Summary Background Observational and laboratory studies suggest that some hormonal contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM), might increase women's susceptibility to HIV acquisition. We aimed to compare DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant among African women seeking effective contraception and living in areas of high HIV incidence. Methods We did a randomised, multicentre, open-label trial across 12 research sites in eSwatini, Kenya, South Africa, and Zambia. We included HIV-seronegative women aged 16–35 years who were seeking effective contraception, had no medical contraindications to the trial contraceptive methods, agreed to use the assigned method for 18 months, and reported not using injectable, intrauterine, or implantable contraception for the previous 6 months. Participants were randomly assigned (1:1:1) to receive an injection of 150 mg/mL DMPA-IM every 3 months, a copper IUD, or a LNG implant with random block sizes between 15 and 30, stratified by site. Participants were assigned using an online randomisation system, which was accessed for each randomisation by study staff at each site. The primary endpoint was incident HIV infection in the modified intention-to-treat population, including all randomised participants who were HIV negative at enrolment and who contributed at least one HIV test. The primary safety endpoint was any serious adverse event or any adverse event resulting in method discontinuation, until the trial exit visit at 18 months and was assessed in all enrolled and randomly assigned women. This study is registered with ClinicalTrials.gov , number NCT02550067 . Findings Between Dec 14, 2015, and Sept 12, 2017, 7830 women were enrolled and 7829 were randomly assigned to the DMPA-IM group (n=2609), the copper IUD group (n=2607), or the LNG implant group (n=2613). 7715 (99%) participants were included in the modified intention-to-treat population (2556 in the DMPA-IM group, 2571 in the copper IUD group, and 2588 in the LNG implant group), and women used their assigned method for 9567 (92%) of 10 409 woman-years of follow-up time. 397 HIV infections occurred (incidence 3·81 per 100 woman-years [95% CI 3·45–4·21]): 143 (36%; 4·19 per 100 woman-years [3·54–4·94]) in the DMPA-IM group, 138 (35%: 3·94 per 100 woman-years [3·31–4·66]) in the copper IUD group, and 116 (29%; 3·31 per 100 woman-years [2·74–3·98]) in the LNG implant group. In the modified intention-to-treat analysis, the hazard ratios for HIV acquisition were 1·04 (96% CI 0·82–1·33, p=0·72) for DMPA-IM compared with copper IUD, 1·23 (0·95–1·59, p=0·097) for DMPA-IM compared with LNG implant, and 1·18 (0·91–1·53, p=0·19) for copper IUD compared with LNG implant. 12 women died during the study: six in the DMPA-IM group, five in the copper IUD group, and one in the LNG implant group. Serious adverse...
Background. Implanon NXT, a long-acting reversible contraceptive, was introduced in South Africa (SA) in early 2014, aiming to expand the method mix and increase its effectiveness. Initial uptake was high, but has since declined considerably. In these early years after the implant's introduction, it is important to identify reasons for the decline, and remedy gaps in services. Objectives. To determine periods of use, reasons for the use and early removal of the implant Implanon NXT. Methods. In 2016, we recruited 152 women from six clinics in the City of Johannesburg, and six in North West Province, SA. A semistructured interview was administered to 91 women currently using the implant and 61 previous users. We examined user perspectives, factors influencing women's experiences with the implant and reasons for discontinuation. Results. The participants' mean age was 30 years, with only 15% aged <25. Implant uptake was motivated by convenience (less frequent visits required than for short-acting methods) and by favourable views of the method among friends, family and healthcare providers. Only about a quarter of women recalled being counselled pre-insertion about implant effectiveness, and half about side-effects pre-insertion. Among discontinuers, the median time to device removal was 8 months (interquartile range 6 -12), and this was primarily as a result of sideeffects (90%), especially bleeding-pattern changes and headaches. Removals were most common among married and cohabiting women, often ascribed to the effects of bleeding on their sexual relationships. Rumours and misinformation contributed to some removals. Overall, women's experiences with the implant were rated 'good' or 'very good' by 74% of those continuing use, many of whom reported not having experienced any side-effects or that these had diminished over time. Conclusion. Levels of acceptability among continuing users were high, mainly linked to the method's convenience. While early favourable views drove uptake, negative perceptions, if unaddressed, may now undermine services. Deficiencies in counselling around effectiveness and side-effects may extend to contraceptive services more generally. Women require more intensive support when experiencing sideeffects, including effective systematic approaches to ameliorating bleeding and headaches. Implant services could specifically target young women and first-time contraceptive users. These actions together could reverse the persistent decline in implant use in SA.
Background. The South African (SA) government introduced Implanon NXT, a long-acting subdermal contraceptive implant, in 2014 to expand contraceptive choice. Following an initial high uptake, its use declined considerably amid reports of early removals and frequent side-effects. We examine providers' perceptions of training and attitudes towards Implanon NXT, as well as their views on the causes of early removals and the impact on the implant service. Objective. To assess healthcare providers' perceptions and attitudes towards implant services in SA. Methods. In-depth interviews were conducted with eight nurses providing implant services in public facilities in Gauteng and North West Province. Emerging themes were identified, manually coded and thematically analysed following an interpretivism approach. Results. Nurses lacked confidence in providing implant services effectively, particularly removals, which they ascribed to the brief, cascade-type training received. Nurses generally held negative views towards the method. They also reported that side-effects are the most common reason for early removals -particularly irregular bleeding -and that men often do not support their partners who use the method. Lastly, it was found that providers require guidance on counselling regarding the method and standardised guidelines on the management of side-effects. Conclusion. Retraining and support of providers are needed to address competency gaps and negative attitudes towards the method. Assessment of providers' readiness to perform removal procedures is also important. Finally, effective plans are necessary to improve implant continuation rates, especially among women whose partners are unsupportive.
In 2014, South Africa (SA) introduced the subdermal contraceptive implant with the aim of expanding the contraceptive method mix and availability of long-acting reversible methods in the public sector. Three years on, concerns have been raised about the decline in uptake, early implant removals and challenges in service delivery. This article explores the lessons learnt from the introduction of contraceptive technologies elsewhere and applies these to the SA context. Drawing on the World Health Organization’s conceptual framework for the introduction of new contraceptive methods, and subsequent literature on the topic, lessons are classified into six cross-cutting themes. Recommendations highlight the need for SA to review and explore strategies to strengthen current implant services, including the provision of improved provider training aimed at sensitive, client-centred approaches; increased community engagement; and improved systems for programmatic monitoring and evaluation. With implementation of these recommendations, worrying trends in the provision of implants could be reversed.
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