Dataset Information

Community-based model for the delivery of antiretroviral therapy in Cambodia: a quasi-experimental study protocol.

ABSTRACT:

Background

Multi-month dispensing (MMD) is the mainstay mechanism for clinically stable people living with HIV in Cambodia to refill antiretroviral therapy (ART) every 3-6 months. However, less frequent ART dispensing through the community-based ART delivery (CAD) model could further reduce the clients' and health facilities' burden. While community-based services have been recognized as an integral component of HIV response in Cambodia, their role and effectiveness in ART delivery have yet to be systematically assessed. This study aims to evaluate the CAD model's effectiveness on the continuum of care and treatment outcomes for stable people living with HIV in Cambodia.

Methods

We will conduct this quasi-experimental study in 20 ART clinics across the capital city and nine provinces between May 2021 and April 2023. Study sites were purposively selected based on the availability of implementing partners, the number of people living with HIV each clinic serves, and the accessibility of the clinics. In the intervention arm, approximately 2000 stable people living with HIV will receive ART and services from the CAD model. Another 2000 stable people living with HIV in the control arm will receive MMD-a standard care model for stable people living with HIV. The primary outcomes will be retention in care, viral load suppression, and adherence to ART. The secondary endpoints will include health providers' work burden, the model's cost-effectiveness, quality of life, mental health, social support, stigma, and discrimination. We will compare the outcome indicators within each arm at baseline, midline, and endline using descriptive and inferential statistics. We will evaluate the differences between the intervention and control arms using the difference-in-differences method. We will perform economic evaluations to determine if the intervention is cost-effective.

Discussion

This study will build the evidence base for future implementation and scale-up of CAD model in Cambodia and other similar settings. Furthermore, it will strengthen engagements with community stakeholders and further improve community mobilization, a vital pillar of the Cambodian HIV response.

Trial registration

ClinicalTrials.gov, NCT04766710 . Registered 23 February 2021, Version 1.

SUBMITTER: Tuot S

PROVIDER: S-EPMC8344198 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND: The burden of cardiovascular disease is rising in sub-Saharan Africa with hypertension being the main risk factor. However, context-specific evidence on effective interventions for primary prevention of cardiovascular diseases in resource-poor settings is limited. This study aims to evaluate the feasibility and cost-effectiveness of one such intervention--the "Sustainable model for cardiovascular health by adjusting lifestyle and treatment with economic perspective in settings of urban poverty". METHODS/DESIGN: DESIGN: A prospective quasi-experimental community-based intervention study. SETTING: Two slum settlements (Korogocho and Viwandani) in Nairobi, Kenya. STUDY POPULATION: Adults aged 35 years and above in the two communities. INTERVENTION: The intervention community (Korogocho) will be exposed to an intervention package for primary prevention of cardiovascular disease that comprises awareness campaigns, household screening for cardiovascular diseases risk factors, and referral and treatment of people with high cardiovascular diseases risk at a primary health clinic. The control community (Viwandani) will continue accessing the usual standard of care for primary prevention of cardiovascular diseases in Kenya. DATA: Demographic and socioeconomic data; anthropometric and clinical measurements including blood pressure. Population-based data will be collected at the baseline and endline--12 months after implementing the intervention. These data will be collected from a random sample of 1,610 adults aged 35 years and above in the intervention and control sites at both baseline and endline. Additionally, operational (including cost) and clinic-based data will be collected on an ongoing basis. MAIN OUTCOMES: (1) A positive difference in the change in the proportion of the intervention versus control study populations that are at moderate or high risk of cardiovascular disease; (2) a difference in the change in mean systolic blood pressure in the intervention versus control study populations; (3) the net cost of the complete intervention package per disability-adjusted life year gained. ANALYSIS: Primary outcomes comparing pre- and post-, and operational data will be analyzed descriptively and "impact" of the intervention will be calculated using double-difference methods. We will also conduct a cost-effectiveness analysis of the intervention using World Health Organization guidelines. DISCUSSION: The outcomes of the study will be disseminated to local policy makers and health planners. TRIAL REGISTRATION: Current controlled trials ISRCTN84424579.

