Effects of Depot Medroxyprogesterone Acetate, Copper Intrauterine Devices, and Levonorgestrel Implants on Early HIV Disease Progression.

Limited data exist on the effects of contraceptives on HIV disease progression. We studied the association between intramuscular injectable depot medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (IUD), and the levonorgestrel (LNG) implant on markers of HIV disease progression at the time of HIV detection and 3 months postdetection and time from detection to CD4 count <350 cells/mm3. Among women initiating antiretroviral therapy (ART), we studied the effect of contraceptive group on time from ART initiation to viral load (VL) <40 copies/mL. We included women 16-35 years randomized to DMPA-IM, copper IUD, or LNG implant with incident HIV infection during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial (n = 382). We analyzed HIV VL and CD4 cell count according to participants' randomized method and also conducted a "continuous use" analysis that excluded follow-up time after method discontinuation. We used adjusted linear models to compare mean VL and CD4 cell levels by contraceptive group up to the time of ART initiation. We compared time from HIV detection to CD4 count <350 cells/mm3 and, following ART initiation, time to viral suppression (VL <40 copies/mL) using Cox proportional hazards models. At HIV detection, women allocated to DMPA-IM had lower VL relative to copper IUD (-0.28 log10 copies/mL; 95% confidence interval [CI]: -0.55 to -0.01) and LNG implant (-0.27, CI: -0.55 to 0.02) and higher mean CD4 than copper IUD users by 66 cells/mm3 (CI: 11-121). In continuous use analyses women allocated to DMPA-IM progressed to CD4 < 350 cells/mm3 slower than copper IUD users (hazard ratio [HR] = 0.6, CI: 0.3-1.1), whereas copper IUD users progressed faster than LNG implant users (HR = 1.8, CI: 1.0-3.3). Time to viral suppression was faster for DMPA-IM than copper IUD (HR = 1.5, CI: 1.0-2.3) and LNG implant 1.4 (CI: 0.9-2.2) users. We found no evidence of more rapid early HIV disease progression among women using DMPA-IM than among women using copper IUD or LNG implant. Our finding of more rapid progression among copper IUD compared with DMPA-IM users should be interpreted cautiously.

Feasibility and Safety of IUD Insertion by Mid-Level Providers in Sub-Saharan Africa.

CONTEXT: The copper IUD is safe and effective, but underutilized in Sub-Saharan Africa, in part because of a lack of trained providers. The World Health Organization recommends training mid-level providers-including nurses and midwives-to insert IUDs; however, the safety of such task shifting has not been evaluated in Sub-Saharan Africa. METHODS: Data were drawn from baseline surveys and study charts of 535 sexually active women aged 18-45 who used a copper IUD while participating in an HIV-prevention clinical trial conducted from August 2012 through June 2015 in Malawi, South Africa, Uganda and Zimbabwe. IUDs were inserted by study physicians, nurses and midwives trained as part of the trial, and by local nonstudy providers. Chi-square and Fisher's exact tests were used to compare women's experiences of adverse events-such as irregular bleeding, pelvic pain or device expulsion-by provider type. RESULTS: Half (54%) of women reported experiencing an adverse event; the most common were irregular bleeding and pelvic pain (45% and 25%, respectively). Compared with women who had received an IUD from a study physician or study nurse, greater proportions of women who had received one from a nonstudy provider reported any adverse event (76% vs. 49% and 51%, respectively), irregular bleeding (57% vs. 41% and 45%) and pelvic pain (35% vs. 15% and 32%); the difference between study physicians and nurses was significant only for pelvic pain. Expulsion rates were comparable for study nurses and nonstudy providers (12.3 and 11.9 per 100 woman-years, respectively), but lower for study physicians (7.3 per 100 woman-years). CONCLUSIONS: The findings support task shifting of IUD insertion to mid-level providers to improve IUD access in Sub-Saharan Africa.

