BACKGROUND: Immediate initiation of depo-medroxyprogesterone acetate (DMPA) increases continuation and decreases pregnancies compared to conventional (next menstrual period) initiation. A drawback is the need to return in 4 weeks for a repeat pregnancy test to identify any pregnancy that was too early to diagnose on the day of injection. If women can perform home pregnancy tests (HPTs) to detect human chorionic gonadotropin (hCG) in urine, the need for this follow-up visit may be eliminated. This study assesses whether women can perform their own HPT. STUDY DESIGN: This is a single-visit observational trial of an HPT kit. Subjects recruited from a waiting room in an urban family planning clinic received an HPT kit with standard instructions to use immediately. Subjects and a research assistant each interpreted the test. Their results were then compared to a standard cassette type test for detection of hCG performed by clinic staff. kappa was calculated to assess the level of agreement. RESULTS: Three hundred ten subjects enrolled. They were young (mean age, 25.2 years), mostly Hispanic (91%) women. A change in the font and explicitness of the instructions decreased the incidence of invalid tests from 12.7% to 4.8%. The subject and research assistant's interpretation of the test had a high level of agreement, kappa=0.95 [95% confidence interval (CI), 0.92-0.99]. There was also a high level of agreement between the subjects' results and the standard test, kappa=0.88 (95% CI, 0.82-0.95). CONCLUSIONS: Women presenting for pregnancy testing at an urban clinic are able to perform HPTs with a high level of accuracy. The appearance of the instructions influenced the incidence of false-negative and invalid tests. Home pregnancy tests may be useful in follow-up protocols when immediate initiation of DMPA is employed.
BACKGROUND: Immediate initiation of depo-medroxyprogesterone acetate (DMPA) increases continuation and decreases pregnancies compared to conventional (next menstrual period) initiation. A drawback is the need to return in 4 weeks for a repeat pregnancy test to identify any pregnancy that was too early to diagnose on the day of injection. If women can perform home pregnancy tests (HPTs) to detect human chorionic gonadotropin (hCG) in urine, the need for this follow-up visit may be eliminated. This study assesses whether women can perform their own HPT. STUDY DESIGN: This is a single-visit observational trial of an HPT kit. Subjects recruited from a waiting room in an urban family planning clinic received an HPT kit with standard instructions to use immediately. Subjects and a research assistant each interpreted the test. Their results were then compared to a standard cassette type test for detection of hCG performed by clinic staff. kappa was calculated to assess the level of agreement. RESULTS: Three hundred ten subjects enrolled. They were young (mean age, 25.2 years), mostly Hispanic (91%) women. A change in the font and explicitness of the instructions decreased the incidence of invalid tests from 12.7% to 4.8%. The subject and research assistant's interpretation of the test had a high level of agreement, kappa=0.95 [95% confidence interval (CI), 0.92-0.99]. There was also a high level of agreement between the subjects' results and the standard test, kappa=0.88 (95% CI, 0.82-0.95). CONCLUSIONS:Women presenting for pregnancy testing at an urban clinic are able to perform HPTs with a high level of accuracy. The appearance of the instructions influenced the incidence of false-negative and invalid tests. Home pregnancy tests may be useful in follow-up protocols when immediate initiation of DMPA is employed.
Authors: Lauren A Wise; Tanran R Wang; Sydney K Willis; Amelia K Wesselink; Kenneth J Rothman; Elizabeth E Hatch Journal: Am J Epidemiol Date: 2020-08-01 Impact factor: 4.897