Pan African Clinical Trials Registry Research Articles

Effects of speculum lubrication on cervical smears for cervical cancer screening: A double blind randomized clinical trial.

Speculum lubrication may help to reduce the pain experienced during Pap-smear collection and hence increase uptake of cervical cancer screening and repeat testing, but there are fears of its interference with cytological results. To determine and compare the adequacy of cervical cytology smears and the mean pain scores of women undergoing cervical cancer screening with or without speculum lubrication. This was a randomised controlled study of 132 women having cervical cancer screening at a tertiary hospital in Nigeria. Sixty-six participants were randomly assigned to the 'Gel' and 'No Gel' groups, respectively. Pap smears were collected from each participant with a lubricated speculum ('Gel group') or a non-lubricated speculum ('No Gel group'). The primary outcome measures were the proportion of women with unsatisfactory cervical cytology smears and the mean numeric rating scale pain scores, while the secondary outcome measures were the proportion of women who were willing to come for repeat testing and the cytological diagnosis of Pap-smear results. The baseline socio-demographic variables were similar in both groups. There was no significant difference in the proportion of unsatisfactory cervical smear results between the two groups (13.6% vs. 21.2%, p = 0.359). However, the mean pain scores were significantly lower in the gel group than in the no gel group (45.04 vs. 87.96; p<0.001). An equal proportion of the participants in each group (90.9% vs. 90.9%; p > 0.999) were willing to come for repeat cervical smears in the future. Speculum lubrication did not affect the adequacy of cervical smears but significantly reduced the pain experienced during pap smear collection. Also, it did not significantly affect the willingness to come for repeat cervical smears in the future. The trial was registered with the Pan-African Clinical Trial Registry with a unique identification and registration number: PACTR2020077533364675.

Evaluation of a digitally enhanced cardiac auscultation learning method in Cameroon: results of a controlled study

SummaryBackgroundCardiac auscultation is an efficient and effective diagnostic tool, especially in low-income countries where access to modern diagnostic methods remains difficult. This study aimed to evaluate the effect of a digitally enhanced cardiac auscultation learning method on medical students’ performance and satisfaction.MethodsWe conducted a double-arm parallel controlled trial, including newly admitted 4th -year medical students enrolled in two medical schools in Yaoundé, Cameroon and allocated into two groups: the intervention group (benefiting from theoretical lessons, clinical internship and the listening sessions of audio recordings of heart sounds) and the control group (benefiting from theoretical lessons and clinical internship). All the participants were subjected to a pretest before the beginning of the training, evaluating theoretical knowledge and recognition of cardiac sounds, and a post-test at the eighth week of clinical training associated with the evaluation of satisfaction. The endpoints were the progression of knowledge score, skills score, total (knowledge and skills) score and participant satisfaction.ResultsForty-nine participants (27 in the intervention group and 22 in the control group) completed the study. The knowledge progression (+ 26.7 versus + 7.5; p ˂0.01) and the total progression (+ 22.5 versus + 14.6; p ˂ 0.01) were higher in the intervention group with a statistically significant difference compared to the control group. There was no significant difference between the two groups regarding skills progression (+ 25 versus + 17.5; p = 0.27). Satisfaction was higher in general in the intervention group (p ˂ 0.01), which recommended this method compared to the control group.ConclusionThe learning method of cardiac auscultation reinforced by the listening sessions of audio recordings of heart sounds improves medical students’ performances (knowledge and global – knowledge and skills) who find it satisfactory and recommendable.Trial RegistrationThis trial has been registered the 29/11/2019 in the Pan African Clinical Trials Registry (http://www.pactr.org) under unique identification number PACTR202001504666847 and the protocol has been published in BMC Medical Education.

A pharmacokinetic randomised interventional study to optimise dihydroartemisinin-piperaquine dosing for malaria preventive treatment in Malawian infants: A protocol for the OPTIMAL study

Background A newer malaria preventive treatment, dihydroartemisinin-piperaquine (DP), has been identified as an effective alternative to sulfadoxine-pyrimethamine, to which malaria parasites are increasingly becoming resistant. However, how best to dose DP to safely prevent malaria in infants when aligned with routine health facility visits remains unresolved. As infants are usually excluded from participating in early dose optimisation clinical trials, the present study seeks to shift the paradigm and develop optimised DP dosing strategies for malaria preventive treatment in infants. Methods A randomised, single-blind, placebo-controlled, two-arm, interventional study will be conducted in southern Malawi. At 10 weeks (2.5 months) of age, 220 eligible infants will be randomised to receive DP (intervention group, n=110) or placebo (control group, n=110) with routine vaccines. They will be followed until 12 months of age and receive three further DP or placebo treatment courses at 14 weeks, six- and nine months. Infants in the intervention group will contribute capillary samples for piperaquine concentrations pre-dose and at three-, seven-, 14- and 28-days post-DP dosing as well as capillary samples pre-dose and on day 28 post-DP to quantify malaria parasitaemia using microscopy and quantitative PCR. In the control group, infants will contribute capillary blood samples for malaria parasitaemia at the same time points as the intervention group. Malaria incidence and adverse events will be compared between the two groups. Population pharmacokinetic-pharmacodynamic modelling techniques will be applied to derive feasible, optimised, efficacious, and safe DP dosing strategies for malaria preventive treatment in infancy. Conclusions The findings will provide the much-needed evidence to inform DP dosing for malaria preventive treatment in infants when administered with routine health facility visits. Additionally, they will help inform optimal DP dosing for malaria treatment in infants. The trial was registered with the Pan African Clinical Trials Registry; (PACTR202211575727659) on 8 November 2022. Protocol version 3.1, dated 29 September 2022.