Project description:BACKGROUND:Violence against women is a well understood devastating global pandemic, and human right violation. One in three women experienced intimate partner violence worldwide. In Ethiopia, the level of domestic violence against women is one of the highest in the world. However, Ethiopia is signatory for various conventions and incorporated in legal frameworks. Nevertheless, effective implementation of the existing policy documents, and engaging different stakeholders is very limited. Therefore, we aimed to pilot feasibility of implementing available research evidence and policy documents at community level to prevent domestic violence against women in Awi zone, northwestern Ethiopia. METHODS:A community-based quasi-experimental study design will be employed using mixed method. Multistage stratified systematic sampling and purposive sampling will be used to recruit quantitative and qualitative study participants, respectively. A total of 1,269 women will be participated in the intervention, active comparator and control groups. Pre and post-test quantitative data will be collected using face-to-face interview. Qualitative data will be collected through in-depth, key informant interview and focus group discussions. INTERVENTION:advocacy meeting will be held to persuade local politicians and sustain the implementation of community based intervention to prevent domestic violence against women. Community representatives will be trained to enhance peer education to promote community awareness and engage stakeholders to transform the traditional gender norm within local context. Awareness creation and husband involvement will be made through integrating the intervention with community health extension program. Only husband involvement will not be promoted in the active comparator to test the role of husband involvement on the domestic violence prevention activities. Intervention progress will be monitored regularly. Gathered data will be entered in Epidata and exported to SPSS (23.0) software for analysis. Descriptive statistics, logistic regressions, intention to treat analysis and difference in differences will be computed. Qualitative data will be transcribed, color coded, thematically analyzed and arranged using Nvivo. DISCUSSION:This interventional study is aimed to design, pilot and translate proven research evidence, agreed conventions and country policy document to real setting implementation. We are expecting to initiate implementation of culturally acceptable intervention through engaging stakeholders. Policy makers, planners and any concerned bodies will be benefited. TRIAL REGISTRATION:ClinicalTrials.gov ID: NCT03265626.

Project description:BackgroundThe Maternal-Child Pastoral is a volunteer-based community organization of the Dominican Republic that works with families to improve child survival and development. A program that promotes key practices of maternal and child care through meetings with pregnant women and home visits to promote child growth and development was designed and implemented. This study aims to evaluate the impact of the program on nutritional status indicators of children in the first two years of age.MethodsA quasi-experimental design was used, with groups paired according to a socioeconomic index, comparing eight geographical areas of intervention with eight control areas. The intervention was carried out by lay health volunteers. Mothers in the intervention areas received home visits each month and participated in a group activity held biweekly during pregnancy and monthly after birth. The primary outcomes were length and body mass index for age. Statistical analyses were based on linear and logistic regression models.Results196 children in the intervention group and 263 in the control group were evaluated. The intervention did not show statistically significant effects on length, but point estimates found were in the desired direction: mean difference 0.21 (95%CI -0.02; 0.44) for length-for-age Z-score and OR 0.50 (95%CI 0.22; 1.10) for stunting. Significant reductions of BMI-for-age Z-score (-0.31, 95%CI -0.49; -0.12) and of BMI-for-age > 85th percentile (0.43, 95%CI 0.23; 0.77) were observed. The intervention showed positive effects in some indicators of intermediary factors such as growth monitoring, health promotion activities, micronutrient supplementation, exclusive breastfeeding and complementary feeding.ConclusionsDespite finding effect measures pointing to effects in the desired direction related to malnutrition, we could only detect a reduction in the risk of overweight attributable to the intervention. The findings related to obesity prevention may be of interest in the context of the nutritional transition. Given the size of this study, the results are encouraging and we believe a larger study is warranted.

Project description:BACKGROUND:Skilled attendance at delivery is a key marker for reducing maternal mortality. Effective community engagement strategies complemented by community health worker (CHW) services can improve access to maternal health services in areas with limited health infrastructure or workforce. METHODS:A quasi-experimental study with matched comparison groups was conducted in Cambodia, Kenya and Zambia to determine the effect of integrated community investments on skilled birth attendance (SBA). In each country, communities in two districts/sub-districts received a package of community-oriented interventions comprised of timed CHW household health promotion for maternal, newborn and child health complemented by social accountability mechanisms using community scorecards. Two matched comparison districts/sub-districts received ongoing routine interventions. Data from the final evaluation were examined to determine the effect of timed CHW services and community-oriented interventions on SBA. RESULTS:Over 80% of the 3037 women in Cambodia, 2805 women in Kenya and 1171 women in Zambia reported SBA. Women in intervention sites who received timely CHW health promotion and social accountability mechanisms in Cambodia showed significantly higher odds of SBA (aOR?=?7.48; 95% CI: 3.87, 14.5). The findings also indicated that women over the age of 24 in Cambodia, women with primary or secondary education in Cambodia and secondary education in Kenya, women from higher wealth quintiles in Cambodia, and women with four or more antenatal care (ANC) visits in all countries reported significantly higher odds of SBA. Inclusion of family members in pregnancy-related discussions in Kenya (aOR?=?2.12; 95% CI: 1.06, 4.26) and Zambia (aOR?=?6.78; 95% CI: 1.15, 13.9) and follow up CHW visits after a referral or health facility visit (aOR?=?2.44; 95% CI: 1.30, 4.60 in Cambodia; aOR?=?2.17; 95% CI 1.25, 3.75 in Kenya; aOR?=?1.89; 95% CI: 1.05, 2.02 in Zambia) also showed significantly greater odds of SBA. CONCLUSIONS:Enhancing people-centered care through culturally appropriate community-oriented strategies integrating timely CHW health promotion and social accountability mechanisms shows some evidence for improving SBA during delivery. These strategies can accelerate the achievement of the sustainable development goals for maternal child and newborn health.

Project description:BackgroundIn sub-Saharan Africa (SSA), millions of pregnant women are exposed to malaria infection. The cornerstone of the WHO strategy to prevent malaria in pregnancy in moderate to high-transmission areas is the administration of intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine at each scheduled antenatal care (ANC) visit. However, overall coverage remains low. 'Transforming IPT for Optimal Pregnancy' (TIPTOP) project aims at delivering IPTp at the community level (C-IPTp) to complement ANC provision with the goal of increasing IPTp coverage and improving maternal and infant's health. This protocol describes the approach to measure the effect of this strategy through household surveys (HHS) in four SSA countries: Democratic Republic of Congo (DRC), Madagascar, Mozambique and Nigeria.Methods and analysisA quasi-experimental evaluation has been designed. Delivery of C-IPTp will start first in one area per country, and later it will be extended to two more areas per country. HHS will be carried out before C-IPTp implementation in all study sites, at midterm in initial implementation areas, and after the implementation in all project areas. A multistage cluster sampling method will be followed for the selection of participants. Women of reproductive age who had a pregnancy that ended in the 6 or 12 months prior to the interview, depending on the survey, will be invited to participate by responding to a questionnaire. The main indicators will be coverage of three or more doses of IPTp and attendance to at least four ANC visits. A difference-in-difference analysis will be performed to evaluate the effectiveness of C-IPTp.Ethics and disseminationThe project has been reviewed by the ethics committees of WHO, Hospital Clinic of Barcelona and all project country boards. Project results will be disseminated to in-country stakeholders and at regional and international meetings. TIPTOP project aims to develop and disseminate global recommendations for C-IPTp delivery.Trial registration numberNCT03600844; Pre-results.