Unintended PregnancyPhase 2/3NCT06923189
Efficacy Testing of a Multi-Level Family Planning Intervention
A Phase 2/3 study testing Family Planning Intervention and Water, Sanitation, and Hygiene (WASH) Intervention in people with Unintended Pregnancy and Family Planning, run by Boston College at 1 site in Uganda.
Trial summary
The goal of this cluster randomized controlled trial is to learn if the multi-level, community-based family planning intervention, known as the Family Health=Family Wealth (FH=FW) program, can improve family planning outcomes in couples of reproductive age in Uganda. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 15 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Unintended Pregnancy, Family Planning
- What is being tested?
- Family Planning Intervention and Water, Sanitation, and Hygiene (WASH) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,464 participants
- Where
- 1 siteUganda
- Study dates
- 12 Jun 2025to 31 Dec 2028
- Phase
- Phase 2/3
- 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 15 to 54 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women aged 18 (or emancipated minors - those 15-17 who are married and/or have children) to 49 and men aged 18 (or emancipated minors age 15-17) to 54. The upper age limits follow those used by the Demographic and Health Surveys (DHS) to define "reproductive age."
- Married or considers themselves married and living together most of the time
- Residing in communities selected for study inclusion
- Luganda speaking
- Sexually active with spouse within the past 3 months or planning to resume sex within the next 3 months if the woman is within 2 months postpartum
- Not currently pregnant (confirmed via pregnancy test); can be eligible to enroll later once postpartum
- The woman has an unmet need for family planning, i.e., the woman reports not wanting to become pregnant within the next 2 years but is not using any effective methods (IUD, injection, oral pill, implant, vasectomy, tubal ligation, condoms 90% of the time or more) or is using only lower-efficacy methods (condoms less than 90% of the time, lactational amenorrhea, fertility-awareness based methods e.g., counting method, withdrawal).
Who cannot join
- At least one person in the couple does not expect to be available for all sessions
- The woman or man is not able to reproduce due to a known medical reason (e.g., hysterectomy, as told by a doctor) or last period greater than 6 months for women that are not postpartum.
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, 1 recruiting
- Recruiting
Makerere School of Public Health
Kampala
Christine Muhumuza, +256772658876, cmuhumuza@musph.ac.ug
Christine Muhumuza
About this study
Official title: Efficacy Testing of a Multi-Level Family Planning Intervention to Increase Contraceptive Use and Reduce Unintended Pregnancy in Low Resource Settings
The goal of this cluster randomized controlled trial is to learn if the multi-level, community-based family planning intervention, known as the Family Health=Family Wealth (FH=FW) program, can improve family planning outcomes in couples of reproductive age in Uganda. The main questions it aims to answer are:
- Does FH=FW participation reduce unintended pregnancy and increase contraceptive uptake among couples who say they want to delay pregnancy over 24-months?
- Does FH=FW participation reduce discontinuation of contraceptive methods for those who adopt them over 24-months?
- What factors affect the implementation of the FH=FW intervention?
Read more
Researchers will compare change in the above outcomes in couples receiving the FH=FW intervention to those who instead receive a water, sanitation, and hygiene intervention.
Couples in the FH=FW arm will be asked to attend 6 groups sessions where they learn about family planning's benefits to their health and well-being alongside content to increase their shared spousal decision-making and communication skills, their access to family planning services, and their perceptions of community acceptance of family planning.
Read the detailed description
In 2022, 29.7% of married women of reproductive age had an unmet need for family planning in Uganda, meaning they wanted to avoid pregnancy but were not using a modern contraceptive method. Filling the unmet need for family planning has important public health implications, including reductions in pregnancy-related health risks and deaths, and infant mortality. On the supply-side, community platforms to deliver family planning, as well as provider capacity to provide effective methods, need to be strengthened, but such efforts will not be optimized without addressing multilevel demand-side barriers to contraceptive use. Misinformation and fear of contraceptive side-effects, relationship dynamics, peer and family influence, and broader community norms promoting large family size and traditional gender roles influence family planning. This study will test the Family Health=Family Wealth (FH=FW) multi-level, community-based intervention, which employs health system strengthening efforts alongside transformative community dialogues to alter individual attitudes and the perception of community norms that discourage family planning. Community dialogues are delivered to groups of couples over 6-sessions enhanced to simultaneously address individual and interpersonal-level determinants of family planning and serve as a platform for community-based family planning and linkage to facility-based family planning services. The study aims are to: (1) In a cluster randomized trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect. (2) Determine the intervention's effect on, and determinants of, contraceptive continuation. (3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment.
