Safety, Quality, and Acceptability of Contraceptive Implant Provision by Community Health Extension Workers versus Nurses and Midwives in Two States in Nigeria.

Task sharing is a strategy with potential to increase access to effective modern contraceptive methods. This study examines whether community health extension workers (CHEWs) can insert contraceptive implants to the same safety and quality standards as nurse/midwives. We analyze data from 7,691 clients of CHEWs and nurse/midwives who participated in a noninferiority study conducted in Kaduna and Ondo States, Nigeria. Adverse events (AEs) following implant insertions were compared. On the day of insertion AEs were similar among CHEW and nurse/midwife clients-0.5 percent and 0.4 percent, adjusted odds ratio (aOR) 0.92 (95 percent CI 0.38-2.23)-but noninferiority could not be established. At follow-up 6.6 percent of CHEW clients and 2.1 percent of nurse/midwife clients experienced AEs. There was strong evidence of effect modification by State. In the final adjusted model, odds of AEs for CHEW clients in Kaduna was 3.34 (95 percent CI 1.53-7.33) compared to nurse/midwife clients, and 0.72 (95 percent CI 0.19-2.72]) in Ondo. Noninferiority could not be established in either State. Implant expulsions were higher among CHEW clients (142/2987) compared to nurse/midwives (40/3517). Results show the feasibility of training CHEWs to deliver implants in remote rural settings but attention must be given to provider selection, training, supervision, and follow-up to ensure safety and quality of provision.

Safety, Quality, and Acceptability of Contraceptive Subdermal Implant Provision by Community Health Extension Workers Versus Nurses and Midwives in Nigeria: Protocol for a Quasi-Experimental, Noninferiority Study.

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

Comparing Effectiveness of Active and Passive Client Follow-Up Approaches in Sustaining the Continued Use of Long Acting Reversible Contraceptives (LARC) in Rural Punjab: A Multicentre, Non-Inferiority Trial.

BACKGROUND: The use of long-acting reversible contraceptive (LARC) methods is very low in Pakistan with high discontinuation rates mainly attributed to method-related side effects. Mixed evidence is available on the effectiveness of different client follow-up approaches used to ensure method continuation. We compared the effectiveness of active and passive follow-up approaches in sustaining the use of LARC-and within 'active' follow-up, we further compared a telephone versus home-based approach in rural Punjab, Pakistan. METHODS: This was a 12-month multicentre non-inferiority trial conducted in twenty-two (16 rural- and 6 urban-based) franchised reproductive healthcare facilities in district Chakwal of Punjab province, between November 2013 and December 2014. The study comprised of three groups of LARC clients: a) home-based follow-up, b) telephone-based follow-up, and c) passive or needs-based follow-up. Participants in the first two study groups received counselling on scheduled follow-up from the field workers at 1, 3, 6, 9, and 12 month post-insertion whereas participants in the third group were asked to contact the health facility if in need of medical assistance relating to LARC method use. Study participants were recruited with equal allocation to each study group, but participants were not randomized. The analyses are based on 1,246 LARC (intra-uterine contraceptive device and implant) users that completed approximately 12-months of follow-up. The non-inferiority margin was kept at five percentage points for the comparison of active and passive follow-up and six percentage points for telephone and home-based approach. The primary outcome was cumulative probability of method continuation at 12-month among LARC users. RESULTS: Women recruited in home-based, telephone-based, and passive groups were 400, 419 and 427, respectively. The cumulative probability of LARC continuation at 12 month was 87.6% (95% CI 83.8 to 90.6) among women who received home-based follow-up; 89.1% (95% CI 85.7, 91.8) who received telephone-based follow-up; and 83.8% (95% CI 79.8 to 87.1) who were in the passive or needs-based follow-up group. The probability of continuation among women who were actively followed-up by field health educators-either through home-based visit or telephone-based follow-up was, 88.3% (95% CI 85.9 to 90.0). An adjusted risk difference of -4.1 (95% CI -7.8 to -0.28; p-value = 0.035) was estimated between active and passive follow-up. Whereas, within the active client follow-up, the telephone-based follow-up was found to be as effective as the home-based follow-up with an adjusted risk difference of 1.8 (95% CI -2.7 to 6.4; p-value = 0.431). CONCLUSION: A passive follow-up approach was 5% inferior to an active follow-up approach; whereas telephone-based follow-up was as effective as the home-based visits in sustaining the use of LARC, and was far more resource efficient. Therefore, active follow-up could improve method continuation especially in the critical post-insertion period.

Engaging with community-based public and private mid-level providers for promoting the use of modern contraceptive methods in rural Pakistan: results from two innovative birth spacing interventions.

