The CAPRISA Clinical Trials: HIV Treatment and Prevention

The CAPRISA Clinical Trials

Quarraisha Abdool Karim, Salim S. Abdool Karim, Cheryl Baxter

• Publisher: Springer
• Year: 2017
• Print ISBN:
  9783319475172
• eBook ISBN:
  9783319475189
• Topic: Medicine
• Subtopic: Diseases & Allergies

Since its inception 14 years ago, CAPRISA has conducted numerous clinical studies that have influenced international TB-HIV treatment guidelines as well as HIV prevention through innovations in the microbicide and vaccine fields. This book provides a historical account of how each of CAPRISA's high impact studies was created, developed, implemented, analysed and communicated.  In doing so, the reader is taken on a journey that provides glimpses into the genesis of research ideas and how this ultimately leads to a range of HIV prevention and treatment studies that have impacted the global response to the HIV and TB epidemics.

Comprised of 5 sections, the book details the following:

1. HIV epidemic in South Africa and the establishment of a research centre to undertake clinical, epidemiological and laboratory research on HIV.
2. CAPRISA's clinical trials on HIV and HSV-2 prevention. These studies investigated the impact of tenofovir gel as topical antiretroviral pre-exposure prophylaxis (PrEP), implementation of topical PrEP through family planning clinics, conditional cash incentives for HIV prevention, HIV vaccines, and passive immunisation with broadly neutralising antibodies.
3. CAPRISA's research on the treatment of HIV and TB co-infection.
4. A review of the major scientific findings from the CAPRISA studies on acute infection and genital mucosal immunology. 
5. Essential support activities for the conduct of clinical trials, including research laboratories and pharmacies, as well as establishing effective communication and sustainable structures for community engagement to maintain effective and respectful partnerships with participating communities. The book concludes with a chapter about the challenges facing future HIV prevention and treatment trials.

The CAPRISA Clinical Trials: HIV Treatment and Prevention is a resource for undergraduate and postgraduate students, health care providers, doctors, decision-makers and researchers who are seeking guidance and insights on clinical trials – their creation, conduct and impact.

Table of contents

• Contents
• Introduction/Background
• 1 Studies Linked to the Evolving HIV Epidemic in South Africa: Informing the CAPRISA Scientific Agenda
• 2 CAPRISA: Establishing a Research Centre to Undertake HIV Clinical Trials
• 3 Overview of Clinical Trials
• CAPRISA Clinical Trials for HIV and HSV-2 Prevention
• 4 Antiretrovirals for HIV Prevention: The CAPRISA 004 Tenofovir Gel Trial
• 5 Rolling Out of Tenofovir Gel in Family Planning Clinics: The CAPRISA 008 Implementation Trial
• 6 The Impact of Conditional Cash Transfers in Reducing HIV in Adolescent Girls and Boys (RHIVA): The CAPRISA 007 Matched Pair, Cluster Randomised Controlled Trial
• 7 HIV Vaccine and Passive Immunity Trials
• CAPRISA Clinical Trials for HIV–TB Treatment
• 8 CAPRISA 003: Timing of Antiretroviral Initiation in HIV-TB Co-infected Patients—The SAPiT Trial
• 9 Scaling up TB-HIV Integration in Public Health Clinics: Translating Research Findings into Practice
• Experiences and Lessons Learnt from Clinical Trials in CAPRISA
• 10 From Bench to Bedside: Lessons from HIV Natural History Cohort Studies
• 11 Advancing Understanding of HIV Infection in Women Through Mucosal Immunology Studies
• Essential Support Activities for the Conduct of Clinical Trials
• 12 Good Practices in the Conduct of Clinical Trials: Good Community, Pharmacy and Laboratory Practices
• 13 Ethical and Legal Considerations for Realising Post-trial Access of Novel Experimental Interventions: Lessons from the CAPRISA 004 Trial
• 14 Grants Management
• 15 Taking Science to the People: CAPRISA Communication and Media Strategies for Announcing Outcomes of Pivotal Study Findings
• 16 What Does the Future Hold for CAPRISA?
• Index