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Background Quality of care is a multidimensional concept that forms an integral part of the uptake and use of modern contraceptive methods. Satisfaction with services is a significant factor in the continued use of services. While much is known about quality of care in the general public health care service, little is known about family planning specific quality of care in South Africa. This paper aims to fill the gap in the research by using the Bruce-Jain family planning quality of care framework. Methods This formative qualitative study was conducted in South Africa, Zambia, and Kenya to explore the uptake of family planning and contraception. The results presented in this paper are from the South African data. Fourteen focus group discussions, twelve with community members and two with health care providers, were conducted along with eight in-depth interviews with key informants. Thematic content analysis using the Bruce-Jain Quality of Care framework was conducted to analyse this data using NVIVO 10. Results Family planning quality of care was defined by participants as the quality of contraceptive methods, attitudes of health care providers, and outcomes of contraceptive use. The data showed that women have limited autonomy in their choice to either use contraception or the method that they might prefer. Important elements that relate to quality of care were identified and described by participants and grouped according to the structural or process components of the framework. Structure-related sub-themes identified included the lack of technically trained providers; integration of services that contributed to long waiting times and mixing of a variety of clients; and poor infrastructure. Sub-themes raised under the process category included poor interpersonal relations; lack of counselling/information exchange, fear; and time constraints. Neither providers nor users discussed follow up mechanisms which is a key aspect to ensure continuity of contraceptive use. Conclusion Using a qualitative methodology and applying the Bruce-Jain Quality of Care framework provided key insights into perceptions and challenges about family planning quality of care. Identifying which components are specific to family planning is important for improving contraceptive outcomes. In particular, autonomy in user choice of contraceptive method, integration of services, and the acceptability of overall family planning care was raised as areas of concern.

Quality family planning and contraceptive (FP/C) services result in positive outcomes such as client satisfaction and sustained use of contraceptives. While most assessments of quality in FP/C services are based on measurable reproductive health outcomes, there is limited consideration of the perspectives and experiences of health providers and community members. This study aimed to address this knowledge gap, by exploring health providers’ and community perspectives on the elements of quality FP/C services in Kabwe district, Zambia. Fourteen focus group discussions and 10 in-depth interviews were conducted in October–December 2016, involving community members, key community stakeholders such as religious and political leaders, health committee members and frontline and managerial healthcare providers. Data were analysed using a thematic approach. According to study participants, quality FP/C services would include provision by skilled personnel with positive attitudes towards clients, availability of preferred methods and affordable products. Additional factors included appropriate infrastructure, especially counselling services spaces and adequate consultation time. Participants stressed the need for reduced waiting time and opportunity for self-expression. The efficiency and effectiveness of service delivery factors, such as information dissemination and community engagement, were also considered important elements of quality FP/C. This study underscores the value of considering both community and health provider perspectives in efforts to improve the quality of FP/C services, with the overall aim of increasing client satisfaction and sustained utilisation. However, service delivery processes must also be addressed in addition to providing for community participation, if quality is to be achieved in FP/C services.

BackgroundChanges in the values, attitudes, and interactions of both service users and health care providers are central to social accountability processes in reproductive health. However, there is little consensus on how best to measure these latent changes. This paper reports on the adaptation and validation of measures that capture these changes in Tanzania and Ghana.MethodsThe CaPSAI theory of change determined the dimensions of the measure, and we adapted existing items for the survey items. Trained data collectors used a survey to collect data from 752 women in Tanzania and 750 women in Ghana attending contraceptive services. We used reliability analysis, exploratory, and confirmatory factor analysis to assess the validity and reliability of these measures in each country.ResultsThe measure has high construct validity and reliability in both countries. We identified several subscales in both countries, 10 subscales in Tanzania, and 11 subscales in Ghana. Many of the domains and items were shared across both settings.ConclusionThe study suggests that the multi-dimensional scales have high construct validity and reliability in both countries. Though there were differences in the two country contexts and in items and scales, there was convergence in the analysis that suggests that this measure may be relevant in different settings and should be validated in new settings.Trial registrationACTRN12619000378123.

ObjectiveTo update a 2016 systematic review on hormonal contraception use and HIV acquisition.MethodsWe searched Pubmed and Embase between 15 January 2016 and 26 June 2019 for longitudinal studies comparing incident HIV infection among women using a hormonal contraceptive method and either non-users or users of another specific hormonal contraceptive method. We extracted information from newly identified studies, assessed study quality, and updated forest plots and meta-analyses.ResultsIn addition to 31 previously included studies, five more were identified; three provided higher quality evidence. A randomised clinical trial (RCT) found no statistically significant differences in HIV risk among users of intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel implant (LNG implant) or the copper intrauterine device (Cu-IUD). An observational study found no statistically significant differences in HIV risk among women using DMPA, norethisterone enanthate (NET-EN), implants (type not specified) or Cu-IUD. Updated results from a previously included observational study continued to find a statistically significant increased HIV risk with oral contraceptives and DMPA compared with no contraceptive use, and found no association between LNG implant and HIV risk.ConclusionsHigh-quality RCT data comparing use of DMPA, LNG implant and Cu-IUD does not support previous concerns from observational studies that DMPA-IM use increases the risk of HIV acquisition. Use of other hormonal contraceptive methods (oral contraceptives, NET-EN and implants) is not associated with an increased risk of HIV acquisition.

