I-CAN Uganda Effectiveness Trial (I-CAN)

Cluster Randomized Controlled Trial of the "I-CAN" Peer Support Intervention to Improve Contraceptive Agency in in Rural Uganda

This is a cluster-randomized controlled trial to determine the effectiveness of the community-based "I-CAN" intervention to improve agency in contraceptive decision-making and use in rural Uganda. Lay women will be trained to serve as peer mentors to other women of reproductive age in the community, using their own lived experience to provide support and information about contraceptive choices.

Villages will be randomized to either receive the intervention or not. A household survey will be conducted at baseline before implementation activities begin and 24[CB5.1][DA5.2][DA5.3][PB5.4] months later. Interviews will also be conducted with mentors, participants, male partners of participants and other stakeholders.

Researchers will compare preference-aligned contraceptive use (primary outcome)[CB6.1], contraceptive agency, contraceptive method satisfaction, preference-aligned fertility management, and use of self-injectable contraception in villages with and without the intervention to determine effectiveness.

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception
• Intervention / Treatment: Behavioral: I-CAN

• Study Type: Interventional
• Enrollment (Estimated): 1560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelsey Holt, ScD, MA; Phone Number: 617-455-2693; Email: kelsey.holt@ucsf.edu

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University School of Public Health
    • Contact: Peter Waiswa; Email: pwaiswa@musph.ac.ug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Woman
• Ages 18-49 years

Exclusion Criteria:

• Women who are not able to respond to the survey questions on their own
• Not usual resident in study village
• Not consenting to the survey

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; Villages in the comparison group will continue with the standard of care for contraceptive services. This includes health facilities offering contraceptive counseling and methods and at least one community health worker (CHW) per village who provides education and counseling in community gathering places and home visits for women with babies and small children. CHWs can provide injectables, pills, condoms, and emergency contraceptives, and refer women for further services such as implants, IUDs, and sterilization. Contraception services are also available through the private sector in private and non-governmental clinics and pharmacies, though these outlets may be in accessible to many women in rural areas due to financial constraints.
Experimental: I-CAN Intervention arm; This arm will receive the I-CAN intervention	Behavioral: I-CAN; I-CAN leverages four social support mechanisms (informational, instrumental, appraisal, emotional) to improve women's agency related to contraceptive decisions and actions. Community-based organizations (CBOs) recruit and train lay women ("mentors") via an intensive four-day training with a mix of didactic and practical sessions. Trained peer mentors will provide tailored social support to interested women in the community, drawing on their lived experiences to "mentor" other women in their village whom they recruit through community outreach. "Mentees" can opt-in to get tailored support (in the form of one-on-one consultations and/or accompaniment to health services) over a period of time they choose. Mentors are trained to provide neutral support and respect women's decisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference-aligned Contraceptive Use[	This is defined as the reported current use or non-use of any contraceptive method that aligns with one's stated preferences for using or not using any method. Participants will be asked 1) whether they or their partner is currently doing anything or using any method to delay or prevent pregnancy and 2) whether they want to do anything or use any method to delay or prevent pregnancy. A binary indicator will be constructed where 1=alignment between behaviour (current use or non-use) and preference (i.e., either using contraception and want to use contraception, or not using contraception and do not want to use contraception) and 0=misalignment (i.e., using contraception but do not want to or not using contraception but want to use contraception).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method Satisfaction	A 1-item measure using a 5-point Likert scale where 1=very dissatisfied and 5=very satisfied.	24 months
Ever-use of self-injectable contraception	A 1-item measure with a binary response of 1=Has ever self-injected and 0=Has never self-injected.	24 months
Agency in Contraceptive Decisions Scale	This 15-item scale includes individual items scored on a scale of 0-3. The composite score is an average of scores on all items. 3=highest agency.	24 months
Preference-aligned Fertility Management (PFM) Index	The PFM Index measures whether current contraception use/non-use aligns with one's preferences for use/non-use (indicator 1) and, for users, with their method-specific preference (indicator 2). The index is a composite calculated as a binary where 1=alignment on both indicators and 0=misalignment on at least one indicator.	24 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Makerere University; Baitambogwe Community Healthcare Initiative (BACHI); AIDS Information Centre - Uganda (AIC)
• Investigators: Principal Investigator: Kelsey Holt, ScD, MA, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Uganda; Rural; Preference-aligned contraceptive use; Self-injectable contraception; Contraceptive agency; Peer social support
• Other Study ID Numbers: 24-43214; R01HD118092 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the time of publication of the initial findings of the study, we will make individual participant data that underlie the results available in a public repository after deidentification.
• IPD Sharing Time Frame: At the time of publication of findings, for a minimum of 6 years after the end of the funding period.
• IPD Sharing Access Criteria: Anyone will be able to access publicly available deidentified data once it is uploaded to a repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No