High Frequency of Unintended Pregnancy and Predictors of Contraceptive Choice among HIVinfected African Women on Lifelong ART Jim K Aizire MD MHS PhD Johns Hopkins University 26 July 2018 PEPFAR PROMOTE STUDY ID: 761211
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High Frequency of Unintended Pregnancy and Predictors of Contraceptive Choice among HIV-infected African Women on Lifelong ART Jim K. Aizire, MD, MHS, PhD Johns Hopkins University 26 July 2018 PEPFAR PROMOTE STUDY J. Aizire , N. Yende , T. Nematadzira , M.E. Nyati , S. Dadabhai , L. Chinula , C. Nakaye , M. Naidoo , M.G. Fowler , T. Taha , US-PEPFAR PROMOTE Cohort
Background Home to more than 90% of the reproductive health needs globallyWomen of reproductive age constitute more than 60% of the HIV/AIDS burdenSeveral countries have more than 60% unmet need for modern family planning methods More than 85% of unintended pregnancies are attributed to non-use of an effective family planning (EFP) method (injectable, oral, intra-uterine contraceptive device (IUCD), or Norplant).Most commonly reported reasons for not using EFP include infrequent sex and safety/side-effects. Others include postpartum/breastfeeding, opposition by the partner, as well as access related reasons. Reproductive health burden in sub-Saharan Africa2 Department of Economic and Social Affairs PDUN. Trends in contraceptive use worldwide 2015. Contraception. 2015: Darroch JE et al, Lancet 2013; Darroch JE et al, Responding to Women’s Needs. New York: Guttmacher Institute; 2011 26 July 2018
HIV infected women on ART Study design 2021 2020 2019 2018 2017 2016 2015 2020 2011 DEC 2016 SEP 2015 PROMISE RCT PEPFAR PROMOTE STUDY GAP JUN 2017 Socio-demographic data Clinical data (reproductive health) Lab data plus stored samples Baseline assessments Follow-up assessments Methods Standardized procedures across 8 sites in 4 countries (Malawi, Uganda, South Africa and Zimbabwe) Wilcoxon Rank-Sum tests (continuous variables) Chi-square test (categorical variables) Poisson regression (with robust variance) to estimate measures of association 3 26 July 2018
Variations by site (P <0.001) High reports of unintended pregnancy (at last conception)(n=271) (n=249)(N=1,985) 4 26 July 2018
Contraceptive use by country Variations by site (P <0.001) 5 26 July 2018
Use of Effective Family Planning (EFP) and Long Acting Reversible Contraceptive (LARC) methods EFP methods (injectable, oral, intra-uterine device (IUD), implant, or tubal-ligation). 1LARC methods (implants or IUD) are the most effective, and suitable for women who report infrequent sex, or hormonal side-effects.2 P =<0.001 P =<0.001 6 26 July 2018 Department of Economic and Social Affairs PDUN. Trends in contraceptive use worldwide 2015. Contraception. 2015: Darroch JE et al, Lancet 2013; Darroch JE et al, Responding to Women’s Needs. New York: Guttmacher Institute; 2011
Baseline characteristics(by reported EFP use at study entry) Characteristic Overall (N=1,295)EFP use (n=1,054) No EFP use (n=241)P valueMaternal-age (years), median [IQR]31 [28-35] 31 [28-35]30 [26-35]0.077Married/regular partner, n (%)1,140 (88.0%)930 (88.2%) 210 (87.1%) 0.936 Unintended pregnancy, n (%) 662 (51.2%) 560 (53.2%) 102 (42.5%) 0.01 Desire another children, n (%) 490 (37.9%) 369 (35.0%) 121 (50.4%) <0.001 No sex in the last 3 months, n (%) 126 (9.7%) 120 (11.4%) 6 (2.5%) <0.001 Clinic travel time ≥ 1 hour (yes), n (%) 365 (28.2%) 284 (26.9%) 81 (33.8%) 0.588 Education (completed primary), n(%) 1,007 (77.8%) 818 (77.6%) 189 (78.4%) 0.029 Unemployed/housewife, n (%) 588 (45.5%) 477 (45.3%) 111 (46.1%) 0.531 Electricity in household, n(%)894 (69.0%)723 (68.6%)171 (71.0%) 0.173Currently on ART, n (%) 1,265 (97.7%)1,030 (97.7%)235 (97.5%) 0.844 Viral load (>1,000 copies/ml), n (%) 112 (8.9%)99 (9.6%)13 (5.7%) 0.029 Demographic and socioeconomic factors 726 July 2018 Baseline characteristics were homogeneous across LARC groups except: Unemployed women were less likely to report LARC use (p = 0.008) ART users less likely to report LARC use (p=0.001) Viral load (>1000 copies/ml) were less like to report LARC use (p=0.003)
Correlates of EFP and LARC use at PROMOTE study baseline EFP use LARC useAdjusted RR (95% CI)P value Adjusted RR (95% CI)P value Unintended pregnancy1.05 (0.99-1.11) 0.0861.18 (0.93-1.49)0.174Desire another child 0.92 (0.87-0.99)0.017 1.05 (0.81-1.37) 0.703 No sex in last 3 months 0.81 (0.76-0.87) <0.001 0.90 (0.61-1.32) 0.582 Married 1.10 (0.99-1.20) 0.064 0.86 (0.61-1.20) 0.365 Not completed primary school 0.92 (0.85-0.99) 0.03 0.83 (0.61-1.11) 0.202 Housewife/ no formal income 0.94 (0.88-1.00) 0.066 0.66 (0.48-0.91) 0.011 Electricity in household, yes 0.97 (0.91-1.04)0.419 1.33 (1.01-1.76)0.04 Clinic travel time ≥ 1 hour0.97 (0.91-1.04)0.401 0.90 (0.68-1.20)0.486 Viral load, ≤1000 copies/ml 1.10 (1.02-1.19) 0.013 1.64 (1.20-2.23) 0.0028 26 July 2018 Modified Poisson regression (robust variance estimator); adjusted for age and country
Conclusion In this large multinational cohort of HIV infected African women on life-long ART we observed the following at baseline: High prevalence of reported unintended pregnancy (at last conception) About 20% women reported use of non-EFP methods, and only about 20% reported use of LARC methods. There were site variations, with a trend towards one predominant method at site level. Unintended pregnancy at last conception was NOT associated with use of EFP or LARC methods. 9 26 July 2018 Future plans/ policy implications Planned PROMOTE cohort analyses Incidence and correlates of unintended pregnancy through 18 months follow-up Interactions between ART (efavirenz) and hormonal contraceptives and risk of unintended pregnancy (quantitative measures of ART and exogenous hormonal levels on stored samples) Policy considerations for HIV infected women on ART Risk of neural tube defects with dolutegravir Tsepamo study, May 2018, and WHO rapid memo
Acknowledgements Sponsors: US PEPFAR (Nareen Abboud) Protocol Chairs : Taha Taha, MG FowlerStatistical and Data Management Center: N, Yende, P Radebe, S Brummel, A Jeewa, N Hua Site PROMOTE Investigators: Blantyre, Malawi B Makanani Lilongwe, Malawi L Chinula Kampala, Uganda M OworHarare, Zimbabwe T Chipato Soweto, South Africa ME Nyati Durban, South Africa S Hanley The PROMOTE protocol team gratefully acknowledges the dedication and commitment of the more than 1,900 STUDY mothers
Baseline characteristics(ART regimens used at study entry) 11 26 July 2018 No reported use of dolutegravir
Correlates of EFP and LARC use at PROMOTE study baseline EFP use LARC useAdjusted RR (95% CI)P value Adjusted RR (95% CI)P valueUnintended pregnancy 1.05 (0.99-1.11) 0.0861.18 (0.93-1.49)0.174Desire another child 0.92 (0.87-0.99)0.017 1.05 (0.81-1.37) 0.703 No sex in last 3 months 0.81 (0.76-0.87) <0.001 0.90 (0.61-1.32) 0.582 Married 1.10 (0.99-1.20) 0.064 0.86 (0.61-1.20) 0.365 Not completed primary school 0.92 (0.85-0.99) 0.03 0.83 (0.61-1.11) 0.202 Housewife/ no formal income 0.94 (0.88-1.00) 0.066 0.66 (0.48-0.91) 0.011 Electricity in household, yes 0.97 (0.91-1.04)0.419 1.33 (1.01-1.76)0.04Clinic travel time ≥ 1 hour 0.97 (0.91-1.04)0.401 0.90 (0.68-1.20)0.486Viral load, ≤1000 copies/ml 1.10 (1.02-1.19) 0.013 1.64 (1.20-2.23)0.002 12 26 July 2018 Modified Poisson regression (robust variance estimator); adjusted for age and country