Lessons from the field: the conduct of randomized controlled trials in Botswana

Bonsu, Janice M.; Frasso, Rosemary; Curry, Allison E.

doi:10.1186/s13063-017-2237-4

Cited by 12 publications

(9 citation statements)

References 15 publications

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“…This may be due to the fact that all participants had a monetary incentive for transportation at follow-up, which probably motivated them to come back to the appointments. The same effect of economic incentives for transportation has been shown by other authors 54,55 . In fact, a key factor affecting retention rates are transportation costs or lack of transportation 15,24,28,30,33,46,50,52,56 .…”

Section: Discussionsupporting

confidence: 82%

Predictors of retention in the prospective HIV prevention OKAPI cohort in Kinshasa

Carlos

Burgueño²,

Ndarabu

et al. 2021

Sci Rep

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Retention is a key element in HIV prevention programs. In Sub-Saharan Africa most data on retention come from HIV clinical trials or people living with HIV attending HIV treatment and control programs. Data from observational cohorts are less frequent. Retention at 6-/12-month follow-up and its predictors were analyzed in OKAPI prospective cohort. From April 2016 to April 2018, 797 participants aged 15–59 years attending HIV Voluntary Counseling and Testing in Kinshasa were interviewed about HIV-related knowledge and behaviors at baseline and at 6- and 12-month follow-ups. Retention rates were 57% and 27% at 6- and 12-month follow up; 22% of participants attended both visits. Retention at 6-month was significantly associated with 12-month retention. Retention was associated with low economic status, being studying, daily/weekly Internet access, previous HIV tests and aiming to share HIV test with partner. Contrarily, perceiving a good health, living far from an antiretroviral center, daily/weekly alcohol consumption and perceiving frequent HIV information were inversely associated with retention. In conclusion, a high attrition was found among people attending HIV testing participating in a prospective cohort in Kinshasa. Considering the low retention rates and the predictors found in this study, more HIV cohort studies in Kinshasa need to be evaluated to identify local factors and strategies that could improve retention if needed.

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Section: Discussionsupporting

confidence: 82%

Predictors of retention in the prospective HIV prevention OKAPI cohort in Kinshasa

Carlos

Burgueño²,

Ndarabu

et al. 2021

Sci Rep

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“…However, most of the studies were not randomized controlled trials. Bonsu et al .,[ 46 ] have reported the logistic and financial hurdles encountered in conducting drug trials in resource limited settings, thereby limiting the number of published randomized clinical trials from such settings. There was significant heterogeneity in the studies.…”

Section: Discussionmentioning

confidence: 99%

Chemoprophylaxis against COVID-19 among health-care workers using Ivermectin in low- and middle-income countries

Azeez

Lakoh

Adeleke

et al. 2021

Indian Journal of Pharmacology

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Coronavirus disease-2019 (COVID-19) is a novel viral infectious disease that the World Health Organization (WHO) has announced to be a pandemic. This meta-analysis was aimed at providing evidence for the use of ivermectin to prevent COVID-19 among hospital workers in low-resource countries. Medical databases including African Journals online, Google Scholar, PubMed, Cochrane library, EMBASE, COVID-19 research database (WHO), Clinicaltrials.gov, and SCOPUS were searched for studies on Ivermectin as a chemoprophylactic drug against COVID-19 among hospital personnel in settings with limited resources. Preprint servers such as bioRxiv and medRxiv as well as the gray literature were also searched. Studies adjudged to be eligible were identified using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses algorithm. Statistical analyses were done using Stata version 14.3. Seven studies were selected for the meta-analysis. The total sample size was 2652. There were two randomized controlled trials and five nonrandomized studies. Some studies dosed Ivermectin daily while some dosed it weekly. However, one of the studies dosed it monthly. The studies reported variable clinical benefits. I 2 statistic was 92%, and random effect model was used. The pooled odd ratio was 0.11 (95% confidence interval 0.09–0.13). This implies that 89% of the participants benefited from taking Ivermectin as a form of preexposure chemoprophylaxis. Ivermectin has a significant clinical benefit as a preventive drug against COVID-19 for hospital personnel in settings with limited resources.

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“…We also faced a high proportion of lost to follow-up. One must recognize that in low-resource settings, implementation and conduct of clinical trials is a major challenge [ [22] , [23] , [24] , [25] ]. In general, weak health systems, poverty, low literacy rates, religious and cultural beliefs, lack of inter-sectoral collaboration, war and civil strife, shortage of trained health care professionals constitute real barriers to cutting-edge clinical research in LMICs.…”

Section: Discussionmentioning

confidence: 99%

Impact of antiviral AV2 in the topical treatment of HPV-associated lesions of the cervix: Results of a phase III randomized placebo-controlled trial

Tozin

Kanyiki

Geertruyden

et al. 2019

Contemporary Clinical Trials Communications

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Background Non-surgical topical therapies have been assessed in the treatment of precancerous lesions of the cervix. Their use can offer logistical and feasibility advantages in low-resource settings. Antiviral AV2 ® is a mixture of natural essential oils (eugenol, carvone, nerolidol, geraniol) in olive oil, and has a broad spectrum anti-viral activity. In a phase II randomized controlled trial (RCT), AV2 ® proved effective in reducing the size of cervical lesions associated with human papillomavirus (HPV). The purpose of the present study was to further evaluate the efficacy of AV2 over placebo in the topical treatment of HPV-associated cervical lesions. Methods Women aged 25 years and older were included in this phase 3 RCT. Cytology screening, HPV testing and visual inspection of the cervix with 5% acetic acid (VIA) were performed on all participants. VIA-positive women were randomized to one of two groups to receive treatment by either AV2® or placebo. The treatment consisted of 2 puffs of spray of the investigational drug directed to the cervix. Participants were subjected to repeat examinations two months and six months later for assessment of outcomes. The primary outcome was the change of lesions on VIA at 2 months after application of the investigational drug. Secondary outcomes were: HPV clearance and cytologic regression at 2 months and 6 months, and number of participants with AEs. Results A total 327 VIA positive women were randomized in two groups (168 in AV2 group and 159 in placebo group). Women in the 2 groups were similar with respect to baseline demographics and clinical characteristics. At 2 months, regression of lesions on VIA was observed in 127 (89.4%) out of 142 women in AV2 group compared to 120 (91.6%) out of 131 women in placebo group (P = 0.7). On cytology, regression of lesions occurred in 14 (56%) out of 25 women in the AV2 arm and in 13 (48.1) out of 27 women in the placebo arm (p = 0.7), and HPV clearance rates were 34.1% and 35% in AV2 group and placebo group respectively (p = 0.8). At 6 months cytologic regression was observed in 64.7% of women in AV2 group and 45.8% in placebo group (p = 0.2), while HPV clearance occurred in 11 (51.9%) out of 17 women in AV2 arm versus 11 (34.4%) in placebo arm (p = 0.3). Some local side effects (burning, itching, irritation) were similarly noted in the 2 groups (p-values = 0.169, 0.623 and 0.172 respectively) but they were mild and transitory. Conclusion A topical application of AV2 onto the cervix can induce the regression of cervical precancerous lesions, but its efficacy does not significantly differ with that of placebo. The discrepancy between the expected and the recorded sample size as well as the huge number of lost to follow-up probably impeded the power of analyses, which could be one of the reasons for the lack of difference seen between AV2 and placebo. Further ev...

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Lessons from the field: the conduct of randomized controlled trials in Botswana

Cited by 12 publications

References 15 publications

Predictors of retention in the prospective HIV prevention OKAPI cohort in Kinshasa

Predictors of retention in the prospective HIV prevention OKAPI cohort in Kinshasa

Chemoprophylaxis against COVID-19 among health-care workers using Ivermectin in low- and middle-income countries

Impact of antiviral AV2 in the topical treatment of HPV-associated lesions of the cervix: Results of a phase III randomized placebo-controlled trial

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