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Marleen Temmerman - One of the best experts on this subject based on the ideXlab platform.
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effects of the Copper Intrauterine Device versus injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in south africa a pragmatic randomized controlled trial
Reproductive Health, 2016Co-Authors: Justus G Hofmeyr, Mandisa Singatamadliki, Eduardo Bergel, Marleen Temmerman, Theresa A LawrieAbstract:Background The Copper Intrauterine Device (IUD) is under-utilised in South Africa, where injectable progestin contraception (IPC) dominates contraception usage. There is a lack of robust comparative data on these contraceptive options to inform policy, programs, clinical counseling, and women’s choices.
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effects of the Copper Intrauterine Device versus injectable progestin contraception on pregnancy rates and method discontinuation among women attending termination of pregnancy services in south africa a pragmatic randomized controlled trial
Reproductive Health, 2016Co-Authors: Justus G Hofmeyr, Mandisa Singatamadliki, Eduardo Bergel, Marleen Temmerman, Theresa A LawrieAbstract:The Copper Intrauterine Device (IUD) is under-utilised in South Africa, where injectable progestin contraception (IPC) dominates contraception usage. There is a lack of robust comparative data on these contraceptive options to inform policy, programs, clinical counseling, and women’s choices. Within the context of a South African program to increase women’s access to the IUD, we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial of the IUD versus IPC at two South African hospitals. The target sample size was 7,000 women and the randomisation ratio was 1:1. The random sequence was computer-generated and group allocation was concealed in sealed, opaque, consecutively-numbered envelopes. Counselled, consenting women attending termination of pregnancy services were randomly assigned to IUD or IPC immediately post-termination. Condoms were promoted for the prevention of sexually-transmitted infections. The primary outcome was pregnancy; secondary outcomes were discontinuation, side-effects, and HIV acquisition and disease progression. Pregnancy and discontinuation outcomes are reported here. The trial closed early with 2,493 participants randomised (IUD = 1,247, IPC = 1,246), due to international concerns regarding a possible association between IPC and HIV acquisition. Median follow-up was 20 months; 982 and 1000 participants were followed up in the IUD and IPC groups, respectively. Baseline group characteristics were comparable. Pregnancy occurred significantly less frequently among women allocated to the IUD than IPC: 56/971 (5.8 %) versus 83/992 (8.4 %), respectively; risk ratio (RR) 0.69, 95 % confidence interval (CI) 0.50 to 0.96; P = 0.025. There were more protocol violations in the IUD group; however, discontinuation rates were similar between IUD and IPC groups (141/855 [16.5 %] and 143/974 [14.7 %], respectively). Women in the IUD group were more likely to discontinue contraceptive use due to abdominal pain or backache and non-specific symptoms, and those in the IPC group due to oligo- or amenorhoea and lack of sexual activity. The IUD was significantly more effective in preventing pregnancy than IPC. Efforts to expand contraception options and improve access to the IUD in settings where it is under-utilised are worthwhile. This trial shows that randomising long-acting, reversible contraceptives is feasible. Pan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).
Thesla Palaneephillips - One of the best experts on this subject based on the ideXlab platform.
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elevated risk of bacterial vaginosis among users of the Copper Intrauterine Device a prospective longitudinal cohort study
Clinical Infectious Diseases, 2021Co-Authors: Kathryn Peebles, Catherine A Chappell, Katherine E Bunge, Bonus Makanani, Flavia Matovu Kiweewa, Thesla Palaneephillips, Devika Singh, Logashvari Naidoo, Nitesha JeenarainAbstract:BACKGROUND Limited evidence suggests that the nonhormonal contraceptive Copper Intrauterine Device (Cu-IUD) may increase bacterial vaginosis (BV) risk, possibly due to increased volume and duration of menses, a common side effect of Cu-IUD use. Although increases in bleeding typically resolve within 6-12 months following initiation, evaluations of the association between Cu-IUD and BV have not included more than 6 months of follow-up. METHODS This secondary analysis of a human immunodeficiency virus type 1 prevention trial included 2585 African women ages 18-45 followed for up to 33 months. Women reported contraceptive use each month. BV was evaluated by Nugent score in 6-monthly intervals and, if clinically indicated, by Amsel criteria. Andersen-Gill proportional hazards models were used to (1) evaluate BV risk among Cu-IUD users relative to women using no/another nonhormonal contraceptive and (2) test changes in BV frequency before, while using, and following Cu-IUD discontinuation. RESULTS BV frequency was highest among Cu-IUD users at 153.6 episodes per 100 person-years (95% confidence interval [CI]: 145.2, 162.4). In adjusted models, Cu-IUD users experienced 1.28-fold (95% CI: 1.12, 1.46) higher BV risk relative to women using no/another nonhormonal contraception. Compared to the 6 months prior to initiation, BV risk was 1.52-fold (95% CI: 1.16, 2.00) higher in the first 6 months of Cu-IUD use and remained elevated over 18 months of use (P < .05). Among women who discontinued Cu-IUD, BV frequency was similar to pre-initiation rates within 1 year. CONCLUSIONS Cu-IUD users experienced elevated BV risk that persisted throughout use. Women and their providers may wish to consider BV risk when discussing contraceptive options.
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sexually transmitted infections among women randomised to depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant
Sexually Transmitted Infections, 2020Co-Authors: Jennifer Deese, Neena Philip, Margaret Lind, Khatija Ahmed, Joanne R Batting, Mags Beksinska, Vinodh A Edward, Cheryl Louw, Maricianah Onono, Thesla PalaneephillipsAbstract:OBJECTIVES Reproductive aged women are at risk of pregnancy and sexually transmitted infections (STI). Understanding drivers of STI acquisition, including any association with widely used contraceptives, could help us to reduce STI prevalence and comorbidities. We compared the risk of STI among women randomised to three contraceptive methods. METHODS We conducted a secondary analysis to assess the risk of chlamydia and gonorrhoea in a clinical trial evaluating HIV risk among 7829 women aged 16-35 randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a Copper Intrauterine Device (IUD) or a levonorgestrel (LNG) implant. We estimated chlamydia and gonorrhoea prevalences by contraceptive group and prevalence ratios (PR) using log-binomial regression. RESULTS At baseline, chlamydia and gonorrhoea prevalences were 18% and 5%, respectively. Final visit chlamydia prevalence did not differ significantly between DMPA-IM and Copper IUD groups or between Copper IUD and LNG implant groups. The DMPA-IM group had significantly lower risk of chlamydia compared with the LNG implant group (PR 0.83, 95% CI 0.72 to 0.95). Final visit gonorrhoea prevalence differed significantly only between the DMPA-IM and the Copper IUD groups (PR 0.67, 95% CI 0.52 to 0.87). CONCLUSIONS The findings suggest that chlamydia and gonorrhoea risk may vary with contraceptive method use. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use.
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elevated risk of bacterial vaginosis among users of the Copper Intrauterine Device a prospective longitudinal cohort study
Clinical Infectious Diseases, 2020Co-Authors: Kathryn Peebles, Catherine A Chappell, Katherine E Bunge, Bonus Makanani, Flavia Matovu Kiweewa, Thesla Palaneephillips, Devika Singh, Logashvari Naidoo, Nitesha JeenarainAbstract:BACKGROUND Limited evidence suggests that the non-hormonal contraceptive Copper Intrauterine Device (Cu-IUD) may increase bacterial vaginosis (BV) risk, possibly due to increased volume and duration of menses, a common side effect of Cu-IUD use. While increases in bleeding typically resolve within 6-12 months following initiation, evaluations of the association between Cu-IUD and BV have not included more than six months of follow-up. METHODS This secondary analysis of an HIV-1 prevention trial included 2,585 African women ages 18-45 followed for up to 33 months. Women reported contraceptive use each month. BV was evaluated by Nugent score in six-monthly intervals and, if clinically indicated, by Amsel's criteria. Andersen-Gill proportional hazards models were used to (1) evaluate BV risk among Cu-IUD users relative to women using no/another non-hormonal contraceptive and (2) test changes in BV frequency before, while using, and following Cu-IUD discontinuation. RESULTS BV frequency was highest among Cu-IUD users at 153.6 episodes per 100 person-years (95% CI: 145.2, 162.4). In adjusted models, Cu-IUD users experienced 1.28-fold (95% CI: 1.12, 1.46) higher BV risk relative to women using no/another non-hormonal contraception. Compared to the six months prior to initiation, BV risk was 1.52-fold (95% CI: 1.16, 2.00) higher in the first six months of Cu-IUD use and remained elevated over eighteen months of use (p<0.05). Among women who discontinued Cu-IUD, BV frequency was similar to pre-initiation rates within one year. CONCLUSIONS Cu-IUD users experienced elevated BV risk that persisted throughout use. Women and their providers may wish to consider BV risk when discussing contraceptive options.
