This is the sixth post in our series, “Adolescent Girls, Microbicides, and HIV Prevention Trials.” This post was written by Anna Kaale, Doreen Bangapi, and Mildred Mwanjesa, who are with Muhimbili University of Health & Allied Sciences (MUHAS) and who work with FHI 360 on the study.
As part of a study entitled “Adolescent Women and Microbicide Trials: Assessing the Opportunities and Challenges of Participation” (see blog #1), researchers sought to determine how adolescent participants would feel about, and whether they would use, a potential study microbicide product.
A total of 135 females ages 15-21 were participating in a mock clinical trial (MCT). Participants made four visits over six months: baseline, month two, month four and month six. MCT participants who made the month four visit were asked if they would be willing to participate in a smaller sub-study. Fifty-seven of the 71 eligible participants at this visit agreed, and they were asked to use a vaginal gel (over-the-counter lubricant) or take a pill (vitamin) for two months.Participants were told that they were being asked to use lubricants or vitamins, and that these were not microbicide products.Those who declined (14) completed a decliner questionnaire. Their reasons for declining included not willing to be randomized to pill or gel, being afraid of being seen by other people like parents when taking pills, being afraid of using the product because it is a new experience, fear of side effects, general dislike of taking pills and not wanting to insert any product in their vagina.
Participants were randomly assigned to the vitamin pill group (44%) or the vaginal gel group (56%).
Most participants liked the product they were given—both the pill and the vaginal gel. Reasons for liking the products included that they could use them without partner knowledge, they were easy to use, and the products did not interrupt sex. Few participants disliked the products; however, some reasons included appearance and/or smell and need to remember to use the product.
Researchers were surprised that most participants said they hoped to be randomized to the gel instead of the pill. Some participants who were randomized to the pill asked the nurse counselors if they could be switched to the gel and others wished to get the same product that their friends received. Some participants came to the study clinic to ask for more product after the sub-study had ended. For example, some asked for more gel, saying that it made sex more pleasurable; others asked for pills and said that the pills gave them more appetite and a “good feeling.” The nurses observed more participants coming in for additional gel than pills during the sub-study, and unused vitamin pills were more likely to be returned to the clinic at the end of the sub-study than unused gel. The study staff also learned that some participants were sharing the gel/pills with family members. Overall, the sub-study provided valuable information about how adolescents might feel about using a microbicide product.