Enhancing the A in SAFE for Trachoma
- Conditions
- Trachoma
- Interventions
- Drug: Two Additional Rounds of Azithromycin for Children
- Registration Number
- NCT05634759
- Lead Sponsor
- Emory University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34630
Not provided
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Routine Community-wide MDA followed by a Second Community-wide MDA Azithromycin for Routine Community-wide MDA 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. Routine Community-wide MDA followed by Two Additional Rounds of Treatment for Children Azithromycin for Routine Community-wide MDA 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. Standard-of-Care Annual MDA Azithromycin for Routine Community-wide MDA 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. Routine Community-wide MDA followed by Two Additional Rounds of Treatment for Children Two Additional Rounds of Azithromycin for Children 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. Routine Community-wide MDA followed by a Second Community-wide MDA Azithromycin for Second Community-wide MDA 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.
- Primary Outcome Measures
Name Time Method Number of Participants Missing Antibiotic Treatment Round Up to 12 months Compliance with the enhanced antibiotic regimens will be assessed as the extent of missed rounds of antibiotic treatment.
Cost 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 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 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.
- Secondary Outcome Measures
Name Time Method Prevalence of Clinical Trachoma by Field Grader Up to 12 months A field grader will assess both eyes of each child age 6 months to 9 years selected for the study. The grader will note their assessment of trachoma grade prior the ocular swab being obtained.
Prevalence of Clinical Trachoma by Photograph Up to 12 months Tarsal conjunctivae photographs will be taken of both eyes of each child age 6 months to 9 years selected to provide an ocular swab for the study. Images will be sent to a grading center located off-site to be graded by a designated standard grader.
Coverage Among Older Children and Adults 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 secondary analysis is the number of individuals aged 10 to 15 years, and the number of persons greater than 15 years old who received the drug in study villages in each treatment round divided by number of individuals in each age group enumerated in the baseline census.
Prevalence of C. trachomatis Infection Up to 12 months Children age 6 months to 9 years selected for the study will receive ocular swabbing for C. trachomatis infection. The conjunctival epithelial specimen will be used for polymerase chain reaction (PCR) analysis in the lab.
Trial Locations
- Locations (1)
Ministry of Health Republic of South Sudan
🇸🇸Juba, South Sudan
Ministry of Health Republic of South Sudan🇸🇸Juba, South Sudan