Dataset Information

Contraceptive Continuation and Experiences Obtaining Implant and IUD Removal Among Women Randomized to Use Injectable Contraception, Levonorgestrel Implant, and Copper IUD in South Africa and Zambia.

ABSTRACT: Few longitudinal studies have measured contraceptive continuation past one year in sub-Saharan Africa. We surveyed 674 women who had been randomized to receive the three-month intramuscular contraceptive injectable (DMPA-IM), levonorgestrel (LNG) implant, or copper intrauterine device (IUD) during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial in South Africa and Zambia and were subsequently followed for two additional years to explore method continuation, reasons for discontinuation, and access to implant and IUD removal services. We also conducted in-depth qualitative interviews with 39 participants. We estimated cumulative discontinuation probabilities using Kaplan-Meier estimates and assessed factors associated with discontinuation using Cox-proportional hazards models. The LNG implant continuation rate over the maximum 44-month study period was 60 percent, while rates for the copper IUD and DMPA-IM were 52 percent and 44 percent, respectively. Reasons for method discontinuation included side effects, particularly menstrual changes, and method stock-outs. Most implant and IUD users who sought removal were able to access services; however, room for improvement exists. In this cohort originally randomized to receive a contraceptive method and attend regular study visits, implants and IUDs continued to be highly acceptable over an additional two years, but facilities should continue to ensure that insertions and removals are available as requested.

SUBMITTER: Cartwright AF

PROVIDER: S-EPMC10239327 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Contraceptive Continuation and Experiences Obtaining Implant and IUD Removal Among Women Randomized to Use Injectable Contraception, Levonorgestrel Implant, and Copper IUD in South Africa and Zambia.

Cartwright Alice F AF Callahan Rebecca L RL Beksinska Mags M Kasaro Margaret P MP Tang Jennifer H JH Milford Cecilia C Wong Christina C Velarde Marissa M Maphumulo Virginia V Fawzy Maria M Chinyama Manze M Chabu Esther E Mudenda Mayaba M Smit Jennifer J

Studies in family planning 20230201 2

Few longitudinal studies have measured contraceptive continuation past one year in sub-Saharan Africa. We surveyed 674 women who had been randomized to receive the three-month intramuscular contraceptive injectable (DMPA-IM), levonorgestrel (LNG) implant, or copper intrauterine device (IUD) during the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial in South Africa and Zambia and were subsequently followed for two additional years to explore method continuation, reasons for disco ...[more]

PMID: 36727169

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Project description:INTRODUCTION:Contraceptives improve women's lives and public health, but many women discontinue their contraceptive method owing to dissatisfaction. An underexamined aspect of contraceptive discontinuation is sexual acceptability, or how contraception affects sexual experiences. Investigators' aims were two-fold: 1) to document changes in multiple domains of women's sexual experiences with their intrauterine device (IUD) or contraceptive implant over time and 2) to examine whether these sexuality factors were associated with method continuation at 12 months. METHODS:We enrolled 200 eligible family planning clients and collected data at baseline and at 1, 3, 6, and 12 months. Sexual acceptability measures included the Female Sexual Function Index-6, the New Sexual Satisfaction Scale, and participants' perceptions of whether their contraceptive method had had a neutral, positive, or negative effect on their sex life. Survival analysis and Cox regression with time-varying covariates related sexuality measures to method continuation over time while controlling for other relevant factors. RESULTS:Among 193 women who received an IUD or implant, 20% selected the copper IUD, 46% the levonorgestrel IUD, and 34% the etonogestrel implant. Ten percent discontinued their method during the year. Although changes in Female Sexual Function Index-6 and New Sexual Satisfaction Scale scores were not associated with discontinuation, individuals who perceived that their method detracted from their sexual experience had significantly higher removal rates than those who reported no sexual changes or positive sexual changes (adjusted hazard ratio, 8.04; 95% CI, 1.53-42.24), even when controlling for method type, bleeding changes, and a variety of covariates and controls. CONCLUSIONS:Although limited by the small sample of discontinuers, we found that women's perceptions of how their method affects their sex life were associated with contraceptive continuation over time. Sexual acceptability should receive more attention in both contraceptive research and counseling.

Project description:BackgroundRecent evidence demonstrates the effectiveness of the levonorgestrel 52-mg intrauterine device for emergency contraception vs the copper T380A intrauterine device. Of note, 1-year pregnancy and continuation rates after intrauterine device placement for emergency contraception remain understudied.ObjectiveThis study compared 1-year pregnancy and intrauterine device continuation rates and reasons for discontinuation among emergency contraception users randomized to the levonorgestrel 52-mg intrauterine device or the copper intrauterine device.Study designThis participant-masked, randomized noninferiority trial recruited emergency contraception individuals desiring an intrauterine device from 6 Utah family planning clinics between August 2016 and December 2019. Participants were randomized 1:1 to the levonorgestrel 52-mg intrauterine device group or the copper T380A intrauterine device group. Treatment allocation was revealed to participants at the 1-month follow-up. Trained personnel followed up the participants by phone, text, or e-mail at 5 time points in 1 year and reviewed electronic health records for pregnancy and intrauterine device continuation outcomes for both confirmation and nonresponders. We assessed the reasons for the discontinuation and used Cox proportional-hazard models, Kaplan-Meier estimates, and log-rank tests to assess differences in the continuation and pregnancy rates between the groups.ResultsThe levonorgestrel and copper intrauterine device groups included 327 and 328 participants, respectively, receiving the respective interventions. By intention-to-treat analysis at 1 year, the pregnancy rates were similar between intrauterine device types (2.8% [9/327] in levonorgestrel 52-mg intrauterine device vs 3.0% [10/328] in copper intrauterine device; risk ratio, 0.9; 95% confidence interval, 0.4-2.2; P=.82). Most pregnancies occurred in participants after intrauterine device removal, with only 1 device failure in each group. Of note, 1-year continuation rates did not differ between groups with 204 of 327 levonorgestrel 52-mg intrauterine device users (62.4%) and 183 of 328 copper T380A intrauterine device users (55.8%) continuing intrauterine device use at 1 year (risk ratio, 1.1; 95% confidence interval, 1.0-1.2; P=.09). There were differences concerning the reasons for discontinuation between intrauterine device types, with more bleeding and cramping cited among copper intrauterine device users.ConclusionThe pregnancy rates were low and similar between intrauterine device types. Of note, 6 of 10 intrauterine device emergency contraception users continued use at 1 year. Moreover, 1-year continuation rates were similar between intrauterine device types.

Project description:OBJECTIVES:To assess the effect of the depot medroxyprogesterone acetate injectable (DMPA) and of the levonorgestrel (LNG) implant on genital HIV shedding among women receiving antiretroviral therapy (ART). METHODS:We randomized HIV-infected Malawian women to either DMPA or LNG implant from May 2014 to April 2015. HIV RNA was measured in cervicovaginal lavage (CVL) fluid and TearFlo Strips (TFS), and HIV DNA was measured in cells collected by CVL. We compared the frequency and magnitude of HIV genital shedding before and for 6 months after initiation of contraception and between arms among women receiving ART. We also compared genital HIV RNA levels obtained by sample type (TFS versus CVL). RESULTS:We analyzed data for 68 HIV-infected women receiving ART: 33 randomized to DMPA and 35 randomized to the LNG implant. Overall, HIV RNA was more often detectable and the quantity was higher on TFS compared with CVL. HIV DNA was detected very rarely in CVL cell samples (4 of 360 samples). The frequency of genital shedding and the genital HIV quantity did not increase after contraceptive initiation with either DMPA or LNG implant among women receiving ART. CONCLUSIONS:HIV-infected women receiving ART initiating contraception with either DMPA or LNG implant did not have any increase in genital HIV shedding during the first 6 months of contraceptive use. These findings are consistent with growing evidence that progestin contraception is not associated with increased HIV transmission risk from such women to their male partners. Consistent with other studies, genital HIV RNA detection was higher in TFS than in CVL fluid. IMPLICATIONS:In this randomized trial, neither DMPA nor the LNG implant, two of the most commonly used hormonal contraceptives among African women with HIV, was associated with increased genital HIV shedding in HIV-infected women receiving ART. These findings are reassuring and add to the currently limited information available for the highly effective contraceptive, LNG implant.

Project description:ObjectiveThis study assessed whether immediate postpartum insertion of levonorgestrel contraceptive implants is associated with a difference in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 and 6 months postpartum compared to delayed insertion at 6 to 8 weeks postpartum.Study designWe conducted a randomized trial of women in Uganda who desired contraceptive implants postpartum. We randomly assigned participants to receive either immediate (within 5 days of delivery) or delayed (6 to 8 weeks postpartum) insertion of a two-rod levonorgestrel contraceptive implant system. This is a prespecified secondary analysis evaluating breastfeeding outcomes. The primary outcome of this secondary analysis was change in infant weight; infants were weighed and measured at birth and 6 months. We used a validated questionnaire to assess onset of lactogenesis daily in person while participants were in the hospital, and then daily by phone after they left the hospital, until lactogenesis was documented. We used interviewer-administered questionnaires to assess breastfeeding continuation and concerns at 3 months and 6 months postpartum.ResultsAmong the 96 women randomized to the immediate group and the 87 women to the delayed group, the mean change in infant weight from birth to 6 months was similar between groups: 4632 g in the immediate group and 4407 g in the delayed group (p=.26). Among the 97 women who had not experienced lactogenesis prior to randomization, the median time to onset of lactogenesis did not differ significantly between the immediate and delayed groups (65 h versus 63 h; p=.84). Similar proportions of women in the immediate and delayed groups reported exclusive breastfeeding at 3 months (74% versus 71%; p=.74) and 6 months (48% versus 52%; p=.58).ConclusionWe found no association between the timing of postpartum initiation of levonorgestrel contraceptive implants and change in infant growth from birth to 6 months, onset of lactogenesis, or breastfeeding continuation at 3 or 6 months postpartum.ImplicationsThis study provides evidence that immediate postpartum initiation of contraception implants does not have a deleterious effect on infant growth or initiation or continuation of breastfeeding.

Project description:BackgroundIn the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose.MethodsThis randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points.ResultsAmong the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group.ConclusionsThe levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).

Dataset Information

Contraceptive Continuation and Experiences Obtaining Implant and IUD Removal Among Women Randomized to Use Injectable Contraception, Levonorgestrel Implant, and Copper IUD in South Africa and Zambia.

Publications

Contraceptive Continuation and Experiences Obtaining Implant and IUD Removal Among Women Randomized to Use Injectable Contraception, Levonorgestrel Implant, and Copper IUD in South Africa and Zambia.

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