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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.

ABSTRACT: 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.

SUBMITTER: Steiner MJ

PROVIDER: S-EPMC7252426 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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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.

Steiner M J MJ Brache V V Taylor D D Callahan R R Halpern V V Jorge A A Wevill S S Sergison J J Venkatasubramanian L L Dorflinger L L

Contraception: X 20190101

<h4>Objective</h4>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.<h4>Study design</h4>This was a randomized controlled trial allocating 650 participants to either Sino-implant (I ...[more]

PMID: 32494772

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Project description:BackgroundContraceptives are used to prevent unwanted pregnancies and treat certain gynecologic conditions, but many women report non-use or inconsistent use because of method dissatisfaction. The sexual acceptability of contraception-how birth control methods affect users' sexual well-being-is likely an important component of contraceptive satisfaction but has yet to be systematically examined.ObjectiveThis study aimed to assess contraceptive satisfaction among new-start contraceptive users and examine whether sexual acceptability measures predict contraceptive satisfaction at 3 months while controlling for more commonly measured contraceptive side effects.Study designThis analysis used data derived from the baseline, 1-month, and 3-month surveys of the HER Salt Lake Contraceptive Initiative, a prospective cohort study of new contraceptive clients. From March 2016 to March 2017, enrolled participants received their desired contraceptive method at no cost and could switch or discontinue at any time (up to 3 years). This analysis included individuals who continued their new contraceptive method for at least 1 month and completed all relevant survey measures. We used ordered logistic regression modeling to predict contraceptive satisfaction at 3 months. Primary predictor variables included changes in sexual functioning (6-item Female Sexual Function Index), sexual satisfaction (New Sexual Satisfaction Scale), and perceived impact of the contraceptive method on sex life at 1 month. Covariates included vaginal bleeding changes, physical side effects, and mood-related side effects.ResultsOur analytical sample included 1879 individuals. At 3 months, 52.1% of participants were "completely satisfied" with their contraceptive method, 30.7% were "somewhat satisfied," 4.2% were "neither satisfied nor dissatisfied," 6.9% were "somewhat dissatisfied," and 6.2% were "completely dissatisfied." Compared with patients who said their contraceptive method made their sex life "a lot" worse at 1 month, patients whose method improved their sex life "a lot" had a 7.7 times increased odds of greater satisfaction at 3 months (95% confidence interval, 4.02-14.60; P<.0001) and patients whose method improved their sex life a "little" had a 5.88 times increased odds of greater satisfaction (confidence interval, 3.12-11.11; P<.001). To a much lesser degree, experiencing less or no bleeding was significantly associated with increased satisfaction, whereas worsening of physical side effects was linked to decreased satisfaction. The only other factors significantly associated with satisfaction were changes in bleeding and physical side effects.ConclusionOur findings suggest that patients' sexual experiences of their contraceptive methods are important correlates of satisfaction. Clinicians may wish to underscore that sexual experiences of birth control methods matter and encourage patients to find a contraceptive method that works for them sexually.

Project description:BACKGROUND:As part of its Family Planning 2020 commitment, the Nigerian government is aiming for a contraceptive prevalence rate of 36% by 2018, and in 2014, approved a policy to allow community health extension workers (CHEWs), in addition to doctors, nurses, and midwives, to provide contraceptive subdermal implants. There is a lack of rigorous evidence on the safety of long-acting reversible contraceptive provision, such as implants, among lower cadres of health providers. OBJECTIVE:This study aimed to compare implant provision by CHEWs versus nurses and midwives up to 14 days post insertion. METHODS:The quasi-experimental, noninferiority study will take place in public sector facilities in Kaduna and Ondo States. In each state, we will select 60 facilities, and from these, we will select a total of 30 nurses and midwives and 30 CHEWs to participate. Selected providers will be trained to provide implant services. Once trained, providers will recruit a minimum of 8125 women aged between 18 and 49 years who request and are eligible for an implant, following comprehensive family planning counseling. During implant insertion, providers will record data about the process and any adverse events, and 14 days post insertion, providers will ask 4410 clients about adverse events arising from the implant. Supervisors will observe 792 implant insertions to assess service provision quality and ask clients about their satisfaction with the procedure. We will conclude noninferiority if the CI for the difference in the proportion of adverse events between CHEWs and nurses and midwives on the day of insertion or 14 days post insertion lies to the right of -2%. RESULTS:In September and October 2015, we trained 60 CHEWs and a total of 60 nurses and midwives from 12 local government areas (LGAs) in Kaduna and 23 LGAs in Ondo. Recruitment took place between November 2015 and December 2016. Data analysis is being finalized, and results are expected in March 2018. CONCLUSIONS:The strength of this study is having a standard care (nurse and midwife provision) group with which CHEW provision can be compared. The intervention builds on existing training and supervision procedures, which increases the sustainability and scalability of CHEW implant provision. Important limitations include the lack of randomization due to nurses and midwives in Nigeria working in separate types of health care facilities compared with CHEWs, and that providers self-assess their own practices. It is unfeasible to observe all procedures independently, and observation may change practice. Although providers will be trained to conduct implant removals, the study time will be too short to reach the sample size required to make noninferiority comparisons for removals. TRIAL REGISTRATION:ClinicalTrials.gov NCT03088722; https://clinicaltrials.gov/ct2/show/NCT03088722 (Archived by WebCite at http://www.webcitation.org/6xIHImWvu).

Dataset Information

Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.

Publications

Randomized trial to evaluate contraceptive efficacy, safety and acceptability of a two-rod contraceptive implant over 4 years in the Dominican Republic.

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