Assessing willingness to participate and methods for improving adherence and self

评估参与意愿以及提高依从性和自我的方法

• 批准号: 7690878
• 负责人: BARBARA Sena MENSCH
• 金额: $ 10.48万
• 依托单位: POPULATION COUNCIL
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-29 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7690878
• 关键词: Adherence; Adult; Affect; Animals; Behavior; Behavioral; Biological Markers; Caring; Cellular Phone; Characteristics; Clinic; Clinical; Collaborations; Collection; Communication; Computer Assisted; Computers; Country; Data; Data Collection; Development; Disclosure; Economics; Enrollment; Female; Future; Gel; Generations; Goals; Gonorrhea; HIV; HIV prevention trial; Herpes Simplex Infections; High Prevalence; Hour; Human Herpesvirus 2; Human Identifications; In Vitro; Incidence; India; Institution; Interview; Joints; Knowledge; Laboratories; Laboratory Study; Lead; Methods; Methylcellulose; Participant; Patient Self-Report; Phase; Phase III Clinical Trials; Placebos; Population; Prevalence; Protocols documentation; Recommendation; Recruitment Activity; Reporting; Research; Research Personnel; Respondent; Risk Behaviors; Sampling; Screening procedure; Seminal fluid; Sex Behavior; Sexually Transmitted Diseases; Simulate; Site; Social Characteristics; Staining method; Stains; Surveys; System; Tablets; Techniques; Testing; Time; Vagina; Validity of Self Report; Visit; Voice; Woman; Writing; base; condoms; design; diaries; efficacy trial; electronic data; experience; high risk; high risk behavior; improved; innovation; microbicide; novel; peer; prevent; research study; response; sex; social; tool; transmission process; willingness

DESCRIPTION (provided by applicant): Disappointing results from several HIV prevention trials have raised questions about the feasibility of future microbicide trials, including the extent to which the selectivity of trial participants, adherence to study protocols and the reliability and validity of self-reported behavioral data undermine researchers' ability to detect efficacy. In collaboration with YRG CARE, a leading Indian research institution based in Chennai, the ultimate goal of this project is to help determine whether it would be fruitful and feasible to conduct an expanded Phase 2 or Phase 3 clinical trial of a Population Council second-generation microbicide in southern India. Through four experiments we will identify behavioral and social factors that may affect the successful implementation of microbicide trials. The specific aims are to: 1. Evaluate how sex workers who participate in a four month simulated microbicide trial of a placebo gel differ from their peers who are unwilling to participate with survey data obtained through respondent driven sampling (RDS), an innovative technique to generate a representative sample of hidden and hard-to-reach populations; 2. Assess whether surveys, rather than the conventional facility-based strategy, are feasible for recruiting trial participants; 3. Investigate rates of HIV and other sexually transmitted infections, including HSV-2 and gonorrhea among women who enroll in the simulated microbicide trial; 4. Compare adherence and high risk behavior among participants in the simulated trial using a variety of innovative research tools tested within an experimental framework; 5. Explore if prior knowledge of biomarkers affects gel adherence and/or self-reports of sexual activity, gel and condom use; 6. Determine whether audio computer assisted self-interviewing yields more accurate reports than computer assisted personal interviewing for the collection of behavioral data. This research will lead to the development of a set of recommendations for the design and implementation of future microbicide trials in India and elsewhere.

