., Hlahla, K., Makanani, B., Nair, G., Schwartz, K., Torjesen, K., Brown, E., Soto-Torres, L., Baeten, J., & Montgomery, E. T. (2018). Impact of partner-related social harms on women's adherence to the dapivirine vaginal ring during a phase III trial. Journal of acquired immune deficiency syndromes (1999), 79(5), 580-589. https://doi.org/10.1097/QAI.0000000000001866, https://doi.org/10.1097/QAI.0000000000001866
BACKGROUND: Long-acting female-initiated methods like the dapivirine ring may give women greater agency in HIV-1 prevention. However, social harms, defined as non-medical adverse consequences of study participation or dapivirine ring use, may reduce product adherence and consequently HIV-1 protection.
BACKGROUND: Long-acting female-initiated methods like the dapivirine ring may give women greater agency in HIV-1 prevention. However, social harms, defined as non-medical adverse consequences of study participation or dapivirine ring use, may reduce product adherence and consequently HIV-1 protection.
RESULTS: Among 2629 women enrolled in ASPIRE, 85 (3.2%) reported 87 social harms during a median follow-up of 1.6 years. Women were significantly more likely to have low adherence, measured by plasma dapivirine levels, at visits with a social harm in the past month than at visits where no social harm was reported (adjusted risk ratio (aRR) 2.53, 95%CI 1.37-4.66, p=0.003). There was no association for social harms reported ≥1-month prior, suggesting an acute, short-term effect. Women were significantly more likely to not return a ring at visits with a social harm reported (aRR 24.70, 95%CI 18.57-32.85, p<0.001). In rings that were returned, social harms were not associated with residual dapivirine levels.
CONCLUSIONS: Although social harms were uncommon (<5% of women with >1 year of use), participants reporting social harms by male partners had lower adherence to the dapivirine ring. Strategies to mitigate non-adherence to product use related to social harms should be evaluated in future studies of female-controlled HIV-1 prevention options.This is an open access article distributed under the terms of the Creative Commons Attribution License 4.0 (CC BY), which permits unrestricted use, distribution, and reproduc in any medium, provided the original work is properly cited.