Clinical outcomes of intrauterine device insertions by newly trained providers: The ECHO trial experience.

Objectives: To assess the rates of failed insertion, expulsion, and perforation when intrauterine device (IUD) insertions were done by newly trained clinicians, and to examine factors that may affect these outcomes. Study design: We evaluated skill-based outcomes following IUD insertion at 12 African sites in a secondary analysis of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial. Before trial initiation, we provided competency-based IUD training to clinicians and offered ongoing clinical support. We used Cox proportional hazards regression to examine factors associated with expulsion. Results: Among 2582 IUD acceptors who underwent first attempted IUD insertion, 141 experienced insertion failure (5.46%) and seven had uterine perforation (0.27%). Perforation was more common among breastfeeding women within three months postpartum (0.65%) compared with non-breastfeeding women (0.22%). We recorded 493 expulsions (15.5 per 100 person-years, 95% confidence interval [CI] 14.1─16.9): 383 partial and 110 complete. The risk of IUD expulsion was lower among women older than 24 years (aHR 0.63, 95% CI 0.50─0.78) and may be higher among nulliparous women. (aHR 1.65, 95% CI 0.97─2.82). Breastfeeding (aHR 0.94, 95% CI 0.72─1.22) had no significant effect on expulsion. IUD expulsion rate was highest during the first three months of the trial. Conclusions: IUD insertion failure and uterine perforation rates in our study were comparable to those reported in the literature. These results suggest that training, ongoing support, and opportunities to apply new skills were effective in ensuring good clinical outcomes for women receiving IUD insertion by newly trained providers. Implications: Data from this study support recommendations to program managers, policymakers, and clinicians that IUDs can be inserted safely in resource-constrained settings when providers receive appropriate training and support.

"PrEP should be available all the time and everywhere": A qualitative assessment of family planning and PrEP integration in Lesotho.

Background: Lesotho has a high HIV burden, with women disproportionately affected. Increased access points for HIV prevention services, including oral pre-exposure prophylaxis (PrEP), should be considered. Using family planning (FP) settings for PrEP services may contribute to greater uptake of HIV prevention methods. Methodology: This formative qualitative assessment was conducted in Maseru District, Lesotho and included in-depth interviews with 15 key informants, 10 FP providers in public facilities and community sites, and 15 FP and PrEP clients from facility and community sites. Interviews were audio recorded and in lieu of producing transcripts, teams completed semi-structured data extraction tables after each interview. Findings were compiled and synthesized by participant group into matrices and themes identified through deductive and inductive analysis. Results: Policy makers were generally supportive of integration but felt hampered by lack of integration policies and separation of HIV and FP departments at Ministry of Health. Funders stressed the need for coordination among partners to avoid duplication of efforts. Partners felt clients would be interested in PrEP/FP integration and that PrEP demand creation and education were crucial needs. Most providers supported integration, stressing the potential benefit to clients. Barriers discussed included heavy workloads, staff shortages, training needs, separate registers for FP and PrEP, and commodity stock-outs. Providers discussed strengthening integrated services through training, increasing staffing, having job aids and guidelines, merging the FP and PrEP registers, and marketing services together to create demand for both. Clients were overwhelmingly willing to have longer visits to receive comprehensive services and were supportive of receiving PrEP services from FP providers. Clients not using PrEP expressed willingness and interest to use. Clients' suggestions for successful integration included consulting with youth, conducting community outreaches, and improving provider availability. Conclusions: Existing FP platforms are established and well-utilized; thus providing opportunities for integrating PrEP. This assessment found support across all groups of respondents for providing PrEP within FP settings and identified a number of facilitators and barriers to integration. As PrEP rollout is relatively nascent in many countries, deepening the evidence base early will enable the utilization of findings to build stronger integrated programs with wider coverage.

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.

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.

Ectopic pregnancy with use of progestin-only injectables and contraceptive implants: a systematic review.

