Trial no.:	PACTR202607625603156	Date of Registration:	16/07/2026
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

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

Official scientific title

The Causal Impact of Integrated Community Health Outreaches on Health and Economic Outcomes in Rural Uganda: A Parallel, Non-Blinded, Cluster-Randomized Controlled Trial

Brief summary describing the background and objectives of the trial

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 192 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 in a sample of 3840 respondents.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Health Care Utilization, Contraception, Family Planning Services, Rural Health, Health Access

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Health outreaches

Anticipated trial start date

01/04/2026

Actual trial start date

Anticipated date of last follow up

31/07/2027

Actual Last follow-up date

Anticipated target sample size (number of participants)

3840

Actual target sample size (number of participants)

Recruitment status

Active, not recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register
AEARCTR0015003	AEA RCT Registry
MUREC2024520	Mildmay Uganda Research Ethics Committee
SS3630ES	Uganda National Council for Science and Technology

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification	Allocation was determined by the holder of the sequence who is situated off site	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	HAC Facilitated Integrated Community Health Outreach		12 months	32 Health facilities randomized to the intervention arm will receive HAC support to conduct regular integrated community health outreach visits in two remote villages within their catchment area. Outreach visits are staffed by public-sector health workers from the corresponding health facility and provide basic primary healthcare services in the community. A total of 1920 respondents will be surveyed in the 2 direct villages (1280) and 1 indirect village (640) associated with the 32 treated health facilities.	1920
Control Group	Status quo comparison		12 months	32 Health facilities randomized to the control arm will continue usual facility-based service delivery during the study period. They will not receive HAC-facilitated outreach support in the study villages during the trial period. 1920 surveys will be completed across 2 direct villages (1280) and 1 indirect community (640) associated with each of the 32 control health facilities.	1920	Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Inclusion Criteria for health facility subject: - Health facilities must be located in a district where HAC has permission to operate. - Health facilities must have at least two villages in their catchment area that meet the criteria for outreach services. Inclusion Criteria for direct village subject: - Direct villages must be located at least 4 km from the health facility or require more than 45 minutes of travel time to reach the health facility. - Direct villages must be within the health facility catchment area. - Direct villages must have a population of at least 150 residents. - Health workers at the corresponding health facility must be willing to conduct regular outreach visits to serve the direct village if the facility is randomized to the intervention arm. Inclusion Criteria for indirect village subject: - Indirect communities must be located within 4 km of the health facility or reachable in less than 45 minutes of travel time. - Indirect communities must be within the health facility catchment area and ineligible to receive HAC outreach services. Inclusion criteria for household subject: - Households must include at least one woman aged 18 to 35 who is currently not pregnant and at least six months postpartum. - In villages where the original household eligibility criteria do not yield the required number of eligible households, the household eligibility age range may be relaxed to include women aged 18 to 45.	Exclusion Criteria for health facility subject: - Health facilities are excluded if there is a specific directive from the District Health Officer requiring the health facility, or villages within its catchment area, to offer outreach services from that health facility. Exclusion Criteria for village subject: - Direct villages are excluded if HAC determines that the village cannot be served because of logistical constraints or infeasibility. Exclusion Criteria for household subject: - Households are excluded if they do not include an eligible woman under the applicable age, pregnancy, and postpartum criteria. - Households are excluded if the eligible respondent does not provide informed consent.	Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	45 Year(s)	Female

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

13/01/2025

Mildmay Uganda Research Ethics Committee

Ethics Committee Address
Street address	City	Postal code	Country
P.O. Box 24985	Kampala	10000	Uganda

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

30/04/2026

Innovations for Poverty Action

Ethics Committee Address
Street address	City	Postal code	Country
1701 Rhode Island Ave NW, 3rd Floor	Washington, DC	20036	United States of America

