Health TrialsbyHealthPanel

I-CAN Uganda Effectiveness Trial

ConditionContraception
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorUniversity of California, San Francisco

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Woman

Ages 18-49 years

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

1,560 Participants
are divided into 2 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: I-CAN Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
24 months

Secondary outcomes

1

Method Satisfaction

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

Time frame
24 months
2

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.

Time frame
24 months
3

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.

Time frame
24 months
4

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Makerere University

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Baitambogwe Community Healthcare Initiative (BACHI)

Collaborator

AIDS Information Centre - Uganda (AIC)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: