Administrative information
Title {1 | Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation |
Trial registration {2a and 2b}. | Registry for International Development Impact Evaluations, RIDIE-STUDY-ID-626008898983a on (20/04/22). ISRCTN registry, ISRCTN 78592382. Retrospectively registered on 17/08/2023, https://www.isrctn.com/ISRCTN78592382. |
Protocol version {3} | Version 2 (24/08/2020) |
Funding {4} | The study is funded by the United Kingdom Foreign, Commonwealth and Development Office (FCDO) under the Programme for Evidence to Inform Disability Action (PENDA) (IATI Identifier: GB-EDU-133903-PENDA). Hannah Kuper is funded by a National Institute for Health and Care Research (NIHR) Global Research Professorship. Intervention implementation is conducted under a separate project led by BRAC Uganda, in partnership with Humanity and Inclusion (HI) and the National Union of Women with Disability in Uganda (NUWODU), with funding from FCDO under Inclusive Futures, Comic Relief and National Lottery. |
Author details {5a} | Elijah Kipchumba[1,2]* & Calum Davey[3,4]* (joint first), Sarah Marks[3], Anthony Mugeere[5], Shanquan Chen[3], Lena Morgon Banks[3], Kazi Eliza Islam[6], Tom Shakespeare[3], Hannah Kuper[3]✉* & Munshi Sulaiman[7]* (joint last) *These authors contributed equally to this work ✉Corresponding author [1]Independent Evaluation and Research Cell (IERC), BRAC International, Kampala, Uganda; [2]Trinity College Dublin, Dublin, Ireland; [3]International Centre for Evidence in Disability, London School of Hygiene & Tropical Medicine, London, United Kingdom; [4]Centre for Evaluation, London School of Hygiene & Tropical Medicine, London, United Kingdom; [5]Department of Sociology and Anthropology, Makerere University, Kampala, Uganda; [6]BRAC International, Dhaka, Bangladesh; [7]BRAC Institute of Governance and Development, BRAC University, Dhaka, Bangladesh. |
Name and contact information for the trial sponsor {5b} | BRAC Uganda Plot 880, Heritage Road, Nsambya P.O: Box 31817 (Clock Tower), Kampala, Uganda T: + 256 (0) 714 274201, + 256 (0) 700861747 E: bracuganda@brac.net |
Role of sponsor {5c} | Study sponsor, BRAC Uganda, is involved in the study design; collection, management, analysis, and interpretation of data; and writing of the report. Ultimate authority regarding study design and decision to submit the report for publication lies with LSHTM. The funders are not involved in any decision making with regard to the study design, implementation, analysis or publications. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Visit | (1) Screening | (2) Verification | RANDOMISATION | (3) Baseline | DIG Programme Implementation | (4) Endline 1 (Participants with disabilities) | (5) Process Evaluation | (6) Endline 2 (All participants) | ||
Timepoint | July 2020 | August 2020 | November 2020 | (December 2020-June 2022) | July 2022 | January–February 2023 | October 2023 | |||
1–6 months | 6–12 months | 12–18 months | ||||||||
Conducted by | BRAC Uganda | BRAC Uganda | BIGD | BRAC Uganda | BRAC Uganda | BRAC Uganda | BIGD | Makerere University | BIGD | |
Activities | □ Household survey to screen for eligibility | □ Verification of ultra-poor households □ Identification of project participants | □ Informed consent of respondents □ Household survey with female head of household and person with disabilities (if not female head of household) | □ Training □ Asset transfer □ One-to-one follow-up and supervision □ Social development and health services support □ Expenditure support: a regular transfer of cash | □ Training □ Further asset transfer □ One-to-one follow-up and supervision □ Group formation □ Village savings and loans groups □ Informal group discussions □ Social development and health services support □ Compliance survey via phone with female head of household in intervention arm (with informed consent) | □ Training □ Individual follow-up □ Group discussion □ Confidence-building training □ Social development and health services support □ Formal weekly meetings □ Loan activities □ Savings activities □ Monthly group-level follow-up | □ Informed consent of respondents □ Household survey with female head of household and person with disabilities (if not female head of household). Limited to just households with a person with disabilities | □ Informed consent of respondents □ Semi-structured interviews with programme beneficiaries and key informants | □ Informed consent of respondents □ Household survey with female head of household and person with disabilities (if not female head of household) |
Sample size {14}
Recruitment {15}
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Stage 1: Selection of potentially eligible households. BRAC Uganda screens households in villages near to their branch offices in the target districts. Eligible households are identified based on the eligibility criteria, as earlier described.
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Stage 2: Verification of eligibility. Verification is completed by the project manager of the DIG programme. The project manager confirms that households meet the eligibility criteria, as earlier described.
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
District | BRAC Branch | Number of Households | ||
---|---|---|---|---|
Control Arm | Intervention Arm | Total | ||
Gulu | Gulu | 367 | 355 | 722 |
Lacor | 288 | 340 | 628 | |
Goma | 280 | 406 | 686 | |
Nwoya | Anaka | 366 | 370 | 736 |
Oyam | Minakulu | 324 | 402 | 726 |
Kamdini | 285 | 357 | 642 | |
Loro | 263 | 311 | 574 | |
Kiryandongo | Kigumba | 229 | 357 | 586 |
Total | 2402 | 2898 | 5300 |
Assignment of interventions: masking
Who will be masked {17a}
Procedure for unmasking if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Female head of household | Person with disability |
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□ Identification and household characteristics □ Household welfare and assets □ Household expenditure □ Household agriculture, livelihoods, and other income-generating activities □ Household loans and savings □ Household use of assistance □ Food security □ Vulnerability to shocks □ Health of household members | □ Self-rated health / perceived well-being; self-stigma/negative attitudes □ Quality of life □ Household decision making □ Participation □ Attitudes & behaviour of others □ Environmental factors □ Personal assistance and assistive devices |