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Maryam Guiahi - One of the best experts on this subject based on the ideXlab platform.
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a pilot study on the effect of isotretinoin on serum etonogestrel concentrations in Contraceptive Implant users
Contraception, 2020Co-Authors: Aaron Lazorwitz, Anne R Davis, Rebecca A Seale, Maryam GuiahiAbstract:Abstract Objective To explore the pharmacokinetic interaction between isotretinoin, a cytochrome P-450 (CYP) inducer and potent teratogen, and the etonogestrel Contraceptive Implant. Study design We enrolled healthy reproductive-age women initiating isotretinoin and using an etonogestrel Implant. We compared serum etonogestrel concentrations at baseline and after four and nine weeks of isotretinoin co-administration using a validated assay. Results Among eight Implant users, all serum etonogestrel concentrations remained >90 pg/mL during isotretinoin co-administration with no significant changes from baseline (p = 0.25, Friedman’s test). Conclusion In this exploratory study, we found that isotretinoin did not cause serum etonogestrel concentrations to fall below the threshold for ovulatory suppression ( Implications Reproductive-age women treated with isotretinoin require reliable contraception to prevent pregnancies impacted by teratogenic-effects. This small study demonstrates that Contraceptive Implant users maintained serum etonogestrel concentrations above the threshold for consistent ovulatory suppression during isotretinoin co-administration. The Contraceptive Implant remains an appropriate option for patients considering isotretinoin therapy.
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relationship between patient characteristics and serum etonogestrel concentrations in Contraceptive Implant users
Contraception, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Jeanelle Sheeder, Stephanie B TealAbstract:Abstract Objective To determine whether serum etonogestrel concentrations in Contraceptive Implant users are associated with certain individual patient characteristics. Study design We enrolled reproductive-age women using etonogestrel Contraceptive Implants between 12–36 months duration and measured a single serum etonogestrel concentration. Participants also completed a questionnaire about demographics. Results We enrolled 350 participants; median age was 22.5 years (range 18.0–39.1), median months of Implant use was 26.0 (range 12.0–36.0), and median body mass index was 25.7 kg/m2 (range 18.5–52.0). Our study population was primarily white/Caucasian (46.6% [163/350]) and Hispanic/Latina ethnicity (51.4% [180/350]). The median serum etonogestrel concentration was 137.4 pg/ml and etonogestrel concentrations varied 12.4 fold in the population (range 55.8–695.1 pg/ml). Using forward stepwise linear regression, months of Implant use (β=−1.74, p Conclusions Individuals demonstrated a wide variability in serum etonogestrel concentrations, which can potentially affect side-effect profiles and efficacy. Increasing body mass index and longer duration of Implant use were associated with small decreases in serum etonogestrel concentrations, while self-reported Black/African American race was associated with a non-significant increase. Despite these findings, most of etonogestrel variability was unaccounted for, suggesting that other clinical, pharmacologic, and genetic factors contributing to variability in etonogestrel concentrations remain to be determined. Implications Although increases in body mass index are associated with lower etonogestrel levels in Contraceptive Implant users, the majority of women will maintain serum concentrations that consistently suppress ovulation. Furthermore, certain patient characteristics can only explain a small portion (13%) of the variability in serum etonogestrel levels among Contraceptive Implant users.
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influence of genetic variants on steady state etonogestrel concentrations among Contraceptive Implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Kris Oreschak, Jeanelle Sheeder, Stephanie B TealAbstract:OBJECTIVE:To identify genetic variants that influence steady-state etonogestrel concentrations among Contraceptive Implant users.METHODS:We enrolled healthy, reproductive-age women in our pharmacogenomic study using etonogestrel Implants for 12–36 months without concomitant use of hepatic enzyme ind
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the effect of carbamazepine on etonogestrel concentrations in Contraceptive Implant users
Contraception, 2016Co-Authors: Aaron Lazorwitz, Anne R Davis, Maryke Swartz, Maryam GuiahiAbstract:Abstract Objective The objective was to determine the impact of carbamazepine on the pharmacokinetics and pharmacodynamics of the etonogestrel Contraceptive Implant. Study design We enrolled healthy, reproductive-age women using an etonogestrel Implant for 1–3 years. We measured etonogestrel levels at baseline and following 3 weeks of coadministered carbamazepine titrated up to 300 mg twice daily. We also evaluated for ovarian follicle-like structures and endometrial thickness using transvaginal ultrasound at the baseline and 3-week visits. Results We enrolled 13 women; 10 completed study procedures. Participants' mean age was 25.6 years (±5.6), mean body mass index was 30.4 (±7.3), and median duration of Implant use was 23 months (range 15–35). The median etonogestrel concentrations before and after carbamazepine coadministration were 158.1 pg/mL (range 128–347) and 50.9 pg/mL (range 39–202), respectively (p=.005). In 8 of 10 subjects, the etonogestrel concentration was below the threshold for ovulatory suppression ( Conclusions Women using a Contraceptive Implant experienced significant reductions in etonogestrel concentrations following coadministration of 600 mg of carbamazepine. We did not find significant pharmacodynamic changes during this abbreviated follow-up period. Implications Carbamazepine use significantly reduces serum etonogestrel concentrations in women using an etonogestrel Contraceptive Implant, with the majority of participants having etonogestrel concentrations below the threshold for ovulatory suppression. Our findings suggest that treatment with carbamazepine might increase the risk of pregnancy in etonogestrel Implant users.