BACKGROUND: Family planning (FP) interventions aimed at reducing population growth have negligible during the last two decades in Pakistan. Innovative FP interventions that help reduce the growing population burden are the need of the hour. Marie Stopes Society--Pakistan implemented an operational research project--'Evidence for Innovating to Save Lives', to explore effective and viable intervention models that can promote healthy timing and spacing of pregnancy in rural and under-served communities of Sindh, Punjab and Khyber Pakhtunkhwa provinces of Pakistan. METHODS: We conducted a quasi-experimental (pre- and post-intervention with control arm) study to assess the effectiveness of each of the two intervention models, (1) Suraj model (meaning 'Sun' in English), which uses social franchises (SF) along with a demand-side financing (DSF) approach using free vouchers, and (2) Community Midwife (CMW) model, in promoting the use of modern contraceptive methods compared to respective controls. Baseline and endline cross-sectional household surveys were conducted, 24 months apart, by recruiting 5566 and 6316 married women of reproductive age (MWRA) respectively. We used Stata version 8 to report the net effect of interventions on outcome indicators using difference-in-differences analysis. Multivariate Cox proportional hazard regression analysis was used to assess the net effect of the intervention on current contraceptive use, keeping time constant and adjusting for other variables in the model. RESULTS: The Suraj model was effective in significantly increasing awareness about FP methods among MWRA by 14% percentage points, current contraceptive use by 5% percentage points and long term modern method--intrauterine device (IUD) use by 6% percentage points. The CMW model significantly increased contraceptive awareness by 28% percentage points, ever use of contraceptives by 7% percentage points and, IUD use by 3% percentage points. Additionally the Suraj intervention led to a 35% greater prevalence (prevalence ratio: 1.35, 95% CI: 1.22-1.50) of contraceptive use among MWRA. CONCLUSION: Suraj intervention highlights the importance of embedding subsidized FP services within the communities of the beneficiaries. The outcomes of the CMW intervention also improved the use of long-term contraceptives. These findings indicate the necessity of designing and implementing FP initiatives involving local mid-level providers to expand contraceptive coverage in under-served areas.

Family Planning Knowledge, Attitudes, and Practices among Married Men and Women in Rural Areas of Pakistan: Findings from a Qualitative Need Assessment Study.

This paper presents the findings of a qualitative assessment aimed at exploring knowledge, attitudes, and practices regarding family planning and factors that influence the need for and use of modern contraceptives. A descriptive exploratory study was conducted with married women and men aged between 15 and 40. Overall, 24 focus group discussions were conducted with male and female participants in three provinces of Pakistan. The findings reveal that the majority knew about some modern contraceptive methods, but the overall contraceptive use was very low. Knowledge and use of any contraceptive method were particularly low. Reasons for not using family planning and modern contraception included incomplete family size, negative perceptions, in-laws' disapproval, religious concerns, side-effects, and lack of access to quality services. The majority preferred private facilities over the government health facilities as the later were cited as derided. The study concluded the need for qualified female healthcare providers, especially for long term family planning services at health facilities instead of camps arranged occasionally. Addressing issues around access, affordability, availability, and sociocultural barriers about modern contraception as well as involving men will help to meet the needs and ensure that the women and couples fulfill their childbearing and reproductive health goals.

Private-Sector Social Franchising to Accelerate Family Planning Access, Choice, and Quality: Results From Marie Stopes International.

BACKGROUND: To achieve the global Family Planning 2020 (FP2020) goal of reaching 120 million more women with voluntary family planning services, rapid scale-up of services is needed. Clinical social franchising, a service delivery approach used by Marie Stopes International (MSI) in which small, independent health care businesses are organized into quality-assured networks, provides an opportunity to engage the private sector in improving access to family planning and other health services. METHODS: We analyzed MSI's social franchising program against the 4 intended outputs of access, efficiency, quality, and equity. The analysis used routine service data from social franchising programs in 17 African and Asian countries (2008-2014) to estimate number of clients reached, couple-years of protection (CYPs) provided, and efficiency of services; clinical quality audits of 636 social franchisees from a subset of the 17 countries (2011-2014); and exit interviews with 4,844 clients in 14 countries (2013) to examine client satisfaction, demographics (age and poverty), and prior contraceptive use. The MSI "Impact 2" model was used to estimate population-level outcomes by converting service data into estimated health outcomes. RESULTS: Between 2008 and 2014, an estimated 3,753,065 women cumulatively received voluntary family planning services via 17 national social franchise programs, with a sizable 68% choosing long-acting reversible contraceptives (LARCs). While the number of social franchisee outlets increased over time, efficiency also significantly improved over time, with each outlet delivering, on average, 178 CYPs in 2008 compared with 941 CYPs in 2014 (P = .02). Clinical quality audit scores also significantly improved; 39.8% of social franchisee outlets scored over 80% in 2011 compared with 84.1% in 2014. In 2013, 40.7% of the clients reported they had not been using a modern method during the 3 months prior to their visit (95% CI = 37.4, 44.0), with 46.1% (95% CI = 40.9, 51.2) of them reporting having never previously used family planning at all. Analysis of age and poverty levels of clients indicate mixed results in bridging equity gaps: 57.4% of clients lived on under US$2.50/day in 2013 (95% CI = 54.9, 60.0) and 26.1% were 15-24 years old (95% CI = 23.8, 28.4), but only 15.1% lived on less than $1.25/day (95% CI = 13.8, 16.4) and 5.0% were 15-19 years old (95% CI = 3.9, 6.1). The services provided via social franchising are estimated to avert 4,958,000 unintended pregnancies and 7,150 maternal deaths. CONCLUSION: Social franchising through the existing private sector has the ability to rapidly scale-up access to high-quality family planning services, including LARCs, for the general population as well as young women and the poor, providing a promising model to help achieve the global FP2020 goal.

