OVERVIEW OF SiVET STUDY DESIGN

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The success of any HIV prevention trial depends on the identification of a suitably

large population of persons at high risk of HIV seroincidence that is willing to

participate in the trial (Seage et al 2001). Studies in Kenya have demonstrated

that men who have sex with men (MSM) and female sex workers (FSW) are at

disproportionately high risk of HIV infection (Sanders et al 2007, McKinnon et al

2013). The purpose of this study is to evaluate if FSW and men who have sex

with men (MSM) who sell sex (MSM-SW) are willing to participate in a simulated

vaccine clinical trial. The trial is designed to mirror the procedures of an actual

HIV vaccine trial but will use a registered hepatitis B vaccine as a proxy. This

will enable assessment of volunteer compliance with protocol procedures

while identifying potential barriers to participation in an actual vaccine trial.

Retention of study volunteers is of critical importance in randomized clinical

trials and this study will determine retention rates in this mixed cohort of

MSM-SW and FSW.

 

The MSM cohort that will be enrolled in this study has an estimated HIV

incidence of 10.9% (McKinnon et al 2013). MSM-SW and FSW are part of the

Sex Worker Outreach Programme (SWOP), a prevention, treatment and care

program that was established in the early 1980s. From 2005, the program was

awarded a CDC-PEPFAR grant that facilitated access to much needed ART

services and allowed scale up of HIV prevention services for sex workers

residing within Nairobi County. Currently, the program has reached over 26,000

sex workers and enrolled at least 21,000 in seven sex-worker dedicated clinics

in Nairobi. Those reached and enrolled into the program access a

comprehensive HIV prevention and care package as per the MOH guidelines.

Throughout its lifespan, the program has been setting the pace and best

practice in community engagement and health care services for sex workers.

 

The existing seven sex worker dedicated clinics have minimized the stigma and

discrimination encountered by key populations when seeking health care,

greatly improving access to friendly and acceptable HIV prevention and care.

Additionally, these clinics have improved the proportion of sex workers screened

for HIV in Nairobi County creating a critical mass that is influencing changes

to their health seeking behaviours. The hotspot based, peer led model

used for community engagement, where peer educators trained and certified by

NASCOP-MOH spearhead activities in the field, has greatly improved the

existing partnerships and ownership of the funded activities within the targeted

communities.

 

Through these cordial and genuine partnerships, we will be able to refine

recruitment strategies for these key populations and define optimal eligibility

criteria for future HIV vaccine studies.

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Contacts

KAVI Institute of Clinical Research (KAVI-ICR)

College of Health Sciences

University of Nairobi

P.O. Box 19676 - 00202

Nairobi,

Kenya.

 

Telephone: +254-20-2717694/2725404

 

Mobile: +254-722-207417

 

Fax: +254-20-2714613

 

E-mail: kavi@kaviuon.org

 

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