Chelsea Morroni - One of the best experts on this subject based on the ideXlab platform.
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factors associated with the use of the Contraceptive Implant among women attending a primary health clinic in cape town south africa
Frontiers in Global Women's Health, 2021Co-Authors: Kim Jonas, Chelsea Morroni, Moira O Kalichman, Seth C Kalichman, Mikateko Mazinu, Carl Lombard, Catherine MathewsAbstract:Background: Long-acting reversible Contraceptives (LARCs), which include the subdermal Contraceptive Implant and intrauterine contraception, offer women safe, highly effective, long-term pregnancy prevention, and expanded Contraceptive options. The Implant greatly expands LARC options for South African women as it is available free of charge at public health facilities, but we know little about factors associated with its uptake. This study describes factors associated with the intention to use the Implant, including knowledge and beliefs about the Implant and perceived outcome expectancies of Implant use among women Cape Town, South Africa. Methods: Between 2015 and 2016, we conducted a quantitative, cross-sectional survey among adult women attending a public, primary health clinic in Cape Town, South Africa between. Using a structured questionnaire, we measured women’s knowledge, awareness and attitudes towards, perceived outcome expectancy, and the intention to use the Contraceptive Implant in future among the women. Results: We surveyed 481 women (mean age 29.1 years). Most (n=364, 75.6%) had heard about the Implant, 45 (9.4%) were currently using it and 97 (20.2%) intended to use it in the future. Knowledge about the safety of the Implant, beliefs about its effectiveness and the ease of insertion and removal, and support from intimate partners were positively associated with the current use and intentions to use the Implant in the future. Conclusions: Limited knowledge of the Implant, having completed secondary schooling, partner’s support for women to use Implant and the perceived outcome expectancies of using the Implant were factors significantly associated with intention to use the Implant. Ensuring that contraception information is available in all South African languages regardless of women’s education levels, and that comprehensive contraception education and counselling is provided during all family planning might help improve the uptake of Contraceptives, include the use of the Implant in the country.
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comparison of plasma etonogestrel concentrations sampled from the contralateral to Implant and ipsilateral to Implant arms of Contraceptive Implant users
Contraception, 2020Co-Authors: Alida M Gertz, Ian J Bishop, Boikhutso Simon, Kwana Lechiile, Aamirah Mussa, Chelsea Morroni, Opelo Badubi, Carolyn WesthoffAbstract:Abstract Objective To compare plasma etonogestrel concentrations sampled from the contralateral- versus ipsilateral-to-Implant arm. Study design Sub-analysis of a cross-sectional study in Botswana in 33 participants who provided contralateral and ipsilateral blood samples. Results Plasma etonogestrel concentrations in contralateral and ipsilateral specimens were highly correlated (correlation coefficient = 0.99; p Conclusions We found no meaningful differences in plasma etonogestrel concentrations between samples taken from the contralateral- versus ipsilateral-to-Implant arm. Implications Our data suggest that etonogestrel plasma concentrations are unlikely to be meaningfully different between samples drawn from the ipsilateral- versus the contralateral-to-Implant arms in etonogestrel Contraceptive Implant users.
