Active surveillance of immunization adverse effects: a multicentre, open-label, three-arm randomized uncontrolled trial in Ethiopia.

BACKGROUND: Participant-centred active adverse event following immunization (AEFI) surveillance can offer real-time vaccine safety data and help in signal detection. This study aimed to evaluate the effectiveness of participant-centred active adverse events (AEs) surveillance following measles immunization in Gedeo Zone health facilities in Ethiopia. METHODS: An open-label, multicentred, three-arm randomized uncontrolled trial was conducted from 1 June to 21 October 2023. After assessing enrolment eligibility, the study participants were randomized into three groups (short message service [SMS], telephone interview, and diary card). They were expected to report AEs in children 1 week after receiving immunization. Binary and multivariable logistic regression and χ2 tests were used to analyse the data. RESULTS: Among the 396 participants randomized into the three groups, 80.8% (320 participants) reported back about their children's AE status. Participants in the telephone interview group exhibited a substantially superior response rate (93.2% of 132 participants; p<0.00001) compared with the SMS (71.2%) and diary card (78%) groups. The likelihood of reporting the status of AEs experienced by children was lower by 77% (adjusted odds ratio 0.23 [95% confidence interval 0.1 to 0.52], p-value <0.00001) in the diary card group compared with the telephone interview group. CONCLUSIONS: In this study, a telephone interview was found to be the best method for AEFI reporting. Participant-centred active AE surveillance could potentially permit more rapid identification of emerging safety signals. Trial registration:  https://clinicaltrials.gov/ct2/show/NCT05803538.

The status of immunization program and challenges in Ethiopia: A mixed method study.

Introduction: Immunization helps reduce morbidity and mortality attributable to severe vaccine-preventable childhood illnesses. However, vaccination coverage and the quality of immunization data remain challenging in Ethiopia. This has led to poor planning, suboptimal vaccination coverage, and the resurgence of vaccine-preventable disease outbreaks in under-immunized pocket areas. The problem is further compounded by the occurrence of the COVID-19 pandemic and the disruption of the health information system due to recurrent conflict. This study assessed the current status of the immunization service and its challenges in Ethiopia. Methods: A mixed-methods study was conducted in three regions of Ethiopia from 21 to 31 May, 2023. A survey of administrative reports was done in a total of 69 health facilities in 14 woredas (districts). Nine KIIs were conducted at a district level among immunization coordinators selected from three regions to explore the challenges of the immunization program. Linear regression and descriptive statistics were used to analyze the quantitative data. Thematic analysis was applied to analyze the qualitative data. The findings from the qualitative data were triangulated to supplement the quantitative results. Result: Two-thirds (66.4%) of the children were fully vaccinated, having received all vaccines, including the first dose of the MCV1, by 12 months of age, as reported through administrative reports collected from health facility records. Catchment area population size and region were significantly associated with the number of fully immunized children (p < 0.001 and p = 0.005, respectively). The vaccination dropout rates of the first to third dose of pentavalent vaccine and the first dose of pentavalent vaccine to the first dose of MCV1 were 8.6% and 7.4%, respectively. A considerable proportion of health facilities lack accurate data to calculate vaccination coverage, while most of them lack accurate data for dropout rates. Longer waiting time, interruptions in vaccine supply or shortage, inaccessibility of health facilities, internal conflict and displacement, power interruption and refrigerator breakdown, poor counseling practice, and caretakers' lack of awareness, fear of side effects, and forgetfulness were the reasons for the dropout rate and low coverage. The result also showed that internal conflict and displacement have significantly affected immunization coverage, with the worst effects seen on the most marginalized populations. Conclusion: The study revealed low vaccination coverage, a high dropout rate, and poor quality of immunization data. Access and vaccination coverage among marginalized community groups (e.g., orphans and street children) were also low. Hence, interventions to address organizational, behavioral, technical, and contextual (conflict and the resulting internal displacement) bottlenecks affecting the immunization program should be addressed.

