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Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial.

ABSTRACT: 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.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.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.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.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.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?

SUBMITTER: DiClemente RJ

PROVIDER: S-EPMC4496945 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial.

DiClemente Ralph J RJ Wingood Gina M GM Sales Jessica M JM Brown Jennifer L JL Rose Eve S ES Davis Teaniese L TL Lang Delia L DL Caliendo Angela A Hardin James W JW

JAMA pediatrics 20141001 10

<h4>Importance</h4>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.<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>In a 2-arm rand ...[more]

PMID: 25155070

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Project description:BackgroundHIV or sexually transmitted infections remain a significant public health concern in the United States, with adolescents affected disproportionately. Adolescents engage in HIV/STI risk behaviors, including drug use and condomless sex, which increase the risk for HIV/STIs. At-risk adolescents, many of whom are racial minorities, experience HIV/STI disparities. Although at-risk adolescents are disproportionately affected by HIV/STI risk behaviors and infections and although the Centers for Disease Control and Prevention recommends routine HIV/STI testing for adolescents, relatively few adolescents report having ever been tested for HIV/STI. With expected increases in health clinic visits as a result of the Affordable Care Act combined with technological advances, health clinics and mobile health (mHealth), including apps, provide innovative contexts and tools to engage at-risk adolescents in HIV/STI prevention programs. Yet, there is a dearth of efficacious mHealth interventions in health clinics to prevent and reduce both condomless sex and drug use and increase HIV/STI testing for at-risk adolescents.ObjectiveTo address this gap in knowledge, we developed a theory-driven, culturally congruent mHealth intervention (hereon referred to as S4E [Storytelling 4 Empowerment]) that has demonstrated feasibility and acceptability in a clinical setting. The next step is to examine the preliminary efficacy of S4E on adolescent HIV/STI testing and risk behaviors. This goal will be accomplished by 2 aims: the first aim is to develop a cross-platform and universal version of S4E. The cross-platform and universal version of S4E will be compatible with both iOS and Android operating systems and multiple mobile devices, aimed at providing adolescents with ongoing access to the intervention once they leave the clinic, and the second aim is to evaluate the preliminary efficacy of S4E, relative to usual care control condition, in preventing or reducing drug use and condomless sex and increasing HIV/STI testing in a clinical sample of at-risk adolescents aged 14-21 years living in Southeast Michigan.MethodsIn this study, 100 adolescents recruited from a youth-centered community health clinic will be randomized via blocked randomization with random sequences of block sizes to one of the 2 conditions: S4E mHealth intervention or usual care. Theory-driven and culturally congruent, S4E is an mHealth adaptation of face-to-face storytelling for empowerment, which is registered with the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-Based Programs and Practices.ResultsThis paper describes the protocol of our study. The recruitment began on May 1, 2018. This study was registered on December 11, 2017, in ClinicalTrials.gov. All participants have been recruited. Data analysis will be complete by the end of March 2024, with study findings available by December 2024.ConclusionsThis study has the potential to improve public health by preventing HIV/STI and substance use disorders.Trial registrationClinicalTrials.gov NCT03368456; https://clinicaltrials.gov/study/NCT03368456.International registered report identifier (irrid)DERR1-10.2196/47216.

Project description:ObjectiveWe sought to determine if a computer delivered brief alcohol intervention (CBI) with or without interactive voice response counseling and text messages (CBI-IVR-TM), reduced alcohol use and sexual risk behaviors compared to attention control.MethodsWe conducted a 3-arm RCT among women (n = 439) recruited from Baltimore City Sexually Transmitted Infection (STI) Clinics. Eligibility included: 1) consumption of >7 drinks per week or 2) ≥2 episodes of heavy episodic drinking or ≥2 episodes of sex under the influence of alcohol in the prior three months. Research assessments conducted at baseline, 3, 6 and 12 months included a 30-day Timeline Followback querying daily alcohol use, drug use, and sexual activity. We used the MINI International Neuropsychiatric Interview-DSM-IV to ascertain drinking severity. Primary alcohol outcomes included: drinking days, heavy drinking days, drinks per drinking day. Secondary sexual risk outcomes included number of sexual partners, days of condomless sex, and days of condomless sex under the influence of drugs and alcohol.ResultsMedian age was 31 (IQR 25-44 years), 88% were African American, 65% reported current recreational drug use, and 26% endorsed depressive symptoms. On the MINI 66% met criteria for alcohol use disorder (49% alcohol dependence, 18% abuse). At follow-up, all three groups reduced drinking days, heavy drinking days, drinks per drinking day and drinks per week with no significant differences between study arms. There was no difference in sexual risk outcomes among the groups.Conclusions Among women attending an urban STI clinic single session CBI with or without IVR and text message boosters was insufficient to reduce unhealthy alcohol use or sexual risk behaviors beyond control. The high severity of alcohol use and the prevalence of mental health symptoms and other substance use comorbidity underscores the importance of developing programs that address not only alcohol use but other determinants of STI risk among women.

Dataset Information

Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial.

Publications

Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial.

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