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factors affecting men s support for the use of the Contraceptive Implant by their female intimate partners
Contraception and Reproductive Medicine, 2020Co-Authors: Chelsea Morroni, Kim Jonas, Moira O Kalichman, Seth C Kalichman, Catherine MathewsAbstract:Family planning services have been available at no cost in the public health settings of South Africa since 1994, and now include the long-acting reversible Contraceptives (LARCs) namely, the Contraceptive Implant and intra-uterine device (IUD). However, the uptake of LARCs has been declining in the recent years and little is known about the cause of the decline. In many relationships, men may influence their female intimate partner’s Contraceptive choices. Thus, men’s involvement in reproductive health decisions and family programming may improve their support for Contraceptive use, including the LARC use by their female intimate partners. This study investigated factors affecting men’s support for the use of Contraceptive Implant by their female intimate partners. A quantitative, cross-sectional survey was conducted among adult men attending a public, primary health clinic in Cape Town, South Africa. Using a structured questionnaire, we measured men’s knowledge, awareness and support of, and attitudes towards use of the Contraceptive Implant by their female intimate partners. Data were analyzed using SPSS version 25. The sample included 65 men with a mean age of 31.2 years. Most (76.6%) believed that both men and women should be responsible for family planning. Support for general contraception use by their female intimate partners was prevalent at 80.0%, but only 33.9% reported that they would like their partners to use the Implant in the future, while 35.6% were unsure and 30.5% did not support their partner’s use of the Implant. Factors significantly associated with men’s support of their partner’s future use of the Contraceptive Implant included men’s reports that their partner wished to have another child in future, knowledge that the Implant is safe for use by women who have not had children, knowledge that the Implant can effectively prevent pregnancy for 3 years, and a positive attitude towards the Implant’s long-lasting effectiveness. Improving men’s knowledge of, and attitudes toward the Contraceptive Implant might increase their support for their partner’s use of the Implant, which in turn might promote uptake of the Implant among women. The findings of our study suggest the importance of actively engaging men in reproductive health and family planning programs.
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case report traumatic incomplete fracture of an implanon nxt Contraceptive Implant
African Journal of Reproductive Health, 2019Co-Authors: Rebecca Howett, Alida M Gertz, Tiroyaone Kgaswanyane, Gregory Petro, Chelsea MorroniAbstract:The etonogestrel (ENG) subdermal Contraceptive Implant (Implanon NXT®) is a safe and highly effective method of contraception which is increasing in popularity globally. This case report describes a 26-year-old woman who requested removal of the Implanon NXT® Contraceptive Implant. She reported that her Implant had bent following direct trauma. The Implant was removed in accordance with her request and without complication, but was noted to be incompletely fractured. We compare this case with a summary of the existing literature on fractured or damaged Contraceptive Implants. Structural damage detected whilst the Implant is in situ is one potential complication of Contraceptive Implant use. The incidence of this complication and the implications for Contraceptive efficacy are unknown. Damaged Implants may present healthcare providers with more technically challenging "difficult removals". With the scale-up of services for Implant provision, consideration should be given to this issue in order to inform counselling and removal services.
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closing the gap ensuring access to and quality of Contraceptive Implant removal services is essential to rights based Contraceptive care
African Journal of Reproductive Health, 2019Co-Authors: Rebecca Howett, Alida M Gertz, Sifelani Malima, Tiroyaone Kgaswanyane, Gregory Petro, Lesego Mokganya, Tshego Maotwe, Melanie Pleaner, Chelsea MorroniAbstract:The use of the subdermal Contraceptive Implant is increasing globally, and particularly so in lower- and middle-income countries in sub-Saharan Africa. For initiation or discontinuation of the Implant, users need to have access to services for insertion and removal by healthcare providers. Providing access to safe and effective Contraceptive Implant removal services presents both clinical and programmatic challenges. The most challenging Implant removal cases, termed -difficult removals‖, place additional demands upon removal services. In this commentary, we outline challenges for the provision of removal services. Based on our experience in this field, we make recommendations on how healthcare providers and health services can plan for these challenges. Through maximising the provision of comprehensive and accessible Implant removal services, including those for difficult removals, Implant users can be empowered to discontinue their use of this method of contraception if they choose, thus upholding the principles of rights-based Contraceptive care.
Aaron Lazorwitz - One of the best experts on this subject based on the ideXlab platform.
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a pilot study on the effect of isotretinoin on serum etonogestrel concentrations in Contraceptive Implant users
Contraception, 2020Co-Authors: Aaron Lazorwitz, Anne R Davis, Rebecca A Seale, Maryam GuiahiAbstract:Abstract Objective To explore the pharmacokinetic interaction between isotretinoin, a cytochrome P-450 (CYP) inducer and potent teratogen, and the etonogestrel Contraceptive Implant. Study design We enrolled healthy reproductive-age women initiating isotretinoin and using an etonogestrel Implant. We compared serum etonogestrel concentrations at baseline and after four and nine weeks of isotretinoin co-administration using a validated assay. Results Among eight Implant users, all serum etonogestrel concentrations remained >90 pg/mL during isotretinoin co-administration with no significant changes from baseline (p = 0.25, Friedman’s test). Conclusion In this exploratory study, we found that isotretinoin did not cause serum etonogestrel concentrations to fall below the threshold for ovulatory suppression ( Implications Reproductive-age women treated with isotretinoin require reliable contraception to prevent pregnancies impacted by teratogenic-effects. This small study demonstrates that Contraceptive Implant users maintained serum etonogestrel concentrations above the threshold for consistent ovulatory suppression during isotretinoin co-administration. The Contraceptive Implant remains an appropriate option for patients considering isotretinoin therapy.
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relationship between patient characteristics and serum etonogestrel concentrations in Contraceptive Implant users
Contraception, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Jeanelle Sheeder, Stephanie B TealAbstract:Abstract Objective To determine whether serum etonogestrel concentrations in Contraceptive Implant users are associated with certain individual patient characteristics. Study design We enrolled reproductive-age women using etonogestrel Contraceptive Implants between 12–36 months duration and measured a single serum etonogestrel concentration. Participants also completed a questionnaire about demographics. Results We enrolled 350 participants; median age was 22.5 years (range 18.0–39.1), median months of Implant use was 26.0 (range 12.0–36.0), and median body mass index was 25.7 kg/m2 (range 18.5–52.0). Our study population was primarily white/Caucasian (46.6% [163/350]) and Hispanic/Latina ethnicity (51.4% [180/350]). The median serum etonogestrel concentration was 137.4 pg/ml and etonogestrel concentrations varied 12.4 fold in the population (range 55.8–695.1 pg/ml). Using forward stepwise linear regression, months of Implant use (β=−1.74, p Conclusions Individuals demonstrated a wide variability in serum etonogestrel concentrations, which can potentially affect side-effect profiles and efficacy. Increasing body mass index and longer duration of Implant use were associated with small decreases in serum etonogestrel concentrations, while self-reported Black/African American race was associated with a non-significant increase. Despite these findings, most of etonogestrel variability was unaccounted for, suggesting that other clinical, pharmacologic, and genetic factors contributing to variability in etonogestrel concentrations remain to be determined. Implications Although increases in body mass index are associated with lower etonogestrel levels in Contraceptive Implant users, the majority of women will maintain serum concentrations that consistently suppress ovulation. Furthermore, certain patient characteristics can only explain a small portion (13%) of the variability in serum etonogestrel levels among Contraceptive Implant users.
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influence of genetic variants on steady state etonogestrel concentrations among Contraceptive Implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Kris Oreschak, Jeanelle Sheeder, Stephanie B TealAbstract:OBJECTIVE:To identify genetic variants that influence steady-state etonogestrel concentrations among Contraceptive Implant users.METHODS:We enrolled healthy, reproductive-age women in our pharmacogenomic study using etonogestrel Implants for 12–36 months without concomitant use of hepatic enzyme ind
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the effect of carbamazepine on etonogestrel concentrations in Contraceptive Implant users
Contraception, 2016Co-Authors: Aaron Lazorwitz, Anne R Davis, Maryke Swartz, Maryam GuiahiAbstract:Abstract Objective The objective was to determine the impact of carbamazepine on the pharmacokinetics and pharmacodynamics of the etonogestrel Contraceptive Implant. Study design We enrolled healthy, reproductive-age women using an etonogestrel Implant for 1–3 years. We measured etonogestrel levels at baseline and following 3 weeks of coadministered carbamazepine titrated up to 300 mg twice daily. We also evaluated for ovarian follicle-like structures and endometrial thickness using transvaginal ultrasound at the baseline and 3-week visits. Results We enrolled 13 women; 10 completed study procedures. Participants' mean age was 25.6 years (±5.6), mean body mass index was 30.4 (±7.3), and median duration of Implant use was 23 months (range 15–35). The median etonogestrel concentrations before and after carbamazepine coadministration were 158.1 pg/mL (range 128–347) and 50.9 pg/mL (range 39–202), respectively (p=.005). In 8 of 10 subjects, the etonogestrel concentration was below the threshold for ovulatory suppression ( Conclusions Women using a Contraceptive Implant experienced significant reductions in etonogestrel concentrations following coadministration of 600 mg of carbamazepine. We did not find significant pharmacodynamic changes during this abbreviated follow-up period. Implications Carbamazepine use significantly reduces serum etonogestrel concentrations in women using an etonogestrel Contraceptive Implant, with the majority of participants having etonogestrel concentrations below the threshold for ovulatory suppression. Our findings suggest that treatment with carbamazepine might increase the risk of pregnancy in etonogestrel Implant users.
