scholarly journals “Our Choice” improves use of safer conception methods among HIV serodiscordant couples in Uganda: a cluster randomized controlled trial evaluating two implementation approaches

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Glenn J. Wagner ◽  
Rhoda K. Wanyenze ◽  
Jolly Beyeza-Kashesya ◽  
Violet Gwokyalya ◽  
Emily Hurley ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Usual Care ◽  
Controlled Trial ◽  
Safer Conception ◽  
Low Intensity ◽  
Randomized Controlled ◽  
Training And Supervision ◽  
Safer Conception Methods ◽  
Cluster Randomized

Abstract Background Safer conception counseling (SCC) to promote the use of safer conception methods (SCM) is not yet part of routine family planning or HIV care. Guidelines for the use of SCM have been published, but to date there are no published controlled evaluations of SCC. Furthermore, it is unknown whether standard methods commonly used in resource constrained settings to integrate new services would be sufficient, or if enhanced training and supervision would result in a more efficacious approach to implementing SCC. Methods In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach (differentiated by amount of training and supervision), or existing family planning services (usual care). Three hundred eighty-nine HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. Results The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]. The arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. Conclusions More intensive provider training and more frequent supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard low intensity implementation approach. Trial registration Clinicaltrials.gov, NCT03167879; date registered May 23, 2017.

scholarly journals Our Choice Improves Use of Safer Conception Methods Among HIV Serodiscordant Couples in Uganda: A Cluster Randomized Controlled Trial Evaluating Two Implementation Approaches

2021 ◽  
Author(s):  
Glenn Wagner ◽  
Rhoda Wanyenze ◽  
Jolly Beyeza-Kashesya ◽  
Violet Gwokyalya ◽  
Emily Hurley ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Usual Care ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Hiv Care ◽  
Safer Conception ◽  
Randomized Controlled ◽  
Safer Conception Methods ◽  
Cluster Randomized

Abstract Background: Safer conception counseling (SCC) to promote safer conception methods (SCM) is not yet part of routine family planning or HIV care, and to date there are no published controlled evaluations of SCC.Methods: In a hybrid, cluster randomized controlled trial, six HIV clinics were randomly assigned to implement the SCC intervention Our Choice using either a high (SCC1) or low intensity (SCC2) approach, or existing family planning services (usual care). 389 HIV clients considering childbearing with an HIV-negative partner enrolled. The primary outcome was self-reported use of appropriate reproductive method (SCM if trying to conceive; modern contraceptives if not) over 12 months or until pregnancy. Results: The combined intervention groups used appropriate reproductive methods more than usual care [20.8% vs. 6.9%; adjusted OR (95% CI)=10.63 (2.79, 40.49)], and SCC1 reported a higher rate than SCC2 [27.1% vs. 14.6%; OR (95% CI)=4.50 (1.44, 14.01)]. Among those trying to conceive, the intervention arms reported greater accurate use of SCM compared to usual care [24.1% vs. 0%; OR (95% CI)=91.84 (4.94, 1709.0)], and SCC1 performed better than SCC2 [34.6% vs. 11.5%; OR (95% CI)=6.43 (1.90, 21.73)]; the arms did not vary on modern contraception use among those not trying to conceive. A cost of $631 per person was estimated to obtain accurate use of SCM in SCC1, compared to $1014 in SCC2. Conclusions: More intensive training and supervision leads to greater adoption of complex SCM behaviors and is more cost-effective than the standard implementation approach.Trial registration: Clinicaltrials.gov, NCT03167879; date registered May 23, 2017; https://clinicaltrials.gov/ct2/show/NCT03167879.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

scholarly journals Healthy Pregnancies Project: Cluster Randomized Controlled Trial of a Community Intervention to Reduce Tobacco Use among Alaska Native Women

2020 ◽  
Vol 17 (24) ◽  
pp. 9302
Author(s):  
Christi A. Patten ◽  
Harry A. Lando ◽  
Chris A. Desnoyers ◽  
Martha J. Bock ◽  
Lucinda Alexie ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Tobacco Use ◽  
Alaska Native ◽  
Controlled Trial ◽  
Study Groups ◽  
Cluster Randomized Controlled Trial ◽  
Community Level ◽  
Randomized Controlled ◽  
Cluster Randomized