Summary Background Observational and laboratory studies suggest that some hormonal contraceptive methods, particularly intramuscular depot medroxyprogesterone acetate (DMPA-IM), might increase women's susceptibility to HIV acquisition. We aimed to compare DMPA-IM, a copper intrauterine device (IUD), and a levonorgestrel (LNG) implant among African women seeking effective contraception and living in areas of high HIV incidence. Methods We did a randomised, multicentre, open-label trial across 12 research sites in eSwatini, Kenya, South Africa, and Zambia. We included HIV-seronegative women aged 16–35 years who were seeking effective contraception, had no medical contraindications to the trial contraceptive methods, agreed to use the assigned method for 18 months, and reported not using injectable, intrauterine, or implantable contraception for the previous 6 months. Participants were randomly assigned (1:1:1) to receive an injection of 150 mg/mL DMPA-IM every 3 months, a copper IUD, or a LNG implant with random block sizes between 15 and 30, stratified by site. Participants were assigned using an online randomisation system, which was accessed for each randomisation by study staff at each site. The primary endpoint was incident HIV infection in the modified intention-to-treat population, including all randomised participants who were HIV negative at enrolment and who contributed at least one HIV test. The primary safety endpoint was any serious adverse event or any adverse event resulting in method discontinuation, until the trial exit visit at 18 months and was assessed in all enrolled and randomly assigned women. This study is registered with ClinicalTrials.gov, number NCT02550067. Findings Between Dec 14, 2015, and Sept 12, 2017, 7830 women were enrolled and 7829 were randomly assigned to the DMPA-IM group (n=2609), the copper IUD group (n=2607), or the LNG implant group (n=2613). 7715 (99%) participants were included in the modified intention-to-treat population (2556 in the DMPA-IM group, 2571 in the copper IUD group, and 2588 in the LNG implant group), and women used their assigned method for 9567 (92%) of 10 409 woman-years of follow-up time. 397 HIV infections occurred (incidence 3·81 per 100 woman-years [95% CI 3·45–4·21]): 143 (36%; 4·19 per 100 woman-years [3·54–4·94]) in the DMPA-IM group, 138 (35%: 3·94 per 100 woman-years [3·31–4·66]) in the copper IUD group, and 116 (29%; 3·31 per 100 woman-years [2·74–3·98]) in the LNG implant group. In the modified intention-to-treat analysis, the hazard ratios for HIV acquisition were 1·04 (96% CI 0·82–1·33, p=0·72) for DMPA-IM compared with copper IUD, 1·23 (0·95–1·59, p=0·097) for DMPA-IM compared with LNG implant, and 1·18 (0·91–1·53, p=0·19) for copper IUD compared with LNG implant. 12 women died during the study: six in the DMPA-IM group, five in the copper IUD group, and one in the LNG implant group. Serious adverse events occurred in 49 (2%) of 2609 participants in the DMPA-IM group, 92 (4%) of 2607 participants in the copper IUD group, and 78 (3%) of 2613 participants in the LNG implant group. Adverse events resulting in discontinuation of the randomly assigned method occurred in 109 (4%) women in the DMPA-IM group, 218 (8%) women in the copper IUD group, and 226 (9%) women in the LNG implant group (p Interpretation We did not find a substantial difference in HIV risk among the methods evaluated, and all methods were safe and highly effective. HIV incidence was high in this population of women seeking pregnancy prevention, emphasising the need for integration of HIV prevention within contraceptive services for African women. These results support continued and increased access to these three contraceptive methods. Funding Bill & Melinda Gates Foundation, US Agency for International Development and the President's Emergency Plan for AIDS Relief, Swedish International Development Cooperation Agency, South African Medical Research Council, and UN Population Fund. Contraceptive supplies were donated by the Government of South Africa and US Agency for International Development.

Background South Africa faces numerous reproductive challenges that include high rates of unplanned and adolescent pregnancies. The uptake and utilization of family planning services and modern contraception methods depend on numerous factors. The male partner plays a key role in reproductive health but data on this topic are outdated or have a predominant HIV prevention focus. The purpose of this paper is to explore the influence of male partners on family planning and contraceptive (FP/C) uptake and use within the contemporary South African setting, and to identify further areas of exploration. Methods This qualitative study was conducted in a community and healthcare provision setting in the eThekwini District in KwaZulu-Natal province, South Africa. Data were collected from twelve community-based focus group discussions (n = 103), two healthcare providers focus group discussions (n = 16), and eight key informant individual in-depth interviews. Following a constructionist paradigm and using the health utilization behaviour model, data were analysed using thematic analysis, allowing a robust and holistic exploration of the data. Results The data from this study revealed the complex and evolving role that male partners play in FP/C uptake and use within this setting. Key themes from the data elucidated the dual nature of male involvement in FP/C use. Culturally influenced gender dynamics and adequate understanding of FP/C information were highlighted as key factors that influenced male attitudes and perceptions about contraceptive use, whether positively or negatively. Male opposition was attributed to limited understanding; misunderstandings about side-effects; male dominance in relationships; and physical abuse. These factors contributed to covert or discontinued use by female partners. Pathways identified through which male partners positively influenced FP/C uptake and access include: social support, adequate information, and shared responsibility. Conclusions Understanding the role that male partners play in FP/C uptake and use is important in preventing unintended pregnancies and improving family planning policy and service delivery programmes. By identifying the barriers that male partners present, appropriate strategies can be implemented. Equally important is identifying how male partners facilitate and promote adherence and use, and how these positive strategies can be incorporated into policy to improve the uptake and use of FP/C.

Background: Social accountability interventions aim to propel change by raising community voices and holding duty bearers accountable for delivering on rights and entitlements. Evidence on the role of such interventions for improving community health outcomes is steadily emerging, including for sexual and reproductive health and rights (SRHR). However, these interventions are complex social processes with numerous actors, multiple components, and a highly influential local context. Unsurprisingly, determining the mechanisms of change and what outcomes may be transferable to other similar settings can be a challenge. We report our methodological considerations to account for complexity in a social accountability intervention exploring contraceptive uptake and use in Ghana and Tanzania. Main Body: The Community and Provider driven Social Accountability Intervention (CaPSAI) study explores the relationship between a health facility-focused social accountability intervention and contraceptive service provision in two countries. This 24-month mixed-method quasi-experimental study, using an interrupted time series with a parallel control group, is being undertaken in 16 sites across Ghana and Tanzania in collaboration with local research and implementation partners. The primary outcomes include changes in contraceptive uptake and use. We also measure outcomes related to current social accountability theories of change and undertake a process evaluation. We present three design components: aspects of co-design, ‘conceptual’ fidelity, and how we aim to track the intervention as ‘intended vs. implemented’ to explore how the intervention could be responsive to the embedded routines, local contextual realities, and the processual nature of the social accountability intervention. Conclusions: Through a discussion of these design components and their rationale, we conclude by suggesting approaches to intervention design that may go some way in responding to recent challenges in accounting for social accountability interventions, bearing relevance for evaluating health system interventions.

Background: There is limited evidence on the impact of the use of progestin-only hormonal contraception (POC) on weight change. We conducted a secondary analysis of prospective weight change among women enrolled in the Evidence for Contraceptive options and HIV Outcomes (ECHO) trial. Methods: The ECHO trial was conducted at 12 sites in eSwatini, Kenya, South Africa and Zambia. HIV negative, women aged 16-35 years, desiring contraception, were randomized (1:1:1) to either 3-monthly intramuscular depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant or copper intrauterine device (IUD). Follow-up was up to 18 months. Weight (kgs) was measured at baseline and study exit. Analysis was performed as intention to treat (ITT) and time on continuous contraceptive use. Findings: 7829 women were randomly assigned to DMPA-IM (n=2609), copper IUD (n=2607) or LNG implant (n=2613). The ITT population included 7014 women 2293 DMPA-IM group, 2372 copper IUD group and 2349 LNG group) who were not lost to follow-up, pregnant on study, or missing weight data. The mean weight increased in all groups but was significantly different in magnitude: 3.5kg (SD=6.3), 2.4kg (SD=5.9) and 1.5kg (SD=5.7) in the DMPA-IM, LNG implant and copper IUD groups, respectively. Comparative differences between groups were (2.02 kg 95% CI, 1.68,2.36, p

Background There is no agreed way to measure the effects of social accountability interventions. Studies to examine whether and how social accountability and collective action processes contribute to better health and healthcare services are underway in different areas of health, and health effects are captured using a range of different research designs. Objectives The objective of our review is to help inform evaluation efforts by identifying, summarizing, and critically appraising study designs used to assess and measure social accountability interventions' effects on health, including data collection methods and outcome measures. Specifically, we consider the designs used to assess social accountability interventions for reproductive, maternal, newborn, child, and adolescent health (RMNCAH). Data sources Data were obtained from the Cochrane Library, EMBASE, MEDLINE, SCOPUS, and Social Policy & Practice databases. Eligibility criteria We included papers published on or after 1 January 2009 that described an evaluation of the effects of a social accountability intervention on RMNCAH. Results Twenty-two papers met our inclusion criteria. Methods for assessing or reporting health effects of social accountability interventions varied widely and included longitudinal, ethnographic, and experimental designs. Surprisingly, given the topic area, there were no studies that took an explicit systems-orientated approach. Data collection methods ranged from quantitative scorecard data through to in-depth interviews and observations. Analysis of how interventions achieved their effects relied on qualitative data, whereas quantitative data often raised rather than answered questions, and/or seemed likely to be poor quality. Few studies reported on negative effects or harms; studies did not always draw on any particular theoretical framework. None of the studies where there appeared to be financial dependencies between the evaluators and the intervention implementation teams reflected on whether or how these dependencies might have affected the evaluation. The interventions evaluated in the included studies fell into the following categories: aid chain partnership, social audit, community-based monitoring, community-linked maternal death review, community mobilization for improved health, community reporting hotline, evidence for action, report cards, scorecards, and strengthening health communities. Conclusions A wide range of methods are currently being used to attempt to evaluate effects of social accountability interventions. The wider context of interventions including the historical or social context is important, as shown in the few studies to consider these dimensions. While many studies collect useful qualitative data that help illuminate how and whether interventions work, the data and analysis are often limited in scope with little attention to the wider context. Future studies taking into account broader sociopolitical dimensions are likely to help illuminate processes of accountability and inform questions of transferability of interventions. The review protocol was registered with PROSPERO (registration # CRD42018108252).

Summary Background As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial's last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment. Methods We did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16–35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067. Findings 2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2·16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4·65%) before PrEP access (adjusted incidence rate ratio [IRR] 0·45, 95% CI 0·25–0·82, p=0·0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5·00 vs 2·29 per 100 person-years; IRR 0·43, 95% CI 0·22–0·88, p=0·012). Interpretation On-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women. Funding Bill & Melinda Gates Foundation, United States Agency for International Development, President's Emergency Plan for AIDS Relief, the Swedish International Development Cooperation Agency, South African Medical Research Council, and United Nations Population Fund.

