Perfect- and typical-use effectiveness of the Dot fertility app over 13 cycles: results from a prospective contraceptive effectiveness trial.

OBJECTIVE: Dynamic Optimal Timing (Dot) is a smartphone application (app) that estimates the menstrual cycle fertile window based on the user's menstrual period start dates. Dot uses machine learning to adapt to cycles over time and informs users of 'low' and 'high' fertility days. We investigated Dot's effectiveness, calculating perfect- and typical-use failure rates. METHODS: This prospective, 13 cycle observational study (ClinicalTrials.gov NCT02833922) followed 718 women who were using Dot to prevent pregnancy. Participants contributed 6616 cycles between February 2017 and October 2018, providing data on menstrual period start dates, daily sexual activity and prospective intent to prevent pregnancy. We determined pregnancy through participant-administered urine pregnancy tests and/or written or verbal confirmation. We calculated perfect- and typical-use failure rates using multi-censoring, single-decrement life-table analysis, and conducted sensitivity, attrition and survival analyses. RESULTS: The perfect-use failure rate was calculated to be 1.0% (95% confidence interval [CI]: 0.9%, 2.9%) and the typical-use failure rate was 5.0% (95% CI: 3.4%, 6.6%) for women aged 18-39 (n = 718). Survival analyses identified no significant differences among age or racial/ethnic groups or women in different types of relationships. Attrition analyses revealed no significant sociodemographic differences, except in age, between women completing 13 cycles and those exiting the study earlier. CONCLUSION: Dot's effectiveness is within the range of other user-initiated contraceptive methods.

Meeting the need for modern contraception: effective solutions to a pressing global challenge.

Voluntary family planning is one of the most efficacious and cost-effective means of improving individual health, gender equity, family well-being, and national development. Increasing contraceptive use and reducing unmet need for family planning are central to improving maternal health (UN Millennium Development Goal 5). In less-developed regions of the world, especially Sub-Saharan Africa and South Asia, human and financial resources are limited, modern contraceptive use is relatively low, unmet need for modern contraception is high, and consequently maternal morbidity and mortality are high. However, the international community is showing renewed commitment to family planning, a number of high impact program practices have been identified, and a number of Sub-Saharan African countries (e.g. Ethiopia, Malawi, and Rwanda) have successfully made family planning much more widely and equitably available. The International Federation of Gynecology and Obstetrics (FIGO) has joined with other international and donor organizations in calling for increased funding and more effective programming to improve maternal health and family planning in low-resource countries. Continued engagement by FIGO, its member societies, and its individual members will be helpful in addressing the numerous barriers that impede universal access to modern contraception in low-resource countries.

Development and implementation of a quality assurance program for a hormonal contraceptive implant.

BACKGROUND: The importance of the distribution of safe, effective and cost-effective pharmaceutical products in resource-constrained countries is the subject of increasing attention. FHI 360 has developed a program aimed at evaluating the quality of a contraceptive implant manufactured in China, while the product is being registered in an increasing number of countries and distributed by international procurement agencies. The program consists of (1) independent product testing; (2) ongoing evaluation of the manufacturing facility through audits and inspections; and (3) post-marketing surveillance. STUDY DESIGN: This article focuses on the laboratory testing of the product. The various test methods were chosen from the following test method compendia, the United States Pharmacopeia (USP), British Pharmacopeia (BP), International Organization for Standardization (ISO), the American Society for Testing and Materials (ASTM), or lot release tests mandated by Chinese regulatory requirements. Each manufactured lot is independently tested prior to its distribution to countries supported by this program. In addition, a more detailed annual testing program includes evaluation of the active ingredient (levonorgestrel), the final product and the packaging material. RESULTS: Over the first 4 years of this 5-year project, all tested lots met the established quality criteria. CONCLUSIONS: The quality assurance program developed for this contraceptive implant has helped ensure that a safe product was being introduced into developing country family planning programs. This program provides a template for establishing quality assurance programs for other cost-effective pharmaceutical products that have not yet received stringent regulatory approval and are being distributed in resource-poor settings.

Provision of DMPA by community health workers: what the evidence shows.

BACKGROUND: To reduce a large unmet need for family planning in many developing countries, governments are increasingly looking to community health workers (CHWs) as an effective service delivery option for health care and as a feasible option to increase access to family planning services. This article synthesizes evidence on the feasibility, safety and effectiveness of community-based delivery of the injectable contraceptive depot-medroxyprogesterone acetate (DMPA). STUDY DESIGN: Manual and electronic search and systematic review of published and unpublished documents on delivery of contraceptive injectables by CHWs. RESULTS: Of 600 identified documents, 19 had adequate information on injectables, almost exclusively intramuscular DMPA, provided by CHWs. The data showed that appropriately trained CHW demonstrate competency in screening clients, providing DMPA injections safely and counseling on side effects, although counseling appears equally suboptimal in both clinic and community settings. Clients and CHWs report high rates of satisfaction with community-based provision of DMPA. Provision of DMPA in community-based programs using CHWs expanded access to underserved clients and led to increased uptake of family planning services. CONCLUSIONS: We conclude that DMPA can be provided safely by appropriately trained and supervised CHWs. The benefits of community-based provision of DMPA by CHWs outweigh any potential risks, and past experiences support increasing investments in and expansion of these programs.