I-CAN Uganda Effectiveness Trial

Sponsor
University of California, San Francisco
Study ID
NCT07711717
Status
Not Yet Recruiting

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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Oct 13, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,560 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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

Primary Outcome Measure

Preference-aligned Contraceptive Use[ [ Time Frame: 24 months ]

Central Contacts

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