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The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial
Lawrence Mbuagbaw, Lehana Thabane, Pierre Ongolo-Zogo, Trudie Lang
Trials , 2011, DOI: 10.1186/1745-6215-12-145
Abstract: Randomized clinical trials are the cornerstone of evidence-based decision making and are considered the 'Gold Standard' for clinical research. In recent years a huge scientific revolution towards evidence-informed health care decision-making has boosted the clinical trial industry [1]. The recognition of systematic reviews (which mostly use randomized trials as units of analysis) as important tools in health care decision making has also given a silent nod towards the growth of the industry. The Cochrane collaboration is one of the largest producers of systematic reviews [2].Even though the clinical trial industry is growing, a simple search by location on the clinical trials website, clinicaltrials.gov [3] will reveal 24 trials in Cameroon as opposed to 7662 in Canada or 50896 in the United States of America (USA). On the World Health Organization (WHO) International Clinical Trials registry Platform (ICTRP), the numbers are similar [4]. These differences reflect the differences in experience in all the parties involved; regulatory bodies, researchers and participants. Additional differences arise from culture, health infrastructure and socioeconomic divides [5]. In low-resource settings, structures such as the Data Safety and Monitoring Board (DSMB), Community Advisory Boards (CAB), Regulatory Authorities (RA) and Institutional Review Boards (IRB) that play key roles in monitoring and approval of trials may be non-existent, non- functional or lack the skills to critically appraise a research protocol. In Cameroon the National Ethics Committee (NEC) plays all these roles. In consequence, trial capacity is lacking, and research centres in low resource settings are unable to lead large scale independent research projects [6].For the purposes of accrued external validity, low costs, faster recruitment and in some cases, reduced set-up times, commercial clinical trials are increasingly being conducted in middle income countries like China and India [5]. It is estimated
Trends and determining factors associated with adherence to antiretroviral therapy (ART) in Cameroon: a systematic review and analysis of the CAMPS trial
Mbuagbaw Lawrence,Thabane Lehana,Ongolo-Zogo Pierre,Yondo David
AIDS Research and Therapy , 2012, DOI: 10.1186/1742-6405-9-37
Abstract: Background The benefits of antiretroviral therapy (ART) cannot be experienced if they are not taken as prescribed. Yet, not all causes of non-adherence are dependent on the patient. Having to pay for medication reduces adherence rates. Non- adherence has severe public health implications which must be addressed locally and globally. This paper seeks to describe the trends in adherence rates reported in Cameroon and to investigate the determinants of adherence to ART in the Cameroon Mobile Phone SMS (CAMPS) trial. Methods We conducted a systematic review of electronic databases (PubMed, Google Scholar, Web of Science, CINAHL, EMBASE and PSYCINFO) for publications on adherence to ART in Cameroon (from January 1999 to May 2012) and described the trend in reported adherence rates and the factors associated with adherence. Data were extracted in duplicate. We used multivariable analyses on the baseline data for 200 participants in the CAMPS trial to determine the factors associated with adherence in four models using different measures of adherence (more than 90% or 95% on the visual analogue scale, no missed doses and a composite measure: 100% on the visual analogue scale, no missed doses and all pills taken on time). Results We identified nine studies meeting our inclusion criteria. Adherence to ART in Cameroon has risen steadily between 2000 and 2010, corresponding to reductions in the cost of medication. The factors associated with adherence to ART in Cameroon are grouped into patient, medication and disease related factors. We also identified factors related to the health system and the patient-provider relationship. In the CAMPS trial, education, side effects experienced and number of reminder methods were found to improve adherence, but only using multiple reminder methods was associated with better adherence in all the regression models (Adjusted Odds Ratio [AOR] 4.11, 95% Confidence Interval [CI] 1.89, 8.93; p<0.001; model IV). Conclusions Reducing the cost of ART is an important aspect of ensuring adequate adherence rates. Using multiple reminder methods may have a cumulative effect on adherence to ART, but should be investigated further.
