Introduction

The lives of young people worldwide, and in particular young women, are strongly affected by HIV by 2013. Because stigma and discrimination remain rife in many parts of the world, this continues to deter those most at risk from seeking essential HIV services [1]. Although prevalence of HIV among young people of sub-Saharan Africa fell by 42% between 2001 and 2014, the prevalence among women remains two times as high as among men because of emerged disturbing signs of increases in sexual risk behaviors, gender inequalities and harmful gender norms [1]. By the end of 2012, HIV prevalence in East Africa was approximately 1% and 2% for males and females aged 15–24 years old, respectively [1]. The overall prevalence of HIV in Tanzania is estimated to be 5%, while corresponding values for women and men 15–24 years old are estimated to be 3% and 1% respectively [2].

The wide array of efforts to prevent HIV that have proven effective nonetheless have certain limitations. To date have these efforts focused overwhelmingly on reducing individual risk, with fewer attempts to address for example, socio-cultural, economic, political, legal and other contextual factors that influence vulnerability to HIV [3]. Furthermore, in Tanzania, efforts to prevent HIV are impeded by stigma, risky sexual behavior, gender inequality, and discrimination [4].

In its effort to curb the spread of this disease, the Joint United Nations Programme on HIV/AIDS (UNAIDS) proposed the Investment Framework Enhanced (IFE) in 2013. This framework described projections that scaling up existing prevention, treatment, and care programs in low and middle-income countries, in combination with new approaches, including a vaccine, could reduce new infections most effectively. Accordingly, vaccination can play a critical role in eliminating HIV in a sustainable manner [5] and development of an effective, socially acceptable and affordable vaccine is needed.

Development of such a vaccine presents a major scientific challenge since HIV mutates very rapidly, allowing the virus to escape the body’ s immune responses while giving rise to numerous clades that circulate around the globe [5]. Nonetheless, a number of trials of HIV vaccines in different phases have been and are being carried out around the globe. Phases I and II focus on the vaccine’s safety and ability to elicit an immune response, while phase III evaluates protection from HIV infection [6]. The database of clinical trials of HIV vaccines maintained by the International AIDS Vaccine Initiatives shows that 222 participants have completed phase I trials, 44 phase II trials and 1 a phase III trial [7].

Tanzania has been conducting phase I and II trials of this nature since 2007. From 2010 to 2012, a phase IIa randomized clinical trial recruited 120 healthy, low risk HIV negative participants from two centers in Tanzania, Dar es Salaam and Mbeya. In Dar es Salaam these participants were police officers and prison guards, as well as young people from a youth friendly clinic, and in Mbeya the general population [8].

It is vital to enroll young people in HIV vaccination trials since their risk of contracting HIV is higher due to their perception of lower risk, low condom usage and multiple sexual partners [2]. Social Cognitive Theory explains that if an individual believes that he/she can solve a problem instrumentally; he/she becomes more inclined to do so and feels more committed to this decision [9]. This has been demonstrated in numerous studies exploring willingness to participate in biomedical HIV interventions such as vaccine trials, where people who felt compelled to take positive action to control the spread of HIV have expressed a moderate to high willingness to participate [10, 11].

In addition, an investigation among African- Americans in United States revealed that of individual and network factors that influence participation in HIV vaccine trials, social activism exerts a significant impact [12]. The respondents felt inclusion and purpose when involved in community-organized research, making them more likely to participate in future HIV vaccine interventions, promote related research in their communities, and mobilize others to the cause [12]. Similarly, in Tanzania parents, teachers and other community members were highly acceptable of vaccinating young girls against Human Papilloma Virus (HPV) with considerable support for a girl’s right to be vaccinated, as long as information was provided to the parents and communities [13].

Despite their moderate to high-level willingness to participate and higher risk of contracting HIV, young people might hesitate to participate in trials of HIV vaccines due to community attitudes. For example, in the Dominican Republic individuals considered to be at low risk of HIV infection feared that since the vaccine could be perceived as a cure for those already infected and that they would therefore be labeled ‘HIV positive’ [14]. They recommended that social support and counseling be employed to counteract potential negative social reactions [14]. Other barriers to participation involve concerns about possible influence on intimate relationships, negative experiences with health care providers, and concerns about confidentiality [15]. Thus, clear and appropriate information to community members would be one way to enhance participation in vaccine trials.

