Texting intervention to sustain HIV prevention in women in high-drug-use contexts

 描述(申请人提供)：健康行为干预的治疗效果受到侵蚀，通常在6个月内复发率超过50%，可能是因为维持行为改变的结构与有利于行为习得的结构不同。这项研究的主要目的是评估Mujer Segura Siempre(MSS，Always Healthy女性)的疗效，这是一种通过定制短信传递的安全性行为维持干预措施。MSS将使用基于理论的、个性化的短信，旨在保持循证咨询干预(Mujer MáS Segura，R01 DA023877)的积极效果，该干预被证明有效地将提华纳和Ciudad(CD)吸毒和非吸毒女性性工作者(FSWs)的艾滋病毒/性传播感染发病率降低了60%以上。墨西哥华雷斯。短信的内容将基于行为维持理论的结构。我们的具体目标是：(1)确定基于理论的MSS短信干预是否与提华纳和CD吸毒者和非吸毒者HIV/STI发病率(主要结果)的长期(24个月)显著下降有关。与时间相同的控制条件相比，(2)确定MSS干预是否与更大程度地减少与男性客户的无保护的阴道和肛门性行为，更好地参加定期安排的性传播感染筛查，以及相对于时间相同的控制条件减少FSW-IDU的药物用具共享(二次结果)有关；(3)确定药物使用因素(频率， (4)评估MSS与对照条件、Mujer MáS Segura单独使用(来自先前研究的数据)以及墨西哥的日常护理相比的成本效益。为了实现这些目标，我们将向600名艾滋病毒阴性性工作者(提华纳300人，CD 300人)提供简短的Mujer MáS Segura咨询干预。华雷斯)报告在过去6个月内与至少一个客户发生不安全性行为的人，并将他们随机分为咨询后24个月的MSS短信维护计划(因为在这段时间内最有可能复发)或咨询后24个月的一般健康短信。两组都将在6个月、12个月、18个月和24个月时接受后续行为评估和STI测试。这项研究将推进普遍可用的信息技术的使用，以增强中低收入国家的高危妇女的能力，延长有效的艾滋病毒预防干预措施的益处。它还涉及妇女健康研究办公室的目标，即将性别问题纳入在高危妇女中预防艾滋病毒的新技术的设计和开发中，并使预防信息个性化，以保持积极的行为变化。

 DESCRIPTION (provided by applicant): Treatment effects of health behavior interventions erode, often with relapse rates greater than 50% within 6 months, perhaps because the constructs that sustain behavior change differ from those that favor behavior acquisition. The overarching aim of this study is to evaluate the efficacy of Mujer Segura Siempre (MSS, Always Healthy Woman), a safer-sex behavior maintenance intervention delivered by means of tailored text messaging. MSS will use theory-based, individually tailored text messages that are designed to maintain the positive effects of an evidence-based counseling intervention (Mujer Más Segura, R01 DA023877) that was shown to be efficacious in reducing HIV/STI incidence by more than 60% among both drug-using and non- drug-using female sex workers (FSWs) in Tijuana and Ciudad (Cd.) Juarez, Mexico. The content of the text messages will be based on constructs from behavior-maintenance theory. Our specific aims are to: (1) deter- mine if the theory-based MSS text-messaging intervention is associated with the long-term (24-month) mainte- nance of significant reductions in HIV/STI incidence (primary outcome) among drug-using and non-drug-using FSWs in Tijuana and Cd. Juarez relative to a time-equivalent control condition; (2) determine if the MSS intervention is associated with greater reductions in unprotected vaginal and anal sex with male clients, better attendance at regularly scheduled STI screenings, and reduced sharing of drug paraphernalia for FSW-IDUs (secondary outcomes) relative to a time-equivalent control condition; (3) determine if substance use factors (frequency, intensity, and patterns of alcohol and drug use) mediate or moderate the efficacy of the interven- tion, taking into account environmental risk factors (e.g., drugs in the workplace), maintenance constructs (e.g., maintenance self-efficacy), and personal characteristics (e.g., age, sexual abuse, depression); and (4) evalu- ate the cost-effectiveness of MSS compared to the control condition, to Mujer Más Segura alone (data from previous studies), and to usual care in Mexico. To meet these aims, we will deliver the brief Mujer Más Segura counseling intervention to 600 HIV-negative FSWs (300 in Tijuana, 300 in Cd. Juarez) who report unsafe sex with at least one client in the previous 6 months, and randomize them to either Group 1 (n=300), the MSS text- messaging maintenance program for 24 months post-counseling (since relapse is most likely to occur within this period) or Group 2 (control condition, n=300), general health text messages for 24 months post-counsel- ing. Both groups will undergo follow-up behavioral assessments and STI testing at 6, 12, 18, and 24 months. This study will advance the use of commonly available information technology to empower high-risk women in lower- to middle-income countries (LMICs) to prolong the benefit of an efficacious HIV prevention intervention. It also addresses the goals of the Office of Research on Women's Health to incorporate gender into the design and development of new technologies for HIV prevention among high-risk women, and to personalize prevention messages that will maintain positive behavioral change.