| Background: Pre-exposure prophylaxis(Pr EP)has been widely used as a novel biological measure for HIV prevention,and the effectiveness and safety of Pr EP has been demonstrated in several studies in various countries.Traditional adherence interventions implemented to ensure the level of Pr EP adherence include side effect management,personalized medication guidance,regular education,setting medication reminders,and providing counseling and social support;new Pr EP interventions include: electronic information interventions,electronic pill boxes,and video interventions.Previous foreign studies have found that video interventions not only alleviate the shortage of medical resources compared to traditional interventions,but also reduce medical costs and provide personalized mobile applications.Although a large number of international studies have been conducted,the results and methods of foreign studies are not fully applicable to the MSM population and healthcare institutions using Pr EP in China.In this study,we propose to use a parallel design randomized controlled trial of a shared-dose video intervention for MSM participating in a national multicenter real-world pre-exposure prophylaxis program to provide a scientific reference for a video intervention for the Pr EP-using MSM population in China.Methods: This study,a randomized controlled trial conducted at the Shenyang site between April 2019 and November 2020,took place online and offline to recruit the MSM population in the Pr EP dosing group simultaneously,which completed baseline surveys including demographic information and behavioral information after enrollment.The study participants were randomized 1:1(video intervention and control groups)by random number table method.Study subjects in the video intervention group were required to share a medication administration video with the investigator when taking their medication within the first month after enrollment,and the control group was given verbal medication instructions by staff at follow-up after enrollment.In this study,medication adherence was calculated by pill counting,where a medication adherence score of ≥90 was considered as good medication adherence.A generalized estimating equation was used to evaluate the effect of the video intervention by comparing the medication adherence of the two study groups at M1,M3,M6,M9,and M12.This trial was registered in the China Clinical Trials Center Registry Registry,Chi CTR1900024545.Results: 1.After randomization,there were 98 participants in the video intervention group and 98 participants in the control group.Among them,8 participants in the video intervention group withdrew from the study after being grouped,and 25 participants were excluded from the study because they did not send qualified medication videos as required.A total of 163 participants were finally enrolled in the study.A chi-square test revealed that the baseline characteristics of the intervention group were generally consistent with those of the control group,with differences in only some variables: a higher proportion of MSM taking medication daily(75.4% vs.48.0%,P<0.001),a higher proportion with a bachelor’s or college degree(72.0% vs.57.0%,P=0.04),a higher proportion with an emotional status of single(60.0% vs.vs.41.8%,P=0.023),and condom use was more frequent(75.4% vs.40.8%,P=0.001).There was no statistically significant difference between the intervention and control groups in the percentage of MSM who perceived their own risk of HIV infection,the risk of HIV infection among their close circle of friends,and the risk of HIV infection among the gay population in the city/region/county in which they lived.The differences in the four dimensions of social/drug-taking support between MSM in the intervention and control groups were not statistically significant.2.The proportion of MSM with good compliance at the point of visit for M1,M3,M6,and M12 was higher in the intervention group than in the control group(95.4% vs.46.4%,P<0.001;90.6% vs.39.4%,P<0.001;93.2% vs.58.5%,P<0.001;75.0% vs.54.5%,P<0.001).The proportion of MSM in the intervention group with a daily dosing regimen that was well adhered to M1,M3,M6,and M12 at the point of visit was higher than in the control group(96.4% vs.33.3%,P<0.001;92.6% vs.47.8%,P<0.001;94.6% vs.67.6%,P=0.003;75.6% vs.43.2%,P=0.002).A higher proportion of MSM in the intervention group with an event-driven dosing regimen had good compliance at the point of visit for M3 than in the control group(80.0% vs.31.3%,P=0.004).3.A univariate GEE analysis with Pr EP medication adherence as the dependent variable(good adherence assigned = 1,poor adherence assigned = 0)found that: intervention group(vs.control group)(OR=5.44,,95% CI=3.77-7.84,P<0.001);medication mode was daily(vs.event-driven medication)(OR=1.49,95% CI=1.04-2.13,P=0.029);HIV knowledge level >7(vs.≤7)(OR=1.67,95% CI=1.15-2.42,P=0.006);sexual role as being a "0"(recipient)(vs.being a "1"(inserted party)(OR=1.72,95% CI=1.07-2.76,p=0.024);not using new drugs(vs.using new drugs)(OR=1.59,95% CI=1.09-2.33,p=0.018);of changing the way of taking drugs(OR=4.76,95% CI=1.79-12.5,P=0.002)were all associated influences of good medication adherence.Multifactorial GEE analysis by correcting for age,ethnicity,literacy,mean monthly income,and residential status found that the intervention group(vs.control group)(OR=5.79,95% CI=3.78-8.88,P<0.001);not using new drugs(vs.using new drugs)(OR=1.49,95% CI=1.03-2.17,P =0.037);and never changing medication regimen among changing medication regimen(vs.stopping medication)(OR=7.14,95% CI=2.13-25,P=0.001)were independent influencing factors for good medication adherence.Conclusion: 1.The intervention of sharing medication taking videos can improve medication adherence among MSM participating in Pr EP in China,with MSM who take medication daily being more receptive to the video intervention and MSM who take medication event-driven being more durable.2.Medication adherence in Pr EP is influenced by multiple factors,and the main findings of this study are: daily medication taking style,high level of HIV awareness,and sex role of "0" sex role were protective factors for medication adherence;use of new drugs and changing medication regimen were risk factors for medication adherence.3.The intervention of sharing medication videos may be more suitable for MSM with high literacy level and daily medication regimen to improve Pr EP’s medication adherence. |
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