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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.
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.
This is the third post in our series, Adolescent Girls, Microbicides, and HIV Prevention Trials. Ms. Doreen Bangapi, community recruitment officer; Ms. Anna Kaale, study coordinator; and Dr. Sylvia Kaaya, local principal investigator, are with Muhimbili University of Healthand Allied Sciences (MUHAS) and work with FHI 360 on the study.
A unique aspect of the trial titled “Adolescents, Women and Microbicide Trials: Assessing the Opportunities and Challenges of Participation,” is the involvement of a youth interactive group (YIG) in various aspects of the research process. The YIG, which is composed of Tanzanian youth ages 20 to 26, was formed as a strategy for involving the community in this study. Community involvement before and throughout HIV prevention trials is essential for a successful trial. Youth are a particularly important group of stakeholders given that this study focuses on adolescent participation in trials. Thus far, YIG members have participated in a research literacy workshop and a study initiation meeting, and they have attended regular meetings where their feedback on various research issues has been solicited. For example, YIG members have provided suggestions and strategies for recruiting study participants, finding high-risk youth to participate, retaining participants in the study, and making our study clinic more youth-friendly and informative.
YIG members have been particularly helpful in the recruitment of study participants. They have helped develop and distribute brochures about the study and they have participated in peer education sessions with potential participants—explaining the study and answering their questions. In a focus group discussion, YIG members told us that challenges to recruitment included participants’ reluctance to admit sexual activity and sexual matters with adults as well as the need for parental support (and perhaps consent) for study participation. Members also said that recruitment was difficult because many youth in the Dar es Salaam area are highly mobile. One YIG member noted, “You find today a young woman is here but some few days later you find she has shifted to another place.”
YIG members felt there were numerous benefits to adolescents and young women participating in the study. Benefits included learning more about sexual health and their risk of HIV/STIs, gaining more opportunities to talk with parents and guardians about HIV and other health issues (particularly for 15-year-olds, who require parental consent to participate), knowing their HIV status, and learning more about the process of evaluating new health products such as microbicides. In addition, YIG members said that study participants might become valuable sources of sexual and reproductive health information within their own peer networks.
Regarding the benefits of their own participation in the research, one YIG participant said, “First of all, I like being part of the YIG of the study because I discover new experiences about reproductive health among girls…and second, I get to know how people know about HIV/AIDS.”
This is the second post in our series, Adolescent Girls, Microbicides, and HIV Prevention Trials. Ms. Anna Kaale, study coordinator; Ms. Doreen Bangapi, community recruitment officer; and Dr. Sylvia Kaaya, local principal investigator, are with the Muhimbili University of Health and Allied Sciences (MUHAS) and work with FHI 360 on the Adolescents, Women, and Microbicides Trial.
An essential component of the “Adolescents, Women and Microbicides” trial is creating clinical spaces where adolescents feel comfortable. The Infectious Disease Centre (IDC) in Dar es Salaam,Tanzania, offers dedicated hours for youth-friendly HIV and reproductive health services to young people ages 12 to 24. They provide voluntary HIV counseling and testing, HIV care and treatment services, prevention and treatment of other sexually transmitted infections, and counseling for prevention of unintended pregnancy. We asked two nurse counselors from this site to share their experiences providing these services and working with adolescent and young women (ages 15-21 years) who are participating in the trial.
The nurses noted the following challenges in providing youth-friendly services (YFS):
- Standalone YFS are often not well known within communities; thus, young people often do not know they exist.
- Providers face challenges in creating dedicated space and time for YFS.
- It is difficult to segregate young people and adults in the same clinical care environment. Young people often report discomfort when meeting adult patients in the clinic. They worry that their parents, guardians, or other adults they know will discover their use of SRH services.
- The clinic faces stock-outs, particularly of HIV testing kits. As a result, nurses must either refer young people to another clinic or ask them to wait until supplies become available. Young people might not have transportation to other health services and also might fail to return once HIV kits are back in stock.
- Stock-outs of drugs used in treatment of STIs were also not uncommon, and the nurses highlighted the higher impact of such stock-outs on youth compared to adults. Many young people do not have the financial resources to purchase drugs privately and may be unable to request assistance from parents or guardians due to threats to their privacy.
- Even after being counseled on risk-reduction strategies, young women often face difficulties in attempts to implement them.
- Increase advocacy about YFS and awareness within the community about the existence and location of YFS.
- Place a greater priority for YFS in the provision of clinical and drug supplies, paying special attention to the logistical challenges young people face during stock-outs.
- Create private spaces for YFS within facilities.
- Augment clinic-based health education with interventions to address broader relationship and community-level factors that affect adolescent and young women’s ability to take measures to prevent unplanned pregnancies and STIs, including HIV.
This blog is the first of a series of entries about FHI 360’s work with adolescent girls and microbicides.
Almost one-quarter of all people living with HIV are less than 25 years old, and youth (ages 15-24) account for 41% of all new HIV infections. Adolescent girls are particularly vulnerable; females comprise more than 60% of all young people living with HIV. In sub-SaharanAfrica, girls are three to five times more likely to be infected with HIV than boys of the same age. Factors such as lack of education, involvement in cross-generational or transactional sexual relationships, pressure to contribute to a family income, and early marriage all contribute to girls’ risk of becoming infected.
New female-initiated HIV prevention methods, including oral and topical microbicides, are urgently needed to address young women’s vulnerability. Unfortunately, adolescent girls are often excluded from studies that explore the effectiveness of these types of methods. There are numerous challenges to recruiting and retaining young women in HIV prevention trials. For example, adolescents might be too young to legally consent to trial participation, and their participation is often opposed by their communities.
However, there are many important scientific, programmatic and ethical reasons to include adolescents in studies on female-initiated HIV prevention methods. Without research on the effectiveness and acceptability of microbicides among adolescents, regulatory bodies are unlikely to allow microbicides to be marketed to adolescents. The failure to include younger adolescents in most microbicide trials also is resulting in missed opportunities for HIV prevention programming. And, given the high HIV incidence rates among female adolescents and the challenges they face in using other risk-reduction methods, including young women in clinical microbicide trials is also a matter of social justice.
To address these issues, FHI 360 is currently conducting a ground-breaking study, “Adolescents Women and Microbicide Trials: Assessing the Opportunities and Challenges of Participation,” in Tanzania and India among young women ages 15-21. This multiphase study is (1) exploring the differences in HIV risk among girls ages 15-17 versus those ages 18-21; (2) evaluating the factors that lead to the exclusion of adolescent girls from HIV prevention trials; and (3) aiming to determine the acceptability of microbicide use among this population. When the study is done, researchers will recommend whether or how trials on microbicides and other HIV prevention methods should be adapted to include adolescent participants. This study is one step toward increasing adolescent girls’ autonomy and decreasing their risk of HIV.