Clinical trial NCT06554418: What Works to Prevent Violence Against Women and Girls in Somalia
Official title: What Works to Prevent Violence Against Women and Girls: Evaluation of the Communities Care Program in Somalia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Violence Prevention
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Comitato Internazionale per los Sviluppo dei Popoli (CISP)
First posted: 2024-08-15
Enrollment: 3500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized at the districts level in two regions of Somalia
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria

* 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)

Exclusion Criteria:

* Less than 10 years old
* Not a participant in CC adult or CC adolescent
* Not a resident of target districts-

Primary outcomes:
measure: Cyber-Sexual Harassment survey score
timeFrame: 9 and 12 months
measure: Peer-to-peer physical and sexual violence in school and community survey score
timeFrame: 9 and 12 months
measure: Harsh punishment in school as assessed by the Parent-Child Conflict Scale adapted for teachers
timeFrame: 9 and 12 months
measure: Witnessing intimate partner violence (IPV) survey score
timeFrame: 9 and 12 months
measure: Harsh Punishment in Household as assessed by the Parent-Child Conflict Scale
timeFrame: 9 and 12 months
measure: IPV victimization and/or perpetration as assessed by Somalia National Survey
timeFrame: 9 and 12 months
measure: Use of Harsh Punishment in Household as assessed by the Parent-Child Conflict Tactics Scale
timeFrame: 9 and 12 months
measure: Non-partner harassment as assessed by the National Somalia Survey
timeFrame: 9 and 12 months
measure: Non-partner physical and/or sexual violence victimization as assessed by the National Somalia Survey
timeFrame: 9 and 12 months
Secondary outcomes:
measure: Personal Beliefs and Social Norms about Gender Based Violence as assessed by the Social Norms and Beliefs about Gender Based Violence Scale
timeFrame: 9 and 12 months
measure: Gender equality survey score
timeFrame: 9 and 12 months
measure: IPV acceptability survey score
timeFrame: 9 and 12 months
measure: Sexual and reproductive health knowledge and empowerment score
timeFrame: 9 and 12 months
measure: Confidence in service providers (adolescents and adults) score
timeFrame: 9 and 12 months
Other outcomes:
Locations:
city: Mogadishu
country: Somalia
facility: CISP Somalia
state: Wadajir District
Study officials:
affiliation: Johns Hopkins University
name: Nancy Glass, PhD
role: PRINCIPAL_INVESTIGATOR
References: