3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

RECRUITMENT AND RETENTION OF AN HIV DISCORDANT COUPLE COHORT IN KIGALI, RWANDA IN PREPARATION FOR VACCINE EFFICACY TRIALS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WePp0203

Shutes E.¹, Karita E.², Kayitenkore K.², Ketter N.³, Kambili C.⁴, Allen S.⁵, Rwanda/Zambia HIV Research Group P.^5
1 Emory University, Kigali, Rwanda, ² Projet San Francisco, Kigali, Rwanda, ³ International AIDS Vaccine Initiative, San Mateo, United States of America, ⁴ International AIDS Vaccine Initiative, Nairobi, Kenya, ⁵ Emory University, Atlanta, United States of America

INTRODUCTION: The Global HIV/AIDS Vaccine Enterprise identified "expanding access to large, well-defined populations of uninfected people at high risk of HIV infection" as a gap in the clinical trials capacity of developing countries. An estimated, 25.4 million people in Africa were living with HIV at the end of 2004. Cohabiting couples in Africa are the largest HIV risk group in the world. In Kigali, Rwanda, we have enrolled 800+ discordant couples (one partner HIV infected, one HIV uninfected) in preparation for HIV prevention trials.

METHODS: Projet San Francisco maintains three Couples' Voluntary Counselling and Testing (CVCT) Centers. HIV discordant couples, who have cohabitated for the last twelve months and live in Kigali are offered enrollment into a heterosexual transmission of HIV study. Follow-up is quarterly; study benefits include free family medical care and prescriptions, family planning, ARV screening and treatment and ongoing counseling.

RESULTS: In 2004, PSF CVCT Centers tested 9770 couples. 513 (5.3%) discordant couples were invited to enroll in the follow-up study. 401 (78%) chose to screen and were enrolled. The majority of couples not enrolled were determined to be false couples by community workers and enrollment of truly eligible couples is 93%. The HIV incidence rate is 4% per year and retention is >90% at 12 months.

CONCLUSIONS: The establishment and retention of a well-defined, high-risk cohort in preparation for vaccine efficacy trials is possible in developing countries. A run-in design, using an existing cohort provides an accurate assessment of HIV incidence and allows the recruitment of volunteers with good follow-up and compliance. Further, the opportunity to determine contraceptive acceptability, an inclusion criteria of vaccine trials, is critical in countries like Rwanda, where up to 75% of eligible women are pregnant or breastfeeding. The limiting factor to the development of such cohorts is the commitment of funding.

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Prevention | WePp0203 | Erin Shutes
Planning For Vaccine Efficacy Trials

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