RESUMEN Contexto: Aunque el DIU de cobre es seguro y efectivo, está subutilizado en África subsahariana, en parte debido a la falta de proveedores de servicios de salud capacitados. La Organización Mundial de la Salud recomienda capacitar a los proveedores de nivel medio ­incluidas las enfermeras y parteras­ para insertar los DIU; sin embargo, la seguridad de tal cambio de tareas ha sido evaluada en África subsahariana. Métodos: Se obtuvieron datos de encuestas de línea de base y cuadros de un estudio de 535 mujeres sexualmente activas, de 18 a 45 años, que usaron un DIU de cobre en un ensayo clínico de prevención del VIH realizado entre agosto de 2012 y junio de 2015 en Malaui, Sudáfrica, Uganda y Zimbabue. Los DIU fueron insertados por médicos participantes en el estudio, enfermeras y parteras capacitadas como parte del ensayo, así como por proveedores de servicios de salud locales no relacionados con el estudio. Las pruebas exactas de Chi-cuadrado y Fisher se usaron para comparar las experiencias de las mujeres con eventos adversos ­como sangrado irregular, dolor pélvico o expulsión del dispositivo­ por tipo de proveedor. Resultados: La mitad (54%) de las mujeres reportaron haber experimentado algún evento adverso; los eventos más comunes fueron sangrado irregular y dolor pélvico (45% y 25%, respectivamente). En comparación con las mujeres que habían recibido un DIU de un médico o de una enfermera del estudio, una gran parte de las mujeres que lo habían recibido de un proveedor no relacionado con el estudio reportaron algún tipo de evento adverso (76% vs. 49% y 51%, respectivamente), sangrado irregular (57 % vs. 41% y 45%) y dolor pélvico (35% vs. 15% y 32%); La diferencia entre los médicos y las enfermeras del estudio fue significativa solo para el dolor pélvico. Las tasas de expulsión fueron comparables para las enfermeras del estudio y los proveedores no relacionados con el estudio (12.3 y 11.9 por 100 años-mujer, respectivamente), pero más bajas para los médicos del estudio (7.3 por 100 años-mujer). Conclusiones: Los hallazgos respaldan el cambio de tareas de inserción del DIU a proveedores de nivel medio para mejorar el acceso al DIU en África Subsahariana.

RÉSUMÉ Contexte: Bien qu'il soit sûr et efficace, le DIU au cuivre est sous-utilisé en Afrique subsaharienne, faute, en partie, de prestataires formés. L'Organisation mondiale de la Santé recommande la formation de prestataires de niveau intermédiaire ­ personnel infirmier et sages-femmes ­ pour la pose du DIU. La sécurité de cette délégation de tâches n'a cependant pas été évaluée en Afrique subsaharienne. Méthodes: Les données proviennent d'enquêtes de base et de graphiques d'étude concernant 535 femmes sexuellement actives âgées de 18 à 45 ans qui utilisaient un DIU au cuivre dans le cadre d'un essai clinique de prévention du VIH réalisé d'août 2012 à juin 2015 en Afrique du Sud, au Malawi, en Ouganda et au Zimbabwe. Les DIU avaient été posés par les médecins, infirmières et sages-femmes de l'étude, formés dans le cadre de l'essai, ainsi que par des prestataires locaux extérieurs à l'étude. Le test chi carré et la méthode exacte de Fisher ont servi à comparer l'expérience d'effets indésirables ­ tels que saignements irréguliers, douleurs pelviennes ou expulsion du DIU ­ vécus par les femmes suivant le type de prestataire. Résultats: La moitié (54%) des femmes ont signalé un effet indésirable, les plus courants étant les saignements irréguliers et les douleurs pelviennes (45% et 25%, respectivement). Par rapport aux femmes dont le DIU avait été posé par un médecin ou une infirmière de l'étude, de plus grandes proportions de celles qui avaient obtenu leur dispositif d'un prestataire extérieur à l'étude ont signalé un effet indésirable quelconque (76% contre 49% et 51%, respectivement), des saignements irréguliers (57% contre 41% et 45%) et des douleurs pelviennes (35% contre 15% et 32%). La différence entre les médecins et le personnel infirmier de l'étude n'est significative que pour les douleurs pelviennes. Les taux d'expulsion sont comparables pour les infirmières de l'étude et les prestataires extérieurs (12,3 et 11,9 pour 100 femmes-années, respectivement), mais il est moindre pour les médecins de l'étude (7,3 pour 100 femmes-années). Conclusions: Les résultats sont favorables à la délégation de la pose du DIU aux prestataires de niveau intermédiaire pour améliorer l'accès au DIU en Afrique subsaharienne.

Community health worker promotions increase uptake of long-acting reversible contraception in Rwanda.

BACKGROUND: We coordinated community health worker (CHW) promotions with training and support of government clinic nurses to increase uptake of long-acting reversible contraception (LARC), specifically the copper intrauterine device (IUD) and the hormonal implant, in Kigali, Rwanda. METHODS: From August 2015 to September 2016, CHW provided fertility goal-based family planning counseling focused on LARC methods, engaged couples in family planning counseling, and provided written referrals to clients expressing interest in LARC methods. Simultaneously, we provided didactic and practical training to clinic nurses on LARC insertion and removal. We evaluated: 1) aggregate pre- versus post-implementation LARC uptake as a function of CHW promotions, and 2) demographic factors associated with LARC uptake among women responding to CHW referrals. RESULTS: 7712 referrals were delivered by 184 CHW affiliated with eight government clinics resulting in 6072 family planning clinic visits (79% referral uptake). 95% of clinic visits resulted in LARC uptake (16% copper IUD, 79% hormonal implant). The monthly average for IUD insertions doubled from 29 prior to service implementation to 61 after (p < 0.0001), and the monthly average for implant insertions increased from 109 to 309 (p < 0.0001). In adjusted analyses, LARC uptake was associated (p < 0.05) with the CHW referral being issued to the couple (versus the woman alone, adjusted odds ratio, aOR = 2.6), having more children (aOR = 1.3), desiring more children (aOR = 0.8), and having a religious affiliation (aOR = 2.9 Protestant, aOR = 3.1 Catholic, aOR = 2.5 Muslim each versus none/other). Implant versus non-LARC uptake was associated with having little or no education; meanwhile, having higher education was associated with IUD versus implant uptake. CONCLUSIONS: Fertility goal-based and couple-focused family planning counseling delivered by CHW, coupled with LARC training and support of nursing staff, substantially increased uptake of LARC methods.

Emergency contraception: Oral and intrauterine options.

BACKGROUND: Emergency contraception can be used to prevent pregnancy where contraception has not been used, or there has been contraceptive misuse or failure. Australian women have three options for emergency contraception: two types of oral pills (levonorgestrel [LNG]-containing pill and ulipristal acetate [UPA]) and the copper intrauterine device (IUD). Both pills are available from pharmacies without prescription, whereas the copper IUD requires insertion by a trained provider. OBJECTIVE: The objective of this article is to describe the indications, efficacy and contraindications for use of the three emergency contraceptive methods available in Australia. DISCUSSION: Emergency contraception can potentially reduce the risk of unplanned pregnancies. The oral methods have similar side effects, but UPA is more effective than LNG and can be used up to five days after intercourse. The copper IUD is the most effective method, and provides ongoing contraception for up to 10 years. Factors to consider when recommending one option over another include time since unprotected sex, body mass index and use of enzyme-inducing medicines.

What Nurses Need to Know About Immediate Postpartum Initiation of Long-Acting Reversible Contraception.

Initiation of long-acting reversible contraception (LARC) in the immediate postpartum period is becoming more common, resulting in increased requests for early removal, primarily because of unpredictable bleeding patterns. Competing interests of healthful spacing of pregnancies, impact on breastfeeding, risks associated with pregnancy versus contraceptive method, potential adverse effects of LARC, and timing of informed consent make immediate postpartum initiation of LARC an important issue. Nearly 40% of women do not attend a postpartum visit at all, resulting in decreased initiation of contraception and increased risk of unplanned pregnancy. Nurses caring for women during the peripartum period can help women make informed decisions and can provide anticipatory guidance regarding this method of contraception. Evidence-based postpartum education and support can result in women's increased continuation of and satisfaction with LARC.

