Testing Community-Led Outreach Clinics to Improve Health in Rural Areas

Last registered on January 27, 2025

Pre-Trial

Trial Information

General Information

Title
Testing Community-Led Outreach Clinics to Improve Health in Rural Areas
RCT ID
AEARCTR-0015003
Initial registration date
January 24, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
January 27, 2025, 10:15 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
The Ohio State University

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2025-01-01
End date
2027-08-18
Secondary IDs
USAID: 7200AA24FA00009
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Access to high quality healthcare is a critical driver of human capital and a cornerstone of broader individual and societal well-being. In Uganda, rural access to health care and to essential medicines remains a persistent challenge; although 86% of Ugandans live in rural areas, only 15-20% of the country’s doctors work in those same areas, which contributes to poorer health outcomes among rural populations. Aside from a few irregular, one-day “mobile clinics” or sponsored medical missions, there are few resources in place for delivering healthcare on a regular basis to people in remote areas. We partnered with Health Access Connect (HAC), a Ugandan-based NGO that coordinates monthly, financially self-sustainable outreach visits by clinical staff from government health facilities to rural communities that are located at least 5 km away from public health facilities. Through a cluster-randomized trial in 64 health facilities and 128 villages, this study will evaluate the impact of HAC’s community-based outreach activities on the demand, quality, and utilization of health services, household health outcomes, child schooling and human capital, and household labor market incomes.
External Link(s)

Registration Citation

Citation
Fitzpatrick, Anne. 2025. "Testing Community-Led Outreach Clinics to Improve Health in Rural Areas." AEA RCT Registry. January 27. https://doi.org/10.1257/rct.15003-1.0
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
The HAC program establishes one-day integrated care outreach clinics in remote communities (communities that are greater than 5 km from the nearest health facility) every 1-2 months. Government healthcare workers are transported from the health faciliy to target communities to provide a range of health services. Local Community Associations in remote communities are trained to lead the program in collaboration with the local health facility and are also supported in financing the costs of the outreach clinics.
Intervention Start Date
2025-07-01
Intervention End Date
2027-08-18

Primary Outcomes

Primary Outcomes (end points)
Health Utilization, Health Outcomes, Schooling Outcomes, and Labor Market Outcomes
Primary Outcomes (explanation)
Health utilization is measured by whether an individual received any healthcare in the past 30 days for all age groups as well as separately for those aged 5–17 and 18–60.

Health outcomes are assessed by the number of days an individual was sick in the past 30 days, analyzed for all age groups as well as separately for those aged 5–17 and 18–60.

Schooling outcomes are measured by the number of school days missed in the past 30 days for individuals aged 5–17.

Labor market outcomes include the number of workdays missed due to usual work activities in the past 30 days for individuals across all age groups and whether individuals aged 18–60 are currently engaged in wage labor. These variables will be collected through multiple rounds of household surveys.

Secondary Outcomes

Secondary Outcomes (end points)
Health Facility Service Delivery
Secondary Outcomes (explanation)
Service delivery is assessed at both the facility and individual levels to capture a comprehensive picture of the intervention's impact. At the individual level, it is measured through health utilization, health status, schooling, and labor market outcomes, focusing on villages located near health facilities that are not actively engaged in the HAC outreaches. At the facility level, service delivery is measured by key operational metrics, including the frequency of drug stockouts, adherence to facility operation schedules, and staffing levels among the participating health facilities.

Experimental Design

Experimental Design
This study is a two-armed randomized control trial that will be conducted among 64 health facilities, 128 corresponding communities / villages (2 villages per health facility) that are located within each health facility’s catchment area, and an estimated 3,200 eligible households (approximately 25 households per selected village). The study consists of a baseline survey with health facilities, villages, and households, followed by randomization of health facilities into the HAC intervention and control arms and the implementation of the two-year family planning intervention. Two follow-up surveys were conducted one and two years after the baseline survey, respectively.

