Contraceptive BehaviorFPIL-SOMNCT07902700
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
A study testing Intensive Gender-Transformative Programming, Light-Touch Gender-Transformative Programming and Standard Family Planning Services (WISH-2) in people with Contraceptive Behavior and Social Norms, run by Guttmacher Institute at 1 site in Somalia.
Trial summary
Since 2019, the International Rescue Committee (IRC) has led family planning programming in Somalia under the Women's Integrated Sexual Health (WISH) program, funded by the United Kingdom's Foreign, Commonwealth and Development Office. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Behavior, Social Norms
- What is being tested?
- Intensive Gender-Transformative Programming, Light-Touch Gender-Transformative Programming and Standard Family Planning Services (WISH-2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,436 participants
- Where
- 1 siteSomalia
- Study dates
- Oct 2026to May 2029
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Married women aged 15 to 49 living within a sampled settlement in Galgaduud
- Married men aged 18 to 60 living within a sampled settlement in Galgaduud
Who cannot join
- Unmarried women
- Unmarried men
- Men who are partners of women enrolled in the study who live in the same households of women enrolled in the study (for safety reasons)
- Individuals unable to provide informed consent due to cognitive impairment or severe mental illness
- Individuals who do not share a common language with the enumerators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Somalia1 site
Multi-site (household surveys) throughout Galgaduud
Dusa Marreb, Galgaduud
About this study
Official title: Estimating the Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia: A Cluster Randomized Controlled Trial for the Family Planning Impact Lab
Since 2019, the International Rescue Committee (IRC) has led family planning programming in Somalia under the Women's Integrated Sexual Health (WISH) program, funded by the United Kingdom's Foreign, Commonwealth and Development Office. This study will assess contraceptive and gender-norms outcomes in communities in Galgaduud region, where the IRC implemented WISH-1 (2019-2025) and continues programming under WISH-2. Approximately one year into WISH-2 implementation, the IRC will add gender-transformative programming, which this study will evaluate over the subsequent two years. The intervention aims to change harmful gender norms that constrain women's family planning decision-making, through programming with women, men, couples, and communities; the IRC will implement an intensive and a light-touch version. This study is independent of the IRC and is one of four studies in the Guttmacher Institute's Family Planning Impact Lab (FPIL), which produces experimental research estimating the causal impact of family planning interventions on women's health, wellbeing, and development outcomes.
Read the detailed description
This study is an independent evaluation of gender-transformative interventions nested within the IRC's family planning programming in Galgaduud region, Somalia. The unit of randomization is the settlement as listed in the International Organization for Migration (IOM)'s Displacement Tracking Matrix, which may be a rural village (tuulo), an urban neighborhood, or a displacement site. Seventy-two settlements were selected before Wave 1, with a minimum separation of 2 km between any two selected settlements to limit contamination, and all are surveyed at Waves 1 and 2 under identical standard WISH-2 programming (double baseline). After Wave 2 (approximately May 2027), the study team will randomize settlements 1:1:1, stratified by district, to standard WISH-2 only (control), WISH-2 plus an intensive gender-transformative intervention, or WISH-2 plus a light-touch gender-transformative intervention (24 settlements per arm). Galgaduud received family planning service delivery under WISH-1 from 2019 to June 2025 and, after a 12-month implementation gap, under WISH-2 from July 2026.
The primary comparison pools the two gender-transformative arms against the control arm. The comparison of the intensive and light-touch arms is a secondary, descriptive comparison: the trial is not powered for a formal non-inferiority test, and the difference in effects is estimated with its confidence interval and interpreted together with cost data.
The investigators will measure intervention effects using four waves of a household survey among married women aged 15 to 49 and married men aged 18 to 60. The women's survey follows a closed longitudinal cohort with dynamic replenishment (i.e., the investigators follow women longitudinally across survey waves and recruit replacement households at each wave to account for participants lost to follow-up); men are sampled cross-sectionally at each wave, one man per household, from households not selected for the women's survey.
