Enhancing the A in SAFE for Trachoma

NCT05634759 | Completed Phase 4

• 1 other identifier: STUDY00002467
• Study Type: interventional
• Target: 34,630
• Locations: 1 country
• Sites: 1

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.

Conditions

Trachoma

Keywords

Mass drug administration; South Sudan; Trachoma

Outcome Measures

Primary Outcomes (4)

• Coverage Among Young Children

  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.

  Up to 12 months

• Number of Participants Missing Antibiotic Treatment Round

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

  Up to 12 months

• Acceptability

  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.

  Up to 12 months

• Cost

  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.

  Up to 12 months

Secondary Outcomes (4)

• Prevalence of C. trachomatis Infection

  Up to 12 months

• 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

Other Outcomes (2)

• Facial cleanliness

  Up to 12 months

• Community awareness of the MDA campaign

  Up to 12 months

Study Arms (3)

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.

Drug: Azithromycin for Routine Community-wide MDA; Drug: Two Additional Rounds of Azithromycin for Children

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.

Drug: Azithromycin for Routine Community-wide MDA; Drug: Azithromycin for Second Community-wide MDA

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.

Drug: Azithromycin for Routine Community-wide MDA

Interventions

Azithromycin for Routine Community-wide MDA DRUG

Oral azithromycin, also known as the brand name Zithromax®, is a macrolide antibiotic and is used in the treatment of active trachoma. The recommended dosage for the treatment of trachoma is a single dose of 20mg/kg of body weight and is implemented by a "Age-height" based dosing strategy for the trachoma MDA campaigns. Oral azithromycin can be administrated in either tablet form or powder for oral suspension (POS). Zithromax® is donated by Pfizer Inc through the International Trachoma Initiative (ITI) to the South Sudan Federal Ministry of Health to use in community-wide MDA throughout South Sudan.

Also known as: Zithromax

Routine Community-wide MDA followed by Two Additional Rounds of Treatment for Children; Routine Community-wide MDA followed by a Second Community-wide MDA; Standard-of-Care Annual MDA

Two Additional Rounds of Azithromycin for Children DRUG

An additional round of treatment will be given one week after the routine community-wide MDA, and a second additional round will be given two weeks later (3 weeks after the routine community-wide MDA).

Also known as: Zithromax

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

Azithromycin for Second Community-wide MDA DRUG

A second community-wide MDA will be given 6 to 8 months after the routine community-wide MDA. The timing of the second MDA will depend on local conditions and logistical concerns.

Also known as: Zithromax

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The village must be located in a district eligible for annual MDA with azithromycin under WHO treatment guidelines.
• The village representatives' consent to participation in the study. Individual consent will also be obtained for each individual within the study.
• Children aged 6 months to 9 years of age

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Ministry of Health Republic of South Sudan

Juba, South Sudan

Location

Related Publications (1)

• Sanders AM, Makoy S, Deathe AR, Ohidor S, Jesudason TC, Nute AW, Odongi P, Boniface L, Abuba S, Delahaut AS, Sebit W, Niquette J, Callahan EK, Walker DG, Nash SD. Cost and community acceptability of enhanced antibiotic distribution approaches for trachoma in the Republic of South Sudan: enhancing the A in SAFE (ETAS) study protocol. BMC Ophthalmol. 2023 Feb 6;23(1):51. doi: 10.1186/s12886-023-02783-x.

  PMID: 36747194 DERIVED

MeSH Terms

Conditions

Trachoma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Scott Nash, PhD

  The Carter Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Model Details: Thirty villages will be randomized to one of two intervention arms (15 villages per study arm). To conduct the cost comparison, comparator data for the standard-of-care annual MDA will be obtained from the MDA conducted in 2022 in a random selection of 15 non-study villages.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: May 4, 2022
• Primary Completion: August 5, 2023
• Study Completion: August 5, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SO (1)