Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.

BACKGROUND: The World Health Organization has yet to endorse deployment of topical repellents for malaria prevention as part of public health campaigns. We aimed to quantify the effectiveness of repellent distributed by the village health volunteer (VHV) network in the Greater Mekong Subregion (GMS) in reducing malaria in order to advance regional malaria elimination. METHODS AND FINDINGS: Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks) to test the effectiveness of 12% N,N-diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp. infection. The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40%). No adverse events were reported during the study. Generalised linear mixed modelling estimated the effect of repellent on infection detected by rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR) (secondary outcome). Overall Plasmodium infection detected by RDT was low (0.16%; 50/32,194), but infection detected by PCR was higher (3%; 419/13,157). There was no significant protection against RDT-detectable infection (adjusted odds ratio [AOR] = 0.25, 95% CI 0.004-15.2, p = 0.512). In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233). Repellent effects were similar when delayed effects were modelled, across risk groups, and regardless of village-level and temporal heterogeneity in malaria prevalence. The incremental cost-effectiveness ratio was US$256 per PCR-detectable infection averted. Study limitations were a lower than expected Plasmodium spp. infection rate and potential geographic dilution of the intervention. CONCLUSIONS: In this study, we observed apparent protection against new infections associated with the large-scale distribution of repellent by VHVs. Incorporation of repellent into national strategies, particularly in areas where bed nets are less effective, may contribute to the interruption of malaria transmission. Further studies are warranted across different transmission settings and populations, from the GMS and beyond, to inform WHO public health policy on the deployment of topical repellents for malaria prevention. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482).

Effectiveness of repellent delivered through village health volunteers on malaria incidence in villages in South-East Myanmar: a stepped-wedge cluster-randomised controlled trial protocol.

BACKGROUND: To combat emerging drug resistance in the Greater Mekong Sub-region (GMS) the World Health Organization and GMS countries have committed to eliminating malaria in the region by 2030. The overall approach includes providing universal access to diagnosis and treatment of malaria, and sustainable preventive measures, including vector control. Topical repellents are an intervention that can be used to target residual malaria transmission not covered by long lasting insecticide nets and indoor residual spraying. Although there is strong evidence that topical repellents protect against mosquito bites, evidence is not well established for the effectiveness of repellents distributed as part of malaria control activities in protecting against episodes of malaria. A common approach to deliver malaria services is to assign Village Health Volunteers (VHVs) to villages, particularly where limited or no services exist. The proposed trial aims to provide evidence for the effectiveness of repellent distributed through VHVs in reducing malaria. METHODS: The study is an open stepped-wedge cluster-randomised controlled trial randomised at the village level. Using this approach, repellent (N,N-diethyl-benzamide - 12% w/w, cream) is distributed by VHVs in villages sequentially throughout the malaria transmission season. Villages will be grouped into blocks, with blocks transitioned monthly from control (no repellent) to intervention states (to receive repellent) across 14 monthly intervals in random order). This follows a 4-week baseline period where all villages do not receive repellent. The primary endpoint is defined as the number of individuals positive for Plasmodium falciparum and Plasmodium vivax infections diagnosed by a rapid diagnostic test. Secondary endpoints include symptomatic malaria, Polymerase Chain Reaction (PCR)-detectable Plasmodium spp. infections, molecular markers of drug resistance and antibodies specific for Plasmodium spp. parasites. DISCUSSION: This study has been approved by relevant institutional ethics committees in Myanmar and Australia. Results will be disseminated through workshops, conferences and peer-reviewed publications. Findings will contribute to a better understanding of the optimal distribution mechanisms of repellent, context specific effectiveness and inform policy makers and implementers of malaria elimination programs in the GMS. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ( ACTRN12616001434482 ). Retrospectively registered 14th October 2016.

Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program.

BACKGROUND: India currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at 'high risk' of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India. METHODS/DESIGN: A total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30-60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned. DISCUSSION: Results from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

Strengthening Noncommunicable Disease Research Capacity and Chronic Disease Outcomes in Low- and Middle-Income Countries in South Asia: Implementation and Evaluation of the ASCEND Program.

This article describes the design, outcomes, challenges, and lessons learned from the ASian Collaboration for Excellence in Non-Communicable Disease (ASCEND) program, implemented between 2011 and 2015 in India, Sri Lanka, and Malaysia. The program involved a blended-delivery model, incorporating online and face-to-face training, mentoring, and supervision of trainees' research projects. Evaluation data were collected at baseline, 6, 12, 18, and 24 months. Intended outcomes, lessons, and challenges were summarized using a logic model. During the program period, 48 participants were trained over 2 cohorts in June 2011 and 2012. The trainees published 83 peer-reviewed articles between 2011 and 2015. Additionally, 154 presentations were given by trainees at national and international conferences. Underutilization of the online learning management system was an important challenge. Utilizing a combination of intensive face-to-face and online learning and mentoring of early career researchers in low- and middle-income countries has great potential to enhance the research capacity, performance, and outputs.

A scoping review of non-communicable disease research capacity strengthening initiatives in low and middle-income countries.