The trial has three co-primary outcomes: women's preference-aligned fertility management, men's endorsement of the norm that a husband should have the final say about his wife's contraceptive use, and modern contraceptive prevalence. Men's endorsement of the final-say norm is analyzed as an ordinal outcome, with the intervention effect expressed as a common odds ratio. Co-primary hypothesis tests will use a Holm-Bonferroni procedure, with ordered p-values tested at alpha levels of 0.0167, 0.025, and 0.05, and each co-primary outcome judged separately. A statistical analysis plan will be finalized and dated after cluster randomization and before any outcome data are analyzed.
- Conditions
- Contraceptive Behavior, Social Norms
- Being tested
- Intensive Gender-Transformative Programming, Light-Touch Gender-Transformative Programming, Standard Family Planning Services (WISH-2)
- Keywords
- Family Planning Impact Lab, Family Planning, Family Planning Services, Contraception, Contraceptive Usage, Contraceptive Method Switching, Cost-effectiveness, Gender Roles, Men's Roles, Modern Contraceptive Use, Gender norms, Preference-concordant contraceptive use, Preference-aligned fertility management, Social networks, Somalia, gender-transformative
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Gender-Transformative ProgrammingBehavioural
Both the intensive and light-dose programming will target the patriarchal gender norms that constrain women's reproductive autonomy in Somalia. These norms manifest in multiple forms: partner opposition to contraceptive use, women's inability to access services without male permission, reproductive coercion, intimate partner violence related to family planning decision-making, and women's limited ability to act on their fertility preferences even when services are available. The intensive version of the intervention may be implemented as a multi-component, community-embedded program built around a structured couples' curriculum supplemented by broader community norm change strategies.
Light-Touch Gender-Transformative ProgrammingBehavioural
A reduced-intensity version of the gender-transformative programming, designed to test whether a less resource-intensive approach can achieve comparable effects at lower cost. The intervention package is being finalized by the IRC; this record will be updated with the final components before implementation begins.
Standard Family Planning Services (WISH-2)Behavioural
The IRC's standard WISH-2 family planning service delivery package, implemented by the IRC independently of the study team in all study settlements. The package strengthens facility-based family planning services through provider training, commodity availability, service integration, and community mobilization, with services delivered through static, outreach, and community-based channels.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Settlements in this arm will have access only to the standard family planning intervention implemented under WISH-2. This arm serves as the control. Receives: Behavioral: Standard Family Planning Services (WISH-2) |
| Intensive Gender Transformative Programming | Experimental | Settlements will have access to WISH-2 services as well as an intensive gender-transformative intervention. Receives: Behavioral: Intensive Gender-Transformative Programming; Behavioral: Standard Family Planning Services (WISH-2) |
| Light-touch Gender Transformative Programming | Experimental | Settlements will have access to WISH-2 services as well as a light-touch gender-transformative intervention. Receives: Behavioral: Light-Touch Gender-Transformative Programming; Behavioral: Standard Family Planning Services (WISH-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion and number of women using preference-aligned fertility management between baseline, midline, and endline
Change in the proportion and number of non-pregnant women aged 15-49 whose contraceptive use or non-use is aligned with their preferences, adapted from the preference-aligned fertility management indicator developed by Holt and colleagues; the study instrument elicits current use before contraceptive preference, whereas the original index elicits preference first. Users are classified as aligned if they want to be using a method, want to be using their current method, and report no other method they would prefer to use; non-users are classified as aligned if they want not to be using a method. A pre-specified sensitivity analysis classifies women reporting any pressure on their use or non-use as discordant.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in men's agreement with the statement "A husband should have the final say about whether his wife uses contraception," between baseline, midline, and endline
Married men aged 18-60 are asked whether they agree, partially agree, or do not agree with the statement: "A husband should have the final say about whether his wife uses contraception." The measure is summarized as the proportion of men in each response category. Men are sampled cross-sectionally at each wave, one man per household, from households not selected for the women's survey.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women aged 15 to 49 using a modern contraceptive method (modern contraceptive prevalence) between baseline, midline, and endline
