Background: To determine whether the 2gether intervention increases use of a dual protection (DP; concurrent prevention of pregnancy and sexually transmitted infections [STIs]) strategy and decreases pregnancy and STIs among young African American females, who disproportionately experience these outcomes. Materials and Methods: We conducted a randomized clinical trial comparing the 2gether intervention to standard of care (SOC). Participants were self-identified African American females aged 14-19 years who were sexually active with a male partner in the past 6 months. Participants were followed for 12 months; 685 were included in the analytic sample. The primary biologic outcome was time to any incident biologic event (chlamydia, gonorrhea, trichomonas infections, or pregnancy). The primary behavioral outcomes were use of and adherence to a DP strategy. Results: 2gether intervention participants had a decreased hazard of chlamydia, gonorrhea, trichomonas infections, or pregnancy during follow-up, hazard ratio = 0.73 (95% confidence interval [CI] 0.58-0.92), and were more likely to report use of condoms plus contraception, generally, adjusted risk ratio (aRR) = 1.61 (95% CI 1.15-2.26) and condoms plus an implant or intrauterine device (IUD), specifically, aRR = 2.11 (95% CI 1.35-3.29) in the prior 3 months compared with those receiving SOC. 2gether participants were also more likely to report use of condoms plus an implant or IUD at last sex and consistently over the prior 3 months. Conclusions: 2gether was efficacious in increasing use of condoms with contraception and decreasing pregnancy or selected STIs in our participants. Implementation of this intervention in clinical settings serving young people with high rates of pregnancy and STIs may be beneficial. ClinicalTrials.gov, No. NCT02291224 (https://clinicaltrials.gov/ct2/show/NCT02291224?term=2gether&draw=2&rank=5).
Keywords: adolescent; contraception; dual methods; dual protection; motivational interviewing; sexually transmitted infections; unintended pregnancy.