The IUB, a newly invented IUD: a brief report.

OBJECTIVE: To evaluate the initial safety and effectiveness of the intrauterine ball (IUB), a copper intrauterine device that, upon insertion in the uterus, takes a three-dimensional spherical form. STUDY DESIGN: Fifteen women were followed for 1 year, with follow-up visits at 1, 3, 6, 9 and 12 months. RESULTS: The physician reported that all devices were very easy to insert. One subject discontinued before the 6-month visit (at 119 days after insertion) for a reason not related to the device. There were no perforations, expulsions, malpositions or complications, or pregnancies. CONCLUSION: No safety or efficacy concerns were raised. IMPLICATIONS: Due to its form and deployment process the IUB is expected to ease insertion and reduce perforation, malposition and expulsion rates and may also reduce dysmenorrhea and menorrhagia.

Biological evaluation of a novel copper-containing composite for contraception.

OBJECTIVE: To investigate the biocompatibility of a novel copper-containing composite to provide preclinical data for clinical application of intrauterine device (IUD) or intra-vas device (IVD). DESIGN: Prospective experimental study. SETTING: Good laboratory practices laboratories. ANIMALS: Twenty healthy adult mice (SPF grade Kunming white mice, animal code SCXK 2003-0005). INTERVENTION(S): Cytotoxicity tests in vitro were conducted to evaluate the influence of the materials on the morphology, growth, and proliferation of cultured L929 mouse fibroblasts. Acute systemic toxicity tests were conducted to investigate the acute systemic toxic reaction with mice, and then the materials were implanted into the spinal muscle of rabbits (n = 15). The rabbits were sacrificed for pathologic examination at 1, 4, and 12 weeks after surgery. MAIN OUTCOME MEASURE(S): Evaluation of cytotoxicity by MTT assay, cytotoxicity test by direct contact assay, acute systemic toxicity test, and material implantation test. RESULT(S): The cytotoxicity grade of the copper-containing composite was 0-1, suggesting that the material was free of cytotoxicity; no acute systemic toxicity was found in any mice; mild inflammatory reaction was observed in the surrounding tissues of the implanted material in the early implantation stage, which was similar to that of the sham-operated sides. Twelve weeks after implantation, the inflammatory reaction was completely disappeared in the implanted tissue, similarly to the sham-operated sides. The fibrosis membrane surrounding the material became stable gradually over time. CONCLUSION: The copper-containing composite has excellent biocompatibility, which is feasible and safe for the clinical application as a novel contraceptive material.

Will ethylene oxide sterilization influence the application of novel Cu/LDPE nanocomposite intrauterine devices?

BACKGROUND: Copper/low-density polyethylene (Cu/LDPE) nanocomposite intrauterine device (IUD) is an implanted medicinal device that must be sterilized before use. Sterilization processes act either chemically or physically, leading to a lethal change in the structure or function of organic macromolecules in microorganisms. Given the nature of their action, sterilization might also attack the macromolecules of polymers by the same mechanisms, resulting in changes in surface functional groups and in the internal structure of the polymer. If sterilization leads to changes in surface functional groups and in the internal structure of the LDPE matrix, which will influence the mechanical property and cupric ions release rate of novel Cu/LDPE nanocomposite IUDs, potential clinical application will be limited. Therefore, it is necessary to study the influence of ethylene oxide sterilization on the potential clinical application of novel Cu/LDPE nanocomposite IUDs. STUDY DESIGN: The influence of ethylene oxide sterilization on the internal structure, surface functional groups, mechanical property and cupric ions release rate of novel Cu/LDPE nanocomposite IUDs was studied using differential scanning calorimetry, attenuated total reflection Fourier transform infrared spectroscopy, tensile testing and absorbance measurement. RESULTS: Ethylene oxide sterilization did not have any influence on the internal structure, surface functional groups, mechanical property and cupric ions release rate of novel Cu/LDPE nanocomposite intrauterine devices. CONCLUSION: Ethylene oxide sterilization will not affect the potential application of novel Cu/LDPE nanocomposite IUDs.

The intrauterine device: rethinking old paradigms.

The United States continues to have one of the highest rates of unintended pregnancy and elective abortion in developed countries. Intrauterine devices (IUDs) available today offer women safe and highly effective contraception along with noncontraceptive benefits, yet IUDs remain underutilized in part because of outdated and biased information about the risks associated with this method of fertility control. New research demonstrates that IUD use does not increase the risk of pelvic infections or subsequent infertility. IUD use decreases the absolute risk of ectopic pregnancies. In light of this data, the IUD should be made available to women at low-risk for sexually-transmitted infections and should not be denied to women on the basis of parity or marital status.

TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age.

OBJECTIVE: The objective of the study was to evaluate the performance of the TCu 380A IUD in women who had been using the device for more than 10 years and who were 35 years of age or more on completion of the 10th year of IUD use. METHODS: A total of 228 women who had an IUD inserted between 1987 and 1992 were included in the study. The cutoff date for analysis was January 31, 2004. Clinical performance was evaluated by life-table analysis. The mean age of women at 10 years of use was 38.8+/-0.4 years and mean parity was 2.2+/-0.08 (mean+/-SD). The duration of follow-up beyond 10 years ranged from 1 to 72 months. No pregnancy was observed in 366 woman-years of observation beyond 10 years of use. The main reason for discontinuation was removal of the device because the clients had previously been informed that the IUD was not approved for use beyond 10 years. This reason accounted for a gross cumulative 6 years discontinuation rate of 42.5 per 100 women beyond 10 years. The other main reasons for discontinuation beyond 10 years of use were surgical sterilization, menopause and expulsion with gross cumulative 6-year termination rates of 19.2, 11.0 and 21.2 per 100 women, respectively. The cumulative continuation rate beyond 10 years was 67.0 at the end of the first year of follow-up and 21.2 at the end of the sixth year. CONCLUSION: We found no evidence that the TCu 380A IUD loses its effectiveness after 10 years of use. RESULTS: The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained.

Acceptability and clinical performance of a copper-containing frameless IUCD in Hong Kong.

This is the first study conducted in Hong Kong to evaluate the acceptability and clinical performance of a copper-containing frameless intrauterine contraceptive device (IUCD; GyneFix/Ji Ni). Sixty-two women chose to use the frameless IUCD for contraception. A learning curve was demonstrated in the insertion technique of this new device. Pain associated with insertion was acceptable. No pregnancy was reported during the 1-year trial period. Objectively, the amount of menstrual loss did not change and dysmenorrhea improved, but the duration of menstrual flow was slightly prolonged during the use of this device. However, there was a 10.7% request rate for removal of the device because of its side effects. The expulsion rate during the first year was 5.3%, and the continuation rate at the end of the first year was 76.7%. It was found that 85% of the 40 subjects interviewed upon the completion of the 1-year trial period wished to replace the same device after the product expiration date and that 92.5% would recommend this device to their friends. In summary, the clinical performance of the frameless IUCD was comparable to its framed counterparts. The device was considered acceptable to a majority of the women.

FFPRHC Guidance (January 2004). The copper intrauterine device as long-term contraception.

