A Mobile Intervention to link Female Entertainment Workers in Cambodia to Health and Gender-based Violence Services: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Carinne Brody ◽  
Pheak Chhoun ◽  
Sovannary Tuot ◽  
Anne E. Fehrenbacher ◽  
Alexander Moran ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Gender Based Violence ◽  
Randomized Controlled ◽  
Outreach Workers ◽  
Female Entertainment Workers ◽  
Secondary Outcomes ◽  
Gender Based ◽  
And Gender ◽  
Mobile Link

BACKGROUND Female entertainment workers (FEWs) in Cambodia experience a greater prevalence of human immunodeficiency virus (HIV), other sexually transmitted infections (STIs), psychological distress, substance use, and gender-based violence (GBV) than the general population. Reaching FEWs with health education and linking them to services has been difficult because of their hidden and stigmatized status. OBJECTIVE This study evaluates the Mobile Link intervention, aiming to improve FEWs’ health by connecting them to health services using automated twice-weekly short message services and voice messages with health information and direct links to outreach workers. METHODS The randomized controlled trial was conducted between March 2018 and June 2019. We employed a stratified random sampling method to select participants from five study sites. Initially, we randomly selected 600 participants from a list of 4000 FEWs by age group and study site using a random number generator and enrolled them in person. The primary outcome measures included self-reported HIV and STI testing, condom use, and contraceptive use, which we assessed through face-to-face structured interviews. We also measured secondary outcomes, including contact with outreach workers, escorted referral services use, forced drinking, and GBV experiences. Intervention effects were modeled using repeated measures, multilevel mixed-effects logistic regression. RESULTS We included 218 FEWs in intervention and 170 FEWs in control arms in the per-protocol analyses after 212 removing dropouts. Evidence of positive intervention effects was detected for the following secondary outcomes: contacting an outreach worker (group by time 2 AOR 3.29, 95% CI 1.28–8.47), receiving an escorted referral (group by time 2 AOR 2.86, 95% CI 1.09–7.52; group by time 3 AOR 8.15, 95% CI 1.65–40.25), and never being forced to drink at work (group by time 3 AOR 3.95, 95% CI 1.62–9.60). No significant differences between intervention and control groups over time were observed for any primary outcomes in the fully adjusted models. CONCLUSIONS The Mobile Link intervention did not show an effect on the primary outcomes but effectively connected FEWs with outreach workers and escorted referrals. Reductions in forced drinking at work were also significantly more extensive in the intervention group than the control group. Longer-term messaging may increase access to services and impact FEWs’ health outcomes in the future. CLINICALTRIAL Clinical trials.gov, NCT03117842 . Registered 31 March 2017, https://clinicaltrials.gov/ct2/show/NCT03117842?term=NCT03117842&rank=1 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-018-2614-7

scholarly journals Improving Access to Health and Gender-based Violence Services for Female Entertainment Workers in Cambodia: Findings From the Mobile Link Randomized Controlled Trial

2021 ◽  
Author(s):  
Carinne Brody ◽  
Pheak Chhoun ◽  
Sovannary Tuot ◽  
Anne E. Fehrenbacher ◽  
Alexander Moran ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Gender Based Violence ◽  
Randomized Controlled ◽  
Outreach Workers ◽  
Female Entertainment Workers ◽  
Secondary Outcomes ◽  
Gender Based ◽  
And Gender ◽  
Mobile Link

Abstract Background: Female entertainment workers (FEWs) in Cambodia experience a greater prevalence of human immunodeficiency virus (HIV), other sexually transmitted infections (STIs), psychological distress, substance use, and gender-based violence (GBV) than the general population. Reaching FEWs with health education and linking them to services has been difficult because of their hidden and stigmatized status. This study evaluates the Mobile Link intervention, aiming to improve FEWs’ health by connecting them to existing HIV, sexual and reproductive health, and GBV services using short message services and voice messages.Methods: This randomized controlled trial was conducted between March 2018 and June 2019. We employed a stratified random sampling method to select participants from five study sites. Initially, we randomly selected 600 participants from a list of 4000 FEWs by age group and study site and randomized them to intervention or standard care control arms. The primary outcome measures included self-reported HIV and STI testing, condom use, and contraceptive use. We also measured secondary outcomes, including contact with outreach workers, escorted referral services use, forced drinking, and GBV experiences. Intervention effects were modeled using repeated measures, multilevel mixed-effects logistic regression.Results: We included 218 FEWs in intervention and 170 FEWs in control arms in the per-protocol analyses after removing dropouts. Evidence of positive intervention effects was detected for the following secondary outcomes: contacting an outreach worker (group by time 2 AOR 3.29, 95% CI 1.28–8.47), receiving an escorted referral (group by time 2 AOR 2.86, 95% CI 1.09–7.52; group by time 3 AOR 8.15, 95% CI 1.65–40.25), and never being forced to drink at work (group by time 3 AOR 3.95, 95% CI 1.62–9.60). No significant differences between intervention and control groups over time were observed for any primary outcomes in the fully adjusted models.Conclusions: The Mobile Link intervention effectively connected FEWs with outreach workers and escorted referrals. Reductions in forced drinking at work were also significantly more extensive in the intervention group than the control group. Longer-term messaging may increase access to services and impact FEWs’ health outcomes in the future.Trial registration: Clinical trials.gov, NCT03117842 . Registered 31 March 2017, https://clinicaltrials.gov/ct2/show/NCT03117842?term=NCT03117842&rank=1

scholarly journals Correction to: Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Carinne Brody ◽  
Sovannary Tuot ◽  
Pheak Chhoun ◽  
Dallas Swendeman ◽  
Kathryn C. Kaplan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Reproductive Health ◽  
Study Protocol ◽  
Sexual And Reproductive Health ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Female Entertainment Workers ◽  
Mobile Link

After publication of our article [1] we became aware that several sections of text in our Methods section were copied from a previously published article [2]. We would like to formally apologize and give credit to the authors of that article [2]: Chris Smith, Uk Vannak, Ly Sokhey, Thoai D Ngo, Judy Gold, Khemrin Khut, Phil Edwards, Tung Rathavy and Caroline Free.

scholarly journals Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aaron Gazendam ◽  
◽  
Seper Ekhtiari ◽  
Nolan S. Horner ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Control ◽  
Shoulder Arthroscopy ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Standard Of Care ◽  
Opioid Prescription ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

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