Feasibility, acceptability and preliminary effect of a community-led HIV self-testing model among adolescent girls and young women in Rural Northern Uganda: a quasi-experimental study protocol

BackgroundAdolescent girls and young women (AGYW) in sub-Saharan Africa face a disproportionately higher HIV/AIDS burden despite the global decline in incidence. Existing interventions often fail to adequately address their unique social, economic, and cultural challenges, limiting access to essential HIV/AIDS services, including HIV testing. Emerging evidence indicates that HIV self-testing, a user-friendly and confidential method, enhances HIV diagnosis and linkage to care by targeting these barriers. This study aims to assess the feasibility, acceptability, and preliminary impact of a peer-delivered, community-health worker (CHW)-facilitated HIV self-testing intervention for AGYW in Northern Uganda.MethodsThis mixed-methods quasi-experimental implementation science study will employ a three-fold approach. Firstly, we will conduct baseline formative qualitative research with 50 AGYW, 50 parents/partners to AGYW, 30 CHWs, 15 community leaders, and the district health office to inform the design of a peer-delivered CHW-facilitated HIV self-testing intervention tailored to AGYW’s needs in Northern Uganda. Secondly, we will implement a mixed-methods pilot study to assess the intervention’s feasibility and acceptability, involving 415 AGYW, 30 AGYW peer leaders, and 10 CHWs in selected parishes and villages in Omoro district, Northern Uganda. Lastly, we will evaluate the implementation outcomes and preliminary impact of the intervention on HIV self-testing rates and linkage to care by collecting and analyzing quantitative data pre- and post-intervention, laying the groundwork for a future robust randomized controlled trial.DiscussionOur intervention combines CHWs and peer-led strategies to address the unique challenges of AGYW in Northern Uganda, leveraging community resilience and peer influence. Successful completion of this project will provide a scalable model to be evaluated in a randomized trial and replicated in similar contexts.Trial registration numberPACTR202404851907736. Registered with the Pan-African Clinical Trials Registry on April 22, 2024.

Periosteal wrapping of the hamstring tendon autograft improves graft healing and prevents tunnel widening after anterior cruciate ligament anatomic reconstruction

IntroductionThe periosteum is a readily available tissue at the hamstring harvest site that could be utilized to enhance graft healing and prevent tunnel widening without additional cost or morbidity. This study aimed to compare graft healing using magnetic resonance imaging (MRI) and functional clinical outcome scores in a matched cohort of patients who underwent anterior cruciate ligament (ACL) reconstruction with hamstring autografts with or without periosteal augmentation.Material and methodsForty-eight patients who underwent ACL reconstruction (ACLR) were prospectively enrolled: 25 with standard ACLR (ST-ACLR) and 23 with periosteal augmented grafts (PA-ACLR). The same surgical techniques, fixation methods, and postoperative protocol were used in both groups. Signal-to-noise quotient (SNQ), graft healing at the bone-graft interface, graft signal according to the Howell scale, and femoral tunnel widening were evaluated using MRI after 1 year of follow-up. International knee documentation score (IKDC), Lysholm, Tegner activity scale, and visual analog scale for pain were used for functional evaluation at a minimum of 2 years postoperative.ResultsThe mean SNQ of the proximal part of the graft was 9.6 ± 9.2 and 2.9 ± 3.3 for the ST-ACLR and PA-ACLR groups, respectively (P = 0.005). The mean femoral tunnel widening was 30.3% ± 18.3 and 2.3% ± 9.9 for the ST-ACLR, PA-ACLR groups, respectively (P < 0.001). Complete graft tunnel healing was observed in 65% and 28% of cases in the PA-ACLR and ST-ACLR groups, respectively. Both groups showed marked improvements in functional scores, with no statistically significant differences.ConclusionPeriosteal wrapping of hamstring tendon autografts is associated with better graft healing and maturation and lower incidence of femoral tunnel widening based on MRI analysis 1 year after ACL reconstruction. However, patient-reported outcomes and measured laxity were similar between the two groups at 2 years follow up.Trial registrationTrail registration number: PACTR202308594339018, date of registration: 1/5/2023, retrospectively registered at the Pan African Clinical Trial Registry (pactr.samrc.ac.za) database.

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention.

Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana. The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress. Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery. A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs. Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.

Effect of Rural Trauma Team Development on the Outcomes of Motorcycle Accident-Related Injuries (Motor Registry Project): Protocol for a Multicenter Cluster Randomized Controlled Trial.

Injury is a global health concern, and injury-related mortality disproportionately impacts low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries shows that trauma education programs, such as the Rural Trauma Team Development Course (RTTDC), increase clinician knowledge of injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of the RTTDC on process and patient outcomes in LMICs. This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident-related injuries in an African low-resource setting. This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident-related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police. The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024. This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs. Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763. DERR1-10.2196/55297.

Comparative effectiveness of low-level laser therapy versus muscle energy technique among diabetic patients with frozen shoulder: a study protocol for a parallel group randomised controlled trial

BackgroundDiabetes mellitus is one of the fastest-growing health challenges of the twenty-first century with multifactorial impact including high rates of morbidity and mortality as well as increased healthcare costs. It is associated with musculoskeletal complications, with frozen shoulder being commonly reported. While low-level laser therapy (LLLT) and muscle energy technique (MET) are commonly used to manage this condition, there remains a lack of agreement on the most effective approach, with limited research available on their comparative efficacy.ObjectivesTo evaluate the comparative effectiveness of LLLT versus MET among diabetic patients with frozen shoulder.MethodsThis is a single-centre, prospective, single-blind, randomised controlled trial with three parallel groups to be conducted at Ahmadu Bello University Teaching Hospital, Zaria, Kaduna State, Nigeria. Sixty diabetic patients with frozen shoulder will be randomly assigned into LLLT group, MET group, or control group in a 1:1:1 ratio. All the groups will receive treatment three times weekly for 8 weeks. The primary outcome will be shoulder function and the secondary outcomes will include pain intensity, shoulder ROM, interleukin-6 (IL-6), depression, anxiety, and quality of life (QoL). All outcomes will be assessed at baseline, at post 8-week intervention, and at 3 months follow-up.DiscussionThis will be the first randomised controlled trial to evaluate the comparative effectiveness of LLLT versus MET on both clinical and psychological parameters among diabetic patients with frozen shoulder. The findings of the study may provide evidence on the efficacy of these interventions and most likely, the optimal treatment approach for frozen shoulder related to diabetes, which may guide clinical practice.Trial Registration: Pan African Clinical Trials Registry (PACTR202208562111554). Registered on August 10, 2022.

A measles and rubella vaccine microneedle patch in The Gambia: a phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial

Microneedle patches (MNPs) have been ranked as the highest global priority innovation for overcoming immunisation barriers in low-income and middle-income countries. This trial aimed to provide the first data on the tolerability, safety, and immunogenicity of a measles and rubella vaccine (MRV)-MNP in children. This single-centre, phase 1/2, double-blind, double-dummy, randomised, active-controlled, age de-escalation trial was conducted in The Gambia. To be eligible, all participants had to be healthy according to prespecified criteria, aged 18-40 years for the adult cohort, 15-18 months for toddlers, or 9-10 months for infants, and to be available for visits throughout the follow-up period. The three age cohorts were randomly assigned in a 2:1 ratio (adults) or 1:1 ratio (toddlers and infants) to receive either an MRV-MNP (Micron Biomedical, Atlanta, GA, USA) and a placebo (0·9% sodium chloride) subcutaneous injection, or a placebo-MNP and an MRV subcutaneous injection (MRV-SC; Serum Institute of India, Pune, India). Unmasked staff ransomly assigned the participants using an online application, and they prepared visually identical preparations of the MRV-MNP or placebo-MNP and MRV-SC or placebo-SC, but were not involved in collecting endpoint data. Staff administering the study interventions, participants, parents, and study staff assessing trial endpoints were masked to treatment allocation. The safety population consists of all vaccinated participants, and analysis was conducted according to route of MRV administration, irrespective of subsequent protocol deviations. The immunogenicity population consisted of all vaccinated participants who had a baseline and day 42 visit result available, and who had no protocol deviations considered to substantially affect the immunogenicity endpoints. Solicited local and systemic adverse events were collected for 14 days following vaccination. Unsolicited adverse events were collected to day 180. Age de-escalation between cohorts was based on the review of the safety data to day 14 by an independent data monitoring committee. Serum neutralising antibodies to measles and rubella were measured at baseline, day 42, and day 180. Analysis was descriptive and included safety events, seroprotection and seroconversion rates, and geometric mean antibody concentrations. The trial was registered with the Pan African Clinical Trials Registry PACTR202008836432905, and is complete. Recruitment took place between May 18, 2021, and May 27, 2022. 45 adults, 120 toddlers, and 120 infants were randomly allocated and vaccinated. There were no safety concerns in the first 14 days following vaccination in either adults or toddlers, and age de-escalation proceeded accordingly. In infants, 93% (52/56; 95% CI 83·0-97·2) seroconverted to measles and 100% (58/58; 93·8-100) seroconverted to rubella following MRV-MNP administration, while 90% (52/58; 79·2-95·2) and 100% (59/59; 93·9-100) seroconverted to measles and rubella respectively, following MRV-SC. Induration at the MRV-MNP application site was the most frequent local reaction occurring in 46 (77%) of 60 toddlers and 39 (65%) of 60 infants. Related unsolicited adverse events, most commonly discolouration at the application site, were reported in 35 (58%) of 60 toddlers and 57 (95%) of 60 infants that had received the MRV-MNP. All local reactions were mild. There were no related severe or serious adverse events. The safety and immunogenicity data support the accelerated development of the MRV-MNP. Bill & Melinda Gates Foundation.