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comparison of pregnancy incidence among african women in a randomized trial of intramuscular depot medroxyprogesterone acetate dmpa im a Copper Intrauterine Device iuds or a levonorgestrel lng implant for contraception
Contraception: X, 2020Co-Authors: Maricianah Onono, Cheryl Louw, Kavita Nanda, Kate Heller, Doug Taylor, Irina Yacobson, Renee Heffron, Margaret P Kasaro, Zelda Nhlabasti, Thesla PalaneephillipsAbstract:Abstract Objective The objective was to address bias in contraception efficacy studies through a randomized study trial of intramuscular depot medroxyprogesterone acetate (DMPA-IM), a Copper Intrauterine Device (IUDs) and a levonorgestrel (LNG) implant. Study design We analyzed data from the Evidence for Contraceptive Options and HIV Outcomes Trial, which assessed HIV incidence among 7829 women from 12 sites in eSwatini, Kenya, South Africa and Zambia seeking effective contraception and who consented to be randomized to DMPA-IM, Copper IUD or LNG implant. We used Cox proportional hazards regression adjusted for condom use to compare pregnancy incidence during both perfect and typical (i.e., allowing temporary interruptions) use. Results A total of 7710 women contributed to this analysis. Seventy pregnancies occurred during perfect and 85 during typical use. There was no statistically significant difference in perfect use pregnancy incidence among the methods: 0.61 per 100 woman-years for DMPA-IM [95% confidence interval (CI) 0.36–0.96], 1.06 for Copper IUD (95% CI 0.72–1.50) and 0.63 for LNG implants (95% CI 0.39–0.96). Typical use pregnancy rates were also largely similar: 0.87 per 100 woman-years for DMPA-IM (95% CI 0.58–1.25), 1.11 for Copper IUD (95% CI 0.77–1.54) and 0.63 for LNG implants (95% CI 0.39–0.96). Conclusions In this randomized trial of highly effective contraceptive methods among African women, both perfect and typical use resulted in low pregnancy rates. Our findings provide strong justification for improving access to a broader range of longer-acting contraceptive options including LNG implants and Copper IUD for African women. Implications statement Data from this study support recommendations to providers, policy makers and patients that all of these methods provide safe and highly effective contraception for African women.
David K Turok - One of the best experts on this subject based on the ideXlab platform.
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Copper Intrauterine Device placement 6 14 days after unprotected sex
Contraception, 2019Co-Authors: I Thompson, Jessica N Sanders, Bimla E Schwarz, Christy M Boraas, David K TurokAbstract:Abstract Objective To evaluate pregnancy risk following Copper (CuT380A) Intrauterine Device (IUD) placement 6–14 days after unprotected intercourse. Study design We used a combined dataset from four protocols in which participants had received a CuT380A IUD regardless of recent unprotected intercourse. At entry, participants had negative point of care urine pregnancy testing and reported all acts of unprotected intercourse in the two weeks prior to IUD placement. We identified a subset of women who had placement 6–14 days after unprotected intercourse and provided follow-up information on pregnancy status 2–4 weeks after IUD insertion. This follow-up within the four protocols included self -administered home urine pregnancy test (UPT) results 2–4 weeks after IUD placement or continued contact for up to 6 months. Results We identified 134 women who had a CuT380A IUD placed 6–14 days after unprotected intercourse and provided follow-up information on pregnancy status. Ninety-five (71%) participants reported UPT results 2–4 weeks after placement and the other 39 women were followed for 6 months after IUD placement to assess pregnancy status. Zero (97.5% CI 0–2.7%) participants reported a pregnancy within four weeks of CuT380A IUD placement. Conclusion In these collected data, no women with recent unprotected intercourse became pregnant within 1 month of CuT380A IUD placement. Implication These data indicate a low likelihood of pregnancy among women who reported unprotected intercourse 6–14 days preceding IUD insertion. For many women and their providers, these data may be sufficient to support same-day placement of a Copper IUD rather than delaying IUD placement until the next menses.
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immediate postpartum Intrauterine Device and implant program outcomes a prospective analysis
American Journal of Obstetrics and Gynecology, 2017Co-Authors: Jennifer L Eggebroten, Jessica N Sanders, David K TurokAbstract:Background In-hospital placement of Intrauterine Devices and contraceptive implants following vaginal and cesarean delivery is increasingly popular and responds to maternal motivation for highly effective postpartum contraception. Immediate postpartum Intrauterine Device insertion is associated with higher expulsion than interval placement, but emerging evidence suggests that the levonorgestrel Intrauterine Device may have a higher expulsion rate than the Copper Intrauterine Device. Objective This study evaluated in-hospital provision, expulsion, and 6-month continuation of immediate postpartum Copper T380 Intrauterine Devices, levonorgestrel Intrauterine Devices, and contraceptive implants. Study Design We offered enrollment in this prospective observational trial to women presenting to the University of Utah labor and delivery unit from October 2013 through February 2016 who requested an Intrauterine Device or implant for postpartum contraception during prenatal care or hospitalization at the time of delivery. Following informed consent, participants completed questionnaires prior to hospital discharge and at 3 and 6 months postpartum. Data on expulsions at 6 months were validated by chart abstraction. Results During the study period, 639 patients requested a postpartum Intrauterine Device or implant and 350 patients enrolled in prospective follow-up prior to discharge from the hospital. Among enrollees, 325 (93%) received their preferred contraceptive Device prior to hospital discharge: 88 (27%) Copper Intrauterine Device users, 123 (38%) levonorgestrel Intrauterine Device users, and 114 (35%) implant users. Participants predominantly were Hispanic (90%), were multiparous (87%), reported a household income Conclusion An immediate postpartum long-acting reversible contraception program effectively provides women who desire highly effective reversible contraceptive Devices with their method of choice prior to hospital discharge. Immediate postplacental levonorgestrel Intrauterine Device users have higher expulsion rates than Copper Intrauterine Device users, but >8 of 10 women initiating an Intrauterine Device or implant continue use at 6 months postpartum.
