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Contraceptive implant failures among women using antiretroviral therapy in western Kenya: a retrospective cohort study.

ABSTRACT: Background: Women living with HIV have the right to choose whether, when and how many children to have. Access to antiretroviral therapy (ART) and contraceptives, including implants, continues to increase due to a multitude of efforts. In Kenya, 4.8% of adults are living with HIV, and in 2017, 54% were receiving an efavirenz-based ART regimen. Meanwhile, 16.1% of all Kenyan married (and 10.4% of unmarried) women used implants. Studies have reported drug interactions leading to contraceptive failures among implant users on ART. This retrospective record review aimed to determine unintentional pregnancy rates among women 15-49 years of age, living with HIV and concurrently using implants and ART in western Kenya between 2011 and 2015. Methods: We reviewed charts of women with more than three months of concurrent implant and ART use. Implant failure was defined as implant removal due to pregnancy or birth after implant placement, but prior to scheduled removal date. The incidence of unintended pregnancy was calculated by woman-years at risk, assuming a constant rate. Results: Data from 1,152 charts were abstracted, resulting in 1,190 implant and ART combinations. We identified 115 pregnancies, yielding a pregnancy incidence rate of 6.32 (5.27-7.59), with 9.26 among ETG and 4.74 among LNG implant users, respectively. No pregnancies were recorded among women on non-NNRTI-based regimens, whereas pregnancy rates for efavirenz and nevirapine-containing regimens were similar, at 6.41 (4.70-8.73) and 6.44 (5.13-8.07), respectively. Conclusions: Our findings highlight the implications of drug interaction on women's choices for contraception.

SUBMITTER: Pfitzer A

PROVIDER: S-EPMC6996231 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Contraceptive implant failures among women using antiretroviral therapy in western Kenya: a retrospective cohort study.

Pfitzer Anne A Wille Jacqueline J Wambua Jonesmus J Stender Stacie C SC Strachan Molly M Ayuyo Christine Maricha CM Muhavi Timothy F Kibidi TFK Wabwile Valentino V Mehta Supriya D SD Sasser Elizabeth E

Gates open research 20190604

<b>Background</b>: Women living with HIV have the right to choose whether, when and how many children to have. Access to antiretroviral therapy (ART) and contraceptives, including implants, continues to increase due to a multitude of efforts. In Kenya, 4.8% of adults are living with HIV, and in 2017, 54% were receiving an efavirenz-based ART regimen. Meanwhile, 16.1% of all Kenyan married (and 10.4% of unmarried) women used implants. Studies have reported drug interactions leading to contracepti ...[more]

PMID: 32051928

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Project description:IntroductionThe rollout of dolutegravir (DTG) in low- and middle-income countries was disrupted by a potential association reported with periconceptional DTG exposure among women living with HIV (WLHIV) and infant neural tube defects. This prompted countries to issue interim guidance limiting DTG use among women of reproductive potential to those on effective contraception. Data to understand the potential impact of such guidance on WLHIV are limited.MethodsWe conducted a retrospective cohort analysis of WLHIV 15-49 years initiating DTG-containing antiretroviral treatment (ART) in Kenya from 2017 to 2020. We determined baseline effective (oral, injectable or lactational amenorrhea) and very effective (implant, intrauterine device or female sterilization) contraception use among women who initiated DTG before (Group 1) or during (Group 2) the interim guideline period. We defined incident contraception use in each group as the number of contraceptive methods initiated ≤180 days post-guideline (Group 1) or post-DTG initiation (Group 2). We determined the proportions of all women who switched from DTG- to non-nucleoside reverse transcriptase inhibitor (NNRTI)- (efavirenz or nevirapine) containing ART ≤12 months post-DTG initiation, compared their viral suppression (<1000 copies/ml) and conducted multivariable logistic regression to determine factors associated with switching from DTG to NNRTI-containing ART.ResultsAmong 5155 WLHIV in the analysis (median age 43 years), 89% initiated DTG after transitioning from an NNRTI. Baseline effective and very effective contraception use, respectively, by the group were: Group 1 (12% and 13%) and Group 2 (41% and 35%). Incident contraception use in each group was <5%. Overall, 498 (10%) women switched from DTG to an NNRTI. Viral suppression among those remaining on DTG versus switched to NNRTI was 95% and 96%, respectively (p = 0.63). In multivariable analysis, incident effective and very effective contraception use was not associated with switching.ConclusionsBaseline, but not incident, effective contraception use was higher during the interim guideline period compared to before it, suggesting women already using effective contraception were preferentially selected to initiate DTG after the guideline was released. These findings reveal challenges in the implementation of policy which ties antiretroviral access to contraceptive use. Future guidance should capture nuances of contraception decision-making and support women's agency to make informed decisions.

