Review question/objective

The objective of this review is to synthesize the best available evidence on perceptions, beliefs and management of blood draw for clinical trials conducted in Africa.

The specific review questions are:

1. What are the perceptions and beliefs of community members about blood draw for clinical trials that are conducted in Africa?

2. How do researchers view perceptions and beliefs of community members concerning blood draw for clinical trials conducted in Africa?

3. What are the experiences of researchers in managing perceptions and beliefs of community members about blood draw for clinical trials that are conducted in Africa?

Background

Several clinical trials that involve blood draw have been conducted in Africa. Blood draw, means taking blood samples from trial participants for the purpose of any clinical trial. However, there are often challenges associated with blood draw in the conduct of clinical trials.1,2,3 Among them are high attrition rates of study participants and refusal of community members to give consent to clinical trials that involve blood draw.1,3,4

Some of the dominant factors behind high attrition (losses to follow-up) rates and refusal to participate in clinical trials in Africa are the perceptions (the way in which something is regarded, understood or interpreted) and the beliefs (an acceptance that something exists or is true, especially one without proof) of members in the community (including study participants) where the trials are conducted.3,4

A clinical trial conducted by Nchito et al. in 2004 in Zambia among school children suffered a huge loss to follow-up which was attributed partly to fear from a rumor in the country that there were blood thefts by satanists.4 The rumor was reinforced by a belief in Zambia that there is a cult who drink human blood, a practice which was regarded as part of their rituals.4 Newton et al. also carried out a clinical trial in Ghana where perceptions from the community about blood draw led to a substantial loss to follow-up.3 As part of the procedures of the study, about 1ml of blood was drawn from infants, and this led to a rumor in the community that the blood collected was sold abroad for transfusion into the aged.4

It is important for researchers to adopt strategies to reduce high losses to follow-up since it has serious implications for clinical trials.3,5 For example, in the Newton et al. trial, the trial had to be extended by four months as a result of huge losses to follow-up. The extension had a cost implication on the study since staff had to be maintained for a longer period. Despite the cost implications of that trial, the researchers adopted a strategy to forestall further huge losses to follow-up, i.e. encouraging mothers of infants to observe the blood collection procedure. In addition, the researchers visited the mothers of the trial infants at home to address their concerns in the presence of their husbands or any other influential person.3

Some of the huge losses to follow-up and refusals are not only due to blood draw but can also be attributed to other factors such as the challenges associated with the informed consent process.6 Many patients refuse to take part because they believe that the trials would put an extra burden on them.6 The refusal by others is also influenced by religious beliefs.6 Many study participants also withdraw at a later stage of the trial because they do not fully understand the informed consent process before appending their signature to participate.6The focus of this review is however solely on perceptions and beliefs about blood draw issues in clinical trials and strategies adopted to manage them.

This topic has become important because a number of studies (i.e. not only clinical trials involving blood draw)and intervention programs were disrupted by rumors entrenched in the beliefs and perceptions of community members.7,8,9 Clinical trials involving blood draw are no exceptions since the decision of study participants and potential study participants to be involved in a clinical trial is often influenced by their perceptions and beliefs.3,4 Researchers often adopt strategies to manage this misconception.3,10 Synthesizing evidence used by researchers to manage issues of blood draw in clinical studies would be useful information for researchers who intend to carryout clinical trials involving blood draw in the future.

A number of primary studies have reported on perceptions, beliefs and management issues associated with clinical trials involving blood draw. However, a preliminary search of Cochrane Library, Campbell Collaboration Library, PubMed and JBI Database of Systematic Reviews and Implementation Reports (JBISRIR) showed that no systematic review on this topic has been conducted. It is anticipated that the evidence generated from this review may inform the approach used by researchers to conduct clinical trials that involve blood draw in Africa

Inclusion criteria

Types of participants

The review will consider studies that report on community members (any member in the community including study participants aged at least five years) and researchers ( any team member of the clinical trial team such as field staff, clinicians, epidemiologists, etc.) involved in blood draws for clinical trials in Africa.

Phenomena of interest

The review will focus on studies that investigate perceptions and beliefs of community members about blood draw for clinical trials in Africa. It will also consider studies that focus on researchers' views on community perceptions and beliefs about blood draw for clinical trials. The review will finally consider studies that focus on experiences of researchers in managing such community perceptions and beliefs during clinical trials in Africa.

Context

The review will consider qualitative studies carried out in African countries, specifically within communities where clinical trials involving blood draws have been conducted.

Types of studies

The review will consider studies that are based on qualitative study designs, including but not limited to phenomenology, grounded theory, ethnography, action research and feminist research.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English language will be considered for inclusion in this review. Studies published from 1980 to 2014 (preliminary searches showed that none of the blood draw issues of clinical trials were published before 1980) will be considered for inclusion in this review.

The databases to be searched include:

PubMed

CINAHL

PsycInfo

PSYCNET

PsycARTICLES

Social Science Citation Index

Social Science abstracts

Sociological abstracts

SCOPUS

Studies identified from reference lists of selected reports and articles will be searched by employing:

Google

The search for unpublished studies will include:

MedNar

ProQuest Dissertations and Theses

Google scholar

Hand searches will be done using:

Social Science and Medicine

Initial keywords to be used will be:

Blood draw, trial, study and Africa (i.e. (blood draw [tw]) and (trial [tw] OR study [tw]) and Africa)

Assessment of methodological quality

Studies that appear to meet the inclusion criteria will be assessed for methodological validity by two independent reviewers prior to inclusion in the review using the standardized critical appraisal tools from the Joanna Briggs Institute's Qualitative Assessment and Review Instrument (JBI-QARI) (Appendix I) Any disagreements that arise between the reviewers will be resolved through discussion by the two reviewers.

Data extraction

Qualitative data will be extracted from papers included in the review using the standardized data extraction tools from JBI-QARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. In order to minimize errors, data will be extracted independently by the two reviewers before conferring. Reviewers will contact authors of primary studies for clarification when there are unclear results or missing information.

Data synthesis

Qualitative research findings will, where possible be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality, and categorizing these findings on the basis of similarity in meaning. These categories are then subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in narrative form.

Conflicts of interest

No potential conflict of interest

References