Reproductive Health Global Program

Sayana Press background resources and references

Contents

Feasibility and acceptability of Sayana Press

Acceptability of Depo-subQ in Uniject, Now Called “Sayana Press” (2013)
Through the PROGRESS project, FHI 360 worked with the Uganda and the Senegal Ministry of Health and local partners to assess acceptability of Sayana Press among intramuscular DMPA users and providers and offer recommendations for method introduction. FHI 360 collaborated with the Uganda Ministry of Health and in Senegal, with the Ministry of Health and CEFOREP, with additional support from PATH and Pfizer, and in partnership with the Bill & Melinda Gates Foundation.

Feasibility of Administering Sayana Press in Clinics and Communities: Summary Findings From an Operational Assessment in Senegal (2013)
This operational assessment of Sayana Press in Senegal examines the extent to which Sayana Press facilitates the logistics of managing and administering injectable contraception and assesses whether providers in Senegal find benefits in this new presentation.

Operational Assessment: Administration and Management of Sayana Press in Clinics and Communities in Uganda (2013)
This operational assessment of Sayana Press in Uganda examines the extent to which Sayana Press facilitates the logistics of managing and administering injectable contraception and assesses whether providers in Uganda find benefits in this new presentation.

Logistics and Waste Management Benefits of depo-subQ in Uniject (2011)
This four-page brief describes results from three analyses conducted by PATH and John Snow Inc. (JSI) comparing the current intramuscular version of depot medroxyprogesterone acetate (DMPA) injectable contraceptive compared with the new formulation packaged in the Uniject injection system. The analyses focused on waste management implications and identified key quantitative and qualitative differences between the two products. The briefing summary based on these three reports is linked above.

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Peer-reviewed literature on feasibility and acceptability

Pharmacokinetics of subcutaneous depot medroxyprogesterone acetate injected in the upper arm (2014)
Halpern V, Combes SL, Dorflinger LJ, et al. Contraception. 2014;89(1):31–35.
The abdomen and thigh are recommended injection sites in the label for Depo-SubQ Provera 104™ (now known as Sayana Press). The authors evaluated the pharmacokinetic profile of medroxyprogesterone acetate (MPA) following injection of Depo-SubQ Provera 104 in the upper arm, a preferred injection site in developing countries. Study findings indicated that injection of Depo-SubQ Provera 104™ in the upper arm provided sufficient MPA levels for contraceptive protection for 3 months (13 weeks). The uptake and metabolism of MPA when injected in the upper arm may be different from the abdomen and thigh.

Observational study of the acceptability of Sayana® Press among intramuscular DMPA users in Uganda and Senegal (2014)
Burke HM, Mueller MP, Perry B, et al. Contraception. 2014;89(5):361–367.
This study measured acceptability of subcutaneous Sayana Press among intramuscular DMPA (DMPA IM) users. This open-label observational study was conducted in clinics in three districts in Senegal and community-based distribution services in two districts in Uganda. Current DMPA IM users in Senegal and Uganda accepted Sayana Press, and most preferred Sayana Press over DMPA IM. Findings indicate that Sayana Press can be safely introduced into family planning programs and administered by trained CHWs, with expectation of client uptake.

Operational assessments of Sayana® Press provision in Senegal and Uganda (2014)
Cover J, Blanton E, Ndiaye D, Walugembe F, LaMontagne DS. Contraception. 2014;89(5):374–378
Researchers conducted 58 semi-structured interviews with clinic providers and community health workers in Senegal and Uganda to identify the merits, challenges, and appeal of Sayana Press relative to intramuscular DMPA. Findings indicated that adding Sayana Press to the family planning method mix is unlikely to have a profound impact on clinic operations but may lessen logistical problems related to supply, storage, and waste management.

Preference for Sayana® Press versus intramuscular Depo-Provera among HIV-positive women in Rakai, Uganda: a randomized crossover trial (2014)
Polis CB, Nakgozi GF, Nakawooya H, Mondo G, et al. Contraception. 2014;89(5): 385–395.
This study assessed acceptability of Sayana Press versus intramuscular DMPA among HIV-positive women and their care providers in Rakai, Uganda. Sayana Press was found to be acceptable to HIV-positive women and health care providers in this rural Ugandan population.

Provider acceptability of Sayana® Press: Results from community health workers and clinic-based providers in Uganda and Senegal (2014)
Burke HM, Mueller MP, Packer C, et al. Contraception. 2014;89(5): 368–373.
This open-label observational study was conducted in clinics in three districts in Senegal and community-based services in two districts in Uganda. Providers administered Sayana Press to clients seeking reinjection of intramuscular DMPA. Researchers conducted in-depth interviews with 86 providers to assess their experiences providing Sayana Press to clients. Almost all providers preferred SP over intramuscular DMPA. Provider recommendations should be considered during Sayana Press introduction planning.