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experiences of advanced practitioners with inserting the Copper Intrauterine Device as emergency contraception
Womens Health Issues, 2016Co-Authors: Rachel L Wright, Caren J Frost, David K TurokAbstract:Abstract Introduction The Copper Intrauterine Device (IUD) is the most effective method of emergency contraception (EC) available for use after unprotected intercourse. Family planning clinics, commonly staffed by advanced practice clinicians, fulfill a significant role in health care and contraceptive service delivery for women in the United States. There are limited data assessing the perspectives and experiences of these providers in using the Copper IUD as EC in these settings. Methods Semistructured individual interviews were conducted with 12 advanced practice clinicians with experience inserting the Copper IUD. A phenomenological approach was used to frame the study and analysis. A modified version of the Van Kaam method of analysis was used to analyze the data from interview transcripts. Results Participants reported feelings of responsibility to support long-acting and highly effective methods of contraception. Patients' abilities to provide an accurate history of the last instance of unprotected intercourse in relation to their menstrual cycles and fear of painful insertions influenced participants’ willingness to offer the Copper IUD. This included provider concerns about causing uterine perforation prompting discontinuation of IUD insertion attempts. The participants perceived patients as having little knowledge about the Copper IUD in general and as not being committed to using the Copper IUD long term. Conclusions Numerous factors influenced advanced practice clinicians’ decisions to present the Copper IUD as a method of EC. Promoting support and sharing practitioner experiences with inserting the Copper IUD as EC may increase practitioner comfort with the Copper IUD as EC.
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the Copper Intrauterine Device for emergency contraception an opportunity to provide the optimal emergency contraception method and transition to highly effective contraception
Expert Review of Medical Devices, 2013Co-Authors: Amna I Dermish, David K TurokAbstract:Worldwide, 40% of all pregnancies are unintended. Widespread, over-the-counter availability of oral emergency contraception (EC) has not reduced unintended pregnancy rates. The EC visit presents an opportunity to initiate a highly effective method of contraception in a population at high risk of unintended pregnancy who are actively seeking to avoid pregnancy. The Copper Intrauterine Device (IUD), the most effective method of EC, continues to provide contraception as effective as sterilization for up to 12 years, and it should be offered as the first-line method of EC wherever possible. Increased demand for and supply of the Copper IUD for EC may have an important role in reducing rates of unintended pregnancy. The EC visit should include access to the Copper IUD as optimal care but should ideally include access to all highly effective methods of contraception.
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criterion based screening for sexually transmitted infection sensitivity specificity and predictive values of commonly used questions
Journal of Midwifery & Women's Health, 2012Co-Authors: Patricia Aikins Murphy, Janet C Jacobson, David K TurokAbstract:INTRODUCTION: Practice protocols that mandate prescreening for sexually transmitted infection prior to insertion of an Intrauterine Device for contraception can pose obstacles for women seeking this highly effective method of birth control. Some practices screen for presumed risk factors for sexually transmitted infection in order to identify those who may be infected or those in whom laboratory testing should be obtained. The value of such criterion-based screening is unclear. METHODS: Data from a prospective observational trial of offering the Copper Intrauterine Device for emergency contraception were used to assess the value of several screening questions in predicting the presence of sexually transmitted infection. Criteria evaluated were age under 25 years history of a sexually transmitted infection and having 2 or more sexual partners in the previous 3 months. The sensitivity specificity and likelihood ratio of both positive and negative test results and positive and negative predictive values were calculated for 3 separate questions as well as for combinations of these 3 questions. RESULTS: There were 197 women who received a Copper Intrauterine Device for emergency contraception at the same time they were tested for sexually transmitted infection. In this sample there were 8 cases of Chlamydia trachomatis identified and no cases of Neisseria gonorrhoeae. The sensitivity of individual and combined questions in identifying those who were infected ranged from 0% to 88%; specificity ranged from 37% to 97%. The positive predictive values for single or combined screening questions were in the range of 4% to 6%. Likelihood ratios for both positive and negative test results did not change posttest likelihood of disease in any appreciable way. DISCUSSION: Standard screening questions used to identify sexually transmitted infection risk could presume infection in large numbers of uninfected women and are of little value in identifying the women who are truly infected. (c) 2012 by the American College of Nurse-Midwives.