Globally, increasing efforts have been made to hold duty-bearers to account for their commitments to improve reproductive, maternal, newborn, child and adolescent health (RMNCAH) over the past two decades, including via social accountability approaches: citizen-led, collective processes for holding duty-bearers to account. There have been many individual studies and several reviews of social accountability approaches but the implications of their findings to inform future accountability efforts are not clear. We addressed this gap by conducting a review of reviews in order to summarise the current evidence on social accountability for RMNCAH, identify factors contributing to intermediary outcomes and health impacts, and identify future research and implementation priorities. The review was registered with the International Prospective Register of Systematic Reviews (PROSPERO CRD42019134340). We searched eight databases and systematic review repositories and sought expert recommendations for published and unpublished reviews, with no date or language restrictions. Six reviews were analysed using narrative synthesis: four on accountability or social accountability approaches for RMNCAH, and two specifically examining perinatal mortality audits, from which we extracted information relating to community involvement in audits. Our findings confirmed that there is extensive and growing evidence for social accountability approaches, particularly community monitoring interventions. Few documented social accountability approaches to RMNCAH achieve transformational change by going beyond information-gathering and awareness-raising, and attention to marginalised and vulnerable groups, including adolescents, has not been well documented. Drawing generalisable conclusions about results was difficult, due to inconsistent nomenclature and gaps in reporting, particularly regarding objectives, contexts, and health impacts. Promising approaches for successful social accountability initiatives include careful tailoring to the social and political context, strategic planning, and multi-sectoral/multi-stakeholder approaches. Future primary research could advance the evidence by describing interventions and their results in detail and in their contexts, focusing on factors and processes affecting acceptability, adoption, and effectiveness.

Background Community dialogues have been used in participatory approaches in various health prevention and awareness programs, including family planning interventions, to increase understanding and alignment of particular issues from different peoples’ perspectives. The main objective of this paper is to document the feasibility of a community dialogue approach, which aimed to promote dialogue between healthcare providers and community members. The feasibility testing was part of formative-phase research needed to design an intervention, with the ultimate goal of increasing the uptake of family planning and contraception. The community dialogue intervention generated discussions on key approaches to improve family planning and contraception provision and uptake. Methods Key stages of the community dialogue were undertaken, with representation from healthcare providers and community members. Participants included frontline and managerial health care providers, community health workers, family planning and contraception users, the youth, other stakeholders from the education sector, and civil society. How the dialogue was implemented (operational feasibility) as well as the cultural feasibility of the community dialogue content was evaluated through participant observations during the dialogue, using a standardised feasibility testing tick-list, and through focus group discussions with the stakeholders who participated in the community dialogue. Results Overall, 21 of the 30 invited participants attended the meeting- 70% attendance. The approach facilitated discussions on how quality care could be achieved in family planning and contraception provision, guided by the ground rules that were agreed upon by the different stakeholders. A need for more time for the discussion was noted. Participants also noted the need for more balanced representation from adolescents as well as other family planning stakeholders, such as community members, especially in comparison to healthcare providers. Some participants were not comfortable with the language used. Young people felt older participants used complicated terminologies while community members felt the health care providers outnumbered them, in terms of representation. Conclusion Generally, the community dialogue was well received by the community members and the healthcare providers, as was observed from the sentiments expressed by both categories. Some key considerations for refining the approach included soliciting maximum participation from otherwise marginalized groups like the youth would provide stronger representation.

Background Although community participation has been identified as being important for improved and sustained health outcomes, designing and successfully implementing it in large scale public health programmes, including family planning and contraceptive (FP/C) service provision, remains challenging. Zambian participants in a multi-country project (the UPTAKE project) took part in the development of an intervention involving community and healthcare provider participation in FP/C services provision and uptake. This study reports key thematic areas identified by the study participants as critical to facilitating community participation in this intervention. Methods This was an exploratory qualitative research study, conducted in Kabwe District, Central Province, in 2017. Twelve focus group discussions were conducted with community members (n = 114), two with healthcare providers (n = 19), and ten in-depth interviews with key community and health sector stakeholders. Data were analyzed using a thematic analysis approach. Results Four thematic categories were identified by the participants as critical to facilitating community participation in FP/C services. Firstly, accountability in the recruitment of community participants and incorporation of community feedback in FP/C. programming. Secondly, engagement of existing community resources and structures in FP/C services provision. Thirdly, building trust in FP/C methods/services through credible community-based distributors and promotion of appropriate FP/C methods/services. Fourthly, promoting strategies that address structural failures, such as the feminisation of FP/C services and the lack FP/C services that are responsive to adolescent needs. Conclusions Understanding and considering community members’ and healthcare providers’ views regarding contextualized and locally relevant participatory approaches, facilitators and challenges to participation, could improve the design, implementation and success of participatory public health programmes, including FP/C.

There is a growing body of research on the role of social accountability in bringing about more accessible and better-quality healthcare. Here, we refer to social accountability as “citizens’ efforts at ongoing meaningful collective engagement with public institutions for accountability in the provision of public goods” (Joshi, World Dev 99:160–172, 2017). These processes have multiple interrelated components and sub-processes and engage a range of actors in community-driven, often unpredictable and context-dependent actions, which pose many methodological challenges for researchers. In June 2017, scientists and implementers working in this area came together to share experiences, discuss approaches, identify research gaps and consider directions for future studies. This paper shares learnings from this discussion. In particular, participants considered (1) how best to define and measure the complex processual nature of social accountability; (2) the study of social accountability as an inherently political process; and (3) the challenges of generalising unpredictable, community-driven and context-dependent processes. Key among a range of consensus areas was the need for researchers to capture a broader range of outcomes and better understand the nuances of implementation processes in order to effectively test theories and assumptions. Furthermore, power relationships are inherent in social accountability and the research process itself. In presenting details on these deliberations, we hope to prompt a wider discussion on the study of social accountability in health programming.

We are grateful to Sharon Achilles for her thoughtful input related to describing potential biological mechanisms, and to all study investigators who provided additional information about their analyses. WHO provided support for the writing of this systmatic review and for the writing group to attend a working meeting in Geneva, Switzerland in October 2015. D.J.W. was partially funded by NIH DP2-HD-08-4070. The review was conducted independently of the WHO guidance development process; and conclusions represent the independent opinions of the authors. The findings and conclusions in this article do not necessarily reflect the positions and policies of the donor. Role of authors: The World Health Organization (J.N.K. and P.S.S.) initiated the idea to conduct this systematic review update. C.B.P. led the conduct of the systematic review, including conducting the systematic literature search and drafting the manuscript. C.B.P., K.M.C., and P.C.H. screened titles, abstracts, and full-text manuscripts to determine study inclusion. S.J.P. conducted the statistical meta-analysis. All coauthors (C.B.P., K.M.C., P.C.H., S.J.P., T.C., J.N.K., D.J.W., and P.S.S.) participated in framing the study question, developing the quality criteria, abstracting study information and assessing study quality, interpreting the data, and contributing to the writing and editing of the manuscript. Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official positions of the Guttmacher Institute, the Centers for Disease Control and Prevention, the World Health Organization, the National Institutes of Health, or other institutions with which the authors are affiliated.

