Dataset Information

Expanding long-acting contraceptive options: a prospective cohort study of the hormonal intrauterine device, copper intrauterine device, and implants in Nigeria and Zambia.

ABSTRACT:

Background

30 years after the introduction of the levonorgestrel-releasing intrauterine device in Europe, several sub-Saharan African countries are seeking to broaden access to this contraceptive method. In this study, we aimed to assess 12-month continuation of the hormonal intrauterine device, copper intrauterine device, and implants, as well as to assess women's experiences and satisfaction using these methods in the private sector in Nigeria and the public sector in Zambia.

Methods

We did a prospective cohort study of long-acting reversible contraceptive users across 40 private sector clinics in Nigeria and 21 public sector clinics in Zambia. Eligible women were aged 18-49 years in Nigeria and 16-49 years in Zambia, had chosen to receive the hormonal intrauterine device, copper intrauterine device, or implant (either a 5-year levonorgestrel-releasing subdermal implant or a 3-year etonogestrel-releasing subdermal implant), and, in Nigeria only, had access to a telephone. Women were interviewed within 100 days of receiving their contraceptive method either via telephone in Nigeria or in person in Zambia, with follow-up surveys at 6 months and 12 months. The primary outcomes were method-specific, 12-month continuation rates-ie, continuation rates of the hormonal intrauterine device, copper intrauterine device, and implant across Nigeria and Zambia. We used Kaplan-Meier methods to estimate the cumulative probabilities of method-specific continuation and a log-rank test to compare contraceptive methods. We analysed self-reported satisfaction and experiences as a secondary outcome.

Findings

Between June 25 and Nov 22, 2018, we enrolled a total of 1542 women (n=860 in Nigeria and n=682 in Zambia) receiving a long-acting reversible contraceptive. In total, 835 women (266 [32%] hormonal intrauterine device users, 274 [33%] copper intrauterine device users, and 295 [35%] implant users) in Nigeria and 367 (140 [38%] hormonal intrauterine device users, 149 [40%] copper intrauterine device users, and 78 [21%] implant users) in Zambia were included in the study analysis. The 12-month cumulative continuation rates were 86·8% (95% CI 82·1-90·4) for the hormonal intrauterine device, 86·9% (82·1-90·4) for the copper intrauterine device, and 85·0% (80·2-88·7) for implants in Nigeria. In Zambia, the 12-month cumulative continuation rates were 94·7% (89·2-97·4) for the hormonal intrauterine device, 89·1% (82·3-93·4) for the copper intrauterine device, and 83·1% (72·2-90·1) for implants. At least 71% of respondents across the timepoints were very satisfied with their method, and at least 55 (79%) of 70 reported having recommended their contraceptive method to someone else. Across the methods, the most commonly self-reported positive aspect of long-acting reversible contraceptive use at 12 months was effectiveness in Nigeria (range 93-94%) and long-lasting duration in Zambia (48-60%). Between 124 (50%) of 248 and 136 (59%) of 230 Nigerian participants and 26 (42%) of 62 and 66 (57%) of 117 Zambian participants reported nothing negative about their contraceptive method.

Interpretation

Our study showed high continuation rates and satisfaction across long-acting reversible contraceptives, including the hormonal intrauterine device, a method that has been largely underused in sub-Saharan Africa. This finding supports the inclusion of the hormonal intrauterine device as a valuable addition to the mix of contraceptive methods in Nigeria and Zambia.

Funding

Bill & Melinda Gates Foundation.

SUBMITTER: Brunie A

PROVIDER: S-EPMC8440225 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. OBJECTIVE:We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. STUDY DESIGN:We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. RESULTS:Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60%) (adjusted odds ratio, 1.89; 95% confidence interval, 1.04-3.44), and for the implant increased more in intervention (41-62%) compared to control sites (48-50%) (adjusted odds ratio, 2.30; 95% confidence interval, 1.28-4.12). Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113). Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions increased 15% more in intervention (0.65-0.79) compared to control sites (0.67-0.66) (adjusted coefficient, 0.15; 95% confidence interval, 0.09-0.21). Routine discussion of intrauterine devices and implants by providers in intervention sites increased significantly, 71-87%, compared to in control sites, 76-82% (adjusted odds ratio, 1.97; 95% confidence interval, 1.02-3.80). CONCLUSION:Professional guidelines encourage intrauterine device and implant competency for all contraceptive care providers. Integrating these methods into routine care is important for access. This replicable training intervention translating evidence into care had a sustained impact on provider attitudes, knowledge, and counseling practices, demonstrating significant changes in clinical care a full year after the training intervention.

Project description:The contraceptive effectiveness of intrauterine devices has been attributed in part to effects of a foreign body reaction on the endometrium. We performed this study to identify compare the effects on the endometrial transcriptome of intrauterine devices and combined oral contraceptives, to better understand their mechanisms of action. We collected endometrial and cervical biopsies from women using the levonorgestrel-intrauterine device, copper intrauterine device or levonorgestrel-containing combined oral contraceptives, and from women not using contraceptives (control group). Transcriptional profiling was performed with Affymetrix arrays, Principal Component Analysis and the bioconductor package limma. Pathway analysis was performed using EnrichR and Reactome 2016. In endometrial samples from copper intrauterine device users (n=13), there were no genes with statistically significant differential expression compared to controls (n=11), whereas in levonorgestrel-intrauterine device users (n=11), 2509 genes were significantly dysregulated and mapped onto several immune and inflammatory pathways. In combined oral contraceptive users (n=12), 133 genes were significantly dysregulated and mapped predominantly onto pathways involving regulation of metal ions. Both levonorgestrel-intrauterine device and combined oral contraceptive use were associated with significant downregulation of members of the metallothionein gene family. In cervical samples, none of the groups showed statistically significant differential gene expression compared to controls. In conclusion, hormonal and copper intrauterine devices differ significantly in their effects on the endometrial transcriptome, with endometrium from copper intrauterine device users being indistinguishable from luteal phase endometrium. These results suggest that the contraceptive mechanisms of intrauterine devices are unlikely to rely on a common pathway involving a foreign body reaction in the endometrium.

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