Stephanie B Teal - One of the best experts on this subject based on the ideXlab platform.
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relationship between patient characteristics and serum etonogestrel concentrations in Contraceptive Implant users
Contraception, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Jeanelle Sheeder, Stephanie B TealAbstract:Abstract Objective To determine whether serum etonogestrel concentrations in Contraceptive Implant users are associated with certain individual patient characteristics. Study design We enrolled reproductive-age women using etonogestrel Contraceptive Implants between 12–36 months duration and measured a single serum etonogestrel concentration. Participants also completed a questionnaire about demographics. Results We enrolled 350 participants; median age was 22.5 years (range 18.0–39.1), median months of Implant use was 26.0 (range 12.0–36.0), and median body mass index was 25.7 kg/m2 (range 18.5–52.0). Our study population was primarily white/Caucasian (46.6% [163/350]) and Hispanic/Latina ethnicity (51.4% [180/350]). The median serum etonogestrel concentration was 137.4 pg/ml and etonogestrel concentrations varied 12.4 fold in the population (range 55.8–695.1 pg/ml). Using forward stepwise linear regression, months of Implant use (β=−1.74, p Conclusions Individuals demonstrated a wide variability in serum etonogestrel concentrations, which can potentially affect side-effect profiles and efficacy. Increasing body mass index and longer duration of Implant use were associated with small decreases in serum etonogestrel concentrations, while self-reported Black/African American race was associated with a non-significant increase. Despite these findings, most of etonogestrel variability was unaccounted for, suggesting that other clinical, pharmacologic, and genetic factors contributing to variability in etonogestrel concentrations remain to be determined. Implications Although increases in body mass index are associated with lower etonogestrel levels in Contraceptive Implant users, the majority of women will maintain serum concentrations that consistently suppress ovulation. Furthermore, certain patient characteristics can only explain a small portion (13%) of the variability in serum etonogestrel levels among Contraceptive Implant users.
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influence of genetic variants on steady state etonogestrel concentrations among Contraceptive Implant users
Obstetrics & Gynecology, 2019Co-Authors: Aaron Lazorwitz, Maryam Guiahi, Christina L Aquilante, Kris Oreschak, Jeanelle Sheeder, Stephanie B TealAbstract:OBJECTIVE:To identify genetic variants that influence steady-state etonogestrel concentrations among Contraceptive Implant users.METHODS:We enrolled healthy, reproductive-age women in our pharmacogenomic study using etonogestrel Implants for 12–36 months without concomitant use of hepatic enzyme ind
Markus J Steiner - One of the best experts on this subject based on the ideXlab platform.
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randomized trial to evaluate Contraceptive efficacy safety and acceptability of a two rod Contraceptive Implant over 4 years in the dominican republic
Contraception: X, 2019Co-Authors: Markus J Steiner, Rebecca L Callahan, V Brache, Douglas Taylor, Vera Halpern, A Jorge, Silver Wevill, Jill E Sergison, L Venkatasubramanian, Laneta J DorflingerAbstract:Objective Sino-Implant (II) is a Contraceptive Implant that had a commodity price one-third of the competing products a decade ago. To make Sino-Implant (II) more widely available, we conducted a trial to collect safety and efficacy data required for World Health Organization (WHO) prequalification, a quality standard allowing global donors to procure a pharmaceutical product. Study design This was a randomized controlled trial allocating 650 participants to either Sino-Implant (II) or Jadelle®. Participants were seen at 1 and 6 months, and then semiannually. The primary efficacy measure was the pregnancy Pearl Index [number of pregnancies per 100 women-years (WY) of follow-up] in the Sino-Implant (II) group during up to 4 years of Implant use. Results For the primary outcome, Sino-Implant (II) had a 4-year Pearl Index of 0.74 (95% confidence interval, 0.36-1.37) compared to 0.00 (95% confidence interval, 0.00-1.04) for Jadelle®. The Sino-Implant (II) pregnancy rate was significantly higher in the fourth year (3.54 per 100 WY) than in the first 3 years combined (0.18 per 100 WY; p <.001). Total levonorgestrel concentrations were equivalent between groups at month 12, but were 19%, 22% and 32% lower in the Sino-Implant (II) group at months 24, 36 and 48, respectively (p <.001 at each time point). Safety and acceptability of the two products were similar, while providers documented significantly higher breakage rates during removal of Sino-Implant (II) (16.3% vs. 3.1%; p <.001). Conclusion Based on these results, WHO prequalified Sino-Implant (II) with a 3-year use label in June 2017, 2 years shorter than the 5-year duration of Jadelle®. Implications WHO prequalification allows global donors to procure Sino-Implant (II), which means women in many low resource countries will have greater access to highly effective and acceptable Contraceptive Implants. Our study noted important clinical differences, including shorter duration of high effectiveness with Sino-Implant (II) when compared to the other available two-rod system, Jadelle®. Introduction strategies should include appropriate training on these differences.
