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. 2016 Nov 23;2016(11):CD007249. doi: 10.1002/14651858.CD007249.pub5

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
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
Interventions Study focus: intervention focus on improving gender attitudes and communication about reproductive health
Theory or model: C‐Change social and behavioral change model
  1. Intervention: 6 interactive sessions over 1 month (2 for men; 2 for women; 2 for couple); raise awareness of gender inequality and gender issues as barriers to sexual and reproductive health, and encourage gender‐equitable attitudes and interest in FP; APROFAM conducted FP component, e.g. distributing information sheets on contraceptive methods

  2. Comparison: delayed intervention

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
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
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