Comparing effectiveness of two client follow-up approaches in sustaining the use of Long Acting Reversible Contraceptives (LARC) among the underserved in rural Punjab, Pakistan: a study protocol and participants' profile.

BACKGROUND: Pakistan observes a very high i.e. 37 percent modern contraceptive method related discontinuation rates within 12 months of their initiation. And almost 10 percent of these episodes of discontinuation happened due to the side effects or health concerns experienced by the women. Most importantly, it was noted that more than 12,000 first-level care facilities are located in the rural areas, including rural health centers, basic health units, and family welfare centers, but more than 30% of these facilities are nonfunctional. This paper presents a study protocol and participants' profiling of a prospective cohort follow-up to compare the effectiveness of household based and telephonic approaches in sustaining the use of Long Acting Reversible Contraceptives (LARC) whilst to facilitate lowering method related discontinuation and increasing switching amongst the contraceptive users. METHODS: A 12-month multi-centre, non-inferiority prospective user follow-up is employed using three different study categories: a) household based follow-up; b) telephonic follow-up; and c) passive or need-based follow-up along with the hypothetical assumption that the telephonic client follow-up is not inferior to the household based follow-up by continuation rate of LARC and the telephonic follow-up is less-costly than the household based client follow-up. This follow-up will be conducted in 22 health facilities - (16 rural and 6 urban based facilities) in district Chakwal. The first two study categories will receive scheduled but different follow-up from the field workers at 1, 3, 6, 9, and 12 month while the third one i.e. the 'passive or need-based follow-up' will serve as a control group. Using sampling software PASS 11, it was estimated to have 414 clients in each study category and around 1366 clients will be recruited to account for 10% attrition rate. DISCUSSION: The study will help us to examine a more convenient method of effective follow-up for managing side effects, decreasing method discontinuation and increasing switching amongst users. The study information will also facilitate to develop a robust, effective and efficient mechanism for client follow-up to promote the continuation rates of LARC methods. The follow-up results and lessons learnt will be widely shared with stakeholders for their implementation and streamlining in health system.

Assessing predictors of contraceptive use and demand for family planning services in underserved areas of Punjab province in Pakistan: results of a cross-sectional baseline survey.

BACKGROUND: Although Pakistan was one of the first countries in Asia to launch national family planning programs, current modern contraceptive use stands at only 26% with a method mix skewed toward short-acting and permanent methods. As part of a multiyear operational research study, a baseline survey was conducted to understand the predictors of contraceptive use and demand for family planning services in underserved areas of Punjab province in Pakistan. This paper presents the baseline survey results; the outcomes of the intervention will be presented in a separate paper after the study has been completed. METHOD: A cross-sectional baseline household survey was conducted with randomly selected 3,998 married women of reproductive age (MWRA) in the Chakwal, Mianwali, and Bhakkar districts of Punjab. The data were analyzed on SPSS 17.0 using simple descriptive and logistic regression. RESULTS: Most of the women had low socio-economic status and were younger than 30 years of age. Four-fifths of the women consulted private sector health facilities for reproductive health services; proximity, availability of services, and good reputation of the provider were the main predicators for choosing the facilities. Husbands were reported as the key decision maker regarding health-seeking and family planning uptake. Overall, the current contraceptive use ranged from 17% to 21% across the districts: condoms and female sterilization were widely used methods. Woman's age, husband's education, wealth quintiles, spousal communication, location of last delivery, and favorable attitude toward contraception have an association with current contraceptive use. Unmet need for contraception was 40.6%, 36.6%, and 31.9% in Chakwal, Mianwali, and Bhakkar, respectively. Notably, more than one fifth of the women across the districts expressed willingness to use quality, affordable long-term family planning services in the future. CONCLUSION: The baseline results highlight the need for quality, affordable long-term family planning services close to women's homes. Furthermore, targeted community mobilization and behavior change efforts can lead to increased awareness, acceptability, and use of family planning and birth spacing services.