- Conditions
- Unintended Pregnancy, Family Planning
- Being tested
- Family Planning Intervention, Water, Sanitation, and Hygiene (WASH) Intervention
- Keywords
- Unintended pregnancy, Contraceptive use, Family planning, Intervention, Cluster randomized controlled trial, Uganda, Couples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Planning InterventionBehavioural
This multilevel intervention is comprised of community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. The intervention is paired with health system strengthening elements implemented with the intervention health clinics (provider training, strengthening skip the queue policies, linkage of family planning services directly to dialogues).
Water, Sanitation, and Hygiene (WASH) InterventionBehavioural
This intervention serves as the attention-matched control. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (handwashing, food preparation) following an intervention manual that was developed for community groups in East Africa and tailored to the local Uganda context.
| Study group | Role | What they receive |
|---|---|---|
| Family Health = Family Wealth | Experimental | This arm receives the Family Health = Family Wealth intervention. Receives: Behavioral: Family Planning Intervention |
| Time- and attention-matched WASH intervention | Active comparator | This arm receives an attention-matched comparator intervention focused on water, sanitation, and hygiene (WASH). Receives: Behavioral: Water, Sanitation, and Hygiene (WASH) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modern contraceptive use among those with an unmet need for family planning
Proportion of couples where the woman currently wants to prevent pregnancy reporting modern contraceptive use.
Measured through structured timeline follow-back (TLFB) interviews, which use cued recall techniques, e.g., identifying key dates to serve as anchors, to assess contraceptive use by week for the prior four-month period (used y/n, method). Pregnancy intentions (desire to prevent pregnancy) are reassessed and accounted for at each follow-up.
Measured: 4-, 8-, 12-, 16-, 20-, 24-months
Unintended pregnancy incidence
Unintended pregnancy incidence (Yes/No) over 24 months. Measured through urine Human Chorionic Gonadotropin rapid pregnancy tests; classified as unintended if reporting they wanted to wait until later or not get pregnant at all at the time of the pregnancy test, captured through a Demographic and Health Survey item.
Measured: 8-, 16-, 24-months
Secondary outcomes (3)
Change from baseline in modern contraceptive use
Proportion of couples reporting modern contraceptive use in the full sample, regardless of pregnancy intentions.
Measured through structured timeline follow-back (TLFB) interviews, which use cued recall techniques, e.g., identifying key dates to serve as anchors, to assess contraceptive use by week for the prior four-month period (used y/n, method).
Measured: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive autonomy
Proportion of women reporting contraceptive autonomy (y/n). Contraceptive autonomy (yes) is defined as those that want to delay pregnancy with modern contraceptives reporting contraceptive use or that do not want to delay pregnancy with modern contraceptives that are not using a method (positive outcome).
Contraceptive autonomy (no) is defined as those not using a modern method when wanting to delay pregnancy with a modern method or using a method when not wanting to delay pregnancy are considered not having contraceptive autonomy.
Contraceptive use is measured through structured timeline follow-back (TLFB) interviews, which use cued recall techniques, e.g., identifying key dates to serve as anchors, to assess contraceptive use by week for the prior four-month period (used y/n, method).
Measured: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive continuation rate
Duration of continuation: The time from starting contraceptive use to discontinuation (a period of discontinuation of 1 month or more).
Contraceptive use is measured through structured timeline follow-back (TLFB) interviews, which use cued recall techniques, e.g., identifying key dates to serve as anchors, to assess contraceptive use by week for the prior four-month period (used y/n, method).