Change in the proportion and number of women aged 15-49 who use, or whose partners use, a modern contraceptive method. Modern methods comprise female and male sterilization, copper and hormonal IUDs, implants, provider-administered and self-administered injectables, oral contraceptive pills, male and female condoms, emergency contraception, foam/jelly, the Lactational Amenorrhea Method, fertility awareness-based methods (standard days method, Billings ovulation method), and other modern methods reported through an open response (e.g., patch/ring, diaphragm). Any-method contraceptive prevalence - adding withdrawal, the rhythm method, other traditional and fertility awareness-based methods, and probe-identified users - will be reported as a pre-specified variant.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Secondary outcomes (11)
Change in the proportion and number of women aged 15 to 49 who have unmet need for family planning between baseline, midline, and endline
Unmet need follows the revised DHS definition (Bradley et al. 2012), which underlies UN SDG indicator 3.7.1. A woman has unmet need if she is fecund; wants to stop childbearing, delay the next birth by at least two years, or is undecided about timing - or is pregnant or postpartum amenorrheic following a mistimed or unwanted pregnancy - and is not using any method. Unmet need for modern methods adds women using a traditional method. The headline estimate is unmet need for modern methods among all women exposed to the risk of pregnancy: currently married or in union (assumed exposed), or unmarried and sexually active (intercourse in the past 30 days). DHS-conventional variants report unmet need for any method and for modern methods, among currently married women and among all sexually active women. SDG indicator 3.7.1 (demand satisfied with modern methods) will be computed from these components and reported. Probe-identified traditional-method users are classified as users.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women aged 15 to 49 with person-centered unmet need for family planning between baseline, midline, and endline
Person-centered unmet need classifies women with unmet need (revised DHS definition, any method, as above) who report that not using contraception is not what they want - that is, women with unmet need who want to be using a contraceptive method (Senderowicz et al., Studies in Family Planning, 2023). Its mirror, unwanted family planning - women currently using a contraceptive method who report that using is not what they want - will also be reported (Gausman et al., Studies in Family Planning, 2025).
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women who report making the final decision about contraceptive use alone or jointly with their partner, between baseline, midline, and endline
Proportion of women aged 15-49 who report that the final decision about their contraceptive use is made by themselves alone or jointly with their husband or partner, in response to a question asking who makes the final decision about the participant's use of contraception. Responses indicating that a partner, parent/guardian, in-laws, a health care provider, or another person decides alone or jointly are classified as not having decision-making autonomy.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women reporting that their contraceptive use or non-use was entirely their own choice, between baseline, midline, and endline
Proportion of non-pregnant women aged 15-49 who report that their current contraceptive status is entirely their own choice, free from pressure. Current users are asked whether use of their current method was their own choice, with no one having pressured or strongly encouraged them to use that particular method; non-users are asked whether not using a method is their own choice, with no one having pressured them into not using. The remaining response options indicate experiencing some pressure but agreeing, or feeling pressured. The measure operationalizes freedom from pressure as a component of contraceptive autonomy.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the level of reproductive self-efficacy as measured by the Contraceptive Self-Efficacy Scale for Sub-Saharan Africa (CSESSA) between baseline, midline, and endline
The Contraceptive Self-Efficacy Scale for Sub-Saharan Africa (CSESSA) is a 10-item validated tool used to measure reproductive self-efficacy. The investigators will assess the level of reproductive self-efficacy among women aged 15-49 in the sample at baseline, midline, and endline.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the mean score on a nine-item self-reported women's agency measure between baseline, midline, and endline
A nine-item self-reported measure of general agency covering decision-making over daily life, voice, capacity to act on life choices, and freedom of movement. Items ask whether the respondent can choose how to spend free time, choose which friends to spend time with, voice opinions and express views when others disagree, decide whether to go to school or to work, act on important life choices, make important decisions that change the course of life, do desired things, and go to desired places. Items were adapted from established frameworks for measuring women's and adolescent girls' agency. Each item is rated on a five-point scale from strongly agree to strongly disagree and combined into a mean score, with higher scores indicating greater agency. Administered to all women aged 15-49 at each survey wave.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in women's agreement with the statement "A husband should have the final say about whether his wife uses contraception," between baseline, midline, and endline
Women aged 15-49 are asked the same item administered to men, with response options agree, partially agree, and do not agree. The measure is summarized as the proportion of women in each response category.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the mean score on the Gender-Equitable Men (GEM) Scale among men, between baseline, midline, and endline
Mean score on the Gender-Equitable Men (GEM) Scale items administered to men aged 18-60, with higher scores indicating more gender-equitable attitudes. Subscale and item-level results are reported descriptively.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women and of men who report discussing family planning with their spouse or partner in the past 12 months, between baseline, midline, and endline
Proportion of partnered women aged 15-49, and of partnered men aged 18-60, who report discussing family planning with their spouse or partner in the past 12 months. Frequency of discussion is reported descriptively.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women reporting any reproductive coercion in the past 12 months, measured with an adapted five-item Reproductive Coercion Scale short form, between baseline, midline, and endline
Proportion of women aged 15-49 reporting at least one reproductively coercive behavior in the past 12 months, measured with five items adapted from the short form of the Reproductive Coercion Scale: being told not to use contraception; having birth control taken away or being kept from obtaining it; being made to have unprotected sex in order to become pregnant; condom removal during sex; and deliberate condom damage. Items are adapted to ask about coercion by any person, not only an intimate partner. The three sexual-behavior items are administered only to women who have ever had sex; the two contraceptive-interference items are administered to all women. The number of coercive behaviors reported (0-5) will be summarized descriptively. Reproductive coercion is additionally monitored by arm throughout the study for participant safety.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women reporting physical, emotional, sexual, or economic intimate partner violence (IPV) between baseline, midline, and endline
Change in the proportion and number of women aged 15-49 in the study who report experiencing physical, emotional, sexual, or economic intimate partner violence in the past 12 months, as assessed using an adapted DHS domestic violence module. Intimate partner violence is additionally monitored by arm throughout the study for participant safety.
Measured: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive BehaviorStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Settlements within Galgaduud region will be randomized to continue receiving only the IRC's standard family planning intervention, or to receive the standard intervention supplemented with an intensive or a light-touch gender-transformative intervention.
- Masking
- None (open label)
- Enrolment
- 5,436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guttmacher Institute
- Sponsor type
- University, hospital or other
- Collaborators
- IMPACT Initiatives
- Responsible party
- Sponsor
- Investigators
- Jewel Gausman, PhD, Principal investigator, Guttmacher Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902700
- Sponsor's protocol ID
- 01-647-31-22-00-SOM
- Acronym
- FPIL-SOM
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia: A Cluster Randomized Controlled Trial for the Family Planning Impact Lab
- ClinicalTrials.gov ID
- NCT07902700
- Acronym / sponsor ID
- FPIL-SOM / 01-647-31-22-00-SOM
- Conditions
- Contraceptive Behavior, Social Norms
- Keywords
- Family Planning Impact Lab, Family Planning, Family Planning Services, Contraception, Contraceptive Usage, Contraceptive Method Switching, Cost-effectiveness, Gender Roles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,436 participants (estimated)
- Lead sponsor
- Guttmacher InstituteUniversity, hospital or other
- Collaborators
- IMPACT Initiatives
- Study start
- Oct 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 29 Oct 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.
Since 2019, the International Rescue Committee (IRC) has led family planning programming in Somalia under the Women's Integrated Sexual Health (WISH) program, funded by the United Kingdom's Foreign, Commonwealth and Development Office. This study will assess contraceptive and gender-norms outcomes in communities in Galgaduud region, where the IRC implemented WISH-1 (2019-2025) and continues programming under WISH-2. Approximately one year into WISH-2 implementation, the IRC will add gender-transformative programming, which this study will evaluate over the subsequent two years. The intervention aims to change harmful gender norms that constrain women's family planning decision-making, through programming with women, men, couples, and communities; the IRC will implement an intensive and a light-touch version. This study is independent of the IRC and is one of four studies in the Guttmacher Institute's Family Planning Impact Lab (FPIL), which produces experimental research estimating the causal impact of family planning interventions on women's health, wellbeing, and development outcomes.
