Mtshweni, Matshediso, Maria Manuela Williams, and Khatija Ahmed. "Challenges encountered in recruiting 16- and 17-year-old sexually active females to participate in the Carraguard^TM Phase 3 clinical trial in Soshanguve, Pretoria."

Abstract

BACKGROUND: The Carraguard^TM Phase 3 vaginal microbicide clinical trial is currently underway at three sites in South Africa, including the Setšhaba Research Centre. Statistics from Human Science Research Council for 2005 state that the prevalence of HIV in the 15–34-year-old group is 20%. The Medical Control Council and the ethics committee at the University of Limpopo approved the recruitment of 16–17-year-old girls without parental consent as per their risk. Further, the Children’s Bill was passed in June 2005 (http://web.uct.ac.za). Recruiting 16–17-year-old sexually active girls into the Phase 3 Carraguard trial is challenging from the community, social, and religious perspectives as it may be viewed as promoting sexual promiscuity. However, recruitment of women in this age group is essential as they are at high risk of acquiring HIV.

METHOD: Areas were identified that are frequented by 16- and 17-year-olds for information sessions. Potential participants are invited to the research center for additional educational sessions if they are already sexually active and interested in participating in the trial.

RESULTS: Six areas were identified where information sessions could be given to the potential participants of this age group. These included two high schools, shopping malls and youth centers where information sessions were given. Information was given during the “Life Skills” classes at two high schools on general women’s health, sex education, and STIs. Girls were encouraged to stay abstinent if they were not already active. Those interested in the study came to the site for a recruitment session and video viewing but despite these sessions from March 2004 to November 2005 only 172 girls 16–17 years old were screened into the study. This is only 5% of the total amount of women screened so far.

CONCLUSION: Recruiting adolescents within this age group is difficult. Despite the clear evidence of sexual activity in young females as a vulnerable group, participation in clinical trials proves to be difficult, probably due to various social and religious factors. There is a need for the education and empowerment of young girls with regard to their sexual health.

Track B & C: Adherence to Trial Procedures and Product Use
Monday, 24 April 2006, 1:30–3:00 pm

Microbicides 2006

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This page updated 3 April 2006

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