This is the fourth post in our series, Adolescent Girls, Microbicides, and HIV Prevention Trials.
A primary objective of the study titled “Adolescents Women and Microbicide Trials: Assessing the Opportunities and Challenges of Participation” is to determine how well-suited adolescents ages 15-17 are for participating in future HIV prevention trials. Usually HIV prevention trials, including microbicide studies, enroll participants ages 18 and older. As part of our mock clinical trial (MCT), we asked the young women who completed the study about their experiences as study participants during their last visit.
Thus far, 135 adolescents and young women (ages 15-21) have enrolled in the MCT, and 23 participants have completed 6 months of participation. Among participants who completed the mock trial, the vast majority felt very positive about their study experience, none felt stigmatized because of their participation, and two-thirds had told someone else that they were part of this study.
We asked the participants what they liked about participating in the study. Responses included, “I learned a lot of things, especially about how to protect myself from HIV and pregnancy,” “They educate, they counsel and they do not favor or discriminate against anyone,” and “I was very happy because I got a chance to know my health status.” A number of participants felt that regular HIV, STI, and pregnancy testing was a benefit, although a couple said they did not like the pelvic exams which were required for STI testing.
However, among the 135 enrolled participants, about 68% experienced challenges to their continued participation. Twenty participants (15%) attended the baseline visit but no other visits, and another 72 (53%) missed at least one visit. Our research team followed up with participants who had either purposefully dropped out of the study or who had not returned for their follow-up study visits. We wanted to learn why they dropped out and to understand any difficulties they experienced remaining in the study.
With community-based follow-up, our team discovered that a number of participants had either moved away or they were in school or working during the week, which made it difficult for them to come to the clinic for their study visits. Others were afraid to continue participating because of misconceptions about the research study. For example, one participant acknowledged that she understood follow-up visits were important for the study goals but she stated, “for me it is not important because I thought you wanted to remove my uterus.” The experience of a first-time pelvic exam was scary for some girls and it highlights that adolescents need counseling both before and after the exam to ensure they understand how STI testing works. Other girls were reluctant to continue with the study because, for example, they did not like answering so many personal questions, but were afraid to tell the study team that they wanted to drop out. Interviewer: “If you were to tell us that you did not want to come to another clinic visit, what did you think would happen?” Participant: “I didn’t think anything would happen but I was scared and I decided to keep quiet—I thought you would look down on me.” This quote illustrates that girls are keenly aware of the potential of disappointing a researcher or of being judged. Therefore, careful attention should be paid to reassuring adolescents that their participation is voluntary and all information that they share with researchers, including reasons for dropping out of a study, makes a valuable contribution to the study.