Detailed description
This study is an independent evaluation of gender-transformative interventions nested within the IRC's family planning programming in Galgaduud region, Somalia. The unit of randomization is the settlement as listed in the International Organization for Migration (IOM)'s Displacement Tracking Matrix, which may be a rural village (tuulo), an urban neighborhood, or a displacement site. Seventy-two settlements were selected before Wave 1, with a minimum separation of 2 km between any two selected settlements to limit contamination, and all are surveyed at Waves 1 and 2 under identical standard WISH-2 programming (double baseline). After Wave 2 (approximately May 2027), the study team will randomize settlements 1:1:1, stratified by district, to standard WISH-2 only (control), WISH-2 plus an intensive gender-transformative intervention, or WISH-2 plus a light-touch gender-transformative intervention (24 settlements per arm). Galgaduud received family planning service delivery under WISH-1 from 2019 to June 2025 and, after a 12-month implementation gap, under WISH-2 from July 2026.
The primary comparison pools the two gender-transformative arms against the control arm. The comparison of the intensive and light-touch arms is a secondary, descriptive comparison: the trial is not powered for a formal non-inferiority test, and the difference in effects is estimated with its confidence interval and interpreted together with cost data.
The investigators will measure intervention effects using four waves of a household survey among married women aged 15 to 49 and married men aged 18 to 60. The women's survey follows a closed longitudinal cohort with dynamic replenishment (i.e., the investigators follow women longitudinally across survey waves and recruit replacement households at each wave to account for participants lost to follow-up); men are sampled cross-sectionally at each wave, one man per household, from households not selected for the women's survey.
The trial has three co-primary outcomes: women's preference-aligned fertility management, men's endorsement of the norm that a husband should have the final say about his wife's contraceptive use, and modern contraceptive prevalence. Men's endorsement of the final-say norm is analyzed as an ordinal outcome, with the intervention effect expressed as a common odds ratio. Co-primary hypothesis tests will use a Holm-Bonferroni procedure, with ordered p-values tested at alpha levels of 0.0167, 0.025, and 0.05, and each co-primary outcome judged separately. A statistical analysis plan will be finalized and dated after cluster randomization and before any outcome data are analyzed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Settlements within Galgaduud region will be randomized to continue receiving only the IRC's standard family planning intervention, or to receive the standard intervention supplemented with an intensive or a light-touch gender-transformative intervention.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Standard Family Planning Services (WISH-2)Settlements in this arm will have access only to the standard family planning intervention implemented under WISH-2. This arm serves as the control. |
| Intensive Gender Transformative Programming | Experimental | Behavioral: Intensive Gender-Transformative Programming, Behavioral: Standard Family Planning Services (WISH-2)Settlements will have access to WISH-2 services as well as an intensive gender-transformative intervention. |
| Light-touch Gender Transformative Programming | Experimental | Behavioral: Light-Touch Gender-Transformative Programming, Behavioral: Standard Family Planning Services (WISH-2)Settlements will have access to WISH-2 services as well as a light-touch gender-transformative intervention. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Married women aged 15 to 49 living within a sampled settlement in Galgaduud
- Married men aged 18 to 60 living within a sampled settlement in Galgaduud
Key exclusion criteria (5 listed)
- Unmarried women
- Unmarried men
- Men who are partners of women enrolled in the study who live in the same households of women enrolled in the study (for safety reasons)
- Individuals unable to provide informed consent due to cognitive impairment or severe mental illness
- Individuals who do not share a common language with the enumerators
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 |
|---|---|---|
| Intensive Gender-Transformative ProgrammingBoth the intensive and light-dose programming will target the patriarchal gender norms that constrain women's reproductive autonomy in Somalia. These norms manifest in multiple forms: partner opposition to contraceptive use, women's inability to access services without male permission, reproductive coercion, intimate partner violence related to family planning decision-making, and women's limited ability to act on their fertility preferences even when services are available. The intensive version of the intervention may be implemented as a multi-component, community-embedded program built around a structured couples' curriculum supplemented by broader community norm change strategies. | Behavioural | Intensive Gender Transformative Programming |
| Light-Touch Gender-Transformative ProgrammingA reduced-intensity version of the gender-transformative programming, designed to test whether a less resource-intensive approach can achieve comparable effects at lower cost. The intervention package is being finalized by the IRC; this record will be updated with the final components before implementation begins. | Behavioural | Light-touch Gender Transformative Programming |