Nelly Mugo - One of the best experts on this subject based on the ideXlab platform.
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incidence of herpes simplex virus type 2 infection among african women using depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant for contraception a nested randomized trial
Social Science Research Network, 2021Co-Authors: Charles S Morrison, Nelly Mugo, Renee Heffron, Caitlin W Scoville, Randy M Stalter, Helen Rees, Athena P Kourtis, Elizabeth A Bukusi, Mags BeksinskaAbstract:Background: Globally, women have higher herpes simplex type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of certain contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM). Methods: Within a randomized trial of the effect of three contraceptive methods – DMPA-IM, a Copper Intrauterine Device (IUD), and a levonorgestrel (LNG) implant – on HIV acquisition, we assessed HSV-2 acquisition. We followed women who were HSV-2 and HIV seronegative, aged 16-35 years, and seeking effective contraception for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015-2018. HSV-2 serologic testing was done at enrollment and final study visits according to a standardized algorithm. Intention–to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method. Findings: At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the Copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI] 0.65-0.97) for DMPA-IM compared with Copper IUD, 0.86 (95% CI 0.71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI 0.89-1.30) for Copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55, 95% CI 2.78-4.48). Interpretation: In a randomized trial, DMPA-IM was not associated with increased risk of HSV-2 acquisition. HSV-2 incidence was >10% per year, emphasizing the need for development of novel HSV-2 prevention strategies for African women. Clinical Trial Registration Details: ClinicalTrials.gov number NCT02550067. Funding Information: The ECHO Trial was made possible by the combined generous support of the Bill & Melinda Gates Foundation, the American people through the United States Agency for International Development and the President’s Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency as part of the EDCTP2 programme supported by the European Union, the South African Medical Research Council, and the United Nations Population Fund. Contraceptive supplies were donated by the Government of South Africa and United States Agency for International Development. Additional funding for testing for herpes simplex type 2 infection was provided in part by the US Centers for Disease Control and Prevention (U48 DP 005013 SIP 14-023) and the University of Washington/Fred Hutch Center for AIDS Research (US National Institutes of Health P30 AI057757). Declaration of Interests: None. Ethics Approval Statement: Ethics review committees at each study site approved the study protocol. All participants provided written informed consent, which included counseling about randomization, each study contraceptive method, and their rights as research participants.
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weight change among women using intramuscular depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant for contraception findings from a randomised multicentre open label trial
EClinicalMedicine, 2021Co-Authors: Mags Beksinska, Justus G Hofmeyr, Rodal Issema, Ivana Beesham, Tharnija Lalbahadur, Katherine K Thomas, Charles S Morrison, Petrus S Steyn, Nelly MugoAbstract:Abstract Background There is limited evidence on the impact of the use of progestin-only hormonal contraception (POC) on weight change. We conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial. Methods The ECHO trial was conducted at 12 sites in eSwatini, Kenya, South Africa and Zambia between December 2015 and October 2018. HIV negative, women aged 16–35 years, desiring contraception, were randomised (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or Copper Intrauterine Device (IUD). Follow-up was up to 18 months. Weight (kg) was measured at baseline and study exit. Analysis was performed as intention to treat (ITT) and time on continuous contraceptive use. The primary outcome of this secondary analysis is weight change from study enrolment to the final visit at study month 12–18. The ECHO trial is registered with ClinicalTrials.gov, NCT02550067. Findings 7829 women were randomly assigned to DMPA-IM (n = 2609), Copper IUD (n = 2607) or LNG implant (n = 2613). The ITT population included 7014 women 2293 DMPA-IM group, 2372 Copper IUD group and 2349 LNG group) who were not lost to follow-up, pregnant on study, or missing weight data. The mean weight increased in all groups but was significantly different in magnitude: 3.5 kg (SD = 6.3), 2.4 kg (SD = 5.9) and 1.5 kg (SD = 5.7) in the DMPA-IM, LNG implant and Copper IUD groups, respectively. Comparative differences between groups were (2.02 kg (95% CI, 1.68, 2.36, p Interpretation We found differences in weight gain between POC users compared to the non-hormonal Copper IUD group over 12–18 months of use. Women using POCs should be counselled about this potential side effect when choosing a contraceptive method.
