Sample Selection: SAFE Project

1. Sample Selection: SAFE Project

2. Study Design • 3-Level Multi Site Cluster Randomized Trial (CRT) with power=0.80; alpha=0.05; and r=0.01 • 3 arms with different combinations of intervention, to be measured at baseline and endline in 18 months apart

3. Why 3 arms? • A comparison between Arms 1 and 2 will inform the added advantage of male groups on top of clinic, community campaigning and female groups • A comparison between Arms 3 and 2 will inform the added advantage of female groups on top of clinic and community campaigning

4. All common intervention components across arms, i.e., clinic, community campaigning and female group sessionsmust be similar across arms of all sitesfor ensuring comparability Standardization of intervention components

5. Study Subjects and Sample Size

6. Process of sample selection • First, identify the three study sites, each with one MS clinic • All sites should have similar type of MS clinics (for instance, 3 UPHCP referral clinics have been selected for the project) • Each site needs to have at least 51 clusters of young females (YF) and 27 clusters of adult females (AF) • Adult female clusters can be merged with YF clusters if each cluster has at least 18 x 2= 36 households; because only one respondent (YF/AF) will be interviewed from each selected household (Caution: This rule does not apply for conducting group sessions) • Thus, each cluster need to have minimum 36 hhs, preferably 50 hhs to avoid refusal/drop out Continued….

7. Process of sample selection • Males cannot be interviewed from the same cluster as that of the females for the safety of the females • Therefore, additional 27 clusters need to be selected from each site • Thus, each site requires a total 78 (Female: 51 + Male: 27) non-contaminated clusters • 78 clusters will be randomly assigned to the three arms, with 26 clusters for each arm

8. How to form a cluster • Cluster, preferably, should have geographical boundary • Cluster, preferably should have natural/administrative characteristics binding them into a group; for instance, a village or a para can be a cluster, which however, is difficult to achieve in a slum setting • Clusters need to be identified and marked during enumeration/listing • Either natural factors or houses should be identified as buffer zone between clusters to control contamination

9. Understanding the temporary settlement/slum setting Three study sites include 3 UPHCP referral clinics- • Mohammadpur Landmark: Sikder Medical, Poolpar No. of slums-8 ; Population-30,285 • Bashabo Landmark: Buddha Mandir No. of slums-7; Population-14,200 (MS will identify more slum population) • Mohakhali Landmark: Mohakhali Flyover No. of slums-5; Population-30,500

10. Understanding the temporary settlement/slum setting Three study sites include 3 UPHCP referral clinics- • Mohammadpur Landmark: Sikder Medical, Poolpar No. of slums-8 ; Population-30,285 • Bashabo Landmark: Buddha Mandir No. of slums-7; Population-14,200 (MS will identify more slum population) • Mohakhali Landmark: Mohakhali Flyover No. of slums-5; Population-30,500

11. Minimum population requirement per site Each site must have 25,000-30,000 population(5,000 to 6,000 households) because--- • 78 clusters x 50 households= 3,900 HHs • 3,900 HHs x 5 members = 19,500 population • Additional 2,000 HHs with 10,000 population are needed for creating buffer zone among clusters Note: 19,500 population is enough to have 918 young females of 15-19 years [19500 x 10% 15-19 years old x 50% female]

12. Each of the three site has 1 clinic and 5 to 8 slums Site-1 Site-2 Site-3 Mohammadpur clinic [Poolpar] Bashabo clinic [Mandir] Mohakhali clinic [Flyover] Slum 1 Slum 4 Slum 2 Slum 3 Slum 5

13. Identification of clusters across 3 arms Mohakhali Clinic Arm 1 Arm 3 Arm 2

14. Re-randomization • Background characteristics, especially proportion of married girls and level of education should be similar across 3 arms of each site • Since ICDDR,B will enter data of the listing, after randomly assigning the clusters and looking into the differences in terms of marital status of young females, arms may be reassigned through rerandomization

15. Scopes for contamination • Contamination by participation- femalessubjects from arm 3 may take part in or recruited into female groups of arms 1 or 2; similarly male subjects from arms 2 and 3 may take part in male groups of arm 2 • Contamination by diffusion- geographically proximate clusters with people having regular and meaningful social interaction may contaminate by diffusion

16. Measures to reduce contamination • Contamination by participation • Each hh will be marked with hh and cluster numbers; • Frontline staff will be cautioned and supervised so that they do not recruit subjects from inappropriate arms (for example, females from arm 3; and males from arms 2 and 3) • Contamination by diffusion • geographical and buffer hhs will be identified; • social groups centering on leaders’ houses/landmarks/shops will be identified and kept in the same cluster to reduce the diffusion through social networking

17. Clusters for survey and groups for intervention per site across 3 arms Mohakhali Clinic Arm 1 26 FCs (17 YF + 9AF) 80 FGs (50 YF + 30 AF) Arm 3 9 MCs 44 MGs (50 YF + 30 AF) 26 FCs (17 YF + 9AF) 9 MCs Arm 2 26 FCs (17 YF + 9AF) 80 FGs (50 YF + 30 AF) 9 MCs

18. Number of female and male groups Groups can be formed according to marital status for 15-29 years old.