INTRODUCTION: As the epidemic of non-communicable diseases (NCDs) is rapidly developing in low and middle-income countries (LMICs), the importance of local research capacity and the role of contextually relevant research in informing policy and practice is of paramount importance. In this regard, initiatives in research capacity strengthening (RCS) are very important. The aim of this study was to review and summarize NCD research capacity strengthening strategies that have been undertaken in LMICs. METHODS: Using both systematic and other literature search, we identified and reviewed NCD-RCS initiatives that have been implemented in LMICs and reported since 2000. Information was extracted from published papers and websites related to these initiatives using a semi-structured checklist. We extracted information on program design, stakeholders involved, and countries of focus, program duration, targeted researchers, disease focus, skill/capacity areas involved and sources of funding. The extracted information was refined through further review and then underwent a textual narrative synthesis. RESULTS: We identified a number of different strategies used by research capacity strengthening programs and in the majority of initiatives, a combination of approaches was utilized. Capacity strengthening and training approaches were variously adapted locally and tailored to fit with the identified needs of the targeted researchers and health professionals. Most initiatives focused on individual level capacity and not system level capacity, although some undoubtedly benefited the research and health systems of LMICs. For most initiatives, mid-term and long-term outcomes were not evaluated. Though these initiatives might have enhanced research capacity in the immediate term, the sustainability of the results in the long-term remains unknown. CONCLUSION: Most of NCD-RCS initiatives in LMICs focused on building individual capacity and only a few focused explicitly on institutional level capacity strengthening. Though many of the initiatives appear to have had promising short-term outcomes, evidence on their long-term impact and sustainability is lacking.

Relationship between self-efficacy and HIV testing uptake among young men who have sex with men in Myanmar: a cross-sectional analysis.

Men who have sex with men (MSM) are disproportionally affected by the HIV epidemic. Self-efficacy is an important individual psychosocial factor associated with access to and use of health and HIV-related services. We estimated HIV testing prevalence and examined the relationship between HIV testing self-efficacy and self-reported HIV testing behavior among young MSM (YMSM) in Myanmar. We enrolled 585 MSM aged 18-24 years from six urban areas using respondent-driven sampling (RDS) technique. RDS analyses were performed to provide estimates for the key outcome of interest. More than a third (34.5%) had never been tested for HIV, whereas 27.5% and 38.0% had their most recent HIV test more than three months and within the past three months from the time of interview, respectively. Young MSM who reported high self-efficacy (adjusted relative risk ratio [ARR]=7.35, 95%CI = 2.29-23.5) and moderate self-efficacy (ARR = 8.61, 95%CI = 3.09-24.0) were more likely to report having tested for HIV in the past three months compared to their counterparts who reported low self-efficacy. Findings highlight a positive association between self-efficacy and HIV testing uptake, indicating a potential causal relationship. Further research is needed to examine the direction of this association and inform future public health interventions targeting YMSM in Myanmar.

Communicative satisfaction of male-to-female transsexuals.

The aim of this qualitative study was to gain an understanding of the way male-to-female transsexuals perceived their communication and their satisfaction with it in different aspects of their lives. Three focus groups were conducted for the purposes of this study, each consisting of four participants. The transcribed dialogues of the groups were analysed using a grounded theory approach to find the common underlying themes. These then formed the basis of the five major categories that identified key themes relating to transsexuals' communicative satisfaction: communicative situations, emotions, groups of people, other contributing factors, and features of communication. The results revealed that although participants commented on the situations and contexts in which they experienced decreased communicative satisfaction, it was not always important to them to maintain their female communicative patterns in situations in which they felt comfortable. These five categories guided the development of a two-part pilot Functional Communicative Satisfaction Questionnaire (FCSQ). The FCSQ explores a variety of situations that the participants identified as impacting on their communicative satisfaction. Further development of the FCSQ is likely to enable speech pathologists to have a more informed approach to the management of this population.

Measuring individual-level needle and syringe coverage among people who inject drugs in Myanmar.

BACKGROUND: Myanmar has prioritised people who inject drugs (PWID) as a key population for HIV mitigation efforts, with targets for needle and syringe distribution set at a population level. However, individual-level coverage, defined as the percentage of an individual's injecting episodes covered by a sterile syringe, is a more sensitive measure of intervention coverage. We sought to examine individual-level coverage in a sample of PWID in Myanmar. METHODS: We recruited 512 PWID through urban drop-in-centres in Yangon, Mandalay and Pyin Oo Lwin. Participants were administered a quantitative questionnaire covering five domains: demographics, drug use, treatment and coverage, and injecting risk behaviour. We calculated past fortnight individual-level syringe coverage, estimating levels of sufficient (≥100% of injecting episodes covered by a sterile syringe) and insufficient (<100%) coverage, and examined associations between key variables and insufficient coverage via logistic regression. RESULTS: Our sample was predominately male (97%), employed (76%), and living in stable accommodation (96%), with a median age of 27. All participants reported heroin as the drug most frequently injected, and injected a median of 27 times in the past two weeks. Nineteen per cent of participants had insufficient coverage in the two weeks before interview. Insufficient coverage was positively associated with syringe re-use (AOR: 5.19, 95% CIs: 2.57, 10.48) and acquiring sterile syringes from a location other than a formal drop-in-centre (AOR: 2.04, 95% CIs: 1.08, 3.82). Participants recruited in Mandalay (AOR: 0.30, 95% CIs: 0.11, 0.80) and Pyin Oo Lwin (AOR: 0.39, 95% CIs: 0.18, 0.87) had lower odds of insufficient coverage than those recruited in Yangon. CONCLUSION: Our study shows coverage in selected areas of Myanmar was comparable with studies in other countries. Our results inform the delivery of harm reduction services for PWID, specifically by encouraging the use of formal drop-in-centres, over other sources of syringe distribution, such as pharmacies.

Factors associated with HIV testing among young men who have sex with men in Myanmar: a cross-sectional study.

INTRODUCTION: In Myanmar, men who have sex with men (MSM) experience high risk of HIV infection. However, access to HIV testing and prevention services remains a challenge among this marginalized population. The objective of this study was to estimate population prevalence and correlates of prior HIV testing among young MSM (YMSM) and informs the development of HIV testing and intervention programmes that respond to the specific needs of this population. METHODS: Five hundred and eighty-five YMSM aged 18 to 24 years were recruited using respondent-driven sampling (RDS) in a cross-sectional survey conducted in six townships of Myanmar. RDS-adjusted population estimates were calculated to estimate prevalence of HIV testing; RDS-weighted logistic regression was used to examine correlates of HIV testing in the past 6 months and in a lifetime. RESULTS: There were 12 participants who reported receiving a HIV-positive test; of those, five were tested in the past 6 months. The RDS-weighted prevalence estimates of lifetime (any prior) HIV testing was 60.6% (95% CI: 53.3% to 66.4%) and of recent (≤ 6 months) HIV testing was 50.1% (95% CI: 44.1% to 55.5%). In multivariable analysis, sexual identity was associated with lifetime but not recent HIV testing. Lifetime and recent HIV testing were associated with having three or more male sexual partners in the past 12 months (adjusted ORs (aORs) = 2.28, 95% CIs: 1.21 to 4.32 and 2.69, 95% CI: 1.59 to 4.56), having good HIV-related knowledge (aORs = 1.96, 95% CIs: 1.11 to 3.44 and 1.77, 95% CI: 1.08 to 2.89), reporting high HIV testing self-efficacy (aORs = 13.5, 95% CIs: 6.0 to 30.1 and 9.81, 95% CI: 4.27 to 22.6) and having access to and use of non-HIV health-related services in the past 12 months (aORs = 13.2, 95% CIs: 6.85 to 25.6 and 7.15, 95% CI: 4.08 to 12.5) respectively. CONCLUSIONS: HIV testing coverage among YMSM aged 18 to 24 years old in Myanmar is still suboptimal. Integrated HIV testing and prevention services in existing health service provision systems with tailored HIV information and education programmes targeting YMSM to improve HIV-related knowledge and self-efficacy may help to promote regular HIV testing behaviour and contribute to sustainable control of the HIV epidemic among this marginalized population in Myanmar.

Effectiveness of an Integrated Community- and Clinic-Based Intervention on HIV Testing, HIV Knowledge, and Sexual Risk Behavior of Young Men Who Have Sex With Men in Myanmar.

PURPOSE: Young men who have sex with men (YMSM) in Myanmar are disproportionately affected by HIV, with prevalence five times that of the general population. The Link Up project implemented an intervention using peer education and outreach providing education and counseling on health seeking around sexually transmitted infections and reproductive health, combined with focused clinic capacity building to improve the sexual and reproductive health of YMSM. This study aimed to evaluate the effectiveness and acceptability of the intervention. METHODS: Using a mixed-methods approach, and employing a quasi-experimental design, we conducted two quantitative repeat cross-sectional surveys in purposively selected control (no intervention) and intervention townships, before and after implementation of the Link Up intervention. Respondent-driven sampling was used to recruit YMSM aged 15-24 years, and study participants were administered a structured questionnaire assessing intervention exposure, health service access, knowledge of HIV, and sexual risk behavior. Focus group discussions were held to elicit perspectives on the use and acceptability of the health services and peer outreach. RESULTS: At baseline, 314 YMSM were recruited in the intervention townships and 309 YMSM in the control townships. At end line, 267 (intervention) and 318 (control) YMSM were recruited. Coverage of the program was relatively low, with one-third of participants in the intervention townships having heard of the Link Up program by the end line. Comparing changes between baseline and end line, a greater proportion of HIV-negative or unknown status YMSM accessed HIV testing in the past 3 months in intervention townships (from 45.0% to 57.1%) compared with those in control townships (remained at 29.0%); however, this difference in the effect over time was not statistically significant in multivariate modeling (adjusted odds ratio: 1.45; 95% confidence interval: .66-3.17). Qualitative findings showed that the intervention was acceptable to YMSM. CONCLUSIONS: Overall, the intervention was perceived as acceptable. Although not statistically significant, results showed some trends toward improvements among YMSM in accessing HIV testing services and HIV-related knowledge. The modest coverage and short time frame of the evaluation likely limits the ability for any significant behavioral improvements.