Regulation of community advisory boards during conduct of clinical trials in Uganda: a qualitative study involving stakeholders.

BACKGROUND: Community advisory structures such as Community Advisory Boards (CABs) play an important role of helping researchers to better understand the community at each phase of the clinical trial. CABs can be a source of accurate information on the community, its perception of proposed research and may identify factors that make community members vulnerable to the problem under investigation. Although CABs help to build mutually beneficial relationships between the researcher(s) and the communities in which the clinical trial is being implemented, effective engagement would require ethical guidance and regulatory oversight. The study assessed the stakeholders' perspectives regarding the regulatory oversight of CABs in Uganda. METHODS: This was an exploratory study employing qualitative methods of data collection and analysis. Key informant interviews (KIIs) with the trial investigators, CAB chairpersons, community liaison officers, regulators and Research Ethics Committee (REC) chairpersons were conducted. A KII guide was designed and utilized during key informant interviews. The guide included questions on role of investigators and CAB members in clinical trials; challenges of community engagement; facilitation of CABs; regulatory oversight of CABs; work relationships between investigators and CABs; and opinions on how community trials should be conducted among others. All interviews were conducted in English. Qualitative data were transcribed verbatim. A code book was generated based on the transcripts and study objectives. Thematic analysis was used to analyze data and identify themes. Atlas ti was used to support data analysis. RESULTS: Of the 34 respondents, 35.3% were investigators, 32.3% CAB chairpersons, 23.5% research regulators/REC Chairs and 8.8% community liaison officers. The findings of the study revealed that CABs are appointed by the research institution/researcher, operate under the guidance of the researcher with limited independence. Additionally, the CABs provide voluntary service and lack guidelines or regulatory oversight. Four themes emerged. CONCLUSION: The operations and activities of CABs are not regulated by the national regulators or RECs. The regulatory oversight of CABs should be based on contextualized ethical guidelines. Need for additional training in research ethics, community engagement and sensitization on available ethics guidelines for research.

Capacity of community advisory boards for effective engagement in clinical research: a mixed methods study.

BACKGROUND: Community engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda. METHODS: We conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis. RESULTS: Seventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24-70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity. CONCLUSION: Though CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants.

Effect of universal test and treat on retention and mortality among people living with HIV-infection in Uganda: An interrupted time series analysis.

BACKGROUND: Few studies have analysed the effect of HIV universal test and treat (UTT) on retention and mortality among people living with HIV (PLHIV) in routine care. We examined six-month retention and mortality at 11 health facilities (HFs) run by a large NGO, The AIDS Support Organisation (TASO), before and after UTT. METHODS: We used a quasi-experimental study using patient data extracted from 11 TASO HFs. Two periods, one before UTT (2015-2016) and the other during UTT (2017-2018) were compared. The primary outcome was six-month retention defined as the proportion of PLHIV who were alive and in care at six months from enrolment. The secondary outcome was six-month mortality defined as the proportion of PLHIV who died within six months from enrolment. We performed an interrupted time series analysis using graphical aids to study trends in six-month retention and mortality and a segmented regression to evaluate the effect of UTT. We used a generalized linear mixed model (GLMM) and generalized estimating equations (GEE) to account for facility-level clustering. RESULTS: Of the 20,171 PLHIV registered between 2015 and 2018 and included in the analysis, 12,757 (63.2%) were enrolled during the UTT period. 5256/7414 (70.9%) of the pre-UTT period compared to 12239/12757 (95.9%) of the UTT were initiated on ART treatment with 6 months from enrolment. The median time from enrolment to initiating ART was 14 (interquartile range (IQR): 0-31) days for the pre-UTT compared to 0 (IQR: 0-0) days for the UTT period. The median age at enrolment was 32.5 years for the pre-UTT and 35.0 years for the UTT period. Overall, the six-month retention just after scale-up of UTT, increased by 9.2 percentage points (p = 0.002) from the baseline value of 82.6% (95% CI: 77.6%-87.5%) but it eventually decreased at a rate 1.0 percentage point (p = 0.014) for cohorts recruited each month after UTT. The baseline six-month mortality was 3.3% (95% CI: 2.4%-4.2%) and this decreased by 1.6 percentage points (p = 0.003) immediately after UTT. The six-month mortality continued decreasing at a rate of 0.1 percentage points (p = 0.002) for cohorts enrolled each month after UTT. Retention differed between some health facilities with Rukungiri HF having the highest and Soroti the lowest retention. Retention was slightly higher among males and younger people. Mortality was highest among people aged 50 years and more. The effect of UTT on retention and mortality was similar across sex and age groups. CONCLUSION: Overall, UTT significantly led to an immediate increase in retention and decrease in mortality among PLHIV enrolled in HIV care from 11 HFs run by TASO in Uganda. However, retention (and mortality) significantly decreased for cohorts enrolled each month after UTT. Retention was highest in Rukungiri and lowest in Soroti HFs and slightly higher in males and younger people. Mortality was highest in older patients and lowest in adolescents. We recommend for innovative interventions to improve the overall retention particularly in facilities reporting low retention in order to achieve the UNAIDS 2030 target of 95-95-95.