Continuation rates and reasons for discontinuation of intra-uterine device in three provinces of Pakistan: results of a 24-month prospective client follow-up.

BACKGROUND: Long-acting reversible contraceptives, such as the intrauterine device (IUD), remain underutilised in Pakistan with high discontinuation rates. Based on a 24-month prospective client follow-up (nested within a larger quasi-experimental study), this paper presents the comparison of two intervention models, one using private mid-level providers branded as "Suraj" and the other using community midwives (CMWs) of Maternal Newborn and Child Health Programme, for method continuation among IUD users. Moreover, determinants of IUD continuation and the reasons for discontinuation, and switching behaviour were studied within each arm. METHODS: A total of 1,163 IUD users, 824 from Suraj and 339 from the CMW model, were enrolled in this 24-month prospective client follow-up. Participants were followed-up by female community mobilisers physically every second month to ascertain continued IUD usage and to collect information on associated factors, switching behaviour, reasons for discontinuation, and pregnancy occurrence. The probabilities of IUD continuation and the risk factors for discontinuation were estimated by life table analysis and Cox proportional-hazard techniques, respectively. RESULTS: The cumulative probabilities of IUD continuation at 24 months in Suraj and CMW models were 82% and 80%, respectively. The difference between the two intervention areas was not significant. The probability distributions of IUD continuation were also similar in both interventions (Log rank test: χ(2) = 0.06, df = 1, P = 0.81; Breslow test: χ(2) = 0.6, df = 1, P = 0.44). Health concerns (Suraj = 57.1%, CMW = 38.7%) and pregnancy desire (Suraj = 29.3%, CMW = 40.3%) were reported as the most prominent reasons for IUD discontinuation in both intervention arms. IUD discontinuation was significantly associated with place of residence in Suraj and with age (15-25 years) in the CMW model. CONCLUSION: CMWs and private providers are equally capable of providing quality IUD services and ensuring higher method continuation. Pakistan's National Maternal Newborn and Child Health programme should consider training CMWs and providing IUDs through them. Moreover, private sector mid-level providers could be engaged in promoting the use of IUDs.

Methods for implementing a medicine outlet survey: lessons from the anti-malarial market.

BACKGROUND: In recent years an increasing number of public investments and policy changes have been made to improve the availability, affordability and quality of medicines available to consumers in developing countries, including anti-malarials. It is important to monitor the extent to which these interventions are successful in achieving their aims using quantitative data on the supply side of the market. There are a number of challenges related to studying supply, including outlet sampling, gaining provider cooperation and collecting accurate data on medicines. This paper provides guidance on key steps to address these issues when conducting a medicine outlet survey in a developing country context. While the basic principles of good survey design and implementation are important for all surveys, there are a set of specific issues that should be considered when conducting a medicine outlet survey. METHODS: This paper draws on the authors' experience of designing and implementing outlet surveys, including the lessons learnt from ACTwatch outlet surveys on anti-malarial retail supply, and other key studies in the field. Key lessons and points of debate are distilled around the following areas: selecting a sample of outlets; techniques for collecting and analysing data on medicine availability, price and sales volumes; and methods for ensuring high quality data in general. RESULTS AND CONCLUSIONS: The authors first consider the inclusion criteria for outlets, contrasting comprehensive versus more focused approaches. Methods for developing a reliable sampling frame of outlets are then presented, including use of existing lists, key informants and an outlet census. Specific issues in the collection of data on medicine prices and sales volumes are discussed; and approaches for generating comparable price and sales volume data across products using the adult equivalent treatment dose (AETD) are explored. The paper concludes with advice on practical considerations, including questionnaire design, field worker training, and data collection. Survey materials developed by ACTwatch for investigating anti-malarial markets in sub-Saharan Africa and Asia provide a helpful resource for future studies in this area.

Got ACTs? Availability, price, market share and provider knowledge of anti-malarial medicines in public and private sector outlets in six malaria-endemic countries.