In connection with clinical trials, it is an ethical requirement that each participant agree to participate autonomously [6]; but this may not actually be possible in many low-income countries, where important decisions are taken by the family and/or community [16]. As such, it can be expected that Tanzanian youth would be influenced by their families when deciding whether or not to participate in a HIV vaccine trial, and, indeed 86.4% of young people in one study reported that they had someone close enough to influence such a decision on their part [17].

In light of the important contribution of community members to the recruitment and retention of volunteers in previous interventions designed to prevent HIV, too little is presently known about the views of community members in Tanzania and elsewhere on such participation by young people. Accordingly, the present investigation was designed to close this gap in our knowledge.

Methods

Data collection and analysis

Data were collected in the form of focus group discussions (FGD) conducted between February and April 2013 to capture beliefs and other cultural factors that influence the feelings, attitudes, and behavior of individuals. FGDs can illuminate differences in the perspectives of different groups of individuals [19]. At the beginning of the FGDs, we asked for and received permission from the participants to record the discussions and in addition, both EAMT and TM took notes, which were used to pose follow up questions and incorporated into the transcripts.

In total seven FGDs were conducted, three with women and four with men, with 5–8 participants, each lasting 30–67 minutes. The FGD guide written in English and then translated into Kiswahili included socio-demographic information and three leading questions: 1. What impedes young people from participating in clinical trial? 2. How would you support such participation? and 3. What other facilitating factors might promote participation? The first author, (TM) and the second author, (EAMT) moderated sessions. We stopped after the seventh group discussion, when the lack of any new information, indicated that we had reached saturation [20].

A research assistant transcribed all of the FGD recordings verbatim. The first author, who is fluent in both English and Kiswahili, then translated these transcripts into English, reading all of them several times to make sure that she understood what the participants had said and, also listening to the audiotapes to make sure that all of the discussions were included in the transcripts. Employing content analysis [21], the results were expressed primarily as manifest and latent content. The views of community members deduced from sentences were incorporated into meaning units, which were then coded and abstracted, with the different codes written into the transcripts using different colors. The first (TM), and last authors, (AK), sorted the codes manually into categories, which were constructed, discussed, reassessed, and reviewed by TM, EAMT and AK, until agreement on three final themes was reached. Please see Table 1 for an example of this analytical process.

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Table 1. An example of our qualitative content analysis.

https://doi.org/10.1371/journal.pone.0168660.t001

Results

Twenty six (59%) men and 18 (41%) women with a mean age of 27.4 years (range 18–47 years) participated. Seventeen (39%) had primary school and 27 (61%) had secondary school or higher education. Thirty eight (86%) participants were single (36 never married and 2 widowed) and 6 (14%) married. They included students, repairmen, social workers, and small business owners as well as some reporting no occupation at the time of the study. Three themes that emerged and relevant categories are presented below.

Discussion

This study highlights the important role of community members in decision-making concerning participation in HIV vaccine trials by Tanzanian youth who are, and sheds light on factors that may impede or facilitate such participation by young people in Dar es Salaam. Community members appear to provide key support to most Tanzanian youth at or above the legal age of adulthood. This study finding demonstrates that preventive biomedical interventions require support from, acceptance by, and collaboration with community since potential young participants in HIV interventions depend on members of their community for social, moral and sometimes even economic support. In agreement, another study conducted by one of the authors here revealed 84.6% of young participants had someone significant who influenced their decisions on important social and medical matters [17].

Furthermore, these current findings reflect accepted norms and traditions that urge young people to listen to and follow the advice given by members of their community, especially elderly members, concerning important decisions in life in Tanzanian setting. For instance, Nigerian women seek permission from their spouses before consenting to participate in research [16]. In addition, women, as mothers and as partners, are likely to exert considerable influence on the acceptability of male circumcision as an intervention to control the spread of HIV in many African settings, and any such effort would be more successful if it appeals to both women and men [22]. Therefore, when designing a HIV vaccine trial involving young people the views of community members should be considered in order to integrate this intervention into the complex local pre-existing customs, norms, beliefs and practices. This will, in turn, improve recruitment and retention [23], as well as reduce discrimination and disharmony in the family and/or community.

In addition, we identified a desire among community members to encourage young people in Tanzania to play an important part in development of an effective HIV vaccine. Such participation in vaccine trials is novel in Tanzania and our participants expressed a sense of collective responsibility for the welfare of any young person, stating that they would offer moral support to face fears, stigma and uncertainties during trial procedures. This shows commitment and communal duty of community members to safeguard good health of youth.This finding supports the beliefs that any program’s success depends as much on the wider community context into which it is implemented as on the technical details [24]. Similarly, in Atlanta, Georgia, USA; community-level support and medical and treatment programs promoted participation in HIV vaccine research [25].

The importance of accurately explaining the content of a trial vaccine is another important outcome here. Most of the participants’ misconceptions on trial procedures and content of vaccine were unfounded. It is an ethical obligation for clinical trial teams to ensure the trial volunteers are counseled to practice safer sex behaviors. Counseling reinforces the need to avoid both sexually transmitted infections, including HIV, and pregnancy. In most trials volunteers receive condoms as part of risk-reduction counseling [6]. Our study participants’ beliefs that the vaccine could cause side effects seem to have contributed to their fear and hesitancy about encouraging young people to participate in the trials, beliefs that may, at least in part, be due to a lack of appropriate information. Identical findings have been made in South India, whereby frontline providers of health services showed a lack of knowledge concerning clinical trials. There, the participants expressed concerns that an HIV vaccine might promote unprotected sexual practices as well as sexual activity in general. Others feared losing the trust of community in the event of harmful side effects [26].

Clearly, it is important to provide appropriate information, not only to potential trial participants make a decision also to allow community members to weigh the advantages and disadvantages of trial participation when advising young people on this matter.

Our present results are in agreement with previous studies on the influence of misunderstandings on participation in HIV vaccine trial. Our participants felt that young people might shy away from volunteering in the vaccine trials due to misinformation, such as that the vaccine could lead to infertility, encourage participants to have unprotected sexual intercourse with HIV infected individuals or, even worse, infect them with HIV. Our participants were echoing misconceptions by young people, but also airing their own suspicions surrounding HIV vaccine research in general. Parents in South Africa were reported to misunderstand the potential for harm from a HIV vaccine, microbicides, and a pre-exposure prophylaxis trial, as a result refusing to let their children participate [27]. In addition, community members influence retention negatively, even when informed consent has been obtained. For example, in Tanzania, police officers declined to participate in a HIV vaccination trial because a significant number of others mistrusted the vaccine [28].

Unfortunately, such misconceptions exert a detrimental impact not only on trial participation, but also on the acceptability and usage of newly licensed vaccines. Thus there was hesitancy to use influenza vaccines in America due to unfounded fears regarding transmissibility, safety, and efficacy [29]. Similarly, a meta- analysis of attitudes about and usage of the human papilloma virus (HPV) vaccine revealed that most fears were based on myth rather than reality. These vaccines are safe and do not increase sexual activity among young people, despite the beliefs of some Americans to the contrary [30].

Finally, our results indicate that common structural problems such as poverty and substance abuse constitute barriers to recruitment to and retention in HIV vaccination trials. Young people living in poverty without opportunity are easy targets for the global drug trade [31]. Moreover, drug use is linked to instability, violence, difficulties working, work overload, neglect and abuse [32], making it difficult for such youth to be recruited and retained in HIV vaccine trials.

Stigma was cited as another barrier keeping youth from participating in HIV vaccine trials. Our participants felt that young people are afraid of being discriminated against, rejected, and/or seen as promiscuous if they do participate in such trials. In South Africa respondents thought that this stigma originates in the association between HIV and sex [32 33]. Such stigma may continue even after termination of an HIV vaccine trial if adequate information concerning post vaccination effects such as vaccine induced sero-positivity (VISP) is not provided appropriately to members of community. VISP can lead to disruption of personal relationships; difficulties in finding or keeping employment; difficulties in obtaining insurance; impediments to travel; the inability to enlist into the military; the inability to donate blood, sperm, and organs; and inappropriate medical treatment [34]. Altogether, the challenge present by this study involves providing useful, practical and culturally sensitive information about participation in HIV vaccine trials designed to alleviate fears, worries and hesitancy among members of community.

Acknowledgments

The authors would like to express their gratitude to all of the participants for their time and cooperation. We thank Beatrice Kikwelele and Shida Mpangala (nurse counselors) for the time they devoted to data collection. We are grateful to the IDC administration and City council for allowing us to conduct this study.