This Guidance provides information for clinicians providing women with copper-bearing intrauterine devices as long-term contraception. A key to the grades of recommendations, based on levels of evidence, is given at the end of this document. Details of the methods used by the Clinical Effectiveness Unit (CEU) in developing this Guidance and evidence tables summarising the research basis of the recommendations are available on the Faculty website (www.ffprhc.org.uk). Abbreviations (in alphabetical order) used include: acquired immune deficiency syndrome (AIDS); actinomyces-like organisms (ALOs); automated external defibrillator (AED); blood pressure (BP); British National Formulary (BNF); confidence interval (CI); copper-bearing intrauterine contraceptive device (IUD); emergency contraception (EC); Faculty Aid to Continuing Professional Development Topic (FACT); levonorgestrel-releasing intrauterine system (IUS); human immunodeficiency virus (HIV); Medicines and Healthcare products Regulatory Agency (MHRA); non-steroidal antiinflammatory drugs (NSAIDs); odds ratio (OR); pelvic inflammatory disease (PID); relative risk (RR); Royal College of Obstetricians and Gynaecologists (RCOG); Scottish Intercollegiate Guidelines Network (SIGN); sexually transmitted infection (STI); termination of pregnancy (TOP); World Health Organization (WHO); WHO Medical Eligibility Criteria (WHOMEC); WHO Selected Practice Recommendations (WHOSPR).

[A multicentre comparative clinical study of uterine cavity shaped device Cu300, TCu220C and TCu380A in ten years].

OBJECTIVE: To observe the clinical effects of uterine cavity shaped device (UCD) Cu300, TCu220C and TCu380A in ten years. METHODS: Two thousand, six hundred and ninety-nine rural parous women were randomized into three groups. UCD Cu300 group had 899 cases, TCu220C group and TCu380A group each had 900 cases. Follow-up visits were performed at 3, 6, 12 months and 2, 3, 5, 10 years after insertion. RESULTS: The cumulative pregnancy rates in the 10th year for UCD Cu300, TCu220C and TCu380A were 2.56, 4.82, and 4.01 per 100 women, respectively. UCD Cu300 group was significantly lower than other two groups (P < 0.05). The expulsion rates were 4.54, 5.46 and 9.68 per 100 women, respectively. TCu380A was significantly higher than UCD Cu300 and TCu220C (P < 0.001). The rates of removal for bleeding and pain for UCDCu300, TCu220C and TCu380A were 6.71, 5.58 and 6.80 per 100 women, respectively, no statistical difference was shown. The cumulative continuation rates were 74.86, 66.22 and 63.56 per 100 women at the 10 th year, UCD Cu300 was the highest, TCu380A was the lowest (P < 0.01). CONCLUSIONS: UCD Cu300, TCu220C and TCu380A are effective for long-term contraception. They are worthy of wide spreading in rural areas.

[Intrauterine devices in general practice: a prospective study of 300 insertions]. / Dispositif intra-utérin en médecine générale: à propos d'une étude prospective sur 300 poses.

OBJECTIVE: To assess the effectiveness of management practices of copper intrauterine devices (IUD) in general medicine. MATERIAL: and methods. A prospective study was conducted over a four-year period. Thirty-four experimented and volunteer general practitioners inserted 300 IUDs. Two hundred and ninety-seven patients were evaluated. A 375-mg copper IUD was used. Results are presented by 12-month device survival, cumulative discontinuation, and event rates per hundred women. RESULTS: At the end of the study 19.8% (n=59) of the women were lost to follow-up. Exposure time to IUD was 9245 cycles. Mean exposure time was 3917 cycles. Discontinuation rates for IUD were 82%, 67%, and 31% at 12, 36, and 48 months respectively. Renewal rate for this contraceptive device was 31.5%. Results confirmed that IUD were highly effective in this population: Pearl index 0.51% with four pregnancies. A very low expulsion rate (1.68%) and good tolerance (cumulative removal rate for medical reasons at 60 months=6.1%) were observed. At the end of the study, 61.3% of the women included had no complaints and had their IUD removed for desired pregnancy, replacement or personal reasons. CONCLUSIONS: Our findings are similar to reports in the literature; there was no evidence of differences between general practitioners and gynecologists. IUDs inserted by experimented general practitioners are safe and should continue to be offered as a contraceptive option for properly selected women. These findings suggest that specific training on contraceptives should be provided to interested general practitioners