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. 2019 Apr 23;2019(4):CD004317. doi: 10.1002/14651858.CD004317.pub5

Jay 1984.

Methods Single site, parallel group RCT
Location: Children and Youth Project site in Augusta, GA, USA
Time frame: no mention
Sample size estimation and outcome of focus: no mention
Participants General with N: 57 adolescents randomized (participants were 14 to 19 years old)
Inclusion criteria:
  • attending adolescent gynaecology clinic and willing to use oral contraceptives (OCs)


Exclusion criteria:
  • no mention

Interventions Study focus: increasing OC adherence
Intervention:
  • peer counselors trained (with role playing) on conversational and interaction skills;

  • observational skills;

  • decision‐making;

  • formal counseling;

  • confidentiality;

  • problem‐solving;

  • birth control.


Comparison:
  • Nurse counselors with same training as peer counselors.


Both groups had 3 appointments.
Outcomes Primary:
  • OC non‐adherence via Guttman scale;

  • avoidance of pregnancy (apparently self‐report);

  • appointment adherence;

  • pill count;

  • urinary fluorescence for riboflavin (marker added to OCs).


Secondary:
  • attrition rate at 4 months (end of study), i.e. failed to keep second rescheduled appointment or discontinued OC regimen.


Follow‐up: 4 months
Notes 31 (54%) subjects were assigned to the nurse‐counselor group, and 26 (46%) were assigned to the peer‐counselor group. 50% (28 or 29) of the participants were expected to be assigned to each group. A sampling error of this degree was not significant with a sample size of 57.
Trial registration: no details
Funding: funded in part by a grant from the Georgia Department of Human Services
Declarations of interest: no details provided
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers table
Allocation concealment (selection bias) Unclear risk No information
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No details provided of blinding of participants or providers; not feasible due to type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Urine samples for fluorescence: 3 independent observers evaluated in double‐blind fashion
No details provided of blinding of self‐reported pregnancy and pill count for non‐adherence scale
Incomplete outcome data (attrition bias) 
 All outcomes High risk Losses to follow‐up: 33% overall; nurse‐counseled, 42%; peer‐counseled, 23%
Selective reporting (reporting bias) Unclear risk No protocol was available, however the outcomes of compliance/non‐compliance prespecified in the manuscript were reported.
Other bias Low risk Appeared free of other sources of bias