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association of progestin Contraceptive Implant and weight gain
Obstetrics & Gynecology, 2016Co-Authors: Maria F Gallo, Carole Rattray, Jennifer Legardywilliams, Denise J Jamieson, Tina Hyltonkong, Athena P Kourtis, Markus J SteinerAbstract:OBJECTIVE: To evaluate initiation of a two-rod 150-mg levonorgestrel Contraceptive Implant on womens perceived and observed body weight. METHODS: We conducted a secondary analysis of data from an open randomized controlled trial of adult nonpregnant human immunodeficiency virus-negative women attending a public clinic in Kingston Jamaica who were assigned to initiate Implant use either immediately or after a 3-month delay. The primary objective of the parent study was to assess the effect of initiation of the Implant on the frequency of condom use. We compared study arms during follow-up using one-sided chi tests for differences in perceived weight gain and loss one-sided Wilcoxon-Mann-Whitney tests for median gain in measured weight and logistic regression with generalized estimating equations for risk of gaining greater than 2 kg. RESULTS: From 2012 to 2014 women were assigned to the Implant (n=208) or delay arm (n=206). At 3 months more women in the Implant arm (15.3%) reported perceived weight gain than in the control arm (4.3%) (P=.01). Despite differences in perception the Implant and control arms did not differ significantly in median weight gain at 1-month (0.0 kg and 0.0 kg respectively; P=.44) and 3-month visits (0.5 kg and 0.0 kg respectively; P=.27). Study arms did not differ in risk of gaining greater than 2 kg (odds ratio 0.9 95% confidence interval 0.6-1.3). CONCLUSION: We found no evidence of weight gain from short-term Implant use. Through the power of the nocebo effect the practice of counseling women to expect possible weight gain from initiating Implant use could lead them to perceive weight gain even in its absence and contribute to the early discontinuation of this highly effective Contraceptive method.
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effects of initiating a Contraceptive Implant on subsequent condom use a randomized controlled trial
Contraception, 2015Co-Authors: Carole Rattray, Jeffrey Wiener, Jennifer Legardywilliams, Elizabeth Costenbader, Karen Pazol, Natalie Medleysingh, Margaret C Snead, Markus J Steiner, Denise J Jamieson, Lee WarnerAbstract:Abstract Objective To evaluate whether initiation of a Contraceptive Implant, a method of long-acting reversible contraception, reduces condom use, as measured by a biomarker of recent semen exposure [prostate-specific antigen (PSA)]. Study design We conducted a randomized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections (STIs) attending family planning clinics received the Contraceptive Implant at baseline (“immediate” insertion arm, N = 208) or at the end (“delayed” insertion arm, N = 206) of a 3-month study period. Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use. Results At baseline, 24.9% of women tested positive for PSA. At both follow-up visits, the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [1-month: 26.1% vs. 20.2%, prevalence ratio (PR)=1.3, 95% confidence interval (CI)=0.9–1.9; 3-month: 25.6% vs. 23.1%, PR = 1.1, 95% CI=0.8–1.6]. The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm (1-sided p-value of .15). Conclusions Contraceptive Implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term. This information strengthens the evidence to support promotion of Implants in such populations and can help refine counseling for promoting and maintaining use of condoms among women who choose to use Implants. Implications Sex unprotected by a condom was not higher over 3 months in women receiving a Contraceptive Implant, compared with those not receiving the Implant.