Violence PreventionNCT06554418
What Works to Prevent Violence Against Women and Girls in Somalia
A study testing Communities Care in people with Violence Prevention, run by Johns Hopkins University at 1 site in Somalia.
Trial summary
The Communities Care (CC) program has demonstrated promise in changing harmful social norms associated with Gender-based violence (GBV) and increasing confidence in services for women and girls. Read more about this study
- Who is it for?
- Ages 10 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence Prevention
- What is being tested?
- Communities Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 1 siteSomalia
- Study dates
- 20 Aug 2024to 1 Nov 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 10 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 10 years or older
- Participant in CC adult or CC adolescent program in collaboration with 9 public schools in districts randomized to intervention or control in two regions of Somalia
- Living/resident of target districts (including internally displaced persons (IDPs) and does not have plans to move/leave the district or surrounding area in the next 12 months (this is critical for the longitudinal data collection with CC program participants)
Who cannot join
- Less than 10 years old
- Not a participant in CC adult or CC adolescent
- Not a resident of target districts-
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, 1 recruiting
- Recruiting
CISP Somalia
Mogadishu, Wadajir District
Michele Stella, michele.stella@cisp-ngo.org
About this study
Official title: What Works to Prevent Violence Against Women and Girls: Evaluation of the Communities Care Program in Somalia
The Communities Care (CC) program has demonstrated promise in changing harmful social norms associated with Gender-based violence (GBV) and increasing confidence in services for women and girls. Therefore, the study will adapt the existing CC program based on previous learnings with adults and expand programming to include adolescent boys and girls, creating the CC adult and CC adolescent program. The CC program intervention implementation will be led by Comitato Internazionale per lo Sviluppo dei Popoli (CISP) non-Governmental Organization (NGO) in partnership with Somalia Ministry of Education and local Women led Organizations (WLO), public schools and mapped GBV and child protection (CP) service providers in Banadir and Galmudug regions of Somalia.
Johns Hopkins will collaborate with local research colleagues to evaluate the CC adult and CC adolescent program. The study will use a hybrid type 2 effectiveness-implementation design guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Quantitative methods will be used to measure outcomes at baseline and endline (24 months post baseline) with adults and adolescents (10 and older) participants in the CC programs in intervention compared to control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.
Read the detailed description
What Works to Prevent Violence Against Women and Children (FCDO funded) has funded a collaboration between Johns Hopkins and Comitato Internazionale per lo Sviluppo dei Popoli (CISP) NGO in partnership with Somalia Ministry of Education and local researchers and Women led Organizations (WLO) to evaluate the Communities Care (CC) violence prevention intervention with both adults and adolescent in community and school-based settings in two regions of Somalia. The study will use a hybrid type 2 effectiveness-implementation design guided by the RE-AIM framework (e.g., reach, effectiveness, adoption, implementation and maintenance). Quantitative methods will be used to measure violence, health and social norms outcomes with adults (18 and older) and adolescents (10 and older) with participants in CC intervention districts and control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.
- Conditions
- Violence Prevention
- Being tested
- Communities Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communities CareBehavioural
Communities Care is a violence prevention program targeting social norms and behavioral change
| Study group | Role | What they receive |
|---|---|---|
| Communities Care | Experimental | Districts in two regions of Somalia randomized to Communities Care violence prevention program with adults and adolescents Receives: Behavioral: Communities Care |
| Control | No intervention | Districts in two regions of Somalia randomized to control - usual programming related to prevention of violence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyber-Sexual Harassment survey score
Adolescent report of experience of peer-to-peer or adult on-line and in-person harassment, Mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Peer-to-peer physical and sexual violence in school and community survey score
Adolescent report of experience of peer to peer violence in schools, Mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Harsh punishment in school as assessed by the Parent-Child Conflict Scale adapted for teachers
Adolescent report of witness or experience harsh punishment in school using the Parent-Child Conflict Tactics Scale adapted for teachers, Mean scale score 1-5, with higher score being worse outcome
