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HIV Incidence in Young Girls in KwaZulu-Natal, South Africa-Public Health Imperative for Their Inclusion in HIV Biomedical Intervention Trials

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Abstract

Young women are particularly vulnerable for acquiring HIV yet they are often excluded from clinical trials testing new biomedical intervention. We assessed the HIV incidence and feasibility of enrolling a cohort of young women for potential participation in future clinical trials. Between March 2004 and May 2007, 594 HIV uninfected 14–30 year old women were enrolled into a longitudinal HIV risk reduction study in KwaZulu-Natal, South Africa. The overall HIV prevalence at screening in young girls below the age of 18 years was 27.6 % compared to 52.0 % in the women above 18 years, p < 0.001. HIV incidence was 4.7 [95 % Confidence interval (CI) 1.5–10.9) and 6.9 (95 % CI 4.8–9.6)/100 women years (wy), p = 0.42 and pregnancy rates were 23.7 (95 % CI 14.9–35.9) and 16.4 (95 % CI 12.9–20.6)/100 wy, p = 0.29, in the women below and above 18 years respectively. Retention was similar in both groups (71.0 vs. 71.5 %, p = 0.90). This study demonstrates that the inclusion of young girls between the ages of 14 and 17 years in longitudinal studies is feasible and their inclusion in clinical trials would maintain scientific integrity and power of the study.

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Acknowledgments

The authors sincerely acknowledge the participation of the women in the study, the site staff for the management of study participants, laboratory staff for the testing and archiving of samples and data management staff for management and quality assurance of data. A special thanks to members of the CAPRISA Community Research Support Groups at the Vulindlela and eThekwini Clinical Research Sites. Sincere thanks to Ms Cheryl Baxter for her critical review of the manuscript. CAPRISA was established as part of the Comprehensive International Program of Research on AIDS (CIPRA) and supported by the National Institute of Allergy and infectious Disease (NIAID), National Institutes of Health (NIH) and the US Department of Health and Human Services (DHHS) (grant# 1 U19 AI51794). The US President’s Emergency Plan for AIDS Relief (PEPfAR) Strategic Information grant for supporting the HIV counseling and testing programme. LIFElab, a biotechnology division of the South African Department of Science and Technology (DST) and Columbia University-Southern African Fogarty AIDS International Training and Research Programme (AITRP) funded by the Fogarty International Center, National Institutes of Health (grant# D43TW00231) for support of training for conduct of clinical trials.

Conflict of Interest

All authors declare that they have no conflict of interests.

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Authors and Affiliations

  1. Centre for the AIDS Programme of Research in South Africa (CAPRISA), Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, 2nd Floor, Private Bag 7, Congella, Durban, 4013, South Africa

    Quarraisha Abdool Karim, Ayesha B. M. Kharsany, Janet A. Frohlich, Lise Werner, Mukelisiwe Mlotshwa, Bernadette T. Madlala & Salim S. Abdool Karim

  2. Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA

    Quarraisha Abdool Karim & Salim S. Abdool Karim

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  1. Quarraisha Abdool Karim
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  2. Ayesha B. M. Kharsany
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  3. Janet A. Frohlich
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  4. Lise Werner
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  5. Mukelisiwe Mlotshwa
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  6. Bernadette T. Madlala
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  7. Salim S. Abdool Karim
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Correspondence to Ayesha B. M. Kharsany.

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Abdool Karim, Q., Kharsany, A.B.M., Frohlich, J.A. et al. HIV Incidence in Young Girls in KwaZulu-Natal, South Africa-Public Health Imperative for Their Inclusion in HIV Biomedical Intervention Trials. AIDS Behav 16, 1870–1876 (2012). https://doi.org/10.1007/s10461-012-0209-y

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