Clinical trial NCT05882097: Transform Randomised Control Trial in Uganda
Official title: Transform Randomised Control Trial in Uganda
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Behavior
Economic Problems
Values, Social
Keywords: values
livelihood
health
program evaluation
intervention
poverty
poverty reduction
Uganda
randomized control trial
Lead sponsor: International Care Ministries, Philippines
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 4800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a cluster-randomised controlled trial. A total of 4,800 participants from 160 communities will be randomly assigned to one of the two treatment arms: Transform and Control. The treatment will be assigned at the community level, so all participating households in a community will be in the same treatment arm. This will prevent dissemination of information and mixing of control and treatment groups among the participants.

The RCT will be rolled out in two batches. For each batch (i.e. 40 communities), a list of eligible communities will be drawn up and randomised into one of the treatment arms. To reduce the risk of bias, communities and participants will be recruited before the clusters have been randomly allocated.
Primary purpose: OTHER

Brief summary: In recent decades, the poverty rate in Uganda decreased by more than half, from 56% in 1992/1993 to 21.4% in 2019/2020. However, Uganda remains as one of the poorest countries in the world. Recognising that poverty is a multifaceted issue, International Care Ministries (ICM), a non-profit organisation, implements a program called Transform to target households living in poverty from 3 dimensions: values, livelihood and health. ICM first started the Transform program in the Philippines and recently expanded to Uganda and Guatemala. The program includes 15 sessions and delivers them to the participants during the course of a 4-month period. Previously, three randomised control trials found positive impacts of Transform on certain poverty indicators in the Philippines. Although positive impacts were found in the Philippines, the effectiveness of Transform in Uganda is unknown.

Detailed description: International Care Ministries (ICM) is a non-governmental organisation with a mission to reduce the burden of extreme poverty. ICM focused its work in the Philippines for more than 30 years and recently expanded to Uganda and Guatemala. The core poverty alleviation program at ICM is called Transform. Transform focuses on improving values, health and livelihood through a 15-week program (1 lesson per week). ICM has conducted three randomized controlled trials (RCT) in the Philippines. This RCT was designed in response to the expansion of ICM's work in Uganda. Realising the poverty issue that was exacerbated by the COVID-19 pandemic, ICM implemented its first Transform program in Uganda in 2020. As of May 2023, more than 210 communities and 5,921 participants received the Transform program in the regions of Kiboga and Kyankwanzi. Despite the fact that previous RCTs found a positive impact of Transform on certain poverty indicators in the Philippines, the effectiveness of Transform is not known in another context. The Philippines and Uganda are vastly different in terms of their economies, cultures and demographics. This study builds on the previous RCTs and aims to evaluate the Transform program on measures of economic outcomes, social capital, health, hope and spiritual well-being in a different context. Whether there will be similar results in Uganda will deepen perspectives in the universal elements of success that can be further adopted and scaled up in other countries. While a key challenge in poverty alleviation initiatives is the lack of high quality evidence to evaluate the effectiveness of programs, this study will use the gold standard of effectiveness research - RCT, to deepen understanding in the causal impact of the Transform program in another context.

Eligibility criteria: Inclusion Criteria:

1. Poverty score of 50 and above in the Philippine Poverty Score Card Survey qualifies the person into Transform. Higher score indicates poorer households.
2. Only the top 30 poorest household will be selected once the community gets approve to host the Transform program.

Exclusion Criteria:

1. Participants who are above the threshold using the poverty score card (less than 50) will be excluded from the study.
2. Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants.

Primary outcomes:
measure: Change from baseline in EuroQol-5 Dimension - 5 levels (EQ-5D-5L) at 6 and 12 months
timeFrame: Baseline, 6 and 12 months
measure: Change from baseline in poverty probability index at 6 and 12 months
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Change from baseline in duckworth index at 6 and 12 months
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: ICM Uganda
state: Kibuye
Study officials:
affiliation: University of Toronto
name: Lincoln L Lau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Owori M. Poverty in Uganda: National and regional data and trends. Development Initiatives. https://devinit. org/resources/poverty-uganda-national-and-regional-data-and-trends. 2020 Oct.
citation: Bryan G, Choi JJ, Karlan D. Randomizing religion: the impact of Protestant evangelism on economic outcomes. The Quarterly Journal of Economics. 2021 Feb;136(1):293-380.