Schuler 2015.
Methods | Design: cluster RCT; communities assigned Location: western highlands of Guatemala Time frame: workshops March to April 2012 Sample size calculation (and outcome of focus): no mention |
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Participants | General with N: 30 communities; 1122 participants completed baseline survey Inclusion criteria for communities: western highlands (5 departments); rural areas where APROFAM (international Planned Parenthood affiliate) provided mobile services and trained volunteers promoting reproductive health Inclusion criteria for participants: live in the community; be married or in civil union; wife 18 to 40 years of age; both members of couple agree to participate; supposed to be well known and respected in community and have good communication with others Exclusion criteria: no mention |
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Interventions | Study focus: intervention focus on improving gender attitudes and communication about reproductive health Theory or model: C‐Change social and behavioral change model
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Outcomes | Primary: gender attitudes (Gender and FP Equity Scale) Secondary: knowledge and use of modern contraceptive methods, i.e. tubal ligation, vasectomy, OCs, emergency contraceptive pills, IUDs, injectables, implants, male and female condoms and spermicide Follow‐up: 2 months after baseline |
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Notes | Manual adapted from Stepping Stones, Sakhi Saheli (Population Council), and EngenderHealth Men Investigator communicated that APROFAM implemented FP component using standard material; due to staffing changes, investigators did not have further information |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information on sequence generation; randomly assigned 9 communities from each of 5 departments to 3 study arms (later dropped 3rd arm, service statistics only) |
Allocation concealment (selection bias) | Low risk | Communities identified prior to assignment; individuals within community were eligible if they met additional criteria |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention; blinding not feasible due to type of intervention |
Blinding of outcome assessment (detection bias) | Unclear risk | No mention |
Outcome measures | High risk | Self‐report of contraceptive use |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: intervention 45% (269/597); control 44% (213/488) |
Other bias | Unclear risk | Analysis for cluster RCT: logistic mixed model for contraceptive use and knowledge; models included random effects to account for community‐level randomization and repeated measures; study group and assessment time were fixed effects in model |