| Standard Family Planning Services (WISH-2)The IRC's standard WISH-2 family planning service delivery package, implemented by the IRC independently of the study team in all study settlements. The package strengthens facility-based family planning services through provider training, commodity availability, service integration, and community mobilization, with services delivered through static, outreach, and community-based channels. | Behavioural | Control, Intensive Gender Transformative Programming, Light-touch Gender Transformative Programming |
Primary outcome
Change in the proportion and number of women using preference-aligned fertility management between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of non-pregnant women aged 15-49 whose contraceptive use or non-use is aligned with their preferences, adapted from the preference-aligned fertility management indicator developed by Holt and colleagues; the study instrument elicits current use before contraceptive preference, whereas the original index elicits preference first. Users are classified as aligned if they want to be using a method, want to be using their current method, and report no other method they would prefer to use; non-users are classified as aligned if they want not to be using a method. A pre-specified sensitivity analysis classifies women reporting any pressure on their use or non-use as discordant.
Change in men's agreement with the statement "A husband should have the final say about whether his wife uses contraception," between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Married men aged 18-60 are asked whether they agree, partially agree, or do not agree with the statement: "A husband should have the final say about whether his wife uses contraception." The measure is summarized as the proportion of men in each response category. Men are sampled cross-sectionally at each wave, one man per household, from households not selected for the women's survey.
Change in the proportion and number of women aged 15 to 49 using a modern contraceptive method (modern contraceptive prevalence) between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women aged 15-49 who use, or whose partners use, a modern contraceptive method. Modern methods comprise female and male sterilization, copper and hormonal IUDs, implants, provider-administered and self-administered injectables, oral contraceptive pills, male and female condoms, emergency contraception, foam/jelly, the Lactational Amenorrhea Method, fertility awareness-based methods (standard days method, Billings ovulation method), and other modern methods reported through an open response (e.g., patch/ring, diaphragm). Any-method contraceptive prevalence - adding withdrawal, the rhythm method, other traditional and fertility awareness-based methods, and probe-identified users - will be reported as a pre-specified variant.
11 secondary outcomes
Change in the proportion and number of women aged 15 to 49 who have unmet need for family planning between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women aged 15 to 49 with person-centered unmet need for family planning between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women who report making the final decision about contraceptive use alone or jointly with their partner, between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women reporting that their contraceptive use or non-use was entirely their own choice, between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the level of reproductive self-efficacy as measured by the Contraceptive Self-Efficacy Scale for Sub-Saharan Africa (CSESSA) between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the mean score on a nine-item self-reported women's agency measure between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in women's agreement with the statement "A husband should have the final say about whether his wife uses contraception," between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the mean score on the Gender-Equitable Men (GEM) Scale among men, between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women and of men who report discussing family planning with their spouse or partner in the past 12 months, between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion of women reporting any reproductive coercion in the past 12 months, measured with an adapted five-item Reproductive Coercion Scale short form, between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
Change in the proportion and number of women reporting physical, emotional, sexual, or economic intimate partner violence (IPV) between baseline, midline, and endline
Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)
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 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Contraceptive Behavior
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception
Enrolling by invitation
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Contraceptive Usage, Contraceptive Behavior
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.
Jewel Gausman, PhD principal investigator
Guttmacher Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Gender-Transformative Programming, Light-Touch Gender-Transformative Programming and Standard Family Planning Services (WISH-2) in people with Contraceptive Behavior and Social Norms, run by Guttmacher Institute at 1 site in Somalia.
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 5 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 29 Oct 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 Somalia. 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 Jewel Gausman, ScD, MHS (212-248-1111, jgausman@guttmacher.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion and number of women using preference-aligned fertility management between baseline, midline, and endline (time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)). The study lists 3 primary outcomes in all. 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 29 Oct 2026.