Study Details
Kottke, M. J., Sales, J. M., Goedken, P., Brown, J. L., Hatfield-Timajchy, K., Koumans, E. H., Hardin, J. W., Kraft, J. M., & Kourtis, A. P. (2022). 2gether: A clinic-based intervention to increase dual protection from sexually transmitted infections and pregnancy in young African American females. Journal of Women’s Health. https://doi.org/10.1089/jwh.2022.0209
2gether
Program Information
Evaluation Setting
Study Sample
Research Design
714
4
12 months after enrollment
Study Findings
The 2gether intervention was evaluated in a randomized controlled trial implemented in a clinical setting. Participants were African American female adolescents who were not pregnant at enrollment, had vaginal sex with a male partner at least once in the previous six months, were self-reported HIV negative, were planning on staying in the study area for the study period, were not previously enrolled in the pilot study, and had a desire to avoid pregnancy for at least 12 months. A total of 1,396 adolescents were assessed, with about half being deemed ineligible; 714 adolescents were randomized, but some were subsequently determined to not be eligible because they either (1) did not complete the enrollment visit, (2) were diagnosed with HIV at enrollment, or (3) were pregnant at enrollment. This left an analytic sample of 685 participants, with 337 assigned to the treatment group and 348 assigned to the control group. Data were collected at a three-month follow-up call, a six-month follow-up visit, a nine-month follow-up call, and a 12-month final follow-up visit. In addition, data on positive STI or pregnancy tests for all participants were collected from medical records. The data collected from these follow-ups were pooled and analyzed cumulatively. The primary analytic approach for assessing program effectiveness was to estimate time to an event (positive STI test or pregnancy) using a proportional hazard model. In addition, the study presented differences in overall rates of outcomes pooled across all observed data collection events. Only the time-to-event analyses meet TPPER reporting requirements.
The study's main outcomes of interest were biologic outcomes (testing positive for chlamydia, gonorrhea, trichomonas, and pregnancy). The study showed a statistically significant and favorable effect on the time to trichomonas event (adjusted hazard ratio = 0.59; CI = [0.36, 0.94]; TPPER-calculated effect size based on prevalence rates of the outcomes = -0.27). That is, it took significantly longer for adolescents in the treatment group to experience a trichomonas event than it took for adolescents in the control group. There were no statistically significant differences observed for any of the other outcomes.
There were a number of outcomes outside the scope of review. The combined biologic outcomes were not eligible for review because they pool information across multiple measures (testing positive for STIs and pregnancy). Other outcomes outside of the scope of the review include contraceptive knowledge, contraceptive self-efficacy, STI knowledge, intentions to use a contraceptive, intentions to use condoms, and reports of verbal or physical threats from a partner.
NA = Not available. This means the authors did not report the information in the manuscripts associated with the studies we reviewed.
a This information was not available whenever authors did not report information for the treatment and comparison groups separately on outcome means, standard deviations, and/or sample sizes.
b Authors reported that the program effect (impact) estimate is statistically significant with a p-value of less than 0.05 based on a two-tailed test.
c For some outcomes, having less of that outcome is favorable. In those cases, an effect with a negative sign is favorable to the treatment group (that is, the treatment group had a more favorable outcome than the comparison group, on average).
d An effect shows credibly estimated, statistically significant evidence whenever it has a p-value of less than 0.05 based on a two-tailed test, includes the appropriate adjustment for clustering (if applicable), and it is not based on an endogenous subgroup.
Language directly from the program model developer or authors.