We will select 64 HC-III or HC-IV health facilities (HFs), and we will identify 128 villages (2 villages per HF) that are located more than 5 km away from the 64 HFs. From each village, we will select 25 households with at least one school-aged child (aged 5-17) for baseline surveys.

Following a baseline survey with 3200 households and 64 HFs, we will randomize HFs, and their corresponding villages and houesholds, into a treatment group or a control group:
• 32 HFs will be randomly selected as the control group. These HFs, and their corresponding villages and households, will receive no interaction with the HAC intervention, and no HAC outreach services will take place.
• 32 HFs will be randomly selected as the treatment group. Staff at these HFs will partner with HAC and will provide outreach services to households in the corresponding villages that are part of the HF's service catchment area..

We will then conduct several rounds of follow-up over a two year period to: (i) measure impacts of the HAC intervention on short-term and long-term outcomes of interest, (ii) identify any effects of the HAC intervention on the service delivery at health facilities. After 1 year of implementation, we will survey an additional 1600 households outside the target villages in order to detect any unintended impacts of the HAC intervention on service utilization at HFs and the resulting spillover effects that these unintended effects may have had on non-target communities.
Experimental Design Details
Not available
Randomization Method
Randomization done in office by a computer.
Randomization Unit
Our study will employ a clustered randomization design, stratified by district. Health facilities will be randomly assigned to either the treatment or control group.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
64 health facilities, with additional 6 facilities as backup in the baseline survey
Sample size: planned number of observations
64 health facilities (plus an additional 6 facilities in the baseline survey), 192 villages, and 4800 households.
Sample size (or number of clusters) by treatment arms
Treatment group: 32 health facilities and their corresponding 64 villages and 1600 households within the catchment area.
Control group: 32 health facilities and their corresponding 64 villages and 1600 households within the catchment area.
Indirect analysis: 64 villages, and their corresponding 1600 households, that are located close to the health facilities.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We focus on the primary outcomes measured in year 2 of our intervention. For health utilization, the standardized MDE for receiving health care among all individuals is 0.15 standard deviation (SD), with a 94% power, corresponding to a 6.7 percentage point (pp) increase in health care receipt. For individuals aged 5–17 and 18–60, the MDEs are also 0.15 SD with power levels of 90% and 85%, respectively, corresponding to a 6.2 pp and 6.5 pp increase in health care receipt. Regarding health outcomes, the MDE for days sick across all individuals is 0.15 SD with 99% power, equating to a 0.74-day reduction in days sick. For school-aged children (5–17), the MDE is 0.15 SD with 95% power, corresponding to a 0.52-day reduction, while for individuals aged 18–60, it is 0.15 SD with 95% power, translating to a 0.75-day reduction. In terms of schooling outcomes, the MDE for days of school missed among children aged 5–17 is 0.11 SD with 83% power, representing a 0.22-day reduction in school absences. For labor market outcomes, the MDE for the likelihood of currently working for pay among individuals aged 18–60 is 0.14 with 81% power, corresponding to a 5.7 pp increase. Additionally, the MDE for days of usual work activity missed among all individuals is 0.07 SD with 87% power, reflecting a 0.24-day reduction. These results indicate the study's strong ability to detect meaningful changes across a range of outcomes, with standardized MDEs ranging from 0.07 to 0.15 SD and high statistical power (≥80%) across all measures. Throughout the power analysis, we assume 20% random attrition rates per year. We also include allowance for the increase in precision due to the inclusion of covariates as follows: 13% increase in R-2 from individual covariates; 8% increase in R-2 from village-level covariates; an increase in R-2 of 27% from HF covariates. These parameters are based upon regression estimates using covariates correlated with days sick and days of usual activity missed due to sickness. We use empirical ICCs at various levels taken from either the 2019-2020 UNPS or 2016 Uganda DHS.
IRB

Institutional Review Boards (IRBs)

IRB Name
Mildmay Uganda Research Ethics Committee (MUREC)
IRB Approval Date
2025-01-13
IRB Approval Number
MUREC-2024-520
IRB Name
Innovations for Poverty Action
IRB Approval Date
2025-01-21
IRB Approval Number
17247