Measured: 9 and 12 months
Witnessing intimate partner violence (IPV) survey score
Adolescent report of witnessing IPV in the household, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Harsh Punishment in Household as assessed by the Parent-Child Conflict Scale
Adolescent report of witness and experience harsh punishment in household using Parent-Child Conflict Tactics Scale, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
IPV victimization and/or perpetration as assessed by Somalia National Survey
Adult report of experience and/or perpetration of IPV, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Use of Harsh Punishment in Household as assessed by the Parent-Child Conflict Tactics Scale
Adult report of use of harsh punishment, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Non-partner harassment as assessed by the National Somalia Survey
Adult report of non-partner harassment, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Non-partner physical and/or sexual violence victimization as assessed by the National Somalia Survey
Adult report of physical and/or sexual violence victimization by non-partner, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Measured: 9 and 12 months
Secondary outcomes (5)
Personal Beliefs and Social Norms about Gender Based Violence as assessed by the Social Norms and Beliefs about Gender Based Violence Scale
Adolescent and adult personal beliefs and social norms about gender based violence, mean scale scores range from 1-5, higher scores being worse outcome
Measured: 9 and 12 months
Gender equality survey score
Adult and adolescent report of equality in access to education, resources and decision making between women/girls and men/boys, mean scale score range from 1-5, higher score is worse outcome
Measured: 9 and 12 months
IPV acceptability survey score
Adult and adolescent report on acceptability of intimate partner violence (IPV), for example, It is justifiable for a husband to hit his wife because she argues with him, it is acceptable for a husband to force his wife to have sex when she does not want to. mean subscale score range from 1-5, higher score is worse outcome
Measured: 9 and 12 months
Sexual and reproductive health knowledge and empowerment score
Adolescent knowledge in the domains of puberty, female genital mutilation (FGM), child marriage, and sexually transmitted infection (STI) and empowerment measured for puberty, child marriage, FGM, PV, and contraception use, mean scale score range from 1-5, higher score is better outcomes
Measured: 9 and 12 months
Confidence in service providers (adolescents and adults) score
Adolescent and adult report on confidence in service providers in responding to gender based violence across several sectors (health care, justice system, elders, psychosocial services and community health workers). Mean scale score range from 1-5, higher score is better outcome
Measured: 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start20 Aug 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence PreventionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized at the districts level in two regions of Somalia
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Comitato Internazionale per los Sviluppo dei Popoli (CISP)
- Responsible party
- Sponsor
- Investigators
- Nancy Glass, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554418
- Sponsor's protocol ID
- IRB00418976
- Status last verified
- Feb 2026
- First submitted
- 12 Aug 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Works to Prevent Violence Against Women and Girls: Evaluation of the Communities Care Program in Somalia
- ClinicalTrials.gov ID
- NCT06554418
- Acronym / sponsor ID
- IRB00418976
- Conditions
- Violence Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Comitato Internazionale per los Sviluppo dei Popoli (CISP)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 15 Aug 2024 (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 Communities Care (CC) program has demonstrated promise in changing harmful social norms associated with Gender-based violence (GBV) and increasing confidence in services for women and girls. Therefore, the study will adapt the existing CC program based on previous learnings with adults and expand programming to include adolescent boys and girls, creating the CC adult and CC adolescent program. The CC program intervention implementation will be led by Comitato Internazionale per lo Sviluppo dei Popoli (CISP) non-Governmental Organization (NGO) in partnership with Somalia Ministry of Education and local Women led Organizations (WLO), public schools and mapped GBV and child protection (CP) service providers in Banadir and Galmudug regions of Somalia.
Johns Hopkins will collaborate with local research colleagues to evaluate the CC adult and CC adolescent program. The study will use a hybrid type 2 effectiveness-implementation design guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Quantitative methods will be used to measure outcomes at baseline and endline (24 months post baseline) with adults and adolescents (10 and older) participants in the CC programs in intervention compared to control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.
Detailed description
What Works to Prevent Violence Against Women and Children (FCDO funded) has funded a collaboration between Johns Hopkins and Comitato Internazionale per lo Sviluppo dei Popoli (CISP) NGO in partnership with Somalia Ministry of Education and local researchers and Women led Organizations (WLO) to evaluate the Communities Care (CC) violence prevention intervention with both adults and adolescent in community and school-based settings in two regions of Somalia. The study will use a hybrid type 2 effectiveness-implementation design guided by the RE-AIM framework (e.g., reach, effectiveness, adoption, implementation and maintenance). Quantitative methods will be used to measure violence, health and social norms outcomes with adults (18 and older) and adolescents (10 and older) with participants in CC intervention districts and control districts in the two regions (Banadir and Galmudug) in South Central Somalia. Quantitative methods will also be used to measure outcomes with adults and adolescents (10 years and older) community members (members that do not participate in the CC program) in intervention and control districts in the 2 regions at baseline, midline (12-months), endline (24-months) and maintenance (36 months). In addition, quantitative and qualitative methods at midline and endline will be used to measure the CC adult and CC adolescent intervention reach, adoption, implementation and maintenance in intervention districts in the two regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized at the districts level in two regions of Somalia
| Arm | Type | Receives |
|---|---|---|
| Communities Care | Experimental | Behavioral: Communities CareDistricts in two regions of Somalia randomized to Communities Care violence prevention program with adults and adolescents |
| Control | No intervention | –Districts in two regions of Somalia randomized to control - usual programming related to prevention of violence |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 10 years or older
- Participant in CC adult or CC adolescent program in collaboration with 9 public schools in districts randomized to intervention or control in two regions of Somalia
- Living/resident of target districts (including internally displaced persons (IDPs) and does not have plans to move/leave the district or surrounding area in the next 12 months (this is critical for the longitudinal data collection with CC program participants)
Key exclusion criteria (3 listed)
- Less than 10 years old
- Not a participant in CC adult or CC adolescent
- Not a resident of target districts-
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 |
|---|---|---|
| Communities CareCommunities Care is a violence prevention program targeting social norms and behavioral change | Behavioural | Communities Care |
Primary outcome
Cyber-Sexual Harassment survey score
Time frame: 9 and 12 months
Adolescent report of experience of peer-to-peer or adult on-line and in-person harassment, Mean scale score ranges from 1 to 5 with higher scores being worse outcome
Peer-to-peer physical and sexual violence in school and community survey score
Time frame: 9 and 12 months
Adolescent report of experience of peer to peer violence in schools, Mean scale score ranges from 1 to 5 with higher scores being worse outcome
Harsh punishment in school as assessed by the Parent-Child Conflict Scale adapted for teachers
Time frame: 9 and 12 months
Adolescent report of witness or experience harsh punishment in school using the Parent-Child Conflict Tactics Scale adapted for teachers, Mean scale score 1-5, with higher score being worse outcome
Witnessing intimate partner violence (IPV) survey score
Time frame: 9 and 12 months
Adolescent report of witnessing IPV in the household, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Harsh Punishment in Household as assessed by the Parent-Child Conflict Scale
Time frame: 9 and 12 months
Adolescent report of witness and experience harsh punishment in household using Parent-Child Conflict Tactics Scale, mean scale score ranges from 1 to 5 with higher scores being worse outcome
IPV victimization and/or perpetration as assessed by Somalia National Survey
Time frame: 9 and 12 months
Adult report of experience and/or perpetration of IPV, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Use of Harsh Punishment in Household as assessed by the Parent-Child Conflict Tactics Scale
Time frame: 9 and 12 months
Adult report of use of harsh punishment, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Non-partner harassment as assessed by the National Somalia Survey
Time frame: 9 and 12 months
Adult report of non-partner harassment, mean scale score ranges from 1 to 5 with higher scores being worse outcome
Non-partner physical and/or sexual violence victimization as assessed by the National Somalia Survey
Time frame: 9 and 12 months
Adult report of physical and/or sexual violence victimization by non-partner, mean scale score ranges from 1 to 5 with higher scores being worse outcome
5 secondary outcomes
Personal Beliefs and Social Norms about Gender Based Violence as assessed by the Social Norms and Beliefs about Gender Based Violence Scale
Time frame: 9 and 12 months
Gender equality survey score
Time frame: 9 and 12 months
IPV acceptability survey score
Time frame: 9 and 12 months
Sexual and reproductive health knowledge and empowerment score
Time frame: 9 and 12 months
Confidence in service providers (adolescents and adults) score
Time frame: 9 and 12 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 13 Feb 2026.
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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.
Nancy Glass, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communities Care in people with Violence Prevention, run by Johns Hopkins University 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 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 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 Nancy Glass, PhD (4432579947, nglass1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyber-Sexual Harassment survey score (time frame: 9 and 12 months). The study lists 9 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 13 Feb 2026.