Background
We examined the influence of depressed mood and psychological stress on oral contraceptive (OC) side effects and discontinuation.
Study Design
We administered standard psychological instruments to 354 young women (13–24 years) beginning a six-month OC continuation intervention trial and questions on OC side effects and use at six months. Logisitic regression determined the relationships between psychological conditions, perceived OC side effects and continuation rates.
Results
Baseline depressed mood (21%) and stress (19%) and six-month mood (25%) and weight changes (57%) were relatively common. Only 38% continued OCs at six months. Depressed mood (OR 2.27, CI 1.25–4.15, p=0.007) and stress (OR 2.07, CI 1.12–3.82, p=0.02) were associated with perceived OC-related moodiness; depressed mood was associated with perceived weight loss (OR 1.89, CI 1.01–3.55, p=0.05). Depressed mood (OR 0.54, CI 0.29–0.99, p=0.04), stress (OR 0.48, CI 0.25–0.91, p=0.03) and perceived weight change (OR 0.60, CI 0.38–0.94, p=0.03) all reduced the likelihood of OC continuation.
Conclusion
Young women with adverse psychological symptoms are at risk for perceived OC side effects and discontinuation.
Background
Racial/ethnic minority patients are often underrepresented in clinical trials. Efforts to address barriers to participation may improve representation, thus enhancing our understanding of how research findings apply to more diverse populations.
Methods
The IDEAS (Information, Description, Education, Assistance, and Support) for a Healthy Baby study was a randomized controlled trial (RCT) of an intervention to reduce barriers to using publicly reported quality data for low-income, racial/ethnic minority women. We used strategies grounded in a health equity framework to address barriers to recruitment and retention in three domains: preparation, process, and patient-centeredness. “Preparation” included teaching study staff about health inequities, role-playing skills to develop rapport and trust, and partnering with clinic staff. “Processes” included use of electronic registration systems to pre-screen potential candidates and determine when eligible participants were in clinic and an electronic database to track patients through the study. Use of a flexible protocol, stipends, and consideration of literacy levels promoted “patient-centeredness.”
Results
We anticipated needing to recruit 800 women over 18 months to achieve a completion goal of 650. Using the recruitment and retention strategies outlined above, we recruited 746 women in 15 months, achieving higher recruitment (87.1 %) and retention rates (97.3 %) than we had anticipated.
Discussion
These successful recruitment and retention strategies used for a large RCT promoted inclusivity and accessibility. Researchers seeking to recruit racial and ethnic minority pregnant women in similar settings may find the preparation, process, and patient-centered strategies used in this study applicable for their own studies.
Trial Registration
ClinicalTrials.gov NCT01784575, 1R21HS021864-01
The lack of a consistent, well-defined measurement of OC use limits our understanding of contraceptive misuse and related negative outcomes. Future research should clarify terminology, develop standardized measures, incorporate multimethod approaches with innovative methods, and publish details of measurement methods.
Objectives
To evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (SC) depot medroxyprogesterone acetate (DMPA).
Study Design
Women presenting to a family planning clinic to initiate, restart, or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self or clinician administered SC DMPA 104mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough MPA levels at six and twelve months.
Results
250 women were invited to participate and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer SC DMPA. Eighty-seven percent completed follow-up. DMPA use at one year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at one year (p = 0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants.
Conclusions
Sixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of SC-DMPA is feasible, and may be an attractive alternative for many women.
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