Project description:Concerns have been raised about efavirenz reducing the effectiveness of contraceptive implants. We aimed to establish whether pregnancy rates differ between HIV-positive women who use various contraceptive methods and either efavirenz-based or nevirapine-based antiretroviral therapy (ART) regimens.We did this retrospective cohort study of HIV-positive women aged 15-45 years enrolled in 19 HIV care facilities supported by Family AIDS Care and Education Services in western Kenya between Jan 1, 2011, and Dec 31, 2013. Our primary outcome was incident pregnancy diagnosed clinically. The primary exposure was a combination of contraceptive method and efavirenz-based or nevirapine-based ART regimen. We used Poisson models, adjusting for repeated measures, and demographic, behavioural, and clinical factors, to compare pregnancy rates among women receiving different contraceptive and ART combinations.24,560 women contributed 37,635 years of follow-up with 3337 incident pregnancies. In women using implants, adjusted pregnancy incidence was 1.1 per 100 person-years (95% CI 0.72-1.5) for nevirapine-based ART users and 3.3 per 100 person-years (1.8-4.8) for efavirenz-based ART users (adjusted incidence rate ratio [IRR] 3.0, 95% CI 1.3-4.6). In women using depot medroxyprogesterone acetate, adjusted pregnancy incidence was 4.5 per 100 person-years (95% CI 3.7-5.2) for nevirapine-based ART users and 5.4 per 100 person-years (4.0-6.8) for efavirenz-based ART users (adjusted IRR 1.2, 95% CI 0.91-1.5). Women using other contraceptive methods, except for intrauterine devices and permanent methods, had 3.1-4.1 higher rates of pregnancy than did those using implants, with 1.6-2.8 higher rates in women using efavirenz-based ART.Although HIV-positive women using implants and efavirenz-based ART had a three-times higher risk of contraceptive failure than did those using nevirapine-based ART, these women still had lower contraceptive failure rates than did those receiving all other contraceptive methods except for intrauterine devices and permanent methods. Guidelines for contraceptive and ART combinations should balance the failure rates for each contraceptive method and ART regimen combination against the high effectiveness of implants.None.

Project description:IntroductionHigh levels of adherence to antiretroviral therapy (ART) are central to HIV management. The objective of this study was to compare multiple measures of adherence and investigate factors associated with adherence among HIV-infected children in western Kenya.MethodsWe evaluated ART adherence prospectively for six months among HIV-infected children aged ≤14 years attending a large outpatient HIV clinic in Kenya. Adherence was reported using caregiver report, plasma drug concentrations and Medication Event Monitoring Systems (MEMS®). Kappa statistics were used to compare adherence estimates with MEMS®. Logistic regression analyses were performed to assess the association between child, caregiver and household characteristics with dichotomized adherence (MEMS® adherence ≥90% vs. <90%) and MEMS® treatment interruptions of ≥48 hours. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were calculated.ResultsAmong 191 children, mean age at baseline was 8.2 years and 55% were female. Median adherence by MEMS® was 96.3% and improved over the course of follow-up (p<0.01), although 49.5% of children had at least one MEMS® treatment interruption of ≥48 hours. Adherence estimates were highest by caregiver report, and there was poor agreement between MEMS® and other adherence measures (Kappa statistics 0.04-0.37). In multivariable logistic regression, only caregiver-reported missed doses in the past 30 days (OR 1.25, 95% CI 1.14-1.39), late doses in the past seven days (OR 1.14, 95% CI 1.05-1.22) and caregiver-reported problems with getting the child to take ART (OR 1.10, 95% CI 1.01-1.20) were significantly associated with dichotomized MEMS® adherence. The caregivers reporting that ART made the child sick (OR 1.12, 95% CI 1.01-1.25) and reporting difficulties in the community that made giving ART more difficult (e.g. stigma) (OR 1.14, 95% CI 1.02-1.27) were significantly associated with MEMS® treatment interruptions in multivariable logistic regression.ConclusionsNon-adherence in the form of missed and late doses, treatment interruptions of more than 48 hours and sub-therapeutic drug levels were common in this cohort. Adherence varied significantly by adherence measure, suggesting that additional validation of adherence measures is needed. Few factors were consistently associated with non-adherence or treatment interruptions.

Project description:The contraceptive needs of illicit opioid users differ from non-drug users but are poorly understood. The aim of this study was to describe contraceptive use and pregnancy outcomes in opioid-using women, and to examine their association with a range of risk factors.This retrospective cohort study used UK general practice records, Treatment Outcomes Profile and National Drug Treatment Monitoring System data, and a nested data validation exercise. A cohort of 376 women aged 20-61 years were in active treatment for opioid addiction in October 2010 at two specialised primary care practices in North-East England. Outcomes were age-adjusted prevalence estimates for contraceptive use and pregnancy outcomes in users of illicit opioids. The association between lifestyle-related risk factors and contraception was explored.Drug-using women made lower use of planned (non-condom) contraception (24% vs 50%, p<0.001), had more frequent pregnancy terminations (0.46 vs. 0.025, p = 0.004) and higher annual incidence of chlamydia (1.1% vs. 0.33%, p<0.001), when compared with age-matched population data. Specifically, there was low use of oral contraceptives (4% vs. 25%, p<0.001), IUCD (1% vs. 6%, p<0.001), and sterilisation (7% vs. 6%, p = 0.053), but higher rates of injectable contraceptives (6% vs. 3%, p = 0.003). A total of 64% of children aged <16 years born to this group did not live with their mother. No individual risk factor (such as sex-working) significantly explained the lower use or type of non-condom contraception.This is the first study to describe planned contraceptive use among drug-users, as well as the association with a range of risk factors and pregnancy outcomes. The low uptake of planned contraception, set against high rates of terminations and sexually transmitted disease demonstrates the urgent clinical need to improve contraceptive services, informed by qualitative work to explore the values and beliefs influencing low contraceptive uptake.

Project description:BackgroundDolutegravir has been widely available in Brazil since 2017. Following the signal that infants born to women with dolutegravir exposure at conception in Botswana had a higher risk of neural tube defects (NTDs), public health leaders initiated a national investigation to evaluate periconception dolutegravir exposure among all pregnant Brazilian women with HIV and its potential association with risk of NTDs, stillbirth, or miscarriage before 22 weeks (also called spontaneous abortion).MethodsIn this retrospective, observational, national, cohort study, we identified all women with pregnancies and possible dolutegravir exposure within 8 weeks of estimated date of conception between Jan 1, 2017, and May 31, 2018, and approximately 3:1 matched pregnant women exposed to efavirenz between Jan 1, 2015, and May 31, 2018, using the Brazilian antiretroviral therapy database. We did detailed chart reviews for identified women. The primary outcomes were NTD and a composite measure of NTD, stillbirth, or miscarriage. NTD incidences were calculated with 95% CI. The composite outcome was examined with logistic regression using propensity score matching weights to balance confounders.FindingsOf 1427 included women, 382 were exposed to dolutegravir within 8 weeks of estimated date of conception. During pregnancy, 183 (48%) of 382 dolutegravir-exposed and 465 (44%) of 1045 efavirenz-exposed women received folic acid supplementation. There were 1452 birth outcomes. There were no NTDs in either dolutegravir-exposed (0, 95% CI 0-0·0010) or efavirenz-exposed groups (0, 95% CI 0-0·0036). There were 23 (6%) stillbirths or miscarriages in 384 dolutegravir-exposed fetuses and 28 (3%) in the 1068 efavirenz-exposed fetuses (p=0·0037). Logistic regression models did not consistently indicate an association between dolutegravir exposure and risk of stillbirths or miscarriages. After study closure, two confirmed NTD outcomes in fetuses with periconception dolutegravir exposure were reported to public health officials. An updated estimate of NTD incidence incorporating these cases and the estimated number of additional dolutegravir-exposed pregnancies between Jan 1, 2015 and Feb 28, 2019, is 0·0018 (95% CI 0·0005-0·0067).InterpretationNeither dolutegravir nor efavirenz exposure was associated with NTDs in our national cohort; incidence of NTDs is probably well under 1% in dolutegravir-exposed HIV-positive women but still slightly above HIV-uninfected women (0·06%) in Brazil.FundingThe Brazilian Ministry of Health and the United States' National Institutes of Health.

Dataset Information

Contraceptive implant failures among women using antiretroviral therapy in western Kenya: a retrospective cohort study.

Publications

Contraceptive implant failures among women using antiretroviral therapy in western Kenya: a retrospective cohort study.

Similar Datasets

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