Ralph J DiClemente1, Gina M Wingood2, Jessica M Sales3, Jennifer L Brown4, Eve S Rose3, Teaniese L Davis3, Delia L Lang3, Angela Caliendo5, James W Hardin6. 1. Division of Infectious Diseases, Epidemiology, and Immunology, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia2Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlan. 2. Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, Georgia3Center for AIDS Research, Emory University, Atlanta, Georgia4Department of Women's Studies, Emory University, Atlanta, Georgia. 3. Department of Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, Georgia3Center for AIDS Research, Emory University, Atlanta, Georgia. 4. Department of Psychology, Texas Tech University, Lubbock. 5. Department of Medicine, Alpert Medical School, Brown University, Providence, Rhode Island7The Miriam Hospitals, Providence, Rhode Island. 6. Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia.
Abstract
IMPORTANCE: Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection (STI)/human immunodeficiency virus (HIV) risk behaviors; however, few have demonstrated long-term efficacy. OBJECTIVE: To evaluate the efficacy of a telephone counseling prevention maintenance intervention (PMI) to sustain STI/HIV-preventive behaviors and reduce incident STIs during a 36-month follow-up. DESIGN, SETTING, AND PARTICIPANTS: In a 2-arm randomized supplemental treatment trial at 3 clinics serving predominantly minority adolescents in Atlanta, Georgia, 701 African American adolescent girls aged 14 to 20 years received aprimary treatment and subsequently received a different (supplemental) treatment (PMI) to enhance effects of the primary treatment. INTERVENTIONS:Participants in the experimental condition (n = 342) received an adapted evidence-based STI/HIV intervention (HORIZONS) and a PMI consisting of brief telephone contacts every 8 weeks over 36 months to reinforce and complement prevention messages. Comparison-condition participants (n = 359) received HORIZONS and a time- and dose-consistent PMI focused on general health. MAIN OUTCOMES AND MEASURES: The primary outcomes were percentage of participants with a laboratory-confirmed incident chlamydial infection and percentage of participants with a laboratory-confirmed gonococcal infection during the 36-month follow-up. Behavioral outcomes included the following: (1) proportion of condom-protected sexual acts in the 6 months and 90 days prior to assessments; (2) number of sexual episodes during the past 90 days in which participants engaged in sexual intercourse while high on drugs and/or alcohol; and (3) number of vaginal sex partners in the 6 months prior to assessments. RESULTS: During the 36-month follow-up, fewer participants in the experimental condition than in the comparison condition had incident chlamydial infections (94 vs 104 participants, respectively; risk ratio = 0.50; 95% CI, 0.28 to 0.88; P = .02) and gonococcal infections (48 vs 54 participants, respectively; risk ratio = 0.40; 95% CI, 0.15 to 1.02; P = .06). Participants completing more telephone contacts had a lower risk of chlamydial infection (risk ratio = 0.95; 95% CI, 0.90 to 1.00; P = .05). Participants in the experimental condition reported a higher proportion of condom-protected sexual acts in the 90 days (mean difference = 0.08; 95% CI, 0.06 to 0.11; P = .02) and 6 months (mean difference = 0.08; 95% CI, 0.06 to 0.10; P = .04) prior to assessments and fewer episodes of sexual acts while high on drugs and/or alcohol (mean difference = -0.61; 95% CI, -0.98 to -0.24; P < .001). CONCLUSIONS AND RELEVANCE: Sustaining the long-term impact of an STI/HIV intervention is achievable with brief, tailored telephone counseling. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00279799.
RCT Entities:
IMPORTANCE: Behavioral change interventions have demonstrated short-term efficacy in reducing sexually transmitted infection (STI)/human immunodeficiency virus (HIV) risk behaviors; however, few have demonstrated long-term efficacy. OBJECTIVE: To evaluate the efficacy of a telephone counseling prevention maintenance intervention (PMI) to sustain STI/HIV-preventive behaviors and reduce incident STIs during a 36-month follow-up. DESIGN, SETTING, AND PARTICIPANTS: In a 2-arm randomized supplemental treatment trial at 3 clinics serving predominantly minority adolescents in Atlanta, Georgia, 701 African American adolescent girls aged 14 to 20 years received a primary treatment and subsequently received a different (supplemental) treatment (PMI) to enhance effects of the primary treatment. INTERVENTIONS:Participants in the experimental condition (n = 342) received an adapted evidence-based STI/HIV intervention (HORIZONS) and a PMI consisting of brief telephone contacts every 8 weeks over 36 months to reinforce and complement prevention messages. Comparison-condition participants (n = 359) received HORIZONS and a time- and dose-consistent PMI focused on general health. MAIN OUTCOMES AND MEASURES: The primary outcomes were percentage of participants with a laboratory-confirmed incident chlamydial infection and percentage of participants with a laboratory-confirmed gonococcal infection during the 36-month follow-up. Behavioral outcomes included the following: (1) proportion of condom-protected sexual acts in the 6 months and 90 days prior to assessments; (2) number of sexual episodes during the past 90 days in which participants engaged in sexual intercourse while high on drugs and/or alcohol; and (3) number of vaginal sex partners in the 6 months prior to assessments. RESULTS: During the 36-month follow-up, fewer participants in the experimental condition than in the comparison condition had incident chlamydial infections (94 vs 104 participants, respectively; risk ratio = 0.50; 95% CI, 0.28 to 0.88; P = .02) and gonococcal infections (48 vs 54 participants, respectively; risk ratio = 0.40; 95% CI, 0.15 to 1.02; P = .06). Participants completing more telephone contacts had a lower risk of chlamydial infection (risk ratio = 0.95; 95% CI, 0.90 to 1.00; P = .05). Participants in the experimental condition reported a higher proportion of condom-protected sexual acts in the 90 days (mean difference = 0.08; 95% CI, 0.06 to 0.11; P = .02) and 6 months (mean difference = 0.08; 95% CI, 0.06 to 0.10; P = .04) prior to assessments and fewer episodes of sexual acts while high on drugs and/or alcohol (mean difference = -0.61; 95% CI, -0.98 to -0.24; P < .001). CONCLUSIONS AND RELEVANCE: Sustaining the long-term impact of an STI/HIV intervention is achievable with brief, tailored telephone counseling. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00279799.
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