Investigating community ownership of a text message programme to improve adherence to antiretroviral therapy and provider-client communication: a mixed methods research protocol
Lawrence Mbuagbaw,Lehana Thabane,Pierre Ongolo-Zogo
- , 2013, DOI: 10.1136/bmjopen-2013-002816
Abstract: Introduction Mobile phone ownership and use are growing fastest in sub-Saharan Africa, and there is evidence that mobile phone text messages can be used successfully to significantly improve adherence to antiretroviral therapy and reduce treatment interruptions. However, the effects of many mobile？health interventions are often reduced by human resource shortages within health facilities. Also, research projects generating evidence for health interventions in developing countries are most often conducted using external funding sources, with limited sustainability and adoption by local governments following completion of the projects. Strong community participation driven by active outreach programmes and mobilisation of community resources are the key to successful adoption and long-term sustainability of effective interventions. Our aim was to develop a framework for community ownership of a text messaging programme to improve adherence to antiretroviral therapy; improve communication between patients and doctors and act as a reminder for appointments. Methods and analysis We will use the exploratory sequential mixed methods approach. The first qualitative phase will entail focus group discussions with people living with HIV at the Yaoundé Central Hospital in Yaoundé, Cameroon (6–10 participants/group). The second quantitative phase will involve a cross-sectional survey (n=402). In this study, binary logistic regression techniques will be used to determine the factors associated with community readiness and acceptability of ownership. Data from both phases will be merged. Ethics and dissemination This study has been approved by the Yaoundé Central Hospital Institutional Review Board. The results of this paper will be disseminated as peer-reviewed publications at conferences and as part of a doctoral thesis
An introduction to systematic reviews and meta-analysis: A workshop report on promoting evidence based medical practice through capacity building in research synthesis
Lawrence Mbuagbaw,Charles Shey Wiysonge,Dickson Shey Nsagha,Pierre Ongolo-Zogo
Pan African Medical Journal , 2011,
Abstract: The increasing urgency for evidence based practice, especially in resource limited settings has inspired many initiatives to this effect. In Africa there is limited skill in research synthesis and the production of systematic reviews. The Centre for the Development of Best Practices in Health, together with the South African Cochrane Centre organised a workshop to train Cameroonian researchers on how to initiate and complete systematic reviews. Five facilitators and fifteen participants met over a period of four days. At the end of the workshop the participants expressed high levels of satisfaction and motivation to conduct systematic reviews, but expressed the need for additional support. Facilitators of future systematic review courses should address challenges related to internet access, adult education and realistic expectations from the participants
The Cameroon Mobile Phone SMS (CAMPS) Trial: A Randomized Trial of Text Messaging versus Usual Care for Adherence to Antiretroviral Therapy
Lawrence Mbuagbaw, Lehana Thabane, Pierre Ongolo-Zogo, Richard T. Lester, Edward J. Mills, Marek Smieja, Lisa Dolovich, Charles Kouanfack
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0046909
Abstract: Background Mobile phone technology is a novel way of delivering health care and improving health outcomes. This trial investigates the use of motivational mobile phone text messages (SMS) to improve adherence to antiretroviral therapy (ART) over six months. Methodology/Principal Findings CAMPS was a single-site randomized two-arm parallel design trial in Yaoundé, Cameroon. We enrolled and randomized HIV-positive adults on ART, aged 21 years and above to receive a weekly standardized motivational text message versus usual care alone. The primary outcome was adherence measured using a visual analogue scale (VAS), number of doses missed (in the week preceding the interview) and pharmacy refill data. Outcomes were measured at 3 and 6 months. Service providers and outcome assessors were blinded to allocation. Analysis was by intention-to-treat. Between November and December 2010, 200 participants were randomized, with 101 in the intervention group and 99 in the control group. At 6 months, overall retention was 81.5%. We found no significant effect on adherence by VAS>95% (risk ratio [RR] 1.06, 95% confidence interval [CI] 0.89, 1.29; p = 0.542; reported missed doses (RR 1.01, 95% CI 0.87, 1.16; p>0.999) or number of pharmacy refills (mean difference [MD] 0.1, 95% CI: 0.23, 0.43; p = 0.617. One participant in the intervention arm reported a possible disclosure of status. Conclusions/Significance Standardized motivational mobile phone text messages did not significantly improve adherence to ART in this study. Other types of messaging or longer term studies are recommended. Registration 1. Pan-African Clinical Trials Registry; PACTR201011000261458 2. Clinicaltrials.gov; NCT01247181
Assessment of policy makers' individual and organizational capacity to acquire, assess, adapt and apply research evidence for maternal and child health policy making in Nigeria: a cross-sectional quantitative survey
Chigozie Jesse Uneke,Ermel Johnson,Henry Chukwuemeka Uro-Chukwu,Issiaka Sombie,Namoudou Keita,Pierre Ongolo-Zogo,Virgil Lokossou
- , 2017, DOI: 10.4314/ahs.v17i3.12
Abstract: Throughout the world, there is increasing awareness and acknowledgement of the value of research evidence in the development of effective health policy and in quality health care practice and administration. Among the major challenges associated with the lack of uptake of research evidence into policy and practice in Nigeria is the capacity constraints of policymakers to use research evidence in policy making
Maternal and Fetal Outcomes of COVID-19 Pregnant Women Followed Up at a Tertiary Care Unit: A Descriptive Study  [PDF]