Background: There are numerous barriers leading to a high unmet need for family planning and contraceptives (FP/C). These include limited knowledge and information, poor access to quality services, structural inefficiencies in service provision and inadequately trained and supervised health professionals. Recently, social accountability programs have shown promising results in addressing barriers to accessing sexual and reproductive health services. As a highly complex participatory process with multiple and interrelated components, steps and actors, studying social accountability poses methodological challenges. The Community and Provider driven Social Accountability Intervention (CaPSAI) Project study protocol was developed to measure the impact of a social accountability intervention on contraceptive uptake and use and to understand the mechanisms and contextual factors that influence and generate these effects (with emphasis on health services actors and community members). Methods: CaPSAI Project is implementing a social accountability intervention where service users and providers assess the quality of local FP/C services and jointly identify ways to improve the delivery and quality of such services. In the project, a quasi-experimental study utilizing an interrupted time series design with a control group is conducted in eight intervention and eight control facilities in each study country, which are Ghana and Tanzania. A cross-sectional survey of service users and health care providers is used to measure social accountability outcomes, and a cohort of women who are new users of FP/C is followed up after the completion of the intervention to measure contraceptive use and continuation. The process evaluation utilizes a range of methods and data sources to enable a fuller description of how the findings were produced. Conclusion: This complex study design could provide researchers and implementers with the means to better measure and understand the mechanisms and contextual factors that influence social accountability processes in reproductive health, adding important findings to the evidence base.

Background Community dialogues have been widely used as a method for community engagement and participation to cover a broad range of areas. However, there has been limited documentation and evaluation of the process, particularly as a method towards achieving family planning and contraception (FP/C) programme goals. As part of the development of an intervention package aimed at increasing community and health care provider (HCP) participation in the provision of FP/C, feasibility testing of the intervention approach (a community dialogue between communities and health facilities) was carried out. Our findings offer a systematic description and evaluation of the community dialogue process, with key recommendations towards future implementation. Methods The dialogue was evaluated in three ways: 1) through participant observation during the community dialogue, 2) via a standardised feasibility testing tick-list for all observers of the dialogue, and 3) through three focus group discussions (FGDs) consisting of different groups of stakeholders who participated in the community dialogue. In total, 28 community members, HCPs, and key stakeholders attended the community dialogue (22 females, 6 males). Twenty-seven of the community dialogue participants participated in one of 3 FGDs held after the dialogue. Six evaluators assessed feasibility of the dialogue process. Results There was good attendance, representation and participation amongst community and provider sectors based on the participant observations using the standardized feasibility check-list. The community dialogue process received positive feedback in the FGDs and was demonstrated to be feasible and acceptable. Key factors contributing to the success of the community dialogue included a skilled facilitator, good representation of participants, establishing ground rules, good timekeeping, and using a Theory of Change to facilitate goal identification and dialogue. Issues to consider are the underlying power differentials related to age, profession and gender which caused initial feelings of anxiety amongst some participants. Conclusions Our formative findings offer a systematic description and evaluation of a community dialogue process with key recommendations that may be considered when constituting similar community dialogues in the future.

Access to safe and effective contraceptive choices is a reproductive right and contributes tremendously to improvements in maternal and child health. Progestin-only injectables, particularly intramuscularly injected depot medroxyprogesterone acetate (DMPA-IM), have received increased attention given findings suggesting a potential association with increased HIV risk. For women at high risk of HIV, the World Health Organization's Medical eligibility criteria for contraceptive use currently aggregate recommendations for all progestin-only injectables, including DMPA-IM, subcutaneously injected DMPA (DMPA-SC) and intramuscularly injected norethindrone/ norethisterone enanthate (NET-EN), except in the case of some drug interactions. We considered whether published data indicate differences or similarities between these injectables relevant to risk of acquiring HIV. In vitro data confirm different biological activities of these distinct progestins, including that MPA, and not NET, binds and activates the glucocorticoid receptor resulting in different biological effects relevant to immune function. Limited clinical data suggest changes in immunologic activity following DMPA-IM and NET-EN initiation, but interstudy variation and study design differences diminish ability to determine clinical relevance and the degree to which DMPA-IM and NET-EN could act differentially. The highest-quality epidemiologic studies suggest a potential 40% increase in HIV incidence in users of DMPA-IM relative to women not using hormonal contraception but no significant increase in risk in users of NET-EN. In our opinion, most of the available biologic activity and epidemiologic data indicate that DMPA and NET-EN are likely to act differently, and data remain too limited to evaluate differences between DMPA-IM and DMPA-SC.