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weight change among women using intramuscular depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant for contraception findings from a randomised multicentre open label trial
Social Science Research Network, 2020Co-Authors: Mags Beksinska, Rodal Issema, Ivana Beesham, Tharnija Lalbahadur, Katherine K Thomas, Charles S Morrison, Petrus S Steyn, Nelly Mugo, G J HofmeyrAbstract:Background: There is limited evidence on the impact of the use of progestin-only hormonal contraception (POC) on weight change. We conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial. Methods: The ECHO trial was conducted at 12 sites in eSwatini, Kenya, South Africa and Zambia. HIV negative, women aged 16-35 years, desiring contraception, were randomized (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or Copper Intrauterine Device (IUD). Follow-up was up to 18 months. Weight (kgs) was measured at baseline and study exit. Analysis was performed as intention to treat (ITT) and time on continuous contraceptive use. Findings: 7829 women were randomly assigned to DMPA-IM (n=2609), Copper IUD (n=2607) or LNG implant (n=2613). The ITT population included 7014 women 2293 DMPA-IM group, 2372 Copper IUD group and 2349 LNG group) who were not lost to follow-up, pregnant on study, or missing weight data. The mean weight increased in all groups but was significantly different in magnitude: 3.5kg (SD=6.3), 2.4kg (SD=5.9) and 1.5kg (SD=5.7) in the DMPA-IM, LNG implant and Copper IUD groups, respectively. Comparative differences between groups were (2.02 kg 95% CI, 1.68,2.36, p<0.001 ) for DMPA-IM versus Copper IUD, 0.87kg (0.53,1.20 p<0.001) for LNG implant compared to Copper IUD and 1.16kg (0.82, 1.50, p<0.001) for DMPA-IM compared with LNG implant. Results for continuous contraceptive use were similar. Interpretation: We found differences in weight gain between POC users compared to the non-hormonal Copper IUD group over 12-18 months of use. Women using POCs should be counselled about this potential side effect when choosing a contraceptive method. Trial Registration: This study is registered with ClinicalTrials.gov, number NCT02550067. Funding Statement: Bill & Melinda Gates Foundation, US Agency for International Development (USAID) and the President’s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UNFPA. Declaration of Interests: None to declare Ethics Approval Statement: Ethics review committees at each study site, FHI 360, and the World Health Organization (WHO) approved the study protocol. Women provided written informed consent in a language of their choice prior to the conduct of any study related procedures.
Mags Beksinska - One of the best experts on this subject based on the ideXlab platform.
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contraceptive method preference and reasons for contraceptive discontinuation among women randomized to intramuscular depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant findings from durban south africa
Contraception, 2021Co-Authors: Ivana Beesham, Mags Beksinska, Shannon L Bosman, Caitlin W Scoville, Jennifer A Smit, Kavita NandaAbstract:Abstract Objectives : The use of Intrauterine Devices (IUDs) and contraceptive implants in South Africa (SA) is low with limited data on patterns of use and reasons for discontinuation. We describe contraceptive preferences and reasons for discontinuation among women enrolled in the Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial from one trial site. Study Design : ECHO, conducted between 2015 and 2018, enrolled and randomized sexually active women, aged 16-35, and desiring contraception, to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a Copper Intrauterine Device (C-IUD) or a levonorgestrel (LNG) implant; follow-up was 12-18 months. We interviewed 829 women at the Durban, SA trial site at ECHO Trial exit to ascertain contraceptive preferences at randomization. Reasons for randomized contraceptive discontinuation were collected at ECHO Trial exit and six months later. Data were analysed descriptively. Results : At the final ECHO Trial visit, among women using their randomized contraceptive method (n=757), 21% discontinued DMPA-IM, 20% discontinued LNG implant and 22% discontinued the C-IUD. About a quarter from each group discontinued due to problems with bleeding. Among women continuing their randomized contraceptive at trial exit (n=597), 25% discontinued DMPA-IM within six months of exiting the study, 8% discontinued LNG implant and 4% discontinued C-IUD. A third of women reported wanting to be assigned DMPA-IM at randomization, 20% wanted the LNG implant and 18% the C-IUD. Conclusions : Despite some women having preferences about which contraceptive they might be randomized to, discontinuation rates for all three methods at ECHO Trial exit and 6-month post-trial follow-up were low. Implications : Despite limited prior use of IUDs and implants among women enrolled in this study, and a desire by some women to not receive these methods at randomization, discontinuation rates remained low. The provision of quality contraceptive counselling and support may increase uptake and continued use of implants and IUDs.
