Knowledge and Perceptions about Clinical Trials and the Use of Biomedical Samples: Findings from a Qualitative Study in Rural Northern Ghana.

INTRODUCTION: Clinical trials conducted in sub-Saharan Africa have helped to address the prevalent health challenges. The knowledge about how communities perceive clinical trials is however only now evolving. This study was conducted among parents whose children participated in past clinical trials in northern Ghana to assess their knowledge and perceptions of clinical trials and the use of biomedical samples. METHOD: This was a qualitative study based on eighty in-depth interviews with parents. The participants were randomly selected from among parents whose children were enrolled in a clinical trial conducted in the Kassena-Nankana districts between 2000 and 2003. The interviews were transcribed and coded into emergent themes using Nvivo 9 software. The thematic analysis framework was used to analyze the data. RESULTS: Study participants reported that clinical trials were carried out to determine the efficacy of drugs and to make sure that these drugs were suitable for human beings to use. The conduct of clinical trials was perceived to have helped to reduce the occurrence of diseases such as malaria, cerebrospinal meningitis and diarrhea. Quality of care was reported to be better in clinical trials than in the routine care. Parents indicated that participation in clinical trials positively influenced their health-seeking behavior. Apprehensions about blood draw and the use to which samples were put were expressed, with suspicion by a few participants that researchers sold blood samples. The issue of blood draw was most contentious. CONCLUSION: Parents perception about the conduct of clinical trials in the study districts is generally positive. However, misconceptions made about the use of blood samples in this study must be taken seriously and strategies found to improve transparency and greater community acceptability.

Factors influencing willingness to participate in new drug trial studies: a study among parents whose children were recruited into these trials in northern Ghana.

BACKGROUND: During the last decade, the number of clinical trials conducted in sub-Saharan Africa has increased significantly which has helped to address priority health problems in the region. Navrongo health research centre since it was established in 1989, has conducted several trial studies including rectal artesunate trial in the Kassena-Nankana districts. However, there is little evidence-based for assessing the impact of new drug trials. This study explored factors that motivate parents to allow their children to participate in new drug trials in northern Ghana. METHOD: The study used both quantitative and qualitative methods. The participants were randomly selected from among parents whose children were enrolled in a new drug trial conducted in the Kassena-Nankana districts between 2000 and 2003. QSR Nvivo 9 software was used to code the qualitative data into themes before analysis while STATA software Version 11.2© was used to analyze the quantitative data. RESULTS: The results showed that majority (95.9%) of the parents were willing to allow their children to be enrolled in future new drug trials. The main factors motivating their willingness to allow their children to be enrolled in these trials were quality of health care services offered to trial participants (92.9%), detail medical examination (90.8%), promptness of care provided (94.4%) and quality of drugs (91.9%). Other factors mentioned included disease prevention (99.5%) and improved living standard (96.1%). Parents reported that the conduct of these trials had reduced the frequency of disease occurrences in the communities because of the quality of health care services provided to the children recruited into these trial studies. CONCLUSION: Though the implementation of clinical trials in the study area is believed to have positive impact on health status of people particularly trial participants, measures should however be taken to address safety and likely side effects of new drugs given to trial participants during these trial studies.

Should consent forms used in clinical trials be translated into the local dialects? A survey among past participants in rural Ghana.

BACKGROUND: Obtaining informed consent is part of the expression of the principle of participant autonomy during clinical trials. It is critical that participants understand the content of informed consent forms and remain in a position to seek independent advice on its content. We conducted a survey among past participants of a clinical trial in the Kassena-Nankana Districts of rural northern Ghana about the usefulness of informed consent forms that are written in the local dialects. The written forms of local dialects are largely undeveloped. METHOD: We contacted a randomly selected sample of caregivers whose children were enrolled in a completed clinical trial and interviewed them using a structured questionnaire. Analysis sought to determine participants' preference and whether or not they were likely to find confidants who will be able to read, understand and give advice on the content of the informed consent form to them when they take the informed consent forms home. RESULTS: We interviewed 394 caregivers, 88.6% of whom were women. About half (54%) of the respondents wanted the informed consent forms to be in the English language. Caregivers with higher than primary level education were more likely to prefer the informed consent form to be in English than those with no formal education (74% versus 26%, p = 0.04). The majority (85%) indicated that they would be able to find close confidants who would be able to read and explain it to them if it is in English. In contrast, only 8% thought they would be able to do the same if the informed consent form was written in the local language. Respondents were more likely to find close confidants to read and explain the informed consent form if it were written in English than if it were written in the local language (94% versus 19%, p value < 0.01). CONCLUSION: The practice of translating informed consent forms into undeveloped local dialects and giving such copies to trial participants to send home needs to be re-evaluated. In populations where the written forms of local dialects are undeveloped and literacy is low, the use of local dialect versions of informed consent forms could ironically enhance the vulnerability of trial participants.

Spatial and socio-demographic determinants of contraceptive use in the Upper East region of Ghana.

BACKGROUND: This paper presents results of baseline data on the determinants of contraceptive use in 7 districts in northern Ghana where there is an ongoing integrated primary health care systems strengthening projectknown as the Ghana Essential Health Intervention Project (GEHIP). METHODS: We used a household survey data conducted within 66 randomly sampled census enumeration areas in seven rural districts of the Upper East Region of northern Ghana where health systems strengthening interventions are currently ongoing in three of the districts with four of the districts serving as comparison districts. This survey was conducted prior to the introduction of interventions. Data was collected on various indices included geographic information systems (GIS) and contraceptive use. The data was analyzed using survey design techniques that accounts for correct variance estimation. Categorical variables were summarized as proportions and associations between these variables and contraceptive use tested using Chi-square test. Uni-variable and multivariable logistic regression techniques were used to assess the effects of the selected covariates on contraceptive use. All tests were deemed to be statistically significant at 5% level statistical significance. RESULTS: Results show that contraceptive use is generally low (about 13 per cent) and use is nearly evenly for spacing and stopping purposes. Factors associated with the use of contraceptives include exposure to integrated primary healthcare services, the level of education, and socioeconomic status, couple fertility preference, marital status, and parity. For instance, the odds of contraceptive use among 15-45 year old women who live 2 km or more from a CHPS compound is 0.74 compared to women who live less than 2 km from a CHPS compound (p-value = 0.035). CONCLUSION: The findings suggest that rapid scale up of the Community based Health Planning and Services (CHPS) program accompanied with improved door-to-door health services would kindle uptake of modern contraceptive use, reduce unwanted pregnancies and hasten the attainment of MDG 4 & 5 in Ghana.