Is deployment of trained nurses to rural villages a remedy for the low skilled birth attendance in Ethiopia? A cluster randomized-controlled community trial.

BACKGROUND: Low coverage of Skilled Birth Attendance (SBA) is one of the major drivers of maternal mortality in many low- and middle-income countries (LMICs) including Ethiopia. We conducted a cluster-randomized controlled community trial to assess the effect of deploying trained community based nurses to rural communities on the uptake levels of SBA in Ethiopia. METHODS: A three-arm, parallel groups, cluster-randomized community trial was conducted to assess the effect of deploying trained community based reproductive health nurses (CORN) on the uptake of SBA services. A total of 282 villages were randomly selected and assigned to a control arm (n = 94) or 1 of 2 treatment arms (n = 94 each). The treatment groups differed by where these new service providers were deployed, a health post (HP) or health center (HC). Baseline and end line surveys were conducted to document and measure the effects of the intervention. Program impacts on SBA coverage were calculated using difference-in-difference (DID) analysis. RESULTS: After nine months of intervention, the coverage of SBA services increased significantly by 81.1% (from 24.61 to 44.59) in the HP based intervention arm, and by 122.9% (from 16.41 to 36.59) in the HC arm, respectively (p <0.01). Conversely, a small and non-significant (2%) decline in SBA coverage were observed in the control arm (P >0.05). The DID estimate indicated a net increase in SBA coverage of 21.32 and 20.52 percentage points (PP) across the HP and HC based intervention arms, respectively (p < 0.001). CONCLUSIONS: Deployment of trained reproductive health nurses to rural communities in Ethiopia significantly improved utilization of SBA services. Therefore; in similar low income settings where coverage of SBA services is very low, deployment of trained community based nurses to grassroots level could potentiate rapid service uptake. Additional cost-effectiveness and validation studies at various setups are required, before scale-up of the innovation, however. TRIAL REGISTRATION: clinicaltrails.gov NCT02501252.

Reaching the unreached through trained and skilled birth attendants in Ethiopia: a cluster randomized controlled trial study protocol.

BACKGROUND: Despite improvements since 1990 to 2014, maternal mortality ratio (MMR) remains high in Ethiopia. One of the key drivers of maternal mortality in Ethiopia is the very low coverage of Skilled Birth attendance (SBA) in rural Ethiopia. This cluster randomized trial piloted an innovative approach of deploying trained community reproductive nurses (CORN) to hard to reach/unreachable rural Ethiopia to improve the coverage of SBA. METHODS: We used a three-arm cluster randomized trial to test the effect of deploying CORN in rural communities in South Ethiopia to improve SBA and other maternal health indicators. A total of 282 villages/clusters (94 from each arm) were randomly selected in the three districts of the zone for the study. The intervention was implemented in four consecutive phases that aimed at of provision of essential maternal, neonatal and child health (MNCH) services mainly focusing on SBA. The CORN were trained and deployed in health centres (arm 1) and in the community/health posts (arm2). A third arm (arm 3) consisting control villages without the intervention. A baseline and end line assessment was conducted to compare the difference in the proportion of SBA and other MNCH service uptake across the three arms Data was entered into computer, edited, cleaned, and analyzed using Epi-data statistical software. The presentation followed the Consolidated Standards of Reporting Trials (CONSORT) statement guidelines for cluster-randomized trials. DISCUSSION: This trial is designed to test the impact of an innovative and newly designed means of distribution for the national health extension program strategy with additional service package with no change to the target population. The focus is on effect of CORN in revitalizing the Health Extension Program (HEP) through improving SBA service uptake and other maternal health service uptake indicators. The study findings may guide national policy to strengthen and shape the already existing HEP that has certain limitations to improve maternal health indicators. The competency based training methodology could provide feedback for health science colleges to improve the national nursing or midwifery training curriculum. TRIAL REGISTRATION: clinicaltrails.gov NCT02501252 dated on July 14, 2015.

Expanding Access to the Intrauterine Device in Public Health Facilities in Ethiopia: A Mixed-Methods Study.

In Ethiopia, modern contraceptive prevalence among currently married women nearly tripled over the last decade, but the method mix remains skewed toward short-acting methods. Since 2011, the Integrated Family Health Program (IFHP+), jointly implemented by Pathfinder International and John Snow Inc., has supported the Federal Ministry of Health to introduce intrauterine devices (IUDs) in more than 800 health centers across 4 regions to improve access to a wider range of methods. Between March and August 2014, Pathfinder conducted a mixed-methods study in 40 purposively selected health centers to assess shifts in the contraceptive method mix following introduction of IUDs using data from family planning registers; determine the characteristics of IUD users through a cross-sectional survey of 2,943 family planning clients who accepted the IUD; explore reasons for method discontinuation among 165 clients seeking IUD removal services; and identify facilitators and barriers to IUD use through focus group discussions (N = 115 clients) and key informant interviews (N = 36 providers, facility heads, and health office heads). Introduction of IUDs into the 40 health centers participating in the study was correlated with a statistically significant increase in the contribution of all long-acting reversible contraceptives (LARCs)-both IUDs and implants-to the method mix, from 6.9% in 2011 to 20.5% in 2014 (P<.001). Our study found that latent demand for the IUD was more prevalent than anticipated and that the method was acceptable to a broad cross-section of women. Of the 2,943 women who sought IUDs during the 6-month study period, 18.0% were new contraceptive users (i.e., those using a contraceptive method for the first time ever), 44.7% reported no educational attainment, 62.5% were from rural areas, and 59.3% were younger than 30 years old, with almost 3 in 10 (27.7%) under the age of 25. The most commonly cited reason for seeking IUD removal services was a desire to become pregnant (43% of women). Qualitative data indicated that while acceptability of the method is growing, limited community awareness, myths and misconceptions about the IUD, and infrastructure deficits at health centers must be addressed to further expand access to a broad range of contraceptive methods.

The Single-Visit Approach as a Cervical Cancer Prevention Strategy Among Women With HIV in Ethiopia: Successes and Lessons Learned.

INTRODUCTION: Cervical cancer is the second most common form of cancer for women in Ethiopia. Using a single-visit approach to prevent cervical cancer, the Addis Tesfa (New Hope) project in Ethiopia tested women with HIV through visual inspection of the cervix with acetic acid wash (VIA) and, if tests results were positive, offered immediate cryotherapy of the precancerous lesion or referral for loop electrosurgical excision procedure (LEEP). The objective of this article is to review screening and treatment outcomes over nearly 4 years of project implementation and to identify lessons learned to improve cervical cancer prevention programs in Ethiopia and other resource-constrained settings. METHODS: We analyzed aggregate client data from August 2010 to March 2014 to obtain the number of women with HIV who were counseled, screened, and treated, as well as the number of annual follow-up visits made, from the 14 tertiary- and secondary-level health facilities implementing the single-visit approach. A health facility assessment (HFA) was also implemented from August to December 2013 to examine the effects of the single-visit approach on client flow, staff workload, and facility infrastructure 3 years after initiating the approach. RESULTS: Almost all (99%) of the 16,632 women with HIV counseled about the single-visit approach were screened with VIA during the study period; 1,656 (10%) of them tested VIA positive (VIA+) for precancerous lesions. Among those who tested VIA+ and were thus eligible for cryotherapy, 1,481 (97%) received cryotherapy treatment, but only 80 (63%) women eligible for LEEP actually received the treatment. The HFA results showed frequent staff turnover, some shortage of essential supplies, and rooms that were judged by providers to be too small for delivery of cervical cancer prevention services. CONCLUSION: The high proportions of VIA screening and cryotherapy treatment in the Addis Tesfa project suggest high acceptance of such services by women with HIV and feasibility of implementation in secondary- and tertiary-level health facilities. However, success of cervical cancer prevention programming must address wider health system challenges to ensure sustainability and appropriate scale-up to the general population of Ethiopia and other resource-constrained settings.