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HealthClinical trials design and implementation

30 Results Found

  • Feature

    Malaria and the impact of clinical research

    In this audio interview, FHI 360’s Ted FitzGerald, Director of Global Research Services, interviews our Director of Clinical Research in Kenya, Ghiorghis (George) Belai, about the status of malaria research.
  • Feature

    China Tuberculosis Clinical Trials Consortium will advance global TB knowledge

    FHI 360 began the China Tuberculosis Clinical Trials Consortium to develop a TB clinical trials research platform that meets international standards and is able to enroll participants in global, multicenter studies.
  • News

    ECHO Study of hormonal contraception and HIV begins

    FHI 360 and partners embark on a landmark study designed to fill a critical gap in the scientific evidence on the relationship between HIV acquisition and hormonal contraceptives.
  • Published research

    Optimizing HIV prevention for women: A review of evidence from microbicide studies and considerations for gender-sensitive microbicide introduction

    Gender-related norms and inequalities that place women and girls at risk of acquiring HIV are also likely to affect their ability to use microbicides. Published vaginal microbicide studies were reviewed to identify gender-related factors that are likely to affect microbicide acceptability, access and adherence. This paper makes recommendations on product design, trial implementation, positioning, marketing and delivery of microbicides in a way that takes into account the gender-related norms and inequalities identified in the review.
  • Past Project

    Regional Prospective Observational Research in Tuberculosis (RePORT) International Coordinating Center

    FHI 360 leads the Regional Prospective Observational Research in Tuberculosis (RePORT) International Coordinating Center (RICC), which manages worldwide research teams.
  • Published research

    Pregnancy and contraceptive use among women participating in the FEM-PrEP trial

    Pregnancy among participants in HIV prevention clinical trials continues to present a challenge. This study found that women who adopted an injectable contraceptive at the beginning of the trial were more likely to adhere to study product than women using combined oral contraceptives. HIV prevention trials should consider requiring long-acting methods, including injectables, for study participation.
  • Past Project

    China Tuberculosis Clinical Trials Consortium (CTCTC) project

    FHI 360’s China Tuberculosis Clinical Trials Consortium provides mentoring and advice on the critical aspects of maintaining a successful tuberculosis clinical trial network in China.
  • Published research

    Lessons learnt from implementing an empirically informed recruitment approach for FEM-PrEP, a large HIV prevention clinical trial

    This paper describes the entire recruitment approach used in the FEM-PrEP clinical trial, starting with data collected during the preparedness phase, how those data were used to inform the recruitment strategies, changes incorporated throughout the clinical trial and lessons learned. 
  • Published research

    Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial

    This study demonstrates that the dynamics of communication between partners about participation in a trial and use of a study product vary and can influence use behavior. Therefore, no single product adherence strategy can be applied to all HIV prevention trials or product introduction campaigns. Guidance is needed for developing adherence strategies that involve male partners of women who want to communicate their study participation and that support women who would like to use a study product without their partner's knowledge.
  • Published research

    Perceptions and experiences with the VOICE adherence strengthening program (VASP) in the MTN-003 trial

    The vaginal and oral interventions to control the epidemic (VOICE) adherence strengthening program (VASP) revealed challenges to mid-study changes in the adherence support approach in a large multisite clinical trial. The research recommended that future adherence support packages: 1) use an integrated, multidisciplinary approach from study start; 2) use multiple modalities for participant engagement to best fit the local culture; and 3) document the fidelity of implementation so the potential impact of adherence support interventions can be assessed.