Social Mobilisation, Consent and Acceptability: A Review of Human Papillomavirus Vaccination Procedures in Low and Middle-Income Countries

Effective communication in the form of social mobilisation during new vaccine introductions is a strategy used to encourage acceptance, uptake, and adherence to multi-dose schedules of human papillomavirus (HPV) vaccine. HPV vaccine is typically delivered to adolescent girls aged between 9 and 13 years (or older, if catch-up campaigns are conducted). Providing vaccination to this age group raises questions around informed consent, including how parental consent should be sought prior to vaccination. This study synthesised experiences and lessons learnt around social mobilisation, consent, and acceptability during 55 HPV vaccine demonstration projects and 8 national programmes in 37 low and middle-income countries (LMICs) between January 2007 and January 2015.

To introduce a new vaccine successfully, early and active engagement of policymakers, practitioners, and communities is necessary. Social mobilisation is promoted by the United Nations Children's Fund (UNICEF) and the World Health Organization (WHO) as a communication process that engages and motivates a wide range of partners at all levels to raise awareness of, and demand for, a particular objective. Social mobilisation is intended to increase HPV vaccination acceptability among girls, parents, and respected influencers. Acceptability, the tacit recognition that HPV vaccination is worthwhile, is considered crucial for high vaccination coverage and effectiveness. Research indicates that mobilisation activities that focus on creating awareness, providing accurate information, building acceptability, and sustaining demand for HPV vaccination are most effective in countering the rumours and misinformation that have negatively influenced some HPV vaccination programmes.

The study design included: (i) a systematic review, in which 1,301 abstracts from 5 databases were screened and 41 publications included; (ii) solicitation of 124 unpublished documents from governments and partner institutions; and (iii) 27 key informant interviews. Data covering 72 HPV vaccine delivery experiences in 37 LMICs were extracted and analysed thematically. In addition, first-dose coverage rates were categorised as above 90%, 90–70 %, and below 70% and cross-tabulated with mobilisation timing, message content, materials and methods of delivery, and consent procedures.

Social mobilisation data were available from 65% of delivery experiences covering 30 LMICs. Sources reported social mobilisation was essential for high HPV vaccine acceptability and coverage, though few experiences formally evaluated different mobilisation strategies. While few experiences reported on timing and duration of mobilisation activities, early initiation and increasing intensity appeared most effective. The majority of messages were framed around the "anti-cancer" benefits of vaccination rather than prevention of a sexually transmitted infection (STI). Various approaches and materials were used to reach intended audiences (usually parents or girls). When reported in the studies, communication approaches were categorised as interactive (e.g., one-to-one or group meetings at schools or health facilities, home visits by health-workers) or non-interactive (e.g., leaflets, posters, loud-speaker, radio, or television announcements). Over half of experiences using interactive approaches (17/26) achieved high first-dose coverage (over 90%) compared to (1/6) 17% for those using only non-interactive approaches (see Table 1). For example, parents in one experience who reported they had attended a teacher-parent meeting about vaccination were more likely to have a vaccinated daughter compared to parents who did not report attending meetings. While interactive approaches were reportedly more successful than non-interactive in influencing HPV vaccination uptake, most experiences (73%) used a combination of communication approaches.

Experiences generally attempted to prevent rumours and institutional refusals (e.g., refusal by schools or religious groups) by conducting intensive and repeated sensitisation activities (see Table 2). Once rumours arose, credible influencers were often mobilised to counteract misinformation with targeted messages to specific communities. Government endorsement was also reported as useful in mitigating rumours and increasing vaccine acceptability if uptake was low - e.g., some experiences distributed government or WHO letters of vaccine endorsement to allay parental concerns. Delays in addressing rumours, especially those around severe side effects or that the demonstration project was actually a clinical trial, resulted in vaccine delivery being delayed in one country and stopping prematurely in 2 countries, including India. A prompt response was critical for success.

In total, 50/72 (69%) delivery experiences reported consent procedures, 32 (64%) of which also reported first-dose HPV coverage. Of these, 18/32 (56%) used opt-in written parental consent, 11/32 (34%) used opt-out implied consent, and 3 (9%) changed from written to implied consent during implementation. Opt-in written consent was defined as parents or guardians actively giving permission for daughters to be vaccinated by returning a signed consent form. In addition to signing a consent form, some experiences required parents/guardians to accompany daughters to vaccination venues. Delivery experiences using opt-out consent were more likely to report higher coverage than those using opt-in consent.

Acceptability data were available from 62% of experiences. HPV vaccination was generally well accepted among individuals and communities in LMICs. However, vaccination refusal by private schools, religious groups, and doubt in some health professionals due to lack of information was reported in 15 countries. In 5 experiences, some school principals or teachers would not allow vaccinators into their schools due to fear of parent reactions, religious beliefs, or rumours. In 2 experiences, the school administration thought they would be held responsible for any severe adverse effects.

Implications and conclusions include:

• To allow sufficient time to address concerns and misconceptions, social mobilisation should be initiated as soon as possible (WHO recommends 3 months prior to starting HPV vaccination) and conducted systematically.
• Simple, clear messages that build interactively on existing knowledge of cancer risks appear to be more effective than either complex or non-interactive approaches.
• • Acceptability was most affected by rumours and misinformation. Rumours were remarkably similar in content across geographical regions and were largely focused on fears the vaccine caused sterility. This suggests messages could be tailored from the outset to address concerns about experimental vaccines and effects on fertility, to pre-empt concerns.
• Mobilising credible influencers, who are trusted by the community, as well as national figureheads and/or celebrities, can increase public confidence and therefore vaccination coverage.
• Particular mobilisation efforts should focus on out-of-school girls and non-government (private) or faith-based schools, where refusals were highest, particularly in countries where the primary delivery strategy for HPV vaccine is school-based.
• Consent procedures should be considered carefully to balance informed consent with public health benefits. Developing a school health programme consent sheet that is signed at school enrolment may be the most efficient option for school-based HPV vaccination. Where opt-in written parental consent is used, particularly if this differs from routine vaccination, reasons should be explained clearly and procedures kept straightforward.