Sex and female empowerment (SAFE): A randomized trial comparing sexual health interventions for women in treatment for opioid use disorder

Drug Alcohol Depend. 2021 Apr 1:221:108634. doi: 10.1016/j.drugalcdep.2021.108634. Epub 2021 Feb 17.


Background: Unintended pregnancies are prevalent among women with opioid use disorder (OUD). The Sex and Female Empowerment (SAFE) project developed a social-cognitive, theory-driven intervention to increase acceptance of and adherence to contraceptive practices among women receiving medication for OUD (MOUD). This study evaluated the feasibility and acceptability of two SAFE interventions (Face-to-face and Computer-adapted) compared to usual care as well as their efficacy to improve contraception utilization.

Methods: This pilot randomized trial enrolled 90 heterosexual, non-pregnant, reproductive-age women receiving MOUD. Participants were randomized into either a: SAFE Face-to-face intervention, SAFE Computer-adapted intervention, or usual care (UC) condition (n = 30 each) and followed for 6 months. Outcome measures included intervention completion, intervention satisfaction, attendance at a contraception consultation appointment, and long-acting reversible contraceptive (LARC) method receipt. A generalized linear model was used for inferential testing and to estimate least squares means (predicted probabilities for binary outcomes) and their standard errors.

Results: Compared to the UC condition, both the SAFE Face-to-face and the SAFE Computer-adapted intervention had higher intervention completion [Means (Standard Errors) = 0.97 (.03) and 0.97 (.03), respectively, vs. 0.53 (.09); ps<.001], higher intervention satisfaction [Ms (SEs) = 3.7 (.11) and 3.8 (.11), respectively, vs. 3.1 (.11); ps<0.001), higher contraception consultation visit attendance [Ms(SEs) = 0.80 (.07) and 0.73 (.08) vs. 0.33 (.09); p < .001], and greater LARC receipt [Ms(SEs) = 0.77 (.08) and 0.73 (.08) vs. 0.23 (.08); p < .001).

Conclusions: SAFE appears feasible and efficacious for supporting women in contraception decision-making. Integrating SAFE into women's comprehensive OUD treatment services holds promise to increase contraceptive decision-making and initiation of a chosen method.

Keywords: Birth control; Buprenorphine; Contraceptive practices; LARC; Methadone; Opioids; Sex; Women.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Cognitive Behavioral Therapy / methods*
  • Contraception / psychology
  • Contraception / statistics & numerical data
  • Contraception Behavior / psychology*
  • Empowerment*
  • Feasibility Studies
  • Female
  • Humans
  • Internet-Based Intervention
  • Linear Models
  • Long-Acting Reversible Contraception / psychology
  • Long-Acting Reversible Contraception / statistics & numerical data
  • Opioid-Related Disorders / psychology*
  • Opioid-Related Disorders / therapy
  • Patient Acceptance of Health Care / psychology
  • Pilot Projects
  • Pregnancy
  • Reproductive Health Services
  • Sexual Health*
  • Treatment Outcome
  • Young Adult