Madye A. Ngo Dingom, Eugène Sobngwi, Félix Essiben, Antoinette N. Assiga, Yves F. Wasnyo, Anicet Ngate, Jean C. Katte, Junie Y. Ngaha, Philemon Nsem, Charles E. Sone, Brigitte Wandji, Gilles T. Libend, Jean J. Bissemou, Filbert E. Eko, Florent Y. Fouelifack, Glwadys Ngono, Jeanne Fouédjio, Rebecca Tonye, Pierre Ongolo-Zogo, Pierre J. Fouda, Robinson E. Mbu
Open Journal of Obstetrics and Gynecology (OJOG) , 2020, DOI: 10.4236/ojog.2020.10100135
Abstract: Background: The SARS-CoV-2 and associated corona virus disease COVID-19 have been declared a pandemic having a poor prognosis among individuals with debilitating conditions and those who are immune-compromised. Current evidence is however limited on maternal and fetal transmission and pregnancy outcomes. We aimed to describe the pattern of SARS-CoV-2 infection and outcomes in a group of pregnant women followed up at a tertiary care unit in Cameroon. Methods: This was an observational study conducted over a period of 3 months (April 1 to June 30, 2020) at the Yaounde Central Hospital. All pregnant women who were tested positive for SARS-CoV-2 and who provided a signed written informed consent were included in the study. Results: Out of 83 pregnant women who presented with symptoms suspicious of COVID-19, 25 were tested positive. The median age of these women was 31 (27 - 35) years. A total of 76% consulted within 6 days of onset of symptoms and 68% had a gestational age greater than 28 weeks. The most common presenting complaint was fever (88%). All 25 pregnant women who were tested positive for COVID-19 were followed up with 9/25 deliveries registered. There were two intra-uterine fetal deaths and seven
Financial barriers to HIV treatment in Yaoundé, Cameroon: first results of a national cross-sectional survey
Boyer,Sylvie; Marcellin,Fabienne; Ongolo-Zogo,Pierre; Abega,Séverin-Cécile; Nantchouang,Robert; Spire,Bruno; Moatti,Jean-Paul;
Bulletin of the World Health Organization , 2009, DOI: 10.1590/S0042-96862009000400013
Abstract: objective: to assess the extent to which user fees for antiretroviral therapy (art) represent a financial barrier to access to art among hiv-positive patients in yaoundé, cameroon. methods: sociodemographic, economic and clinical data were collected from a random sample of 707 hiv-positive patients followed up in six public hospitals of the capital city (yaoundé) and its surroundings through face-to-face interviews carried out by trained interviewers independently from medical staff and medical questionnaires filled out by prescribing physicians. logistic regression models were used to identify factors associated with self-reported financial difficulties in purchasing art during the previous 3 months. findings: of the 532 patients treated with art at the time of the survey, 20% reported financial difficulty in purchasing their antiretroviral drugs during the previous 3 months. after adjustment for socioeconomic and clinical factors, reports of financial difficulties were significantly associated with lower adherence to art (odds ratio, or: 0.24; 95% confidence interval, ci: 0.15-0.40; p < 0.0001) and with lower cd4+ lymphocyte (cd4) counts after 6 months of treatment (or: 2.14; 95% ci: 1.15-3.96 for cd4 counts < 200 cells/μl; p = 0.04). conclusion: removing a financial barrier to treatment with art by eliminating user fees at the point of care delivery, as recommended by who, could lead to increased adherence to art and to improved clinical results. new health financing mechanisms based on the public resources of national governments and international donors are needed to attain universal access to drugs and treatment for hiv infection.
Guidance for Evidence-Informed Policies about Health Systems: Linking Guidance Development to Policy Development
John N. Lavis ,John-Arne R？ttingen,Xavier Bosch-Capblanch,Rifat Atun,Fadi El-Jardali,Lucy Gilson,Simon Lewin,Sandy Oliver,Pierre Ongolo-Zogo,Andy Haines
PLOS Medicine , 2012, DOI: 10.1371/journal.pmed.1001186
Abstract:
The cameroon mobile phone sms (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy
Lawrence Mbuagbaw, Lahana Thabane, Pierre Ongolo-Zogo, Richard T Lester, Edward Mills, Jimmy Volmink, David Yondo, Marie Essi, Renée-Cecile Bonono-Momnougui, Robert Mba, Jean Ndongo, Francois C Nkoa, Henri Ondoa
Trials , 2011, DOI: 10.1186/1745-6215-12-5
Abstract: This is a single-centered randomized controlled single-blinded trial. A central computer generated randomization list will be generated using random block sizes. Allocation will be determined by sequentially numbered sealed opaque envelopes. 198 participants will either receive the mobile phone text message or usual care. Our hypothesis is that weekly motivational text messages can improve adherence to Highly Active Antiretroviral Treatment and other clinical outcomes in the control group by acting as a reminder, a cue to action and opening communication channels. Data will be collected at baseline, three months and six months. A blinded program secretary will send out text messages and record delivery.Our primary outcomes are adherence measured by the visual analogue scale, self report, and pharmacy refill data. Our secondary outcomes are clinical: weight, body mass index, opportunistic infections, all cause mortality and retention; biological: Cluster Designation 4 count and viral load; and quality of life. Analysis will be by intention-to-treat. Covariates and subgroups will be taken into account.This trial investigates the potential of SMS motivational reminders to improve adherence to Highly Active Antiretroviral Treatment in Cameroon. The intervention targets non-adherence due to forgetfulness and other forms of non-adherence.Pan-African Clinical Trials Registry PACTR201011000261458http://clinicaltrials.gov/ webciteNCT01247181Mobile text messages using the short message service (SMS) are a cheap and non-invasive means of communication that can be used to convey health related messages to owners of mobile phones. There is contradictory evidence concerning the role of mobile phones in ameliorating health outcomes, especially in less developed countries where private ownership and use of mobile phones is not as widespread as in other more developed countries[1]. Currently, Africa has the greatest uptake of mobile phone technology [2].The advent of Highly Active A
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