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Healthcare utilization in the past 30 days. Indicator for whether an individual received any healthcare service in the past 30 days, measured through the household survey. This outcome will be measured for all household members in the sample and may be analyzed overall and by age subgroup.	12 months after intervention implementation
Primary Outcome	Current contraceptive use among eligible women. Indicator for whether the primary female respondent is currently using any contraceptive method at the time of the follow-up survey. Women who are pregnant at endline will be coded as non-users of contraception, consistent with the study protocol.	12 months after intervention implementation
Secondary Outcome	Current modern contraceptive use among eligible women. Indicator for whether the primary female respondent is currently using a modern contraceptive method at the time of the follow-up survey. Modern methods include contraceptive implants, intrauterine devices, injectables, sterilization, condoms, oral contraceptive pills, emergency contraception, the Standard Days Method, and other modern contraceptive methods.	12 months after intervention implementation
Secondary Outcome	Contraceptive concordance with fertility preferences. Measure of alignment between the respondent's fertility preferences and contraceptive behavior, based on household survey responses about fertility preferences and contraceptive use.	12 months after intervention implementation
Secondary Outcome	Days of usual activity lost due to illness or health reasons	Past 30 days at 12-month follow-up / endline
Secondary Outcome	Adult labor force participation	Past 7 days and/or past 12 months at 12-month follow-up / endline
Secondary Outcome	Health facility service delivery outcomes. Measures of health facility operations and service delivery, including patient volumes, staffing, medication and commodity inventories, stockouts, and facility management practices, measured through health facility surveys and administrative or monitoring data.	Baseline to 12month follow up, monthly administrative or monitoring data where available
Secondary Outcome	Indirect effects on healthcare utilization in facility proximate communities. Healthcare utilization outcomes among households living near study health facilities and not eligible to receive HAC outreach services. These outcomes are used to assess whether the outreach intervention affects service availability or use among facility-proximate populations.	12 months after intervention implementation / endline
Secondary Outcome	Indirect effects on current contraceptive use in facility proximate communities. Current contraceptive use among eligible women living near study health facilities and not eligible to receive HAC outreach services.	12 months after intervention implementation / endline

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Health Access Connect	PO Box 215, Ntinda	Kampala	00001	Uganda
Innovations for Poverty Action Uganda	21 Kanjokya St	Kampala	00001	Uganda

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
JPAL Gender and Economic Agency Initiative	400 Main Street, E19-201	Cambridge	02142	United States of America
Weiss Fund for Development Economics	5801 S. Ellis Ave,	Chicago	60637	United States of America
Project Resource Optimization	NA	NA		United States of America

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	The Ohio State University	281 W Lane Ave	Columbus	43210	United States of America	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Anne Fitzpatrick	2120 Fyffe Road	Columbus OH	43210	United States of America
Aggrey Semeere	Infectious Disease Institute Makerere University	Kampala		Uganda
Maria Dieci	1518 Clifton Rd. NE	Atlanta	30322	United States of America
Mahesh Karra	722 W 168th St	New York	10032	United States of America
Xufeng Liu	2120 Fyffe Road	Columbus	43210	United States of America
Juliana Namutundu	Infectious Disease Institute - Makerere University	Kampala		Uganda
Anthony Kamwesige	21 Kanjokya St	Kampala		Uganda
Aziz Buyinza	21 Kanjokya St	Kampala		Uganda

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Anne Fitzpatrick	fitzpatrick.88@osu.edu	6142922676	College of Food, Agricultural, and Environmental Sciences Agricultural Administration Building 2120 Fyffe Road
City	Postal code	Country	Position/Affiliation
Columbus	43210	United States of America	Associate Professor
Role	Name	Email	Phone	Street address
Public Enquiries	Anne Fitzpatrick	fitzpatrick.88@osu.edu	6142922676	College of Food, Agricultural, and Environmental Sciences Agricultural Administration Building 2120 Fyffe Road
City	Postal code	Country	Position/Affiliation
Columbus	43210	United States of America	Associate Professor
Role	Name	Email	Phone	Street address
Scientific Enquiries	Anne Fitzpatrick	fitzpatrick.88@osu.edu	6142922676	College of Food, Agricultural, and Environmental Sciences Agricultural Administration Building 2120 Fyffe Road
City	Postal code	Country	Position/Affiliation
Columbus	43210	United States of America	Associate Professor
Role	Name	Email	Phone	Street address
Public Enquiries	Anthony Kamwesige	akamwesigye@poverty-action.org	+256702402160	21 Kanjokya St
City	Postal code	Country	Position/Affiliation
Kampala	00001	Uganda	Research Manager

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	De-identified individual participant data generated during the study will be made available in a public repository after completion of the pre-specified analyses. Shared data materials will include primary data, metadata, codebooks, program code, and supporting documentation. Identifiable personal information, including names, contact information, and other direct identifiers, will be removed before public release. Full identifiable datasets will not be publicly released but may be available upon request, subject to review and approval by the Mildmay Uganda Research Ethics Committee.	Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol	Within three years of final data collection, following completion of the pre-specified analyses and de-identification procedures.	De-identified data and supporting documentation will be made available through a public repository for research, replication, and reuse, subject to applicable ethical approvals and data-use requirements. Requests for identifiable data will require review and approval by the Mildmay Uganda Research Ethics Committee and any other relevant institutional review bodies.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	09/07/2026	Have updated overview to include total number of surveyed individuals (3840).	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 192 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.	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 192 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 in a sample of 3840 respondents.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Eligibility	Age group	09/07/2026	Updated to include middle aged group, as eligible participants can be up to 45 (inclusive).	Adult: 18 Year(s)-44 Year(s)	Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s)
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	09/07/2026	Updated group size to reflect total number of survey respondents, updated description of intervention to provide detail.	Experimental Group, HAC Facilitated Integrated Community Health Outreach, , 12 months, Health facilities randomized to the intervention arm will receive HAC support to conduct regular integrated community health outreach visits in two remote villages within their catchment area. Outreach visits are staffed by public-sector health workers from the corresponding health facility and provide basic primary healthcare services in the community., 32,	Experimental Group, HAC Facilitated Integrated Community Health Outreach, , 12 months, 32 Health facilities randomized to the intervention arm will receive HAC support to conduct regular integrated community health outreach visits in two remote villages within their catchment area. Outreach visits are staffed by public-sector health workers from the corresponding health facility and provide basic primary healthcare services in the community. A total of 1920 respondents will be surveyed in the 2 direct villages (1280) and 1 indirect village (640) associated with the 32 treated health facilities., 1920,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	09/07/2026	Updated group size to reflect total number of survey respondents, with rationale updated in intervention description.	Control Group, Status quo comparison group, , 12 months, Health facilities randomized to the control arm will continue usual facility-based service delivery during the study period. They will not receive HAC-facilitated outreach support in the study villages during the trial period. , 32, Uncontrolled	Control Group, Status quo comparison, , 12 months, 32 Health facilities randomized to the control arm will continue usual facility-based service delivery during the study period. They will not receive HAC-facilitated outreach support in the study villages during the trial period. 1920 surveys will be completed across 2 direct villages (1280) and 1 indirect community (640) associated with each of the 32 control health facilities. , 1920, Uncontrolled
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Recruitment Centre	RecruitmentCentre List	09/07/2026	Updated with correct recruitment centre details		Health Access Connect, PO Box 215, Ntinda, Kampala, 00001, Uganda
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Recruitment Centre	RecruitmentCentre List	09/07/2026	Updated with correct recruitment centre details		Innovations for Poverty Action Uganda, 21 Kanjokya St, Kampala, 00001, Uganda
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	09/07/2026	Updated to include original IRB approval letter,	TRUE, Mildmay Uganda Research Ethics Committee, P.O. Box 24985 , Kampala, 10000, Uganda, , 13 Jan 2025, 701472492, racheal.dedibo@mildmay.or.ug, 42601_39932_4737.pdf	TRUE, Mildmay Uganda Research Ethics Committee, P.O. Box 24985 , Kampala, 10000, Uganda, , 13 Jan 2025, 701472492, racheal.dedibo@mildmay.or.ug, 42601_39932_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Contact People	Contacs List	09/07/2026	Updating to include Ugandan contact for enquiries.		Public Enquiries, Anthony, Kamwesige, Mr., akamwesigye@poverty-action.org, , +256702402160, 21 Kanjokya St, Kampala, 00001, Uganda, Research Manager

Pan African Clinical Trials Registry