Efficacy and Cost-Benefit of Onsite Contraceptive Services With and Without Incentives Among Women With Opioid Use Disorder at High Risk for Unintended Pregnancy: A Randomized Clinical Trial.

Importance: Rates of in utero opioid exposure continue to increase in the US. Nearly all of these pregnancies are unintended but there has been little intervention research addressing this growing and costly public health problem.

Objective: To test the efficacy and cost-benefit of onsite contraceptive services with and without incentives to increase prescription contraceptive use among women with opioid use disorder (OUD) at high risk for unintended pregnancy compared with usual care.

Design, Setting, and Participants: A randomized clinical trial of 138 women ages 20 to 44 years receiving medication for OUD who were at high risk for an unintended pregnancy at trial enrollment between May 2015 and September 2018. The final assessment was completed in September 2019. Data were analyzed from October 2019 to March 2021. Participants received contraceptive services at a clinic colocated with an opioid treatment program.

Interventions: Participants were randomly assigned to receive 1 of 3 conditions: (1) usual care (ie, information about contraceptive methods and community health care facilities) (n = 48); (2) onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction (n = 48); or (3) those same onsite contraceptive services plus financial incentives for attending follow-up visits (n = 42).

Main Outcomes and Measures: Verified prescription contraceptive use at 6 months with a cost-benefit analysis conducted from a societal perspective.

Results: In this randomized clinical trial of 138 women (median age, 31 years [range, 20-44 years]), graded increases in verified prescription contraceptive use were seen in participants assigned to usual care (10.4%; 95% CI, 3.5%-22.7%) vs contraceptive services (29.2%; 95% CI, 17.0%-44.1%) vs contraceptive services plus incentives (54.8%; 95% CI, 38.7%-70.2%) at the 6-month end-of-treatment assessment (P < .001 for all comparisons). Those effects were sustained at the 12-month final assessment (usual care: 6.3%; 95% CI, 1.3%-17.2%; contraceptive services: 25.0%; 95% CI, 13.6%-39.6%; and contraceptive services plus incentives: 42.9%; 95% CI, 27.7%-59.0%; P < .001) and were associated with graded reductions in unintended pregnancy rates across the 12-month trial (usual care: 22.2%; 95% CI, 11.2%-37.1%; contraceptive services: 16.7%; 95% CI, 7.0%-31.4%; contraceptive services plus incentives: 4.9%; 95% CI, 0.6%-15.5%; P = .03). Each dollar invested yielded an estimated $5.59 (95% CI, $2.73-$7.91) in societal cost-benefits for contraceptive services vs usual care, $6.14 (95% CI, $3.57-$7.08) for contraceptive services plus incentives vs usual care and $6.96 (95% CI, $0.62-$10.09) for combining incentives with contraceptive services vs contraceptive services alone.

Conclusions and Relevance: In this randomized clinical trial, outcomes with both onsite contraceptive service interventions exceeded those with usual care, but the most efficacious, cost-beneficial outcomes were achieved by combining contraceptive services with incentives. Colocating contraceptive services with opioid treatment programs offers an innovative, cost-effective strategy for preventing unintended pregnancy.

Trial Registration: ClinicalTrials.gov Identifier: NCT02411357.