Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate

Abstract

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.

Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial

“…However, the scarcity of pregnancies at intervention discontinuation visits is consistent with continued use of DMPA-SC in the periods that women reported adhering to DMPA-SC. In a randomised study of Depo-subQ Provera 104 in New York, 17 all women who reported continuation had MPA concentrations in the contraceptive range, although the investigators did not find a difference in continuation rates between self-administration and clinicadministration groups. This absence of a difference was possibly because women had to return to the clinic to provide blood specimens, thus hindering one of the anticipated benefits of self-administration.…”

“…This absence of a difference was possibly because women had to return to the clinic to provide blood specimens, thus hindering one of the anticipated benefits of self-administration. 17 The requirement for pregnancy tests might have encouraged women to report their continuation status more accurately during our trial. Another possibility is that women in the provider-administered group might be less likely to overreport continuation than those in the self-injection group if they thought that we could follow up with the providers to confirm re-injection-something that we could not do for women in the self-injection group.…”

“…Indeed, previous research in high-income countries has shown that self-injection of DMPA-SC is feasible and safe. In a trial in New York (NY, USA), 17 in which women were randomly assigned to self-administration or clinic administration of DMPA-SC, the continuation rates and MPA serum concentrations were similar between the selfadministered (71%) and clinic-administered (63%) groups. Similarly, results from a non-comparative study at Planned Parenthood clinics in Florida (USA) showed high continuation (74%) of self-injected DMPA-SC at the fourth injection.…”

Self‐administration of injectable contraceptives: a systematic review

“…We identified a total of 8926 unique citations, and of those citations, 44 underwent full‐text review. Three studies, one randomised controlled trial (RCT) and two prospective cohort studies, met the inclusion criteria for this review (Figure ) . Two studies evaluated the self‐administration of DMPA SC, compared with DMPA SC or DMPA IM administered by a healthcare provider; the third study included women self‐administering versus nurse administration of a combined hormonal contraceptive IM injectable .…”

“…The study design contributed to the serious risk of bias for two studies (Table ). Low‐certainty evidence shows that there was little or no difference in continuation rates when women self‐administered contraceptive injections in the RCT . For the two non‐RCT trials, the effect of the intervention on the continuation rate was uncertain because the certainty of the evidence was assessed as very low .…”