Substantial gaps remain in the evidence base for prenatal tobacco use interventions among Indigenous women. Using a cluster randomized controlled trial (RCT), the Healthy Pregnancies Project evaluated a community-level intervention for Alaska Native (AN) women in rural western Alaska. Sixteen villages were randomly assigned to usual care (control, n = 8 villages) or usual care plus a community-level intervention delivered by local AN “Native Sisters” (n = 8 villages). Outcomes were tobacco use rate at delivery and at 2 and 6 months postpartum, with biochemical confirmation obtained at 6 months. The program had high reach, enrolling 73% of all eligible women screened. Of the 352 participants, 67% used tobacco at baseline. No significant differences emerged between study groups on follow-up in tobacco use rates. More intervention than control participants made a quit attempt at 2 months postpartum (70% vs. 51%, respectively, p = 0.012). Participants in both study groups reported the program helped to raise awareness of healthy pregnancies in the study villages. This trial supports the reach of a community-level intervention, but not its efficacy for reducing tobacco use during pregnancy or postpartum. Efforts to sustain early quit attempts appear warranted. The community involvement, and reported impact on raising awareness of the importance of healthy pregnancies, supports the value of the research program in this community.

scholarly journals LINDA – a solution-focused low-intensity intervention aimed at improving health behaviors of young females: a cluster-randomized controlled trial

2013 ◽  
Vol 13 (1) ◽  
Author(s):  
Päivi Valve ◽  
Susanna Lehtinen-Jacks ◽  
Tiina Eriksson ◽  
Matti Lehtinen ◽  
Pirjo Lindfors ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Behaviors ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Young Females ◽  
Low Intensity ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Solution Focused

scholarly journals A family planning clinic-based intervention to address reproductive coercion: a cluster randomized controlled trial

Contraception ◽  
2016 ◽  
Vol 94 (1) ◽  
pp. 58-67 ◽  
Author(s):  
Elizabeth Miller ◽  
Daniel J. Tancredi ◽  
Michele R. Decker ◽  
Heather L. McCauley ◽  
Kelley A. Jones ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Family Planning Clinic ◽  
Randomized Controlled ◽  
Reproductive Coercion ◽  
Cluster Randomized

scholarly journals Screening and patient-tailored care for emotional and cognitive problems compared to care as usual in patients discharged home after ischemic stroke (ECO-stroke): a protocol for a multicenter, patient-blinded, cluster randomized controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
J. P. L. Slenders ◽  
R. M. Van den Berg-Vos ◽  
C. M. van Heugten ◽  
J. M. A. Visser-Meily ◽  
S. M. A. A. Evers ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Emotional Problems ◽  
Clinical Effectiveness ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Ischemic stroke patients with a good outcome in terms of motor functioning and communication are likely to be discharged home without further rehabilitation. A significant number of these patients experience cognitive and emotional problems resulting in lower quality of life and decreased participation in society. This paper presents the protocol of a study examining the clinical effectiveness, cost-effectiveness and implementation of an intervention focused on screening and patient-tailored care for cognitive and emotional problems as compared to usual care in patients discharged home after ischemic stroke. Methods / design A multicenter, patient-blinded, cluster randomized controlled trial will be performed. Centers will be randomized (1:1) to the intervention group or the usual care group. Patients (> 18 years old) with a neurological confirmed diagnosis of ischemic stroke who can be discharged home without follow-up treatment at an outpatient rehabilitation clinic will be included. In the intervention group, patients will receive a short, individualized, semi-structured consultation by specialized nurses in addition to usual care. This consultation includes 1) screening for cognitive and emotional problems, 2) screening for restrictions in participation, 3) promotion of self-management strategies and 4) a decision tool for referral to rehabilitation services. The intervention will be performed approximately 6 weeks after the stroke at the neurology outpatient clinics and will take approximately 60 min. The control group will receive care as usual. Both groups will be followed-up at 6 weeks, 3 months and 12 months after stroke. The primary outcome will be the level of participation measured with the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation on the level of Participation (USER-Participation-R) at 12 months. A cost-effectiveness analysis and process evaluation will be performed alongside. Discussion This trial is the first to evaluate clinical effectiveness, cost-effectiveness and implementation of screening and patient-tailored care for cognitive and emotional problems compared to care as usual in patients discharged home after ischemic stroke. Potentially, this will improve the outcomes for patients with frequently occurring cognitive and emotional problems after stroke. Trial registration Netherlands Trial Register: NL7295, registered 25 September 2018

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