This is the fifth post in our series, Adolescent Girls, Microbicides, and HIV Prevention Trials. It was written by Ms. Doreen Bangapi, community recruitment officer. Ms Bangapi and Dr. Sylvia Kaaya, local principal investigator, are with Muhimbili University of Health & Allied Sciences (MUHAS) and work with FHI 360 on the study.
A total of 135 participants, ages 15 to 21, have been recruited and enrolled into an ongoing mock clinical trial as part of the study entitled “Adolescent Women and Microbicide Trials: Assessing the Opportunities and Challenges of Participation.” A number of strategies have been used to recruit these adolescents and young women including information sessions for potential participants organized through community and ‘girl power’ meetings, meeting with students at their schools, word-of-mouth to relatives and neighbors of the study staff, and recruitment of regular clinic clients of the Infectious Disease Centre (IDC) where the study is being conducted. Other strategies included working with FHI 360’s local Tanzanian partners through NGOs and representatives who work with adolescent girls in the community. In addition, some study participants recruited their friends, relatives and neighbors.
Locating interested participants is only the first challenge; there are also special logistical issues related to adolescent participation. For example, many potential participants lacked bus fare/transport to get to the clinic because they are financially dependent upon their parents or guardians. Others didn’t have a phone, which made it difficult to schedule clinic visits. All of this was complicated by the fact that many participants did not want to disclose their study participation to parents or guardians and therefore could not ask for their assistance.
One recruitment strategy that was helpful for some participants was group recruitment. While many participants were recruited as individuals, others were recruited as a group. Some of the groups were comprised of friends from a neighborhood, others of classmates from school, others of a mix of friends and strangers recruited through a community information session. The group dynamics of coming in with friends or school peers was particularly supportive to the recruitment process.
Another helpful recruitment strategy was providing transport for some participants for baseline visits. Local daladalas, or mini buses, were hired to bring potential participant groups to the clinic for study information sessions, including viewing a video by the International Partnership for Microbicides (IPM) about microbicides trials. For other participants, a community recruitment assistant helped transport potential participants to the clinic through public transport by paying their bus fare and accompanying them to the clinic.
Once potential participants reached the study clinic, determining study eligibility was particularly challenging. To be eligible for the study, the young women needed to be between 15 and 21 years old, HIV negative, not pregnant and not wanting to have a child within the next 6 months, sexually active in the past three months, and able to attend the clinic for scheduled appointments. While pregnancy testing was not an issue for the young women, some were not willing to get tested for HIV—especially those who came from high-risk populations, such as commercial sex workers. Age verification was the most challenging aspect for determining eligibility. Many young women do not have documents like birth certificates, voting cards, health facility cards, or school records that could verify their age. Study staff therefore had to (1) ask participants to complete an age verification form that asked a series of questions to help validate self-reported age and then (2) call a trusted adult who was familiar with the girl’s age for verification without revealing that the girl was participating in the study.
Once a participant is recruited into the study, retention is the next challenge. Our study staff are working hard to retain participants by calling them and making home visits. Other strategies include picking up participants from home and bringing them to the clinic for follow-up visits, informing them how important it is for them to attend their scheduled appointments, and explaining that the follow-up visits are shorter than the baseline visit. Some of the retention challenges include high mobility among adolescents (moving in and out of the city), loss of phone contact, and loss of peer support when a friend becomes ineligible to participate in the study at a follow-up visit (for example because she became pregnant between baseline and follow-up). In summary, recruiting and retaining adolescents in a clinical trial can be challenging, but with special effort by the study team, they can be successful participants in HIV prevention trials.