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Not yet recruiting NCT07711717

I-CAN Uganda Effectiveness Trial

No phase Interventional Contraception

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: I-CAN.
Who it may be relevant to
Registry conditions: Contraception. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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 vill

Primary outcome measures

  • Preference-aligned Contraceptive Use [Time frame: 24 months]
Secondary outcome measures (4)
  • Method Satisfaction [Time frame: 24 months]
  • Ever-use of self-injectable contraception [Time frame: 24 months]
  • Agency in Contraceptive Decisions Scale [Time frame: 24 months]
  • Preference-aligned Fertility Management (PFM) Index [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Uganda · 1 center
  • Makerere University School of Public Health — Kampala

Identifiers

NCT: NCT07711717 · 24-43214 · R01HD118092

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