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Not yet recruitingNCT07902700FPIL-SOMUpdated Oct 29, 2026

Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia

An interventional study of Intensive Gender-Transformative Programming and Light-Touch Gender-Transformative Programming in Contraceptive Behavior and Social Norms, sponsored by Guttmacher Institute. Not yet recruiting at 1 site in Somalia. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Guttmacher Institute · Not applicable, Interventional, and Health services research

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5,436
Allocation
Randomized
Ages
15 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Contraceptive Behavior
  • Social Norms

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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
03

In context

Contraception Behavior

37 studies on the registry are indexed under Contraception Behavior; 14 are open to participants now.

This study's planned enrollment of 5,436 is above the median of 773 across 32 interventional studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Guttmacher Institute is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,436 participants (estimated)

Study arms

  • Active comparator
    Control

    Settlements in this arm will have access only to the standard family planning intervention implemented under WISH-2. This arm serves as the control.

    Behavioral: Standard Family Planning Services (WISH-2)

  • Experimental
    Intensive Gender Transformative Programming

    Settlements will have access to WISH-2 services as well as an intensive gender-transformative intervention.

    Behavioral: Intensive Gender-Transformative Programming · Behavioral: Standard Family Planning Services (WISH-2)

  • Experimental
    Light-touch Gender Transformative Programming

    Settlements will have access to WISH-2 services as well as a light-touch gender-transformative intervention.

    Behavioral: Light-Touch Gender-Transformative Programming · Behavioral: Standard Family Planning Services (WISH-2)

Interventions

  • BehavioralIntensive Gender-Transformative Programming

    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.

  • BehavioralLight-Touch Gender-Transformative Programming

    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.

  • BehavioralStandard 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  2. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  3. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

Secondary outcomes

  1. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  2. 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).

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  3. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  4. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  5. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  6. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  7. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  8. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  9. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  10. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  11. 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.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

Other outcomes

  1. Change in the 12-month contraceptive discontinuation rate, estimated from the contraceptive calendar, between baseline, midline, and endline

    The proportion of episodes of modern contraceptive method use discontinued within 12 months of initiation, estimated from the survey's month-by-month contraceptive calendar using single-decrement life-table methods, following DHS analytic conventions. An episode ends with the first calendar month of non-use; a switch to another modern method in the same or immediately following month is treated as continued contraceptive use in the overall rate and as method-specific discontinuation in method-level rates. Overall and method-specific 12-month discontinuation rates will be reported, distinguishing discontinuation while still in need of contraception from discontinuation due to reduced need (e.g., seeking pregnancy). The calendar administered at each wave covers at least the preceding 12 months, so each assessment reflects use episodes observable in that window.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  2. Change in the proportion of women aged 15 to 49 with unmet need for family planning attributed to partner or family opposition, between baseline, midline, and endline

    Women with unmet need (revised DHS definition, any method) whose reported reasons for not using contraception include opposition from their husband or partner, or opposition from other family or community members.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  3. Change in the proportion of current contraceptive users whose husband or partner is unaware of their contraceptive use (covert use), between baseline, midline, and endline

    Among women aged 15-49 currently using a contraceptive method, the proportion who report that their husband or partner does not know they are using it.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  4. Change in mean scores on the Gender Norms Scale (G-NORM) between baseline, midline, and endline

    Mean scores on the Gender Norms Scale (G-NORM) items measuring perceived descriptive norms (what the respondent believes others in the community do) and perceived injunctive norms (what the respondent believes others expect) related to family planning and gender roles, reported separately by subscale and for women and men.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  5. Change in indicators of women's economic empowerment (economic participation, control over earnings, participation in household financial decisions, and asset ownership) between baseline, midline, and endline

    Four indicators reported separately among women aged 15-49: (1) economic participation - the proportion who did any work aside from housework in the past 12 months; (2) control over earnings - among women who earn, the proportion who decide alone or jointly with their partner how their earnings are used; (3) participation in household financial decisions - the proportion who decide alone or jointly about major household purchases; (4) asset ownership - the proportion reporting rights to use land for their own farming, business, or housing.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  6. Change in the proportion of men reporting participation in household tasks in the past 7 days, between baseline, midline, and endline

    Proportion of men aged 18-60 who report having cared for children, cooked, cleaned or washed clothes, fetched water or firewood, or cared for a sick household member in the past 7 days; the number of task types reported is summarized descriptively.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

  7. Change in gender-equitable attitudes and family planning discussion within men's social networks, as reported through an egocentric network module, between baseline, midline, and endline

    Men aged 18-60 complete an egocentric social network module naming up to ten network members (alters). Measures include the proportion of named alters with whom the respondent discusses family planning, the perceived supportiveness of alters toward contraceptive use, perceived alter endorsement of the final-say norm, and (from Wave 2 onward) reported dialogue about gender roles with alters, reported descriptively by arm to examine diffusion of gender-equitable attitudes beyond direct program participants.

    Time frame: Pre-Baseline (Month 8 pre-intervention); Baseline (Month 1 pre-intervention); Midline (Month 11 post-intervention); Endline (Month 23 post-intervention)

07

Study locations

1 site
  • Multi-site (household surveys) throughout Galgaduud
    Dusa Marreb, Galgaduud, Somalia
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08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07902700
Lead sponsor
Guttmacher Institute
Collaborators
IMPACT Initiatives
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Oct 2026 (estimated)
Primary completion
May 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Oct 29, 2026

Study contacts

Jewel Gausman, ScD, MHS
Contact
jgausman@guttmacher.org
212-248-1111
Jewel Gausman, PhD
principal investigator · Guttmacher Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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