Recruitment strategies used to enrol healthy volunteers in the first pneumococcal human infection study in Africa: Lessons from Blantyre, Malawi

Background Human infection studies (HIS) also known as Controlled Human Infection Models (CHIM) are a relatively new concept in African countries to clinicians, scientists, and communities alike. We have introduced HIS/CHIM studies to Malawi during the last four years by developing an experimental human pneumococcal carriage model. This CHIM was used to test the efficacy of a licensed 13-valent Pneumococcal Conjugate Vaccine (PCV13) against experimental nasal pneumococcal carriage. Traditional and digital recruitment strategies into this novel trial were explored. Objectives To describe various methods of recruitment in this first CHIM study in Malawi. Methods The clinical trial within the context of which these data were recorded was registered with the Pan African Clinical Trials Registry (REF: PACTR202008503507113) on 03 August 2020. The project was conducted at the Malawi Liverpool Wellcome Programme (MLW) in Blantyre, Malawi between April 2021, and September 2022. Source populations were college students and community members within Blantyre. Recruitment strategies included sharing study information in written or visual form, community sensitization meetings, snowball contacts (word of mouth from previous volunteers), branded clothing and participating in radio and television programs. Results 299 volunteers attended screening clinic, of whom 278 were recruited. Sixty-six recruited volunteers (23.7%) were college students and 212 (76.3%) were from the community. Snowball word-of-mouth contacting was the most successful recruitment strategy, with 201 (72.3%) participants recruited using this method. 195 (70.1%) were men of whom 149 (76.4%) joined the study through snowballing. Conclusion or recommendation Using a variety of recruitment strategies led to successful recruitment in this novel controlled human infection study. Most participants were recruited through snowballing.

Improving patient-centred counselling skills among lay healthcare workers in South Africa using the Thusa-Thuso motivational interviewing training and support program.

We developed a motivational interviewing (MI) counselling training and support program for lay counsellors in South Africa-branded "Thusa-Thuso-helping you help", commonly referred to as Thusa-Thuso. We present the results of a pilot study to determine the program's impact on MI technical skills and qualitatively assess the feasibility of a training-of-trainers (TOT) scale-up strategy among counselling staff of non-governmental (NGO) support partners of the human immunodeficiency virus (HIV) treatment program in South Africa. We enrolled adult (≥ 18 years) lay counsellors from ten primary healthcare clinics in Johannesburg (South Africa) selected to participate in the Thusa-Thuso training and support program. Counsellors attended the ten-day baseline and quarterly refresher training over 12 months (October 2018-October 2019). Each counsellor submitted two audio recordings of mock counselling sessions held during the ten-day baseline training and two additional recordings of sessions with consenting patients after each quarterly contact session. We reviewed the recordings using the MI treatment integrity (MITI) coding system to determine MI technical (cultivating change talk and softening sustain talk) and relational (empathy and partnership) competency scores before and after training. After 12 months of support with pilot site counsellors, we were asked to scale up the training to NGO partner team trainers in a once-off five-day Training of trainers (TOT) format (n = 127 trainees from November 2020 to January 2021). We report TOT training experiences from focus group discussions (n = 42) conducted six months after the TOT sessions. Of the 25 enrolled lay counsellors from participating facilities, 10 completed the 12-month Thusa-Thuso program. Attrition over the 12 months was caused by death (n = 3), site exclusion/resignations (n = 10), and absence (n = 2). MI competencies improved as follows: the technical skills score increased from a mean of 2.5 (standard deviation (SD): 0.8) to 3.1 (SD: 0.5), with a mean difference of 0.6 (95% confidence interval (CI): 0.04, 0.9). The MI relational skills score improved from a mean of 3.20 (SD: 0.7) to 3.5 (SD: 0.6), with a mean difference of 0.3 (95% CI: -0.3, 8.5). End-point qualitative data from the counsellors highlighted the value of identifying and addressing specific skill deficiencies and the importance of counsellors being able to self-monitor skill development using the MITI review process. Participants appreciated the ongoing support to clarify practical MI applications. The TOT program tools were valuable for ongoing on-the-job development and monitoring of quality counselling skills. However, the MITI review process was perceived to be too involved for large-scale application and was adapted into a scoring form to document sit-in mentoring sessions. The Thusa-Thuso MI intervention can improve counsellor motivation and skills over time. In addition, the program can be scaled up using an adapted TOT process supplemented with fidelity assessment tools, which are valuable for skills development and ongoing maintenance. However, further studies are needed to determine the effect of the Thusa-Thuso program on patient ART adherence and retention in care. Trial registration: Pan African Clinical Trials Registry No: PACTR202212796722256 (12 December 2022).

Laparoscopic assisted versus ultrasound guided transversus abdominis plane block in laparoscopic bariatric surgery: a randomized controlled trial

BackgroundTransversus abdominis plane block (TAPB) guided by laparoscopy and ultrasound showed promise in enhancing the multimodal analgesic approach following several abdominal procedures. This study aimed to compare the efficacy and safety between Laparoscopic (LAP) TAP block (LTAP) and ultrasound-guided TAP block (UTAP) block in patients undergoing LAP bariatric surgery.Patients and methodsThis non-inferiority randomized controlled single-blind study was conducted on 120 patients with obesity scheduled for LAP bariatric surgeries. Patients were allocated into two equal groups: LTAP and UTAP, administered with 20 mL of 0.25% bupivacaine on each side.ResultsThere was no statistically significant difference in the total morphine consumption, Visual Analogue Scale (VAS) score at all times of measurements, and time to the first rescue analgesia (p > .05) between both groups. The duration of anesthesia and duration of block performance were significantly shorter in the LTAP group than in the UTAP group (p < .001). Both groups had comparable post-operative heart rate, mean arterial pressure, adverse effects, and patient satisfaction.ConclusionsIn LAP bariatric surgery, the analgesic effect of LTAP is non-inferior to UTAP, as evidenced by comparable time to first rescue analgesia and total morphine consumption with similar safety blocking through the low incidence of post-operative complications and patient satisfaction.Trial registrationThe study was registered in Pan African Clinical Trials Registry (PACTR) (ID: PACTR202206871825386) on June 29, 2022.

Effect of treadmill ambulatory training on glucose control and blood pressure in persons with type 2 diabetes: A pilot study.

Lack of time is often cited by persons with type 2 diabetes for non-participation in regular exercise. This highlights the need to explores ways to help persons with type 2 diabetes to engage in an active lifestyle. This study evaluated the effect of a short duration norm intensity exercise on blood glucose and blood pressure in persons with type 2 diabetes. Twenty persons with type 2 diabetes were randomly assigned to either training group (n = 10) or control group (n = 10). The training group received 4-weeks ambulatory training on a motor-driven treadmill (2 x 20 min per week at 60% target heart rate). The control group received no training. Blood glucose, and systolic and diastolic blood pressures were assessed before and after the 4-weeks training. Repeated measures ANOVA were used to examine training effect. Training significantly improved blood glucose (mean difference = -2.73; p = 0.03). No effects were found for systolic blood pressure (mean difference = -0.30; p = 0.96) and diastolic blood pressure (mean difference = -0.90; p = 0.82). Training improved blood glucose but not blood pressure. A short-duration ambulatory training is an appropriate exercise mode to elicit beneficial effect, and exercise adoption in persons with type 2 diabetes. This pilot trial is registered with the Pan African Clinical Trial Registry at pactr.samrc.ac.za (PACTR202306601940612).

Effect of home-based pulmonary rehabilitation on exercise capacity in post COVID-19 patients: a randomized controlled trail

BackgroundCoronavirus 2019 (COVID-19) is an epidemic condition that compromises various consequences. The goal of this study was to investigate the effect of home-based pulmonary rehabilitation on exercise capacity in patients with post COVID-19 syndrome.MethodsThe study was designed as a randomized control trial. A total of sixty-eight patients with post COVID-19 syndrome complaining of fatigue, dyspnea, and exercise intolerance participated in this study. Their ages ranged from 40 to 70 years old. The patients were randomly classified into two equal groups. The control group received usual medical care only, whereas the rehabilitation group received a selected home-based pulmonary rehabilitation exercise program plus the same usual medical care. The Physical Fitness Index (PFI), Chalder fatigue index, SF-36 questionnaire, dyspnea scale, and six-minute walk test (6 MWT) were measured before and after 12 weeks of intervention.ResultsThe rehabilitation group showed a significant lower mean of Chalder fatigue (11.1 ± 0.94) and a higher mean of 6MWT (439.7 ± 25.3) and PFI (52.3 ± 10.2), in addition to a higher mean of the SF-36 Questionnaire (66.4 ± 3.7) and a significant improvement of dyspnea in the mMRC score (26.7%), grade 2, (63.3%), grade 1 (10%), and grade 0 with a p-value < 0.001 when compared to the control group.ConclusionHome-based pulmonary rehabilitation (HBPR) for patients with post COVID-19 syndrome is effective and has a potential direct influence on exercise capacity, fatigue, dyspnea, and quality of life. HBPR could be considered an adjunctive, applicable, and low-cost therapy for patients with post COVID-19 syndrome.Trial registration: The study was registered in Pan African Clinical Trial Registry as a clinical trial ID (PACTR202111640499636), November 2021.

Cervical ripening with vaginal Misoprostol plus Hyoscine-N-Butylbromide versus vaginal Misoprostol alone among pregnant women: a double-blind randomised controlled trial.

To compare cervical ripening time with the use of vaginal Misoprostol plus Hyoscine-N-Butylbromide, with vaginal Misoprostol alone. A double-blind randomized controlled trial with Pan-African Clinical Trials Registry (PACTR) approval number PACTR202112821475292. Federal Medical Centre, Asaba, Nigeria. A total of 126 eligible antenatal patients for cervical ripening were enrolled. Participants in Group A had 25µg of vaginal misoprostol with 1ml of intramuscular placebo, and those in Group B had 25µg of vaginal misoprostol with 20mg of Intramuscular Hyoscine (1 ml). Oxytocin infusion was used when indicated, and the labour was supervised as per departmental protocol. Cervical ripening time. The mean cervical ripening time was statistically significantly shorter in the hyoscine group (8.48±4.36 hours) than in the placebo group (11.40±7.33 hours); p-value 0.02, 95% CI 0.80-5.05. There was no statistically significant difference in the mean induction-delivery interval in Group A (7.38±5.28 hours) compared to Group B (7.75±5.04 hours), with a value of 0.54. The mode of delivery was comparable. However, women in Group B (53, 84.1%) achieved more vaginal deliveries than women in Group A (50, 79.4%); p-value 0.49. Thirteen women in Group A (20.6%) had a caesarean section, while ten women (15.9%) in Group B had a caesarean section (p-value 0.49, RR 0.94, CI 0.80-1.11). Adverse maternal and neonatal outcomes were not statistically significant between the two groups. Intramuscular hyoscine was effective in reducing cervical ripening time when used as an adjunct to vaginal Misoprostol, with no significant adverse maternal or neonatal outcome. None declared.

A qualitative analysis of community health worker perspectives on the implementation of the preconception and pregnancy phases of the Bukhali randomised controlled trial.

Community health workers (CHWs) play an important role in health systems in low- and middle-income countries, including South Africa. Bukhali is a CHW-delivered intervention as part of a randomised controlled trial, to improve the health trajectories of young women in Soweto, South Africa. This study aimed to qualitatively explore factors influencing implementation of the preconception and pregnancy phases of Bukhali, from the perspective of the CHWs (Health Helpers, HHs) delivering the intervention. As part of the Bukhali trial process evaluation, three focus group discussions were conducted with the 13 HHs employed by the trial. A thematic approach was used to analyse the data, drawing on elements of a reflexive thematic and codebook approach. The following six themes were developed, representing factors impacting implementation of the HH roles: interaction with the existing public healthcare sector; participant perceptions of health; health literacy and language barriers; participants' socioeconomic constraints; family, partner, and community views of trial components; and the HH-participant relationship. HHs reported uses of several trial-based tools to overcome implementation challenges, increasing their ability to implement their roles as planned. The relationship of trust between the HH and participants seemed to function as one important mechanism for impact. The findings supported a number of adaptations to the implementation of Bukhali, such as intensified trial-based follow-up of referrals that do not receive management at clinics, continued HH training and community engagement parallel to trial implementation, with an increased emphasis on health-related stigma and education. HH perspectives on intervention implementation highlighted adaptations across three broad strategic areas: navigating and bridging healthcare systems, adaptability to individual participant needs, and navigating stigma around disease. These findings provide recommendations for the next phases of Bukhali, for other CHW-delivered preconception and pregnancy trials, and for the strengthening of CHW roles in clinical settings with similar implementation challenges. Trial registration: Pan African Clinical Trials Registry; PACTR201903750173871, Registered March 27, 2019.

