Rendall‐Mkosi 2013.

Methods	Design: individually randomized Location: Bergrivier Municipality, Western Cape, South Africa Time frame: recruited June to November 2007 Sample size calculation (and outcome of focus): anticipated reduction in prevalence for alcohol‐exposed pregnancy risk from 100% to 70% intervention and 90% control with power 0.80. Anticipated minimum 30 in each arm. Because recruitment easier than expected and needed greater power to detect effect size OR 2, continued to randomize 196 among 3 groups (Notes below)
Participants	General with N: 165 women Sources: primary care clinics and farms within study area Inclusion criteria: age 18 to 44 years; not pregnant; engaged in risky drinking over past 3 months (> 5 drinks at 1 sitting or > 7 drinks in 1 week); ineffective or no contraceptive use; no sterilization or hysterectomy; had vaginal sex in past 3 months; resided within 25‐km radius of main town Exclusion criteria: found to be pregnant
Interventions	Study focus: reduce risk of alcohol‐exposed pregnancy (AEP) Theory or model: Motivational interviewing (MI) Intervention: based on Project CHOICES (Floyd 2007) but with contraception integrated into all 5 MI sessions, conducted over 2 months (build rapport and set agenda; assess participant's readiness to change and perceived confidence in enacting behavior change; development of behavior change plan; implementation of behavior change plan; review of counseling experience and progress); handouts (below) Comparison: pamphlet on preventing fetal alcohol syndrome and handbook on women's health
Outcomes	Primary: ineffective contraception (not using any method, using ineffective method (any method other than OCs, injectable, IUC), or incorrect use of such methods) in past 3 months Secondary: NA Follow‐up: 3 and 12 months
Notes	Third arm for life‐skills arm: stopped after 30 in each group; poor adherence to intervention and difficulty with recruitment
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated
Allocation concealment (selection bias)	Low risk	Sealed envelopes to indicate random group allocation prepared in advance
Blinding of participants and personnel (performance bias) All outcomes	High risk	Presume no blinding of participants or providers; not feasible due to type of intervention
Blinding of outcome assessment (detection bias)	High risk	Report states difficult to blind field workers in rural community
Outcome measures	High risk	Contraceptive use by self‐report (face‐to‐face interview)
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss to follow‐up: 3 months, 30.5% MI and 27% control; 12 months, 26% MI and 23% control
Other bias	Unclear risk	Analysis for cluster randomized trial: NA