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incidence of herpes simplex virus type 2 infection among african women using depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant for contraception a nested randomized trial
Social Science Research Network, 2021Co-Authors: Charles S Morrison, Nelly Mugo, Renee Heffron, Caitlin W Scoville, Randy M Stalter, Helen Rees, Athena P Kourtis, Elizabeth A Bukusi, Mags BeksinskaAbstract:Background: Globally, women have higher herpes simplex type 2 (HSV-2) prevalence than men; data from observational studies suggest a possible association of HSV-2 acquisition with use of certain contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM). Methods: Within a randomized trial of the effect of three contraceptive methods – DMPA-IM, a Copper Intrauterine Device (IUD), and a levonorgestrel (LNG) implant – on HIV acquisition, we assessed HSV-2 acquisition. We followed women who were HSV-2 and HIV seronegative, aged 16-35 years, and seeking effective contraception for 12-18 months at 12 sites in Eswatini, Kenya, South Africa, and Zambia from 2015-2018. HSV-2 serologic testing was done at enrollment and final study visits according to a standardized algorithm. Intention–to-treat analysis using Poisson regression with robust standard errors compared HSV-2 incidence by contraceptive method. Findings: At baseline, 4062 randomized women were HSV-2 seronegative, of whom 3898 (96.0%) had a conclusive HSV-2 result at their final study visit. Of these, 614 (15.8%) acquired HSV-2, at an incidence of 12.4/100 person-years (p-y): 10.9/100 p-y among women assigned DMPA-IM, 13.7/100 p-y the Copper IUD, and 12.7/100 p-y the LNG implant. Incidence rate ratios (IRR) for HSV-2 acquisition were 0.80 (95% confidence interval [CI] 0.65-0.97) for DMPA-IM compared with Copper IUD, 0.86 (95% CI 0.71-1.05) for DMPA-IM compared with LNG implant, and 1.08 (95% CI 0.89-1.30) for Copper IUD compared with LNG implant. HSV-2 acquisition risk was significantly increased among women who also acquired HIV during follow-up (IRR 3.55, 95% CI 2.78-4.48). Interpretation: In a randomized trial, DMPA-IM was not associated with increased risk of HSV-2 acquisition. HSV-2 incidence was >10% per year, emphasizing the need for development of novel HSV-2 prevention strategies for African women. Clinical Trial Registration Details: ClinicalTrials.gov number NCT02550067. Funding Information: The ECHO Trial was made possible by the combined generous support of the Bill & Melinda Gates Foundation, the American people through the United States Agency for International Development and the President’s Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency as part of the EDCTP2 programme supported by the European Union, the South African Medical Research Council, and the United Nations Population Fund. Contraceptive supplies were donated by the Government of South Africa and United States Agency for International Development. Additional funding for testing for herpes simplex type 2 infection was provided in part by the US Centers for Disease Control and Prevention (U48 DP 005013 SIP 14-023) and the University of Washington/Fred Hutch Center for AIDS Research (US National Institutes of Health P30 AI057757). Declaration of Interests: None. Ethics Approval Statement: Ethics review committees at each study site approved the study protocol. All participants provided written informed consent, which included counseling about randomization, each study contraceptive method, and their rights as research participants.
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weight change among women using intramuscular depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant for contraception findings from a randomised multicentre open label trial
EClinicalMedicine, 2021Co-Authors: Mags Beksinska, Justus G Hofmeyr, Rodal Issema, Ivana Beesham, Tharnija Lalbahadur, Katherine K Thomas, Charles S Morrison, Petrus S Steyn, Nelly MugoAbstract:Abstract Background There is limited evidence on the impact of the use of progestin-only hormonal contraception (POC) on weight change. We conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial. Methods The ECHO trial was conducted at 12 sites in eSwatini, Kenya, South Africa and Zambia between December 2015 and October 2018. HIV negative, women aged 16–35 years, desiring contraception, were randomised (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or Copper Intrauterine Device (IUD). Follow-up was up to 18 months. Weight (kg) was measured at baseline and study exit. Analysis was performed as intention to treat (ITT) and time on continuous contraceptive use. The primary outcome of this secondary analysis is weight change from study enrolment to the final visit at study month 12–18. The ECHO trial is registered with ClinicalTrials.gov, NCT02550067. Findings 7829 women were randomly assigned to DMPA-IM (n = 2609), Copper IUD (n = 2607) or LNG implant (n = 2613). The ITT population included 7014 women 2293 DMPA-IM group, 2372 Copper IUD group and 2349 LNG group) who were not lost to follow-up, pregnant on study, or missing weight data. The mean weight increased in all groups but was significantly different in magnitude: 3.5 kg (SD = 6.3), 2.4 kg (SD = 5.9) and 1.5 kg (SD = 5.7) in the DMPA-IM, LNG implant and Copper IUD groups, respectively. Comparative differences between groups were (2.02 kg (95% CI, 1.68, 2.36, p Interpretation We found differences in weight gain between POC users compared to the non-hormonal Copper IUD group over 12–18 months of use. Women using POCs should be counselled about this potential side effect when choosing a contraceptive method.
