Establishing a Cohort at High Risk of HIV Infection in South Africa: Challenges and Experiences of the CAPRISA 002 Acute Infection Study

Francois Van Loggerenberg,Quarraisha Abdool Karim,Clive M Gray,Sara C Auld,Anneke Grobler,Salim S Abdool Karim,Lynn Morris,Itua Iriogbe,Carolyn Williamson,For The Caprisa 002 Acute Infection Study Team ,Nomampondo Barnabas,Koleka Mlisana

doi:10.1371/journal.pone.0001954

Francois Van Loggerenberg, Quarraisha Abdool Karim + Show 10 more

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https://doi.org/10.1371/journal.pone.0001954

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Journal: PloS one	Publication Date: Apr 16, 2008
Citations: 201	License type: CC BY 4.0

Affiliation: University of KwaZulu-Natal

Abstract

ObjectivesTo describe the baseline demographic data, clinical characteristics and HIV-incidence rates of a cohort at high risk for HIV infection in South Africa as well as the challenges experienced in establishing and maintaining the cohort.Methodology/Principle FindingsBetween August 2004 and May 2005 a cohort of HIV-uninfected women was established for the CAPRISA 002 Acute Infection Study, a natural history study of HIV-1 subtype C infection. Volunteers were identified through peer-outreach. The cohort was followed monthly to determine HIV infection rates and clinical presentation of early HIV infection. Risk reduction counselling and male and female condoms were provided. After screening 775 individuals, a cohort of 245 uninfected high-risk women was established. HIV-prevalence at screening was 59.6% (95% CI: 55.9% to 62.8%) posing a challenge in accruing HIV-uninfected women. The majority of women (78.8%) were self-identified as sex-workers with a median of 2 clients per day. Most women (95%) reported more than one casual sexual partner in the previous 3 months (excluding clients) and 58.8% reported condom use in their last sexual encounter. Based on laboratory testing, 62.0% had a sexually transmitted infection at baseline. During 390 person-years of follow-up, 28 infections occurred yielding seroincidence rate of 7.2 (95% CI: 4.5 to 9.8) per 100 person-years. Despite the high mobility of this sex worker cohort retention rate after 2 years was 86.1%. High co-morbidity created challenges for ancillary care provision, both in terms of human and financial resources.Conclusions/SignificanceChallenges experienced were high baseline HIV-prevalence, lower than anticipated HIV-incidence and difficulties retaining participants. Despite challenges, we have successfully accrued this cohort of HIV-uninfected women with favourable retention, enabling us to study the natural history of HIV-1 during acute HIV-infection. Our experiences provide lessons for others establishing similar cohorts, which will be key for advancing the vaccine and prevention research agenda in resource-constrained settings.

Highlights

As we move into the third decade of the AIDS epidemic, the need to increase and improve the research being conducted in some of the hardest hit areas of the developing world has become increasingly clear
Between August 2004 and May 2005, 775 women who were classified as high-risk either by self-identification as sex workers or self-report of more than three sexual partners in the previous 3 months were screened for participation in the observational cohort
We investigated if the number of new HIV infections reduced over time, which could be due to women who were most at risk of getting infected seroconverting early during follow-up or women reducing their risky behaviour over time and in response to repeated risk-reduction counselling

Summary

Introduction

As we move into the third decade of the AIDS epidemic, the need to increase and improve the research being conducted in some of the hardest hit areas of the developing world has become increasingly clear. These regions pose unique challenges for scientific research as they are typically resource-poor settings with minimal existing infrastructure and populations that are not well integrated into a formal health care system. In order to determine which host and viral factors during the acute and early phases of HIV-1 infection have a significant impact on the subsequent course of disease, the Centre for the AIDS Programme of Research in South Africa (CAPRISA) initiated the CAPRISA 002 Acute Infection Study. As a prospective observational cohort study, this study will provide a methodology for setting up and managing an observational cohort requiring frequent visits over an extended period of time against within a very challenging, resource-constrained environment with participants who tend to be highly mobile and difficult to contact by conventional means

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