Background Unmet need for contraception results in several health challenges such as unintended pregnancies, unwanted births and unsafe abortions. Most interventions have been unable to successfully address this unmet need due to various community and health system level factors. Identifying these inhibiting and enabling factors prior to implementation of interventions forms the basis for planning efforts to increase met needs. This qualitative study was part of the formative phase of a larger research project that aimed to develop an intervention to increase met needs for contraception through community and health system participation. The specific study component reported here explores barriers and enablers to family planning and contraceptive services provision and utilisation at community and health systems levels. Methods Twelve focus group discussions were conducted with community members (n = 114) and two with healthcare providers (n = 19). Ten in-depth interviews were held with key stakeholders. The study was conducted in Kabwe district, Zambia. Interviews/discussions were translated and transcribed verbatim. Data were coded and organised using NVivo 10 (QSR international), and were analysed using thematic analysis. Results Health systems barriers include long distances to healthcare facilities, stock-outs of preferred methods, lack of policies facilitating contraceptive provision in schools, and undesirable provider attitudes. Community level barriers comprise women’s experience with contraceptive side effects, myths, rumours and misconceptions, societal stigma, and negative traditional and religious beliefs. On the other hand, health systems enablers consist of political will from government to expand contraceptive services access, integration of contraceptive services, provision of couples counselling, and availability of personnel to offer basic methods mix. Functional community health system structures, community desire to delay pregnancy, and knowledge of contraceptive services are enablers at a community level. Conclusions These study findings highlight key community and health systems factors that should be considered by policy, program planners and implementers in the design and implementation of family planning and contraceptive services programmes, to ensure sustained uptake and increased met needs for contraceptive methods and services. Electronic supplementary material The online version of this article (10.1186/s12913-018-3136-4) contains supplementary material, which is available to authorized users.

BACKGROUND: Women who undergo a cesarean section (CS) are in a unique position to receive the intrauterine contraceptive device (IUD). They may also want to use the IUD as a long-acting reversible contraceptive method provided the IUD is safe and effective in the presence of a CS scar. SEARCH STRATEGY: We researched and reviewed the MEDLINE POPLINE Google Scholar and ClinicalTrials.gov databases from January 1968 to June 2015. SELECTION CRITERIA: Eligible studies reported event rates or practical problems relating to IUD usage in post-placental or interval insertion (>90 days) after CS. Studies with >/=20 subjects were included. DATA COLLECTION AND ANALYSIS: Analysis of eligible data collected from the search followed the PRISMA guidelines. MAIN RESULTS: Twelve eligible studies of post-placental IUD insertion after CS included four randomized controlled trials of post-placental versus delayed insertion. Women randomized to delayed insertion were less likely to receive a device. Six studies examined the problem of missing IUD threads at follow-up with only 30%-60% presence of strings observed. CONCLUSION: The IUD is a long-acting reversible contraceptive method that is suitable for use in all women undergoing CS. The problems of device expulsion missing threads at follow-up and the tendency of increased puerperal bleeding need to be solved. Solutions are proposed.

Whether use of various types of hormonal contraception (HC) affect risk of HIV acquisition is a critical question for women's health. For this systematic review, we identified 22 studies published by January 15, 2014 which met inclusion criteria; we classified thirteen studies as having severe methodological limitations, and nine studies as "informative but with important limitations". Overall, data do not support an association between use of oral contraceptives and increased risk of HIV acquisition. Uncertainty persists regarding whether an association exists between depot-medroxyprogesterone acetate (DMPA) use and risk of HIV acquisition. Most studies suggested no significantly increased HIV risk with norethisterone enanthate (NET-EN) use, but when assessed in the same study, point estimates for NET-EN tended to be larger than for DMPA, though 95% confidence intervals overlapped substantially. No data have suggested significantly increased risk of HIV acquisition with use of implants, though data were limited. No data are available on the relationship between use of contraceptive patches, rings, or hormonal intrauterine devices and risk of HIV acquisition. Women choosing progestin-only injectable contraceptives such as DMPA or NET-EN should be informed of the current uncertainty regarding whether use of these methods increases risk of HIV acquisition, and like all women at risk of HIV, should be empowered to access and use condoms and other HIV preventative measures. Programs, practitioners, and women urgently need guidance on how to maximize health with respect to avoiding both unintended pregnancy and HIV given inconclusive or limited data for certain HC methods.

Background. Women with diabetes mellitus type I and type II need effective contraception for personal and medical reasons. Long acting reversible contraceptive (LARC) methods are among the most efficient and cost-effective methods. Study Design. We searched the Popline, PubMed, and clinicaltrials.gov databases from 1961 to March 2013 for studies on the efficacy of the IUD in diabetic women and the possible changes it may produce in laboratory parameters. Studies of at least 30 subjects with DM1 or DM2 who were studied for 6 to 12 months depending on the method of analysis were eligible. Results. The search produced seven articles which gave event rate efficacy evaluable results and three which evaluated the effect of the IUD on laboratory parameters. One of the earlier efficacy studies showed an abnormally high pregnancy rate which sparked a controversy which is discussed in the Introduction section. The remaining 6 studies produced acceptable pregnancy rates. The three laboratory studies showed that the copper and levonorgestrel releasing IUD/IUS do not affect the diabetic state in any way. Conclusions. The copper bearing and levonorgestrel releasing IUDs are safe and effective in women with diabetes type I and diabetes type II although the evidence in the latter is limited.

Background All postpartum women, including those who are breastfeeding or have had a cesarean section, appear potentially suited to intrauterine contraception, a long acting reversible contraceptive (LARC). Like any other method used after delivery, it should not interfere with lactation or be affected by cesarean section. Study design We searched the MEDLINE, PubMed, Popline, Google Scholar, and Clinicaltrials.gov databases from January 1968 through to December 2012. Studies were included if they reported event rates in women who had a cesarean section and event rates and clinical outcomes in lactating women or their infants in the breastfeeding group. Summary odds ratios were not calculated because of the diverse methods of reporting event rates in the cesarean section group and the heterogeneity of the results in the breastfeeding group. Results We found 26 articles on event rates in interval and post-placental intrauterine device (IUD) use, and 18 on event rates and clinical outcomes in breastfeeding IUD users. Four prospective studies and one retrospective study showed an increased expulsion rate in interval insertion. There were 19 studies, of which five were controlled in post-placental IUD insertion after cesarean section. Four studies had expulsion rates of 10 or more per 100 woman-years of use and 15 expulsion rates below 10 per 100 woman-years of use. Three studies showed that event rates for lactating IUD users are the same as those for non-lactating users. Fifteen controlled studies showed that the IUD had no effect on milk production and seven of these showed no effect on infant growth. Pharmacovigilance databases report an increased rate of IUD perforations in lactating women, while the event rate studies report that insertion is generally easier and less painful than expected. These were uncontrolled reports. Conclusion The IUD is a long-acting reversible method of contraception with expulsion rates of 5–15 per 100 woman-years of use when used as a post-placental method immediately after cesarean section. As an interval procedure (6 or more weeks after cesarean section) it appears to have a high expulsion rate (5% or higher) notably in older devices. The IUD does not affect breastfeeding and is easy to insert in these women, but appears to be associated with a higher perforation rate (>1 per 100). Providers should not be deterred from using this contraception method, especially in developing countries, but should be attentive to preventing these potential problems.