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weight change among women using intramuscular depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant for contraception findings from a randomised multicentre open label trial
Social Science Research Network, 2020Co-Authors: Mags Beksinska, Rodal Issema, Ivana Beesham, Tharnija Lalbahadur, Katherine K Thomas, Charles S Morrison, Petrus S Steyn, Nelly Mugo, G J HofmeyrAbstract:Background: There is limited evidence on the impact of the use of progestin-only hormonal contraception (POC) on weight change. We conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial. Methods: The ECHO trial was conducted at 12 sites in eSwatini, Kenya, South Africa and Zambia. HIV negative, women aged 16-35 years, desiring contraception, were randomized (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or Copper Intrauterine Device (IUD). Follow-up was up to 18 months. Weight (kgs) was measured at baseline and study exit. Analysis was performed as intention to treat (ITT) and time on continuous contraceptive use. Findings: 7829 women were randomly assigned to DMPA-IM (n=2609), Copper IUD (n=2607) or LNG implant (n=2613). The ITT population included 7014 women 2293 DMPA-IM group, 2372 Copper IUD group and 2349 LNG group) who were not lost to follow-up, pregnant on study, or missing weight data. The mean weight increased in all groups but was significantly different in magnitude: 3.5kg (SD=6.3), 2.4kg (SD=5.9) and 1.5kg (SD=5.7) in the DMPA-IM, LNG implant and Copper IUD groups, respectively. Comparative differences between groups were (2.02 kg 95% CI, 1.68,2.36, p<0.001 ) for DMPA-IM versus Copper IUD, 0.87kg (0.53,1.20 p<0.001) for LNG implant compared to Copper IUD and 1.16kg (0.82, 1.50, p<0.001) for DMPA-IM compared with LNG implant. Results for continuous contraceptive use were similar. Interpretation: We found differences in weight gain between POC users compared to the non-hormonal Copper IUD group over 12-18 months of use. Women using POCs should be counselled about this potential side effect when choosing a contraceptive method. Trial Registration: This study is registered with ClinicalTrials.gov, number NCT02550067. Funding Statement: Bill & Melinda Gates Foundation, US Agency for International Development (USAID) and the President’s Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UNFPA. Declaration of Interests: None to declare Ethics Approval Statement: Ethics review committees at each study site, FHI 360, and the World Health Organization (WHO) approved the study protocol. Women provided written informed consent in a language of their choice prior to the conduct of any study related procedures.
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sexually transmitted infections among women randomised to depot medroxyprogesterone acetate a Copper Intrauterine Device or a levonorgestrel implant
Sexually Transmitted Infections, 2020Co-Authors: Jennifer Deese, Neena Philip, Margaret Lind, Khatija Ahmed, Joanne R Batting, Mags Beksinska, Vinodh A Edward, Cheryl Louw, Maricianah Onono, Thesla PalaneephillipsAbstract:OBJECTIVES Reproductive aged women are at risk of pregnancy and sexually transmitted infections (STI). Understanding drivers of STI acquisition, including any association with widely used contraceptives, could help us to reduce STI prevalence and comorbidities. We compared the risk of STI among women randomised to three contraceptive methods. METHODS We conducted a secondary analysis to assess the risk of chlamydia and gonorrhoea in a clinical trial evaluating HIV risk among 7829 women aged 16-35 randomised to intramuscular depot medroxyprogesterone acetate (DMPA-IM), a Copper Intrauterine Device (IUD) or a levonorgestrel (LNG) implant. We estimated chlamydia and gonorrhoea prevalences by contraceptive group and prevalence ratios (PR) using log-binomial regression. RESULTS At baseline, chlamydia and gonorrhoea prevalences were 18% and 5%, respectively. Final visit chlamydia prevalence did not differ significantly between DMPA-IM and Copper IUD groups or between Copper IUD and LNG implant groups. The DMPA-IM group had significantly lower risk of chlamydia compared with the LNG implant group (PR 0.83, 95% CI 0.72 to 0.95). Final visit gonorrhoea prevalence differed significantly only between the DMPA-IM and the Copper IUD groups (PR 0.67, 95% CI 0.52 to 0.87). CONCLUSIONS The findings suggest that chlamydia and gonorrhoea risk may vary with contraceptive method use. Further investigation is warranted to better understand the mechanisms of chlamydia and gonorrhoea susceptibility in the context of contraceptive use.