ContraceptionI-CANNCT07711717
I-CAN Uganda Effectiveness Trial
A study testing I-CAN in people with Contraception, run by University of California, San Francisco at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- I-CAN
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,560 participants
- Where
- 1 siteUganda
- Study dates
- 13 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman
- Ages 18-49 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Makerere University School of Public Health
Kampala
Peter Waiswa, pwaiswa@musph.ac.ug
About this study
Official title: Cluster Randomized Controlled Trial of the "I-CAN" Peer Support Intervention to Improve Contraceptive Agency in in Rural Uganda
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
- Being tested
- I-CAN
- Keywords
- Preference-aligned contraceptive use, Self-injectable contraception, Contraceptive agency, Peer social support, Uganda, Rural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-CANBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: I-CAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
Secondary outcomes (4)
Method Satisfaction
A 1-item measure using a 5-point Likert scale where 1=very dissatisfied and 5=very satisfied.
Measured: 24 months
Ever-use of self-injectable contraception
A 1-item measure with a binary response of 1=Has ever self-injected and 0=Has never self-injected.
Measured: 24 months
Agency in Contraceptive Decisions Scale
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.
Measured: 24 months
Preference-aligned Fertility Management (PFM) Index
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start13 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Baitambogwe Community Healthcare Initiative (BACHI), AIDS Information Centre - Uganda (AIC)
- Responsible party
- Sponsor
- Investigators
- Kelsey Holt, ScD, MA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711717
- Sponsor's protocol ID
- 24-43214
- Other IDs
- R01HD118092
- Acronym
- I-CAN
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the time of publication of the initial findings of the study, we will make individual participant data that underlie the results available in a public repository after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Controlled Trial of the "I-CAN" Peer Support Intervention to Improve Contraceptive Agency in in Rural Uganda
- ClinicalTrials.gov ID
- NCT07711717
- Acronym / sponsor ID
- I-CAN / 24-43214
- Conditions
- Contraception
- Keywords
- Preference-aligned contraceptive use, Self-injectable contraception, Contraceptive agency, Peer social support, Uganda, Rural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,560 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Makerere University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Baitambogwe Community Healthcare Initiative (BACHI), AIDS Information Centre - Uganda (AIC)
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: I-CANThis arm will receive the I-CAN intervention |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Woman
- Ages 18-49 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-CANI-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 | Behavioural | I-CAN Intervention arm |
Primary outcome
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Yes. At the time of publication of the initial findings of the study, we will make individual participant data that underlie the results available in a public repository after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelsey Holt, ScD, MA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-CAN in people with Contraception, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Holt, ScD, MA (617-455-2693, kelsey.holt@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference-aligned Contraceptive Use (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.