BACKGROUND: Use of contraception lowers a woman's risk of experiencing an ectopic pregnancy. In the case of method failure, however, progestin-only contraceptives may be more likely to result in ectopic pregnancies than some other methods such as combined hormonal and barrier contraceptives. OBJECTIVE: To describe ectopic pregnancy risk associated with use of implants and progestin-only injectable contraceptives through a systematic review of published studies. DATA SOURCES: We searched electronic databases for articles in any language published through May 2015 describing studies of progestin-only injectables and implants. We also searched bibliographies and review articles for additional studies. STUDY SELECTION AND EXTRACTION: Studies that reported any pregnancies were included in the review. Independent data extraction was performed by two authors based on predefined data fields, and where possible, we calculated the proportion of pregnancies that were ectopic and the ectopic pregnancy incidence rate per 1000 woman-years. RESULTS: Fifty-three studies of implants and 28 studies of injectables were identified; 79% reported pregnancy location. The proportion of ectopic pregnancy ranged from 0 to 100% with an incidence of 0-2.9 per 1000 woman-years in studies of marketed levonorgestrel implants. Studies of etonogestrel implants and the injectables, depot-medroxyprogesterone acetate and norethisterone enanthate, reported few ectopic pregnancies. CONCLUSION: Progestin-only contraceptive implants and injectables protect against ectopic pregnancy by being highly effective in preventing pregnancy overall; however, the absolute risk of ectopic pregnancy varies by type of progestin. Risk of ectopic pregnancy should not be a deterrent for use or provision of these methods.

Hormonal contraception and area of cervical ectopy: a longitudinal assessment.

BACKGROUND: The effect of combined oral contraceptives (COCs) and depot-medroxyprogesterone acetate (DMPA) on the area of cervical ectopy is not well understood. STUDY DESIGN: From 1996 to 1999, we recruited women not using hormonal contraception from two family planning centers in Baltimore, MD. Upon study entry and 3, 6 and 12 months after the initial visit, participants were interviewed and received visual cervical examinations with photography. Ectopy was measured from digitized photographs and was analyzed both continuously and categorically (small [≤0.48 cm(2)] vs. large [>0.48 cm(2)]). RESULTS: Of 1003 enrolled women, 802 returned for at least one follow-up visit. At 12 months, the numbers of women using COCs, DMPA or no hormonal method at least 50% of the time since the prior visit were 230, 76 and 229, respectively. After multivariable adjustment, COC use (vs. no hormonal use) was associated with large area of ectopy (odds ratio [OR]: 1.8, 95% confidence interval [CI]: 1.0-3.3). No significant relationship was observed between DMPA and large area of ectopy (OR: 0.5, 95% CI: 0.2-1.3). The incidence of large area of ectopy by contraceptive exposure (COC, DMPA or no hormonal method) was 17.4 (CI: 11.8-24.6), 10.9 (CI: 4.4-22.4) and 4.6 (CI: 2.2-8.4) per 100 woman-years, respectively. CONCLUSIONS: Use of COCs, but not DMPA, was associated with large area of cervical ectopy. Area of ectopy at baseline was the strongest predictor of area of ectopy at follow-up.

Hormonal contraceptive use, cervical ectopy, and the acquisition of cervical infections.

BACKGROUND AND OBJECTIVES: Several previous studies have suggested that hormonal contraception could be associated with increased risk of cervical infections. However, few high-quality prospective studies have examined this relationship. GOAL: The goal of this study was to measure the effect of oral contraceptives (OC) and depot-medroxyprogesterone acetate (DMPA) on the acquisition of cervical chlamydial and gonococcal infections. STUDY: Women attending 2 reproductive health centers in Baltimore, MD, were enrolled into a prospective cohort study. Participants were 15 to 45 years and were initiating OCs or DMPA or not using hormonal contraception. Interviews, physical examinations, and testing for incident cervical infections were conducted at 3, 6, and 12 months. RESULTS: The analysis included 819 women. Most were single (77%) and nulliparous (75%); 43% were black. Median age was 22 years. During the study, 45 women acquired a chlamydial or gonococcal infection (6.2 per 100 women-years). DMPA use (hazard ratio [HR], 3.6; 95% confidence interval [CI], 1.6-8.5), but not OC use (HR, 1.5; 95% CI, 0.6-3.5), was significantly associated with increased acquisition of cervical infections after adjusting for other risk factors. Cervical ectopy was not an important mediator of cervical infection risk. CONCLUSIONS: DMPA use, but not OC use, appeared to be significantly associated with increased acquisition of cervical chlamydial and gonococcal infections.