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

 描述（由申请人提供）：健康行为干预的治疗效果减弱，通常在6个月内复发率超过50%，这可能是因为维持行为改变的结构不同于有利于行为获得的结构。这项研究的首要目的是评估Mujer塞古拉Siempre（MSS，永远健康的女人）的疗效，这是一种通过量身定制的短信提供的更安全的性行为维持干预。MSS将使用基于理论的、个性化定制的短信，旨在维持循证咨询干预的积极效果（Mujer Más塞古拉，R 01 DA 023877），该干预已被证明在蒂华纳和Ciudad的吸毒和非吸毒女性性工作者（FSW）中有效降低了60%以上的艾滋病毒/性传播感染发病率（Cd.）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短信干预是否与长期（24个月）维持显著降低的HIV/STI发病率（主要结局）相关。（2）确定MSS干预是否与与时间等效控制条件相比，与男性客户无保护阴道和肛交的更大减少，定期定期STI筛查的更好出勤率以及减少FSW-IDUs共享药物用具（次要结局）有关;（3）确定物质使用因素（频率， 酒精和药物使用的强度和模式）介导或缓和干预的功效，同时考虑环境风险因素（例如，工作场所中的药物），维护构造（例如，维持自我效能），和个人特征（例如，年龄、性虐待、抑郁）;（4）与对照条件、单独使用Mujer Más塞古拉（数据来自先前研究）和墨西哥的常规护理相比，评估MSS的成本效益。为了实现这些目标，我们将向600名艾滋病毒阴性的性工作者（300名在蒂华纳，300名在克罗地亚）提供简短的“妇女最大塞古拉”咨询干预。Juarez），他们报告在过去6个月内与至少一名客户发生不安全性行为，并将他们随机分配到第1组（n=300），即咨询后24个月的MSS短信维护计划（因为复发最有可能发生在此期间）或第2组（对照条件，n=300），咨询后24个月的一般健康短信。两组患者将在6个月、12个月、18个月和24个月时接受随访行为评估和STI检测。这项研究将促进使用普遍可用的信息技术，以增强中低收入国家（LMIC）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，将性别问题纳入高危妇女预防艾滋病毒新技术的设计和开发，并个性化预防信息，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.