Effect of a chimney-fitted improved stove on pregnancy outcomes in Northwest Ethiopia: a randomized controlled trial

BackgroundExposure to household air pollution during pregnancy has been linked to adverse pregnancy outcomes. Improved stove was implemented in Ethiopia to reduce this exposure and related health problems. However, the effects of improved stove interventions on pregnancy outcomes remains uncertain.MethodIndividually randomized stove replacement trial was conducted among 422 households in six low-income rural kebeles of Northwestern Ethiopia. Pregnant women without known health conditions were recruited at ≤ 24 weeks gestation and randomized to an intervention or control group with a 1:1 ratio. A baseline survey was collected and a balance test was done. Two-sided independent samples t-test for continuous outcomes and chi-square for categorical variables were used to compare the effect of the intervention between the groups. Mean differences with 95% CIs were calculated and a p-value of < 0.05 was considered statistically significant.ResultIn this study, the mean birth weight was 3065 g (SD = 453) among the intervention group and not statistically different from 2995 g (SD = 541) of control group. After adjusting for covariates, infants born from intervention group weighed 55 g more [95% CI: − 43 to 170) than infants born from the control group, but the difference was not statistically significant (P = 0.274). The respective percentages for low birth weight were 8% and 10.3% for intervention and control groups respectively (P = 0.346). However, the average gestational age at delivery was higher among improved stove users (38 weeks (SD = 8.2) compared to control groups 36.5 weeks (SD = 9.6) with statistically significant difference at 0.91 weeks (95% CI: 0.52 to 1.30 weeks, p < 0.001). The corresponding difference in risk ratio for preterm birth is 0.94 (95% CI:0.92 to 0.97; p < 0.001). The percentages for maternal complications, stillbirth, and miscarriage in the intervention group were not statistically different from the control group.ConclusionsWhile the increase in average birth weight among babies born to mothers using improved stoves was not statistically significant, babies had a longer gestational age on average, offering valuable health benefits. However, the study didn’t find a significant impact on other pregnancy outcomes like stillbirth, miscarriage, or maternal complications.Trial registrationThe study was registered at the Pan African Clinical Trial Registry website under the code PACTR202111534227089, (https://pactr.samrc.ac.za/ (Identifier). The first trial registration date was (11/11/2021).

The role of a community health worker-delivered preconception and pregnancy intervention in achieving a more positive pregnancy experience: the Bukhali trial in Soweto, South Africa

BackgroundA patient-centered, human-rights based approach to maternal care moves past merely reducing maternal mortality and morbidity, towards achieving a positive pregnancy experience. When evaluating an intervention, particularly in the context of the complex challenges facing maternal care in South Africa, it is therefore important to understand how intervention components are experienced by women. We aimed to qualitatively explore (i) factors influencing the pregnancy and postpartum experience amongst young women in Soweto, South Africa, and (ii) the influence of Bukhali, a preconception, pregnancy, and early childhood intervention delivered by community health workers (CHWs), on these experiences.MethodsSemi-structured, in-depth interviews were conducted with 15 purposively sampled participants. Participants were 18–28-year-old women who (i) were enrolled in the intervention arm of the Bukhali randomized controlled trial; (ii) were pregnant and delivered a child while being enrolled in the trial; and (iii) had at least one previous pregnancy prior to participation in the trial. Thematic analysis, informed by the positive pregnancy experiences framework and drawing on a codebook analysis approach, was used.ResultsThe themes influencing participants’ pregnancy experiences (aim 1) were participants’ feelings about being pregnant, the responsibilities of motherhood, physical and mental health challenges, unstable social support and traumatic experiences, and the pressures of socioeconomic circumstances. In terms of how support, information, and care practices influenced these factors (aim 2), four themes were generated: acceptance and mother/child bonding, growing and adapting in their role as mothers, receiving tools for their health, and having ways to cope in difficult circumstances. These processes were found to be complementary and closely linked to participant context and needs.ConclusionOur findings suggest that, among women aged 18–28, a CHW-delivered intervention combining support, information, and care practices has the potential to positively influence women’s pregnancy experience in South Africa. In particular, emotional support and relevant information were key to better meeting participant needs. These findings can help define critical elements of CHW roles in maternal care and highlight the importance of patient-centred solutions to challenges within antenatal care.Trial registrationPan African Clinical Trials Registry PACTR201903750173871, 27/03/2019.

