I-CAN Uganda Effectiveness Trial

NCT07711717 | Not Yet Recruiting

• 2 other identifiers: 24-43214R01HD118092
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 1

Brief Summary

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 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), 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.

Conditions

Contraception

Keywords

Preference-aligned contraceptive use; Self-injectable contraception; Contraceptive agency; Peer social support; Uganda; Rural

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Method Satisfaction

  24 months

• Ever-use of self-injectable contraception

  24 months

• Agency in Contraceptive Decisions Scale

  24 months

• Preference-aligned Fertility Management (PFM) Index

  24 months

Study Arms (2)

Standard of care

NO INTERVENTION

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.

I-CAN Intervention arm

EXPERIMENTAL

This arm will receive the I-CAN intervention

Behavioral: I-CAN

Interventions

I-CAN BEHAVIORAL

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

I-CAN Intervention arm

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Woman
• Ages 18-49 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Makerere University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Baitambogwe Community Healthcare Initiative (BACHI): collaborator
• AIDS Information Centre - Uganda (AIC): collaborator

Study Sites (1)

Makerere University School of Public Health

Kampala, Uganda

Location

Study Officials

• Kelsey Holt, ScD, MA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Holt, ScD, MA

CONTACT

617-455-2693; kelsey.holt@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): October 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of publication of findings, for a minimum of 6 years after the end of the funding period.
• Access Criteria: Anyone will be able to access publicly available deidentified data once it is uploaded to a repository.

Locations

UG (1)