Objective: Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention.
Design: Longitudinal randomized controlled trial.
Settings: An academic HIV clinic and a community-based organization in Seattle.
Subjects: In a total of 240 HIV-positive adults on ART, 209 completed 9-month follow-up (87% retention).
Intervention: Randomization to computerized counseling or assessment only, 4 sessions over 9 months.
Main Outcome Measures: HIV-1 viral suppression, and self-reported ART adherence and transmission risks, compared using generalized estimating equations.
Results: Overall, intervention participants had reduced viral load: mean 0.17 log10 decline, versus 0.13 increase in controls, P = 0.053, and significant difference in ART adherence baseline to 9 months (P = 0.046). Their sexual transmission risk behaviors decreased (odds ratio = 0.55, P = 0.020), a reduction not seen among controls (odds ratio = 1.1, P = 0.664), and a significant difference in change (P = 0.040). Intervention effect was driven by those most in need; among those with detectable virus at baseline (>30 copies/mL, n = 89), intervention effect was mean 0.60 log10 viral load decline versus 0.15 increase in controls, P = 0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, P = 0.038.
Conclusions: Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior.
*New York University College of Nursing, New York, NY;
†School of Nursing, Biobehavioral Nursing and Health Systems, University of Washington, Seattle, WA;
‡Research Triangle Institute, San Francisco, CA;
Departments of §Global Health;
‖Medicine, University of Washington, Seattle, WA;
¶Pangaea Global AIDS Foundation, Oakland, CA;
#University of California, San Francisco, CA;
**Harborview Medical Center, HIV-Specialty Clinic Affiliated With UW, Seattle, WA; and
††Department of Psychology, University of Washington, Seattle, WA.
Correspondence to: Ann E. Kurth, CNM, PhD, New York University College of Nursing, 726 Broadway, 10th floor, New York, NY 10003 (e-mail: firstname.lastname@example.org).
Supported by a Health Promotion Research Initiative Mentored Scientist Award to A.E.K. (5 K01 PS000066), CDC. Holmes' and Simoni's time was supported by the University of Washington Center for AIDS Research (CFAR), an NIH funded program (P30 AI027757) that is supported by the following NIH Institutes and Centers: NIAID, NCI, NIMH, NIDA, NICHD, NHLBI, and NIA.
A.E.K. and F.S. were co-developers of underlying software (CARE) adapted for use in this intervention, with media company Resources Online, Seattle WA, from an original SBIR Grant by the Centers for Disease Control and Prevention (CDC). The remaining authors have no conflicts of interest to disclose.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the CDC or the NIH. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the article.
Trial Registration: ClinicalTrials.gov NCT00443378, http://clinicaltrials.gov/ct2/show/NCT00443378?term=04-3810-C+01&rank=1.
A.E.K. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: A.E.K., F.S., D.R.B., and K.K.H. Intervention content: A.E.K., M.C., F.S., P.A.F., and J.M.S. Acquisition of data: A.O.S., M.C., and B.L. Analysis and interpretation of data: A.E.K. and C.M.C. Statistical analysis: D.L., B.L., R.G.N., and C.M.C. Drafting of the article: A.E.K., B.L., and C.M.C. Critical revision of the article for important intellectual content: All authors.
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Received December 20, 2013
Accepted December 20, 2013