Women treated for opioid dependence have a higher rate of unintended pregnancies (67%-86%) than the general population (49%). Given that opioid-dependent women have regular contact with health care providers during agonist-treatment, this setting is ideal for integrating unintended pregnancy interventions. Objective: The proximal goal of this R34 proposal is to develop and initially evaluate a social- cognitive, theory driven intervention, Sex and Female Empowerment (SAFE), designed to increase acceptance of and adherence to contraceptive practices among opioid-agonist- maintained women of childbearing age. SAFE comprises four 60-minute sessions that will be delivered in one of two formats: a face-to-face brief intervention approach or a novel, internet- based, computer-adaptive platform. The distal goal is to determine the extent to which either or both SAFE delivery formats yield long-term contraceptive practice improvements for women in substance abuse treatment. Design: The proposed study has three specific aims:
Aim 1. To conduct individual interviews with providers of health services to opioid-agonist- maintained women of childbearing age, followed by focus groups and individual interviews with opioid-agonist-maintained women of childbearing age and opioid-agonist-maintained men in order to develop the content and structure of the SAFE intervention.
Aim 2. To iteratively develop and pretest the SAFE intervention in a sample of women (N=36) assigned at random to either the face-to-face or computer-adaptive delivery format. SAFE's focus will be on increasing effective contraceptive use by (1) resolving ambivalence about contraceptive use and pregnancy through motivational interviewing (MI) techniques that will address pregnancy/childbearing motivation and planning challenges; (2) increasing contraceptive competence through male and female condom practice (on plastic models), receipt of emergency contraception prescription and MI style discussions about overcoming barriers to effective contraceptive use and contraceptive method side-effects; (3) reducing interpersonal violence risk through practicing effective partner communication, safer-sex negotiation, and physical and emotional safety techniques; and (4) immediate transport and escort to the Health Department for an evaluation for her contraceptive method(s) of choice.
Aim 3. To conduct a small-scale, three-arm (face-to-face SAFE v. computer-adaptive SAFE v. usual care) randomized trial (N=90) to estimate effect sizes and determine the initial efficacy of both SAFE formats relative to each other and to usual care in terms of their relative impacts on (a) intervention completion, (b) intervention satisfaction, (c) contraceptive consultation appointment attendance, and (d) effective contraceptive method choice. Secondary foci include reproduction and contraceptive methods knowledge, contraceptive self-efficacy, effective contraceptive behavior, and risky sexual behavior. Summary: To the extent that either version of SAFE is found to be efficacious, it has the potential to reduce the number of unintended pregnancies and consequently decrease the need for and the costs of child protective services. Improving women's ability to make and adhere to contraceptive choices and better time their pregnancies while also decreasing risky sexual behavior that can lead to HIV and other sexually transmitted infections (STIs) adds to the promise of this interventions' potential overall public health impact.
This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an intervention designed to increase acceptance of and adherence to contraceptive practices among opioid-agonist-maintained women of childbearing age. The intervention will be delivered in one of two formats: a face-to-face brief intervention approach or a novel computer-adaptive platform. To the extent that either version of SAFE is found to be efficacious compared with usual care, it has the potential to reduce the number of unintended pregnancies and consequently decrease the need for and the costs of child protective services.