Recent articles by Ralph et al. [1,2] and Gollub and Stein [3], as well as an accompanying commentary by Jones [4] in the current issue of Contraception, have challenged the concept of conducting a randomized trial to determine whether injectable depot medroxyprogesterone acetate (DMPA) increases the risk of HIV acquisition. They all raise concerns about the evidence, the methodology, the ethics, the feasibility and the return on investment of such an undertaking. While those authors acknowledge the uncertainty of the evidence regarding the effect of hormonal contraception, particularly DMPA, on increased HIV risk, they argue that the observational data are of sufficiently high quality to inform women of the potential risks and recommend against investing in a randomized trial to answer the question. The widespread use of DMPA in areas of high HIV incidence means that the issue of whether DMPA increases HIV susceptibility relative to other methods is of major global health importance and requires the strongest evidence possible to resolve any uncertainty. As members of the multiorganizational collaborative team called ECHO (Evidence for Contraceptive Options and HIV Outcomes), we are currently developing a protocol for a randomized trial of contraception and HIV acquisition. In this Commentary, we consider the evidence, ethics and feasibility of a possible experimental design. First is the quality of the current observational evidence. In February 2012, a World Health Organization (WHO) expert panel reviewed all the available studies on hormonal

Background: In vitro, animal, biological and observational clinical studies suggest that some hormonal methods, particularly depot medroxyprogesterone acetate – DMPA, may increase women’s risk of HIV acquisition. DMPA is the most common contraceptive used in many countries worst affected by the HIV epidemic. To provide robust evidence for contraceptive decision-making among women, clinicians and planners, we are conducting the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study in four countries with high HIV incidence and DMPA use: Kenya, South Africa, Swaziland, and Zambia (Clinical Trials.gov identifier NCT02550067). Study design: We randomized HIV negative, sexually active women 16-35 years old requesting effective contraception and agreeing to participate to either DMPA, the copper T 380A intrauterine device or levonorgestrel implant. Participants attend a contraception support visit after 1 month and quarterly visits thereafter for up to 18 months. Participants receive a standard HIV prevention package and contraceptive side-effect management at each visit. The primary outcome is HIV seroconversion. Secondary outcomes include pregnancy, serious adverse events and method discontinuation. The sample size of 7800 women provides 80% power to detect a 50% relative increase in HIV risk between any of the three method pairs, assuming 250 incident infections per comparison. Ethical considerations: Several WHO consultations have concluded that current evidence on HIV risk associated with DMPA is inconclusive and that a randomized trial is needed to guide policy, counselling and choice. Previous studies suggest that women without a specific contraceptive preference are willing to accept randomization to different contraceptive methods. Stringent performance standards are monitored by an independent data and safety monitoring board approximately every 6 months. The study has been conducted with extensive stakeholder engagement. Conclusions: The ECHO study is designed to provide robust evidence on the relative risks (HIV acquisition) and benefits (pregnancy prevention) between three effective contraceptive methods.

The objective of the present study is to investigate the effect of skills training on knowledge and attitudes of post-placental intra-uterine device (PPIUD) use, including the uptake thereof, and suggest training proposals. In-service skills training, alongside departmental protocol implementation, on PPIUD insertions were offered to healthcare professionals at Tygerberg Hospital, South Africa. Training was based on The postpartum intrauterine device. A training course for service providers, participant handbook from EngenderHealth (New York, NY, USA). Participants completed a questionnaire at enrolment and after 6 months to assess their knowledge and attitude towards PPIUD use. Most participants reported having the necessary skills to fulfil their family planning responsibilities (Ppost-partum women (P=0.03), especially those who desire no more children (P=0.05), resulting in more participants providing IUDs (P=0.03) that could be attributed to the increased availability of reference material, i.e. training materials (P=0.02) and protocols (P=0.02). In conclusion, in-service PPIUD skills training guided by local protocol implementation resulted in an improvement of self-reported competency, counselling and PPIUD insertion. Repeated training with adequate supervision is imperative.

As efforts to address unmet need for family planning and contraception (FP/C) accelerate, voluntary use, informed choice and quality must remain at the fore. Active involvement of affected populations has been recognized as one of the key principles in ensuring human rights in the provision of FP/C and in improving quality of care. However, community participation continues to be inadequately addressed in large-scale FP/C programmes. Community and healthcare providers’ unequal relationship can be a barrier to successful participation. This scoping review identifies participatory approaches involving both community and healthcare providers for FP/C services and analyzes relevant evidence. The detailed analysis of 25 articles provided information on 28 specific programmes and identified three types of approaches for community and healthcare provider participation in FP/C programmes. The three approaches were: (i) establishment of new groups either health committees to link the health service providers and users or implementation teams to conduct specific activities to improve or extend available health services, (ii) identification of and collaboration with existing community structures to optimise use of health services and (iii) operationalization of tools to facilitate community and healthcare provider collaboration for quality improvement. Integration of community and healthcare provider participation in FP/C provision were conducted through FP/C-only programmes, FP/C-focused programmes and/or as part of a health service package. The rationales behind the interventions varied and may be multiple. Examples include researcher-, NGO- or health service-initiated programmes with clear objectives of improving FP/C service provision or increasing demand for services; facilitating the involvement of community members or service users and, in some cases, may combine socio-economic development and increasing self-reliance or control over sexual and reproductive health. Although a number of studies reported increase in FP/C knowledge and uptake, the lack of robust monitoring and evaluation mechanisms and quantitative and comparable data resulted in difficulties in generating clear recommendations. It is imperative that programmes are systematically designed, evaluated and reported.

