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Implementing good participatory practice guidelines in the FEM-PrEP Preexposure Prophylaxis Trial for HIV Prevention among African Women: a focus on local stakeholder involvement

Authors Mack N, Kirkendale S, Omullo P, Odhiambo J, Ratlhagana M, Masaki M, Siguntu P, Agot K, Ahmed K, Kapiga S, Lombaard J, Van Damme L, Corneli A

Received 25 March 2013

Accepted for publication 8 May 2013

Published 25 October 2013 Volume 2013:5 Pages 127—135


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

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Natasha Mack,1 Stella Kirkendale,1 Paul Omullo,2 Jacob Odhiambo,2 Malebo Ratlhagana,3 Martha Masaki,4 Phumzile Siguntu,5 Kawango Agot,2 Khatija Ahmed,3 Saidi Kapiga,4 Johan Lombaard,5 Lut Van Damme,1 Amy Corneli1

1FHI 360, Durham, NC, USA; 2Impact Research and Development Organization, Bondo, Kenya; 3Setshaba Research Centre, Soshanguve, South Africa; 4Kilimanjaro Christian Medical Center, Moshi, Tanzania; 5Josha Research, Bloemfontein, South Africa

Abstract: 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.

Keywords: stakeholder engagement, community engagement, community involvement, HIV-prevention trials, good participatory practice guidelines, FEM-PrEP

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