Trachoma
Conditions
Keywords
Trachoma, Azithromycin, Mass treatment
Brief summary
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that all communities would have annual rounds of MDA if infection is greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The proportion of communities that are able to stop mass treatment will be compared in the group of communities randomized to mass treatment plus the newcomer/traveler treatment program compared to the communities randomized to mass treatment alone after 24 months. At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months will be surveyed at 30 months. At risk of trachoma re-infection communities have C. trachomatis infection rates less than or equal to 1% or TF \< 5% at the time of the 18 month survey. Surveillance of communities for families that meet the newcomer or traveler status will extend 6 months beyond the 24 month survey to 30 months in the intervention communities only. A survey of sentinel children in the intervention and control communities at 30 months will be conducted to assess the level of trachoma and infection in all 38 communities at risk of trachoma re-emergence.
Interventions
OTHERSurveillance and treatment with azithromycin of newcomer and traveler families
The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
OTHERUsual care
Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.
Sponsors
National Eye Institute (NEI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Census and Mass Drug Administration (MDA): All persons residing in the 52 study communities will be eligible for both the census and the annual mass azithromycin administrations. Intervention: In the 26 intervention communities, active surveillance for new families and returning travelers will be undertaken, and those meeting the criteria below will be eligible for family treatment with azithromycin if: Families are newcomers and * They have children under 10 years of age * They have moved into a new house in the community or into an existing household * They plan to reside for at least 1 month in the study community and * They have moved from a community that has not had an MDA in the last year Families are classified as having traveled and * They have children under 10 years of age * They participated in a previous census in the same community * They left the community for at least 8 weeks (2 months) for an area that has not received MDA in the past year and at least one child has returned and * They have returned to reside in the community for at least 2 months Sentinel Children: In all 52 communities, samples of 135 children will be selected from the community census lists every six months for survey and examination. These children: * must be between 1 year and 9.9 years of age, * must be a resident in the community and not a short-term (less than 2 months) visitor, * must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen, * must be willing to have a swab taken as part of being a sentinel child (this is critical, as each swab result counts towards the criteria for stopping MDA), and * must have an identifiable guardian capable of providing consent to participate. Adult Women: In all 52 communities, samples of 100 women will be selected from the baseline community census list. These women: * must be aged 15 years and over * must be a resident in the community and not a short term (less than 2 months) visitor * must not have an ocular condition that precludes grading of scarring on upper conjunctiva * must be able to provide informed consent.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below | 24 months | The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below | 24 months | — |
| The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms. | Baseline only | Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center. If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval. |
Countries
United States
Participant flow
Pre-assignment details
The trial was conducted at the community level and not at the participant level.Therefore, we are presenting the data only at the community level.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.
Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e | 26 |
| Intervention Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.
Surveillance and treatment with azithromycin of newcomer and traveler families: The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-e | 26 |
| Usual Care Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.
Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. | 26 |
| Usual Care Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.
Usual care: Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. | 26 |
| Total | 104 |
Baseline characteristics
| Characteristic | Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Customized Age not analyzed at community level | NA community | NA community | NA community |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Tanzania | 26 community | 52 community | 26 community |
| Sex: Female, Male Female | NA community | NA community | NA community |
| Sex: Female, Male Male | NA community | NA community | NA community |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm
Time frame: 24 months
Population: The trial was conducted at the community level
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intervention | The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below | 7 community |
| Usual Care | The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below | 4 community |
p-value: >0.0595% CI: [0.56, 11.9]Regression, Logistic
Secondary
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center. If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval.
Time frame: Baseline only
Population: The trial was conducted at the community level
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms. | 5.2 community |
| Usual Care | The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms. | 4.9 community |
Secondary
The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below
Time frame: 24 months
Population: The trial was conducted at the community level
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Intervention | The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below | 21 community |
| Usual Care | The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below | 20 community |
p-value: 1Fisher Exact