1. Misreporting of contraceptive hormone use in clinical research participants
- Author
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Achilles, Sharon L, Mhlanga, Felix G, Musara, Petina, Poloyac, Samuel M, Chirenje, Zvavahera M, and Hillier, Sharon L
- Subjects
Reproductive Medicine ,Biomedical and Clinical Sciences ,Behavioral and Social Science ,Contraception/Reproduction ,Prevention ,Clinical Trials and Supportive Activities ,Clinical Research ,Good Health and Well Being ,Adult ,Condoms ,Contraception ,Contraception Behavior ,Contraceptives ,Oral ,Hormonal ,Female ,HIV Infections ,Humans ,Observational Studies as Topic ,Self Report ,Steroids ,Truth Disclosure ,Young Adult ,Zimbabwe ,Self-report ,Hormonal contraception ,LARC ,Misreporting ,Oral contraceptive pills ,Clinical Sciences ,Paediatrics and Reproductive Medicine ,Public Health and Health Services ,Obstetrics & Reproductive Medicine ,Clinical sciences ,Reproductive medicine ,Health services and systems - Abstract
ObjectiveResearchers traditionally rely on participant self-report for contraceptive use. We hypothesized that self-reported contraceptive use by clinical research participants may disagree with objectively measured hormonal status.Study designWe enrolled women in Harare, Zimbabwe, aged 18-34, who by self-report had not used hormonal or intrauterine contraception for >30 days, or depot medroxyprogesterone acetate for >10 months, into a study designed to assess biologic changes with contraceptive initiation and use. Blood samples obtained at enrollment and each follow-up visit (N=1630 from 447 participants) were evaluated by mass spectrometry for exogenous hormones. We individually interviewed a subset of participants (n=20) with discrepant self-reported and measured serum hormones to better understand nondisclosure of contraceptive use.ResultsDiscrepant with self-reported nonuse of hormonal contraception, synthetic progestogens were detectable in 120/447 (27%, 95% confidence interval 23%-31%) enrolled women. Measured exogenous hormones consistent with use of contraceptive pills (n=102), injectables (n=20) and implants (n=3) were detected at enrollment, with 7 women likely using >1 contraceptive. In-depth interviews revealed that participants understood the requirement to be hormone free at enrollment (100%). Most (85%) cited partner noncooperation with condoms/withdrawal and/or pregnancy concerns as major reasons for nondisclosed contraceptive use. All interviewed women (100%) cited access to health care as a primary motivation for study participation. Of participants who accurately reported nonuse of hormonal contraception at enrollment, 41/327 (12.5%) had objective evidence of nonstudy progestin use at follow-up that disagreed with self-reported nonuse.ConclusionsWomen joining contraceptive research studies may misrepresent their use of nonstudy contraceptive hormones at baseline and follow-up. Objective measures of hormone use are needed to ensure that study population exposures are accurately categorized.Implications statementAmong Zimbabwean women participating in a contraceptive research study, 27% had objective evidence of use of nonstudy contraceptives at enrollment that disagreed with self-report. Studies that rely on self-report to identify contraceptive hormone exposure could suffer from significant misclassification.
- Published
- 2018