Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: A focus on local stakeholder involvement
Open Access Journal of Clinical Trials, Volume 5, No. 1, Year 2012
Notification
URL copied to clipboard!
Description
Biomedical HIV-prevention research is most likely to succeed when researchers actively engage with community stakeholders. To this effect, the Joint United Nations Programme on HIV/AIDS and the AIDS Vaccine Advocacy Coalition developed good participatory practice guidelines for biomedical HIV-prevention trials in 2007 and updated them in 2011. The Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP) clinical trial, testing once-daily Truvada as preexposure prophylaxis among women at higher risk of HIV in Kenya, South Africa, and Tanzania, included a community program to engage with local stakeholders. Following the trial, we revisited the community program to situate activities in the context of the 2011 guidelines. In the paper, we describe implementation of the six guidelines relevant to local stakeholder engagement - stakeholder advisory mechanisms, stakeholder engagement plan, stakeholder education plan, communications plan, issues management plan, trial closure, and results dissemination - in light of on-the-ground realities of the trial. We then identify two cross-cutting themes from our considerations: (1) stakeholder education beyond the good participatory practice recommendation to increase research literacy about the specific trial is needed; education efforts should also communicate a base of information on HIV transmission and prevention; and (2) anticipatory preparation is useful in communications planning, issues management, and trial closure and results dissemination, and may contribute to successful conduct of the trial; in FEM-PrEP, this was possible through integration of the community program with social, behavioral, and clinical research. © 2013 Mack et al, publisher and licensee Dove Medical Press Ltd.
Authors & Co-Authors
Mack, Natasha
United States, Durham
Fhi 360
Kirkendale, Stella
United States, Durham
Fhi 360
Omullo, Paul
Kenya, Kisumu
Impact Research and Development Organization
Odhiambo, Jacob O.
Kenya, Kisumu
Impact Research and Development Organization
Ratlhagana, Mary Jane Malebo
South Africa, Pretoria
Setshaba Research Centre
Masaki, Martha
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Siguntu, Phumzile
South Africa, Bloemfontein
Josha Research
Agot, Kawango E.
Kenya, Kisumu
Impact Research and Development Organization
Ahmed, Khatija
South Africa, Pretoria
Setshaba Research Centre
Kapiga, Saidi Hussein
Tanzania, Moshi
Kilimanjaro Christian Medical Centre
Lombaard, Johan J.
South Africa, Bloemfontein
Josha Research
van Damme, Lut
United States, Durham
Fhi 360
Corneli, Amy L.
United States, Durham
Fhi 360
Statistics
Citations: 21
Authors: 13
Affiliations: 5
Identifiers
Doi:
10.2147/OAJCT.S45717
e-ISSN:
11791586
Research Areas
Infectious Diseases
Study Locations
Kenya
South Africa
Tanzania
Participants Gender
Female