Sayana® Press: Can it be a “game changer” for reducing unmet need for family planning? (2014)
Spieler J. Contraception. 2014;89(5):335–338.
This article provides an overview of Sayana Press product characteristics, history, and research.

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Evidence and guidance: Progestin-only injectable contraception

World Health Organization statement on hormonal contraceptive eligibility for women at high risk of HIV (2017)
While some studies have suggested that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association. In 2017, based on a review of available evidence, WHO released new guidance on hormonal contraception and HIV offering new recommendations for progestin-only injectables such as those that contain depot medroxyprogesterone acetate (DMPA). Use of DMPA products among women at high risk of HIV has changed from category 1 to category 2 in WHO’s Medical eligibility criteria for contraceptive use (MEC). This means that, for women at high risk of HIV, the advantages of using DMPA products generally outweigh the theoretical or proven risk.

WHO offers the following clarification to accompany the MEC reclassification:

“There continues to be evidence of a possible increased risk of acquiring HIV among progestogen-only injectable users. Uncertainty exists about whether this is due to methodological issues with the evidence or a real biological effect. In many settings, unintended pregnancies and/or pregnancy-related morbidity and mortality are common, and progestogen-only injectables are among the few types of methods widely available. Women should not be denied the use of progestogen-only injectables because of concerns about the possible increased risk. Women considering progestogen-only injectables should be advised about these concerns, about the uncertainty over whether there is a causal relationship, and about how to minimize their risk of acquiring HIV.”

AVAC resources on hormonal contraception and potential HIV risk (2017)
These comprehensive AVAC resources and background on hormonal contraception and potential HIV risk explain key issues in clear language.

DMPA and HIV: What advocates need to know (2017)
This two-page document summarizes important takeaways for advocates from new guidance released by the WHO in 2017 on hormonal contraception, including DMPA injectables, and HIV for women at high risk of HIV. The document is intended as a tool for inclusion in advocacy strategy development and messaging, especially for advocates in countries with high rates of HIV among women and adolescent girls.

Webinars on hormonal contraception and potential HIV risk

Hormonal contraception and HIV: Putting new developments in context. In this March 10, 2017 webinar hosted by AVAC, panelists discussed what the WHO grading system for family planning methods is, what impact a change in classification for DMPA and NET-EN has for women, programs and research, and what needs to happen next.

Guidance on hormonal contraceptive eligibility for women living at high risk of HIV acquisition. WHO hosted this April 18, 2017 webinar to provide a guidance update to colleagues from the international NGO community that focus on contraceptive options for women.

AVAC and WHO webinar on hormonal contraception and HIV. This April 26, 2017 webinar hosted by AVAC and WHO presented the new guidance from WHO and gave webinar participants a chance to ask questions and learn about what is happening to put the guidance into practice.

Strategic Communication Framework for Hormonal Contraceptive Methods and Potential HIV-Related Risks (2016)
This framework from the Health Communication Capacity Collaborative is intended to guide those working in HIV or family planning to communicate effectively about the potential risks certain hormonal contraceptives may have for women at risk of HIV. It is designed for country-based stakeholders to tackle this issue and should be adapted to a country’s individual context. It can help countries develop communication strategies on how to discuss this issue of hormonal contraception with a variety of audiences, including providers, women, and their partners.

The Evidence for Contraceptive Options and HIV Outcomes (ECHO) Study website
The Evidence for Contraceptive Options and HIV Outcomes (ECHO) Study is an open-label randomised clinical trial that will compare three highly effective, reversible methods of contraception to evaluate whether there is a link between use of any of these methods and increased risk of acquiring HIV infection. This website includes information about the ECHO study as well as resources and information on the topic of hormonal contraception and HIV.

Medical eligibility criteria for contraceptive use: Fifth edition (2015)
The World Health Organization’s Medical eligibility criteria for contraceptive use (MEC) presents current WHO guidance on the safety of various contraceptive methods for use in the context of specific health conditions and characteristics. WHO included Sayana Press in its fifth edition. The product is referenced in the MEC as DMPA-SC, the non-branded name. Based on a systematic review of the evidence, the MEC confirms that Sayana Press and DMPA-IM (Depo-Provera) have a similar safety profile. Pages 82-87 address recommendations for use of hormonal contraception among women at high risk of HIV, women living with HIV, and women living with HIV using antiretroviral therapy.

WHO Selected practice recommendations for contraceptive use: Third edition (2016)
Along with WHO’s Medical eligibility criteria for contraceptive use, this is one of two evidence-based guidance documents of the WHO’s initiative to develop and implement family planning guidelines for national programs. This document provides guidance for how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate. Safety considerations include common barriers to safe, correct and consistent use of contraception and the benefits of preventing unintended or unwanted pregnancy.

