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I-CAN Uganda Effectiveness Trial

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07711717
Acronym
I-CAN
Enrollment
1560
Registered
2026-07-17
Start date
2026-10-13
Completion date
2028-12-31
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

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

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.

Interventions

BEHAVIORALI-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

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Makerere University
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Baitambogwe Community Healthcare Initiative (BACHI)
CollaboratorUNKNOWN
AIDS Information Centre - Uganda (AIC)
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preference-aligned Contraceptive Use24 monthsThis 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).

Secondary

MeasureTime frameDescription
Method Satisfaction24 monthsA 1-item measure using a 5-point Likert scale where 1=very dissatisfied and 5=very satisfied.
Ever-use of self-injectable contraception24 monthsA 1-item measure with a binary response of 1=Has ever self-injected and 0=Has never self-injected.
Agency in Contraceptive Decisions Scale24 monthsThis 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.
Preference-aligned Fertility Management (PFM) Index24 monthsThe 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.

Countries

Uganda

Contacts

CONTACTKelsey Holt, ScD, MA
kelsey.holt@ucsf.edu617-455-2693
PRINCIPAL_INVESTIGATORKelsey Holt, ScD, MA

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026