Unintended pregnancy (UIP) poses considerable humanistic and economic burden in both developed and developing countries. In the analysis described here, we evaluate the costs of unintended pregnancies based on estimates in South Africa. To estimate the burden of UIP, a decision-analytic model was developed using probabilities for pregnancy related outcomes related to UIPs in a single year, which included miscarriage, ectopic pregnancy, abortion and live birth. Costs to the public health system were estimated for each birth outcome. We estimated 636,040 annual unintended pregnancies. The annual maternal deaths were estimated to be 1134 of which 219 (19.3%) are attributed to abortions and 915 (80.7%) attributed to complications from miscarriages, ectopic pregnancies and deliveries. The costs attributed to UIP birth outcomes accounted for 3.42 billion Rand annually. Annual costs of UIP live births were estimated to be 82.8% of the total costs with abortion and miscarriage accountable for 8.3% and 8.4% of costs, respectively. In conclusion, despite weaknesses of modelling approaches in healthcare, we believe that our findings here will support further preventative initiatives in South Africa and more broadly to improve access to affordable and effective contraception.

Purpose To evaluate whether the updated South African national contraception policy and guidelines adequately address the needs of adolescents. Methods We used the World Health Organization (WHO) guidance and recommendations on ensuring human rights in the provision of contraceptive information and services as an analytic framework. We assessed the South African policy in relation to each WHO summary recommendation. Specifically, we determined where normative guidance pertaining to adolescents is present and whether it is adequate, normative guidance pertaining to all populations but not specifically adolescents is present, or normative guidance for that recommendation is missing from the policy. We developed an analytic table to discuss with coauthors and draw conclusions. Results We found specific guidance for adolescents relating to 6/9 WHO summary recommendations and 11/24 subrecommendations. Adolescents are highlighted throughout the policy as being at risk for discrimination or coercion, and laws protecting the rights of adolescents are cited. Confidentiality of services for young people is emphasized, and youth-friendly services are described as a key element of service delivery. Areas to strengthen include the need for normative guidance ensuring both availability of contraceptive information and services for young people and adolescent participation in development of community programs and services. Conclusions South Africa's contraception policy and guidelines are comprehensive and forward looking. Nevertheless, there are gaps that may leave adolescents vulnerable to discrimination and coercion and create barriers to accessing contraceptive services. These findings provide insight for the revision and development of adolescent health policies in South Africa and other settings.

Multicountry teamwork in qualitative research is receiving increased recognition in an attempt to address global health problems. We report our experience of teamwork implementing a multicountry st...

Women living with HIV are often of reproductive age, and many desire effective contraceptive options to delay or prevent pregnancy. We review the safety of various hormonal and non-hormonal contraceptive methods for women living with human immunodeficiency virus (HIV). Additionally, we discuss drug interactions between contraceptive methods and antiretrovirals and the safety of methods with respect to onward transmission to HIV-negative partners for women in sero-discordant partnerships. In general, most methods are safe for most women living with HIV. An understanding of the reproductive goals of each individual patient, as well as her medical condition and medication, should be taken into account when counselling women on their contraceptive options. Further research is needed to understand drug interactions between contraceptives and antiretrovirals better and how to fulfil the contraceptive needs of HIV-positive women.

The provision of contraception to adolescents requires specific attention. Adolescents require contraceptive methods which are safe, effective and simple to use. While long-acting reversible contraceptive methods are preferable, they should have a choice and not be forced or mandated especially in situations where this may compromise safety. After counselling they should have the ability to choose any method of contraception. Under the appropriate circumstances, each method of contraception may have a place. This chapter will be devoted to evaluating the most current scientific rationale for the indication for use of each method of contraception in adolescents.

Objectives This study aims to systematically review evidence published on the safety of Sino-implant (II) [SI (II)] among women with medical conditions or characteristics identified by the World Health Organization for eligibility for contraceptive use. Study design We searched PubMed, WEIPU, CNKI and Wanfang to identify all relevant evidence published in peer-reviewed journals from 1991 through 2014 regarding the safety of SI (II). We considered studies among women with medical conditions or other characteristics, such as age and parity, as direct evidence and studies among healthy women or a general population of women as indirect evidence. Results We identified 108 articles of which 9 met our inclusion criteria. Among women with medical conditions, no evidence was identified for the outcomes of interest, including serious adverse events or outcomes related to medical conditions. Among healthy women, evidence regarding efficacy of SI (II) for women weighing ≥ 70 kg was conflicting; one study showed an increased pregnancy rate and another showed no relationship. Women with menorrhagia did not experience worsened symptoms and may benefit from SI (II) use. Healthy women using SI (II) were no more likely than users of other methods to gain weight, develop elevated blood pressure, have abnormal liver or bone density tests or develop ovarian cysts or uterine myomas. Conclusions Evidence among healthy women suggests SI (II) is safe and had health outcomes similar to those of other levonorgestrel implants. Studies were limited and conflicting regarding efficacy for women ≥ 70 kg. All included studies were conducted in China, limiting generalizability.