Measured: 4-, 8-, 12-, 16-, 20-, 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start12 Jun 2025
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unintended PregnancyStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Diego State University, Yale University, University of North Carolina, Chapel Hill, Makerere University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923189
- Sponsor's protocol ID
- 25.018.01
- Other IDs
- R01HD113806
- Status last verified
- Mar 2026
- First submitted
- 4 Apr 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected quantitative IPD. For the qualitative data, we will limit the sharing to include the sharing of codes, themes, and interview guides. We will not share transcripts or segments of coded transcripts, given difficulty to fully de-identify qualitative data, to protect participant privacy and confidentiality.
Publications
Sileo KM, Muhumuza C, Wanyenze RK, Kershaw TS, Sekamatte S, Lule H, Kiene SM. A pilot quasi-experimental controlled trial of a community-based, multilevel family planning intervention for couples in rural Uganda: evidence of feasibility, acceptability, and effect on contraceptive uptake among those with an unmet need for family planning. Contraception. 2023 Sep;125:110096. doi: 10.1016/j.contraception.2023.110096. Epub 2023 Jun 22.
PubMed 37355086
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of a Multi-Level Family Planning Intervention to Increase Contraceptive Use and Reduce Unintended Pregnancy in Low Resource Settings
- ClinicalTrials.gov ID
- NCT06923189
- Acronym / sponsor ID
- 25.018.01
- Conditions
- Unintended Pregnancy, Family Planning
- Keywords
- Unintended pregnancy, Contraceptive use, Family planning, Intervention, Cluster randomized controlled trial, Uganda, Couples
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,464 participants (estimated)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), San Diego State University, Yale University, University of North Carolina, Chapel Hill, Makerere University
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Apr 2025 (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.
The goal of this cluster randomized controlled trial is to learn if the multi-level, community-based family planning intervention, known as the Family Health=Family Wealth (FH=FW) program, can improve family planning outcomes in couples of reproductive age in Uganda. The main questions it aims to answer are:
- Does FH=FW participation reduce unintended pregnancy and increase contraceptive uptake among couples who say they want to delay pregnancy over 24-months?
- Does FH=FW participation reduce discontinuation of contraceptive methods for those who adopt them over 24-months?
- What factors affect the implementation of the FH=FW intervention?
Researchers will compare change in the above outcomes in couples receiving the FH=FW intervention to those who instead receive a water, sanitation, and hygiene intervention.
Couples in the FH=FW arm will be asked to attend 6 groups sessions where they learn about family planning's benefits to their health and well-being alongside content to increase their shared spousal decision-making and communication skills, their access to family planning services, and their perceptions of community acceptance of family planning.
Detailed description
In 2022, 29.7% of married women of reproductive age had an unmet need for family planning in Uganda, meaning they wanted to avoid pregnancy but were not using a modern contraceptive method. Filling the unmet need for family planning has important public health implications, including reductions in pregnancy-related health risks and deaths, and infant mortality. On the supply-side, community platforms to deliver family planning, as well as provider capacity to provide effective methods, need to be strengthened, but such efforts will not be optimized without addressing multilevel demand-side barriers to contraceptive use. Misinformation and fear of contraceptive side-effects, relationship dynamics, peer and family influence, and broader community norms promoting large family size and traditional gender roles influence family planning. This study will test the Family Health=Family Wealth (FH=FW) multi-level, community-based intervention, which employs health system strengthening efforts alongside transformative community dialogues to alter individual attitudes and the perception of community norms that discourage family planning. Community dialogues are delivered to groups of couples over 6-sessions enhanced to simultaneously address individual and interpersonal-level determinants of family planning and serve as a platform for community-based family planning and linkage to facility-based family planning services. The study aims are to: (1) In a cluster randomized trial, compare the efficacy of the FH=FW intervention vs. a time/attention matched comparator intervention at increasing modern contraceptive use and reducing unintended pregnancy among couples with an unmet need for family planning through 24-months, and identify potential mediators of the intervention effect. (2) Determine the intervention's effect on, and determinants of, contraceptive continuation. (3) Through a mixed-methods process evaluation, explore factors affecting the implementation of the intervention in order to improve feasibility, acceptability, and the likelihood of future adoption and sustainment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Health = Family Wealth | Experimental | Behavioral: Family Planning InterventionThis arm receives the Family Health = Family Wealth intervention. |
| Time- and attention-matched WASH intervention | Active comparator | Behavioral: Water, Sanitation, and Hygiene (WASH) InterventionThis arm receives an attention-matched comparator intervention focused on water, sanitation, and hygiene (WASH). |
Who may qualify
- Ages
- 15 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Women aged 18 (or emancipated minors - those 15-17 who are married and/or have children) to 49 and men aged 18 (or emancipated minors age 15-17) to 54. The upper age limits follow those used by the Demographic and Health Surveys (DHS) to define "reproductive age."
