PE04.01
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Correlates of dapivirine vaginal ring uptake among women participating in an open label extension trial-MTN-025/HOPE

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BACKGROUND: MTN-025/HOPE was a Phase IIIb open-label extension trial of the dapivirine vaginal ring (DVR) for former participants of MTN-020/ASPIRE, one of two phase 3 studies that showed the DVR was well-tolerated and reduced the risk of HIV infection by approximately 30%. Use of the DVR was not required for participation in HOPE and women could change their mind about ring acceptance during study follow-up. We explored factors associated with DVR uptake in MTN-025/HOPE.
METHODS: MTN-025/HOPE was conducted at 14 sites in Malawi, South Africa, Uganda, and Zimbabwe between July 2016 and August 2018. To be eligible for the study, women had to be HIV uninfected, not pregnant, not breastfeeding and willing to provide informed consent. The DVR was offered monthly for the first 3 months, then quarterly (3 rings dispensed) thereafter at months 3, 6 and 9. Logistic regression analysis was used to assess correlates of DVR uptake from entry to month 9 adjusting for region, including demographics, participant/partner characteristics, sexual behavior, HIV risk perception, family planning methods, and intention to use the ring in future. Covariates from univariate analyses that were significant at p<0.10 were included in a multivariate analysis.
RESULTS: A total of 1456 women (median age 31 years) enrolled in HOPE and 8390 visits were included in the analysis. At baseline, 1342 (92.0%) chose to accept the DVR and 1153 (79.2%) were consistent acceptors (accepted the ring at all visits). Significant correlates of ring uptake (at p<0.05) are included in table 1 below:
Table 1: Results from multivariable logistic regression adjusted for site accepting a DVR at enrolment visit and consistently accepting a ring in Multivariate Analyses. Cells marked NA indicate the variable was not included in that multivariable regression.
Baseline CharacteristicAccepting DVR at Enrollment
N=1342(92%)
Consistently Accepting DVR
N=1153(79.2%)
OR(95% CI)p-valueOR(95% CI)p-value
Education level less than secondary schoolN/AN/A0.67(0.43,1.04)0.07
Had Primary Partner at enrollment3.88(1.62,9.28)<0.013.44(1.77,6.69)<0.01
Any unprotected sex in the past 7 daysN/AN/A0.87 (0.62, 1.21)0.41
HIV risk perception
Not worried
Somewhat low risk
Very worried
N/AN/A(ref)
0.95(0.67,1.33)
1.47(1,2.18)
0.75
0.05
Perceives the ring
to offer a lot of protection
1.67(1.01,2.78)0.051.08(.075,1.55)0.68
Very likely to use the ring if it becomes available1.77(1.11,2.81)0.021.68(1.23,2.29)<0.01
Reports use of Oral HC0.5(0.29,0.87)<0.010.4(0.27,0.58)<0.01
Has implant for contraceptionN/AN/A1.19(0.8,1.77)0.39

CONCLUSIONS: Uptake and sustained acceptance of the DVR was high in HOPE. Factors predictive of ring acceptance included: having a primary partner, high perception of HIV risk and use of oral contraceptives. Future efforts should consider these factors when targeting populations for DVR rollout and in designing counseling messages.