描述（由申请人提供）：几项HIV预防试验的令人失望的结果提出了有关未来杀菌剂试验的可行性的问题，包括试验参与者的选择性，对研究方案的遵守以及自我报告的行为数据的依从性和有效性的程度，都破坏了检测效率的能力。与位于钦奈的主要印度研究机构YRG Care合作，该项目的最终目标是帮助确定印度南部人口委员会第二代微生物的第2期或第3期临床试验是否有效和可行。通过四个实验，我们将确定可能影响微生物试验实施的行为和社会因素。具体目的是：1。评估如何参加四个月的安慰剂凝胶模拟杀菌剂试验的性工作者与同龄人不同，他们不愿意参与通过受访者驱动的采样（RDS）获得的调查数据，这是一种创新的技术，是一种创新的技术，以生成一项代表性的隐藏和难道种群的样本； 2.评估调查是否而不是基于常规设施的策略，对于招募试验参与者是可行的； 3。研究参加模拟杀生型试验的妇女中的艾滋病毒和其他性传播感染率，包括HSV-2和淋病； 4。在模拟试验中，使用在实验框架中测试的各种创新研究工具比较模拟试验中的参与者的依从性和高风险行为； 5。探索生物标志物的先验知识是否会影响性活动，凝胶和避孕套的凝胶依从性和/或自我报告； 6.确定音频计算机协助自我访问是否比计算机辅助个人面试收集行为数据更准确的报告。这项研究将导致一系列建议在印度和其他地方设计和实施未来的杀微生物试验。

项目成果

Using a 2-stage strategy with respondent-driven sampling to recruit a hard-to-reach population for a placebo microbicide gel clinical trial in Nellore, Andhra Pradesh (India).

采用两阶段策略和受访者驱动抽样，招募难以接触的人群，在安得拉邦内洛尔（印度）进行安慰剂杀菌剂凝胶临床试验。

• DOI: 10.1007/s10461-014-0938-1
• 发表时间: 2015
• 期刊: AIDS and behavior
• 影响因子: 4.4
• 作者: Tun,Waimar;Katzen,LaurenL;Abbott,SharonA;Srikrishnan,AylurK;Kelly,ChristineA;Sarna,Avina;Friedland,BarbaraA;Solomon,Suniti;Mensch,BarbaraS
• 通讯作者: Mensch,BarbaraS

Sexually transmitted infections and reproductive health morbidity in a cohort of female sex workers screened for a microbicide feasibility study in Nellore, India.

• DOI: 10.5539/gjhs.v5n3p139
• 发表时间: 2013-02-24
• 期刊: Global journal of health science
• 作者: Sarna A;Friedland BA;Srikrishnan AK;Katzen LL;Tun W;Abbott SA;Rawiel U;Kelly CA;Shalini CS;Solomon S;Mensch BS
• 通讯作者: Mensch BS

Characteristics of female sex workers in southern India willing and unwilling to participate in a placebo gel trial.

• DOI: 10.1007/s10461-012-0259-1
• 发表时间: 2013-02
• 期刊: AIDS AND BEHAVIOR
• 影响因子: 4.4
• 作者: Mensch, Barbara S.;Friedland, Barbara A.;Abbott, Sharon A.;Katzen, Lauren L.;Tun, Waimar;Kelly, Christine A.;Sarna, Avina;Srikrishnan, Aylur K.;Solomon, Suniti
• 通讯作者: Solomon, Suniti

Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators.

• DOI: 10.1097/olq.0b013e31822e6160
• 发表时间: 2011-11
• 期刊: Sexually transmitted diseases
• 影响因子: 3.1
• 作者: Katzen LL;Fernández-Romero JA;Sarna A;Murugavel KG;Gawarecki D;Zydowsky TM;Mensch BS
• 通讯作者: Mensch BS

An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India.

对印度安得拉邦安慰剂凝胶试验中改善依从性报告的方法进行评估。

• DOI: 10.1007/s10461-012-0402-z
• 发表时间: 2013
• 期刊: AIDS and behavior
• 影响因子: 4.4
• 作者: Abbott,SharonA;Friedland,BarbaraA;Sarna,Avina;Katzen,LaurenL;Rawiel,Ulrike;Srikrishnan,AylurK;Shalini,CS;Tun,Waimar;Kelly,ChristineA;Solomon,Suniti;Mensch,BarbaraS
• 通讯作者: Mensch,BarbaraS