Effect of nutrition counseling on nutritional status and gestational weight gain of pregnant adolescents in West Arsi, Central Ethiopia: a cluster randomized controlled trial

When pregnancy occurs in adolescence, the growth and development of the mother and fetus may be impaired due to strong competition for nutrients between the still-growing adolescent and the fetus. Pregnant adolescents constitute an underserved population; they lack adequate nutritional knowledge. Therefore, this study investigated the effect of nutritional behavior change communication (NBCC) through alliance for development (AFD) on the nutritional status and gestational weight gain (GWG) of pregnant adolescents. A two-arm parallel cluster randomized controlled community trial was conducted in the West Arsi Zone, central Ethiopia, from August 2022 to July 2023. The nutritional status of the pregnant adolescent was assessed using mid-upper arm circumference. Weight was measured at baseline and at the end of the intervention. A total of 207 and 219 pregnant adolescents participated in the intervention and control clusters, respectively. The intervention started before 16 weeks of gestation, and the intervention group attended four NBCC sessions. The NBCC was based on the health belief model (HBM) and was given at the participants’ homes with their husbands. The NBCC intervention was delivered by AFDs and community-level health actors. Pregnant adolescents in the control group received routine nutrition education from the health care system. A linear mixed-effects model and difference in difference (DID) were used to measure the intervention effect after adjusting for potential confounders. After the implementation of the trial, the mean mid-upper arm circumference (MUAC) in the intervention arm significantly increased from baseline (p ≤ 0.001), 23.19 ± 2.1 to 25.06 ± 2.9 among intervention group and 23.49 ± 2.1 to 23.56 ± 2.0 among control group and the mean difference in the MUAC (DID) was 1.89 ± 2 cm (p ≤ 0.001); the mean GWG in the intervention arm significantly increased from baseline; 51.54 ± 4.7 to 60.98 ± 4.6 among intervention group and 52.86 ± 5.27 to 58 ± 5.3 among control group; the mean GWG in the intervention group was 9.4 kg, and that in the control group was 5.14 kg, and the difference in difference was 4.23 kg and this was statically significant p ≤ 0.001). This study demonstrated that the use of the HBM for NBCC delivered through the AFD was effective at improving the nutritional status and GWG of pregnant adolescents. These results imply the need for the design of model-based nutritional counseling guidelines.Clinical trial registration: PACTR202203696996305, Pan African Clinical Trials Registry, date of first registration: 16/03/2022.

Safety and efficacy of pyronaridine–artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study

BackgroundChildren are particularly at risk of malaria. This analysis consolidates the clinical data for pyronaridine–artesunate (PA) paediatric granules in children from three randomized clinical trials and a real-world study (CANTAM).MethodsAn integrated safety analysis of individual patient data from three randomized clinical trials included patients with microscopically-confirmed Plasmodium falciparum, body weight ≥ 5 kg to < 20 kg, who received at least one dose of study drug (paediatric safety population). PA was administered once daily for 3 days; two trials included the comparator artemether–lumefantrine (AL). PCR-adjusted day 28 adequate clinical and parasitological response (ACPR) was evaluated. Real-world PA granules safety and effectiveness was also considered.ResultsIn the integrated safety analysis, 63.9% (95% CI 60.2, 67.4; 426/667) of patients had adverse events following PA and 62.0% (95% CI 56.9, 66.9; 222/358) with AL. Vomiting was more common with PA (7.8% [95% CI 6.0, 10.1; 52/667]) than AL (3.4% [95% CI 1.9, 5.8; 12/358]), relative risk 2.3 (95% CI 1.3, 4.3; P = 0.004), occurring mainly following the first PA dose (6.7%, 45/667), without affecting re-dosing or adherence. Prolonged QT interval occurred less frequently with PA (3.1% [95% CI 2.1, 4.8; 21/667]) than AL (8.1% [95% CI 5.7, 11.4; 29/358]), relative risk 0.39 (95% CI 0.22, 0.67; P = 0.0007). In CANTAM, adverse events were reported for 17.7% (95% CI 16.3, 19.2; 460/2599) of patients, most commonly vomiting (5.4% [95% CI 4.6, 6.4; 141/2599]), mainly following the first dose, (4.5% [117/2599]), with all patients successfully re-dosed, and pyrexia (5.4% [95% CI 4.6, 6.3; 140/2599]). In the two comparative clinical trials, Day 28 ACPR in the per-protocol population for PA was 97.1% (95% CI 94.6, 98.6; 329/339) and 100% (95% CI 99.3, 100; 514/514) versus 98.8% (95% CI 95.7, 99.9; 165/167) and 98.4% (95% CI 95.5, 99.7; 188/191) for AL, respectively. In CANTAM, PA clinical effectiveness was 98.0% (95% CI 97.3, 98.5; 2273/2320).ConclusionsAnti-malarial treatment with PA paediatric granules administered once daily for 3 days was well tolerated in children and displayed good clinical efficacy in clinical trials, with effectiveness confirmed in a real-world study.Trial registration Clinicaltrials.gov: SP-C-003-05: identifier NCT00331136; SP-C-007-07: identifier NCT0541385; SP-C-021-15: identifier NCT03201770. Pan African Clinical Trials Registry: SP-C-013-11: identifier PACTR201105000286876