BACKGROUND: Artemisinin-based combination therapy (ACT) is the first-line malaria treatment throughout most of the malaria-endemic world. Data on ACT availability, price and market share are needed to provide a firm evidence base from which to assess the current situation concerning quality-assured ACT supply. This paper presents supply side data from ACTwatch outlet surveys in Benin, the Democratic Republic of Congo (DRC), Madagascar, Nigeria, Uganda and Zambia. METHODS: Between March 2009 and June 2010, nationally representative surveys of outlets providing anti-malarials to consumers were conducted. A census of all outlets with the potential to provide anti-malarials was conducted in clusters sampled randomly. RESULTS: 28,263 outlets were censused, 51,158 anti-malarials were audited, and 9,118 providers interviewed. The proportion of public health facilities with at least one first-line quality-assured ACT in stock ranged between 43% and 85%. Among private sector outlets stocking at least one anti-malarial, non-artemisinin therapies, such as chloroquine and sulphadoxine-pyrimethamine, were widely available (> 95% of outlets) as compared to first-line quality-assured ACT (< 25%). In the public/not-for-profit sector, first-line quality-assured ACT was available for free in all countries except Benin and the DRC (US$1.29 [Inter Quartile Range (IQR): $1.29-$1.29] and $0.52[IQR: $0.00-$1.29] per adult equivalent dose respectively). In the private sector, first-line quality-assured ACT was 5-24 times more expensive than non-artemisinin therapies. The exception was Madagascar where, due to national social marketing of subsidized ACT, the price of first-line quality-assured ACT ($0.14 [IQR: $0.10, $0.57]) was significantly lower than the most popular treatment (chloroquine, $0.36 [IQR: $0.36, $0.36]). Quality-assured ACT accounted for less than 25% of total anti-malarial volumes; private-sector quality-assured ACT volumes represented less than 6% of the total market share. Most anti-malarials were distributed through the private sector, but often comprised non-artemisinin therapies, and in the DRC and Nigeria, oral artemisinin monotherapies. Provider knowledge of the first-line treatment was significantly lower in the private sector than in the public/not-for-profit sector. CONCLUSIONS: These standardized, nationally representative results demonstrate the typically low availability, low market share and high prices of ACT, in the private sector where most anti-malarials are accessed, with some exceptions. The results confirm that there is substantial room to improve availability and affordability of ACT treatment in the surveyed countries. The data will also be useful for monitoring the impact of interventions such as the Affordable Medicines Facility for malaria.

Monitoring fever treatment behaviour and equitable access to effective medicines in the context of initiatives to improve ACT access: baseline results and implications for programming in six African countries.

BACKGROUND: Access to artemisinin-based combination therapy (ACT) remains limited in high malaria-burden countries, and there are concerns that the poorest people are particularly disadvantaged. This paper presents new evidence on household treatment-seeking behaviour in six African countries. These data provide a baseline for monitoring interventions to increase ACT coverage, such as the Affordable Medicines Facility for malaria (AMFm). METHODS: Nationally representative household surveys were conducted in Benin, the Democratic Republic of Congo (DRC), Madagascar, Nigeria, Uganda and Zambia between 2008 and 2010. Caregivers responded to questions about management of recent fevers in children under five. Treatment indicators were tabulated across countries, and differences in case management provided by the public versus private sector were examined using chi-square tests. Logistic regression was used to test for association between socioeconomic status and 1) malaria blood testing, and 2) ACT treatment. RESULTS: Fever treatment with an ACT is low in Benin (10%), the DRC (5%), Madagascar (3%) and Nigeria (5%), but higher in Uganda (21%) and Zambia (21%). The wealthiest children are significantly more likely to receive ACT compared to the poorest children in Benin (OR = 2.68, 95% CI = 1.12-6.42); the DRC (OR = 2.18, 95% CI = 1.12-4.24); Madagascar (OR = 5.37, 95% CI = 1.58-18.24); and Nigeria (OR = 6.59, 95% CI = 2.73-15.89). Most caregivers seek treatment outside of the home, and private sector outlets are commonly the sole external source of treatment (except in Zambia). However, children treated in the public sector are significantly more likely to receive ACT treatment than those treated in the private sector (except in Madagascar). Nonetheless, levels of testing and ACT treatment in the public sector are low. Few caregivers name the national first-line drug as most effective for treating malaria in Madagascar (2%), the DRC (2%), Nigeria (4%) and Benin (10%). Awareness is higher in Zambia (49%) and Uganda (33%). CONCLUSIONS: Levels of effective fever treatment are low and inequitable in many contexts. The private sector is frequently accessed however case management practices are relatively poor in comparison with the public sector. Supporting interventions to inform caregiver demand for ACT and to improve provider behaviour in both the public and private sectors are needed to achieve maximum gains in the context of improved access to effective treatment.