Progestin-only contraception: Injectables and implants (2014)
Jacobstein R, Polis CB. Best Practice & Research Clinical Obstetrics and Gynecology. 2014;28(6):795–806.
This article provides an overview of characteristics, recent research, and particular areas of controversy surrounding progestin-only contraceptive injectables and implants. Progestin-only contraceptive injectables and implants are ideally offered as part of a wide range of contraceptive options. The advantages of these progestin-only contraceptive methods include convenience, high efficacy, and ability to be used by women who cannot use contraception containing oestrogen.

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Community-based distribution of injectable contraception

Community Health Workers: Bringing family planning services to where people live and work (2015)
This brief from Family Planning High Impact Practices outlines how when appropriately designed and implemented, community health worker programs can increase use of contraception, particularly where unmet need is high, access is low, and geographic or social barriers to use of services exist. The brief describes the importance of community-based family planning programs as a means of reducing inequities in access to services and outlines key issues for planning and implementation.

Global Experience of Community Health Workers for Delivery of Health Related Millennium Development Goals: A Systematic Review, Country Case Studies, and Recommendations for Integration into National Health Systems (2010)
This report by the Global Health Workforce Alliance and the World Health Organization (WHO) describes the systematic review of community health worker interventions for their impact on Millennium Development Goals undertaken by the WHO. The report also details eight in-depth country case studies in Sub-Saharan Africa, Southeast Asia, and Latin America. Topics covered include typology of community health workers, selection, training, supervision, standards for evaluation and certification, deployment patterns, in-service training, performance, and impact assessment.

Community Health Workers: Key Messages (2010)
This short booklet details key messages developed by the Global Health Workforce Alliance as a result of a study conducted to gather the current evidence on wide-scale use of community health workers. The messages relate to the planning and production process for community health workers, the attraction and retention of this cadre, and performance management of community health workers.

Community-Based Health Workers Can Safely and Effectively Administer Injectable Contraceptives: Conclusion From a Technical Consultation (2009)
This report by WHO, US Agency for International Development, and FHI 360 followed a technical consultation held in 2009. The consultation concluded that evidence supports the introduction, continuation, and scale-up of community-based provision of progestin-only injectable contraceptives. Experts reviewed scientific and programmatic experience, which largely focused on the progestin-only injectable, depot-medroxyprogesterone acetate (DMPA). The experts found that community-based provision of progestin-only injectable contraceptives by appropriately trained community health workers is safe, effective, and acceptable. Such services should be part of a family planning program offering a range of contraceptive methods.

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Planning for Sayana Press introduction

How to Introduce and Scale Up Sayana Press (DMPA-SC in Uniject): Practical Guidance from PATH Based on Lessons Learned During Pilot Introduction (2017)

This document was created to support ministry of health and nongovernmental implementing partners as they develop strategies and activities to introduce and scale up Sayana Press (generic: DMPA-SC in Uniject) in the hopes of expanding the contraceptive method mix and increasing access. Offering women a new, easy-to-access option for injectable contraception promises to transform family planning, especially for women in remote locations. The document provides practical guidance based on results, evidence, and learning from the pilot introductions of Sayana Press in four countries in Africa. It focuses mainly on PATH’s successful experience coordinating introduction of Sayana Press administered by providers. Self-injection was not yet approved or practiced outside a research context in any of the four countries during the pilot phase.

Uganda Sayana Press Introduction Plan Summary (2014)

This executive summary outlines the core elements of Uganda’s pilot introduction plan, including the country’s family planning goals, product registration process, Sayana Press partners and their roles, geographic coverage, and plans for training, end-user communications, and monitoring.

Assessing Demand for depo-subQ in Uniject: A Five-Country Modeling Exercise (2011)
This six-page brief summarizes the strategic demand models developed by PATH and the Futures Institute in Kenya, Malawi, Pakistan, Rwanda, and Senegal. These models will help inform global and country introduction planning for Sayana Press.

The Uniject Injection System: Multi-Country Experience and Evidence (2011)
This four-page brief summarizes key findings from a literature review conducted by PATH to identify published and gray literature reporting international experiences with the Uniject injection system. The findings shed light on user acceptability and highlight potential cost savings in terms of training time, waste management, and reduction in drug wastage when Uniject is used instead of a standard autodisable syringe. This document synthesizes the experience and evidence on the use of Uniject worldwide with medicines such as the injectable contraceptive Cyclofem®, hepatitis B and tetanus toxoid vaccines, as well as the drug oxytocin, which is used to prevent postpartum hemorrhage.

Initial Country Assessments (2009)
These executive summaries reveal findings and recommendations from initial assessments conducted in Bangladesh, Ethiopia, Kenya, Malawi, Nigeria, Pakistan, Rwanda, and Senegal. These countries were evaluated in terms of service delivery and supply systems and stakeholder perspectives with respect to the feasibility and appropriateness of introducing depo-subQ in Uniject (now known as Sayana Press). Executive summaries of the final reports are linked above.