Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07711717

I-CAN Uganda Effectiveness Trial

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University School of Public Health

Kampala, Uganda

Location contact

Peter Waiswa

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Preference-aligned Contraceptive Use

    Time frame: 24 months

    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).

Secondary outcomes

  1. Method Satisfaction

    Time frame: 24 months

    A 1-item measure using a 5-point Likert scale where 1=very dissatisfied and 5=very satisfied.

  2. Ever-use of self-injectable contraception

    Time frame: 24 months

    A 1-item measure with a binary response of 1=Has ever self-injected and 0=Has never self-injected.

  3. Agency in Contraceptive Decisions Scale

    Time frame: 24 months

    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.

  4. Preference-aligned Fertility Management (PFM) Index

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey Holt, ScD, MA

CONTACT

[email protected]

617-455-2693

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Acronym: I-CAN

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.