- Married or considers themselves married and living together most of the time
- Residing in communities selected for study inclusion
- Luganda speaking
- Sexually active with spouse within the past 3 months or planning to resume sex within the next 3 months if the woman is within 2 months postpartum
Key exclusion criteria (2 listed)
- At least one person in the couple does not expect to be available for all sessions
- The woman or man is not able to reproduce due to a known medical reason (e.g., hysterectomy, as told by a doctor) or last period greater than 6 months for women that are not postpartum.
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 |
|---|---|---|
| Family Planning InterventionThis multilevel intervention is comprised of community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of "family-wealth" and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a "successful family" inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community. The intervention is paired with health system strengthening elements implemented with the intervention health clinics (provider training, strengthening skip the queue policies, linkage of family planning services directly to dialogues). | Behavioural | Family Health = Family Wealth |
| Water, Sanitation, and Hygiene (WASH) InterventionThis intervention serves as the attention-matched control. The format and delivery will mirror that of the "Family Health = Family Wealth" intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (handwashing, food preparation) following an intervention manual that was developed for community groups in East Africa and tailored to the local Uganda context. | Behavioural | Time- and attention-matched WASH intervention |
Primary outcome
Change from baseline in modern contraceptive use among those with an unmet need for family planning
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Proportion of couples where the woman currently wants to prevent pregnancy reporting modern contraceptive use. Measured through structured timeline follow-back (TLFB) interviews, which use cued recall techniques, e.g., identifying key dates to serve as anchors, to assess contraceptive use by week for the prior four-month period (used y/n, method). Pregnancy intentions (desire to prevent pregnancy) are reassessed and accounted for at each follow-up.
Unintended pregnancy incidence
Time frame: 8-, 16-, 24-months
Unintended pregnancy incidence (Yes/No) over 24 months. Measured through urine Human Chorionic Gonadotropin rapid pregnancy tests; classified as unintended if reporting they wanted to wait until later or not get pregnant at all at the time of the pregnancy test, captured through a Demographic and Health Survey item.
3 secondary outcomes
Change from baseline in modern contraceptive use
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive autonomy
Time frame: 4-, 8-, 12-, 16-, 20-, 24-months
Change from baseline in contraceptive continuation rate
Time frame: 4-, 8-, 12-, 16-, 20-, 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 Mar 2026.
- Background: PubMed 37355086Sileo KM, Muhumuza C, Wanyenze RK, Kershaw TS, Sekamatte S, Lule H, Kiene SM. A pilot quasi-experimental controlled trial of a community-based, multilevel family planning intervention for couples in rural Uganda: evidence of feasibility, acceptability, and effect on contraceptive uptake among those with an unmet need for family planning. Contraception. 2023 Sep;125:110096. doi: 10.1016/j.contraception.2023.110096. Epub 2023 Jun 22.
- Individual participant dataSharing planned: Yes. All collected quantitative IPD. For the qualitative data, we will limit the sharing to include the sharing of codes, themes, and interview guides. We will not share transcripts or segments of coded transcripts, given difficulty to fully de-identify qualitative data, to protect participant privacy and confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Family Planning Intervention and Water, Sanitation, and Hygiene (WASH) Intervention in people with Unintended Pregnancy and Family Planning, run by Boston College 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Mar 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Katelyn M Sileo, PhD, MPH (860-977-8447, sileoka@bc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in modern contraceptive use among those with an unmet need for family planning (time frame: 4-, 8-, 12-, 16-, 20-, 24-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06923189, which also lists 1 linked publication.
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 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.