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临床试验/NCT05634759
NCT05634759已完成4 期

Enhancing the A in SAFE: Accelerating Trachoma Elimination in the Republic of South Sudan

Emory University1 个研究点 分布在 1 个国家目标入组 34,630 人开始时间: 2022年5月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
34,630
试验地点
1
主要终点
Number of Participants Missing Antibiotic Treatment Round

研究概览

简要总结

This study will assess the cost and feasibility of two strategies of enhanced Mass Drug Administration (MDA) of Zithromax to treat trachoma in the Republic of South Sudan. The secondary objectives of this study are to measure trachoma infection outcomes during the 12-month follow-up period among children up to 9 years of age.

详细描述

Trachoma is an ocular disease caused by the bacterium Chlamydia trachomatis. The World Health Organization (WHO) has recently targeted trachoma for global elimination as a public health problem by 2030. Though progress has been made in reducing the burden of trachoma in many endemic countries, those affected by conflict and humanitarian emergencies have been left behind and will likely take decades to reach trachoma elimination targets. To "catch-up", these countries must consider enhancements to the surgery, antibiotic, facial cleanliness, and environmental improvement (SAFE) strategy.

Evidence for the importance of enhanced mass drug administration (MDA) strategies is growing, particularly with the help of modeling studies. Recent work by the neglected tropical disease (NTD) modeling consortium has recently demonstrated that in some hyperendemic districts, annual MDA will not result in a district reaching the elimination as a public health problem threshold within 10 years. Delays in implementation whether due to insecurity or to coronavirus disease 2019 (COVID-19) would likely lead to higher prevalence trachoma prevalence in these districts for years to come. However, when testing alternative MDA strategies, modelers found that the annual trajectory of trachoma prevalence could be changed. One MDA alternative characterized by a community-wide MDA followed by two extra rounds of treatment to children aged 2 to 9 years 1 week and again 3 weeks after the normal community wide MDA, demonstrated a considerable faster time to elimination compared to standard of care. Empirical data from the field under different alternative MDA strategies are needed to verify these modeling results.

The Republic of South Sudan has historically had one of the highest burdens of trachoma in the world. Currently the county has many districts considered highly endemic, and therefore reaching the elimination of trachoma as a public health problem by the year 2030 will likely be a large challenge. Based on 2015 trachoma prevalence data, trachomatous inflammation-follicular among children ages 1 to 9 years ranged from 30% to 48% across three Kapoeta counties in Eastern Equatoria state, Republic of South Sudan and trachomatous trichiasis ranged from 2.6% to 3.7% in those ages 15 years and above, both indicators above WHO elimination thresholds. The Republic of South Sudan Ministry of Health, with support from The Carter Center, has been implementing the SAFE strategy in these three counties (Kapoeta North, Kapoeta South, and Kapoeta East) for over 10 years. Interventions have included the provision of surgery, conducting MDA, and providing health education. All three counties conducted their fifth consecutive annual round of MDA between October 2020 to December 2020 and will therefore be scheduled to conduct an impact survey in 2021.

Thirty villages in the Republic of South Sudan will be randomized to participate in one of two enhanced MDA strategies. Enhanced MDA strategy 1 consists of a routine community-wide MDA followed by two additional rounds targeted to children age 6 months to 9 years. The additional rounds of treatment will occur 2 weeks apart and will begin 1 week after the community-wide MDA. Enhanced MDA Strategy 2 consist of a routine community-wide MDA followed by a second community-wide MDA approximately 6-8 months later. Participants will be followed for 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Routine Community-wide MDA followed by Two Additional Rounds of Treatment for Children

Experimental

The enhanced MDA Strategy 1 consists of a routine community-wide MDA followed by two additional rounds targeted to children age 6 months to 9 years. The additional rounds of treatment will occur 2 weeks apart and will begin 1 week after the community-wide MDA.

干预措施: Azithromycin for Routine Community-wide MDA (Drug)

Routine Community-wide MDA followed by Two Additional Rounds of Treatment for Children

Experimental

The enhanced MDA Strategy 1 consists of a routine community-wide MDA followed by two additional rounds targeted to children age 6 months to 9 years. The additional rounds of treatment will occur 2 weeks apart and will begin 1 week after the community-wide MDA.

干预措施: Two Additional Rounds of Azithromycin for Children (Drug)

Routine Community-wide MDA followed by a Second Community-wide MDA

Experimental

The enhanced MDA Strategy 2 consist of a routine community-wide MDA followed by a second community-wide MDA approximately 6-8 months later. The timing of the second MDA will depend on local conditions and logistical concerns.

干预措施: Azithromycin for Routine Community-wide MDA (Drug)

Routine Community-wide MDA followed by a Second Community-wide MDA

Experimental

The enhanced MDA Strategy 2 consist of a routine community-wide MDA followed by a second community-wide MDA approximately 6-8 months later. The timing of the second MDA will depend on local conditions and logistical concerns.

干预措施: Azithromycin for Second Community-wide MDA (Drug)

Standard-of-Care Annual MDA

Active Comparator

Programmatic Control Comparator data for the standard-of-care annual MDA will come from the MDA conducted in 2022 in a random selection of 15 non-study villages.

干预措施: Azithromycin for Routine Community-wide MDA (Drug)

结局指标

主要结局

Number of Participants Missing Antibiotic Treatment Round

时间窗: Up to 12 months

Compliance with the enhanced antibiotic regimens will be assessed as the extent of missed rounds of antibiotic treatment.

Cost

时间窗: Up to 12 months

The cost of enhanced antibiotic regimens will be compared to each other and compared to the standard-of-care, annual MDA. The researchers will examine both financial costs (expenditures from the implementation of the intervention), and economic costs (full value of the resources used to implement the intervention). Cost data will be categorized under the following categories: capital costs, medical personnel costs, non-medical personnel costs, commodities, field consumable costs, and lab costs as informed by previous studies.

Coverage Among Young Children

时间窗: Up to 12 months

Feasibility of enhanced antibiotic regimens will be assessed as antibiotic coverage during each of the subsequent treatment rounds, allowing for the calculation of the number of doses each participant received. The definition of coverage for this study is the number of individuals ages 6 months to 9 years who received the drug in study villages in each treatment round divided by number of children ages 6 months to 9 years enumerated in the baseline census. MDA coverage will be further validated through use of the WHO's Supervision Coverage Tool.

Acceptability

时间窗: Up to 12 months

The acceptability of enhanced antibiotic regimens will be assessed through focus group discussions which are led by a trained qualitative researcher using a guided discussion tool. Discussion topics include perceptions of trachoma disease and treatment, perception of the MDA campaigns, and community mobilization. This qualitative assessment will not generate a summary score.

次要结局

  • Prevalence of Clinical Trachoma by Field Grader(Up to 12 months)
  • Prevalence of Clinical Trachoma by Photograph(Up to 12 months)
  • Coverage Among Older Children and Adults(Up to 12 months)
  • Prevalence of C. trachomatis Infection(Up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Nash

Epidemiologist

Emory University

研究点 (1)

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